Migard 2.5mg Film-coated tablets

(frovatriptan succinate)

Patient Information Leaflet

Ref: LTT0121 /250216/1 /F

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

*    Keep this leaflet. You may need to read it again.

*    If you have any further questions, ask your doctor or pharmacist.

*    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

*    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

What Migard is and what it is used for ^ What you need to know before you take Migard ,3 How to take Migard Possible side effects How to store Migard

_l6 j Contents of the pack and other information

^ What Migard is and what is it used for

Migard 2.5 mg tablets contain frovatriptan, an anti-migraine treatment belonging to the class of triptans (5-hydroxytryptamine (5HT1) selective receptor agonists). Migard 2.5 mg tablets is a medicine for the treatment of the headache phase of a migraine attack with or without aura (a temporary strange feeling before a migraine, which varies from person to person but can affect, for example, vision, smell, hearing).

Migard 2.5 mg tablets should not be used to prevent a migraine attack.

Migard is used to treat migraine attacks in adults.

^ What you need to know before you take Migard

The diagnosis of migraine must have been clearly established by your doctor

Do not take Migard

*    If you are allergic to frovatriptan or any of the other ingredients of this medicine (listed in section 6.1).

_*    if you have had a heart attack, or suffer or have suffered from certain cardiovascular diseases such as angina pectoris (characterised by crushing pain in the chest which can extend into the left arm), or circulation disorders of the legs or arms (especially in the fingers and toes),

*    if you have had a stroke or a transient ischaemic attack (TIA),

_*    if you have severely or moderately high blood pressure, or if your blood pressure is not adequately controlled,

_*    if you have severe liver disease,

_*    in combination with certain other medicines also used in the treatment of migraine (ergotamine and ergotamine derivatives (including methysergide) or other triptans (5-hydroxytryptamine (5HT1) agonists).

Warning and precautions

Talk to your doctor before taking Migard:

if you are a patient at risk of coronary artery disease, including if:

_*    you are a heavy smoker or a user of nicotine substitution therapy

_*    you are a post-menopausal female or a male aged over 40 years

Stop taking Migard and talk to your doctor right away if you:

_*    experience a feeling of tightness or pain in the chest, shortness of breath and/or pain or discomfort in one or both arms, your back, shoulders, neck, jaw, or upper part of the stomach; these might be symptoms of a heart attack, which can occur when taking triptans, even in patients with no history of cardio-vascular disease (see also section 4).

*    have generalized skin rash and itching, rapid-onset swelling (especially around the lips, eyes, or of the tongue), with possible sudden difficulty in breathing and a fast heartbeat and thumping heart. These are all symptoms and signs of allergy and whole-body hypersensitivity reaction (see also section 4).

Children and adolescents

Do not give this medicine to children and adolescents (under 18 years of

age) because the safety and efficacy of Migard have not been established in

these groups.

Other medicines and Migard

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

You should not take this medicine at the same time as certain other medicines used for the treatment of migraine:

*    especially ergotamine, ergotamine derivatives (including methysergide); you should allow at least 24 hours to elapse between the discontinuation of these medicines and the administration of Migard 2.5 mg tablets. Similarly, you should not take these medicines within 24 hours following a dose of Migard 2.5 mg tablets.

*    especially other triptans (5-HT1 agonists, such as sumatriptan, almotriptan, eletriptan, naratriptan, rizatriptan or zolmitriptan).

Unless otherwise directed by your doctor, you should not take this medicine at the same time as monoamine oxidase inhibitor (MAOI) medicines used in the treatment of depression (phenelzine, isocarboxazid, tranylcypromine, moclobemide).

_*    you should also tell your doctor or pharmacist if you are taking oral contraceptives or selective serotonin-reuptake inhibitors (citalopram, fluoxetine, fluvoxamine, paroxetine, sertraline).

It is recommended that you do not take Migard 2.5 mg tablets at the same time as taking St. John's Wort (hypericum perforatum).

Concomitant use of Migard with the medicines listed above (especially monoamine oxidase inhibitors, selective serotonin-reuptake inhibitors and hypericum perforatum) may also increase the risk of serotonin syndrome (the symptoms of serotonin syndrome include: shivering, sweating, agitation, trembling and abrupt contraction of muscles, nausea, fever, confusion).

If you have any doubt about taking other medicines with Migard 2.5 mg tablets, consult your doctor or pharmacist.

Migard with food and drink

Migard 2.5 mg tablets can be taken with food or on an empty stomach, always with an adequate amount of water.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Migard 2.5 mg tablets should not be used during pregnancy or when breast feeding, unless you are told so by your doctor. In any case, you should not breastfeed for 24 hours after taking Migard and during this time any breast milk expressed should be discarded.

Driving and using machines

Migard 2.5 mg tablets and the migraine itself can cause drowsiness. If affected, driving or operating machinery can be dangerous and should be avoided.

Migard contains lactose

This product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to take Migard

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

Take Migard 2.5 mg tablets as early as possible after the onset of the migraine headache. Swallow one tablet whole with water.

If the first dose does not give you any relief, do not take a second dose during the same attack. You can use Migard 2.5 mg tablet for any following attacks. If you obtain relief after the first dose, but later on suffer from the re-appearance of a headache within 24 hours, you can take a second dose provided that at least 2 hours have elapsed between the 2 doses.

Do not exceed the maximum dose of 5 mg (two tablets) in 24 hours.

Excessive use (repeated use over several consecutive days) of Migard 2.5 mg tablets constitutes incorrect use of this medicine and may cause an increase in side effects and lead to chronic daily headaches requiring the temporary discontinuation of treatment. Consult your doctor if you start having too frequent or daily headaches as you may be suffering from medication overuse headache.

Use in children and adolescents

Migard should not be used in patients under 18 years of age.

Older people

As there is little experience in patients over 65 years, the use of MIGARD is not recommended in patients in this age group.

If you take more Migard than you should

If you accidentally take an overdose of this medicine, tell your doctor or pharmacist immediately or go to the emergency department of your nearest hospital. Please remember to take the remaining tablets or this leaflet with you.

Patient Information Leaflet (continued)

If you stop taking Migard

No special precautions are necessary when stopping the drug.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Migard and tell your doctor right away if you experience any of the following symptoms:

_*    a feeling of tightness or pain in the chest, shortness of breath and/or pain or discomfort in one or both arms, your back, shoulders, neck, jaw, or upper part of the stomach; these might be symptoms of a heart attack (myocardial infarction), which can occur when taking triptans, even

in patients with no history of cardio-vascular disease;

*    have generalized skin rash and itching, rapid-onset swelling (especially around the lips, eyes, or of the tongue and mucosa), with possible sudden difficulty in breathing and a fast heartbeat and thumping heart. These are all symptoms and signs of allergy and whole-body hypersensitivity reaction (hypersensitivity reactions, angioedema, anaphylaxis).

The side-effects reported with Migard 2.5 mg tablets were temporary, generally mild to moderate and disappeared spontaneously. Some symptoms reported may be caused by the migraine itself.

The following side-effects were commonly observed (estimated frequency is more than 1 person out of 100 and less than 1 person out of 10):

*    nausea (feeling sick), dry mouth, digestion problems, stomach pain,

*    fatigue, chest discomfort (sensation of slight heaviness, pressure or tightness in the chest),

*    headache, dizziness, sensation of pins and needles, most frequently in the arms and legs, reduction or disturbance of the sensations of touch, extreme sleepiness,

*    hot flushes,

*    tightness in the throat,

*    sight disturbances,

*    increased sweating.

The following were uncommonly observed (estimated frequency is more than 1 person out of 1000 and less than 1 person out of 100):

_*    altered sense of taste, trembling, poor concentration, lethargy, increased sensation of touch, drowsiness, involuntary muscle contractions,

_*    diarrhoea, difficulty in swallowing, gas in stomach or bowel, stomach discomfort, bloated stomach,

_*    awareness of heart beat (palpitations), fast heart beat, high blood pressure, chest pain (intense tightness or feeling of pressure in the chest),

_*    feeling hot, reduced tolerance of heat and cold, pain, weakness, thirst, sluggishness, increased energy, generally feeling unwell, sensation of spinning,

_*    anxiety, inability to sleep, confusion, nervousness, agitation, depression, loss of sense of personal identity,

_*    coldness in the hands and feet,

_*    irritation of the nose, inflamed sinus, sore throat and/or voice box,

_*    muscle stiffness, muscle and bone pain, pain in the hands and feet, back pain, painful joints,

_*    eye pain, eye irritation, painful oversensitivity to light,

_*    itchiness,

_*    ringing in the ears, earache,

_*    dehydration,

_*    passing urine frequently, production of large amounts of urine.

The following were rare (estimated frequency is more than 1 person out of

10,000 and less than 1 person out of 1000):

_*    muscle spasm, floppy muscles, diminution of reflexes (hyporeflexia), movement problems,

_*    constipation, burping, heartburn, irritable bowel syndrome, lip blisters, lip pain, spasm of the gullet, blisters in the mouth, ulcer in the stomach or upper part of the small intestine, pain in the salivary gland, inflammation of the mouth, toothache,

_*    fever,

_*    loss of memory, abnormal dreams, personality disorder,

_*    nosebleed, hiccups, overbreathing, breathing disorder, irritation in the throat,

_*    night blindness,

_*    skin reddening, sensation of hairs standing on end, purplish spots or patches on skin and mucous surfaces of the body, hives,

_*    slow heart beat,

*    ear discomfort, earorder, ear itchiness, sensitive hearing,

*    increase in bilirubin (a substance produced by the liver) in the blood, decrease of calcium in the blood, abnormal urine analysis,

*    low sugar in the blood,

*    passing urine frequently at night, pain in the kidneys,

*    self-inflicted injury (eg bite or bruising),

*    swollen lymph nodes,

*    breast pain or discomfort.

Although the frequency cannot be estimated from the available data, the following events were also reported:

*    allergic reactions (hypersensitivity) including generalized skin rash and itching, rapid-onset swelling (especially around the lips, eyes, or of the tongue), with possible sudden difficulty in breathing, that can be associated with fast heartbeat and thumping heart (anaphylaxis),

*    heart attack (myocardial infarction),

*    chest discomfort or pain that is caused by a temporary spasm (constriction) in your coronary arteries (the blood vessels that bring oxygen and nutrients to your heart, i.e. coronary artery spasm).

Reporting of side effects

If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme

at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

[5) How to store Migard

Do not use Migard 2.5 mg tablets after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Do not store above 30°C.

Store in the original package.

Keep out of the sight and reach of children

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

[£) Contents of the pack and other information

What Migard contains:

The active substance is 2.5 mg of frovatriptan as succinate monohydrate per tablet. The other ingredients are: anhydrous lactose, microcrystalline cellulose, magnesium stearate, sodium starch glycollate (type A), silica colloidal anhydrous. Film coating: OPADRY white: titanium dioxide (E171), anhydrous lactose, hypromellose (E464), macrogol 3000, triacetin.

What Migard looks like and contents of the pack

Migard 2.5 mg tablets are round biconvex white film-coated tablets, debossed with "m" on one side and "2.5" on the other.

Each blister pack contains 6 tablets.

Manufacturer and Licence Holder

This medicine is manufactured by, Almac Pharma Services Limited, Almac House, 20 Seagoe Industrial Estate, Craigavon, Co Armagh, Northern Ireland, BT63 5UA. Procured from within the EU. Product Licence Holder: LTT Pharma Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE. Repackaged by Lexon (UK) Limited, B98 0RE.

If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.

POM PL 33723/0121 Migard 2.5mg Film-coated tablets. Migard is a registered trademark of Vernalis Development Limited. Revision date: 25/02/16

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited, Tel: 01527 505414 for help.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

*    Keep this leaflet. You may need to read it again.

*    If you have any further questions, ask your doctor or pharmacist.

*    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

*    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

What Migard is and what it is used for ^ What you need to know before you take Migard ,3 How to take Migard Possible side effects How to store Migard

_l6 j Contents of the pack and other information

^ What Migard is and what is it used for

Migard 2.5 mg tablets contain frovatriptan, an anti-migraine treatment belonging to the class of triptans (5-hydroxytryptamine (5HT1) selective receptor agonists). Migard 2.5 mg tablets is a medicine for the treatment of the headache phase of a migraine attack with or without aura (a temporary strange feeling before a migraine, which varies from person to person but can affect, for example, vision, smell, hearing).

Migard 2.5 mg tablets should not be used to prevent a migraine attack.

Migard is used to treat migraine attacks in adults.

^ What you need to know before you take Migard

The diagnosis of migraine must have been clearly established by your doctor

Do not take Migard

*    If you are allergic to frovatriptan or any of the other ingredients of this medicine (listed in section 6.1).

_*    if you have had a heart attack, or suffer or have suffered from certain cardiovascular diseases such as angina pectoris (characterised by crushing pain in the chest which can extend into the left arm), or circulation disorders of the legs or arms (especially in the fingers and toes),

*    if you have had a stroke or a transient ischaemic attack (TIA),

_*    if you have severely or moderately high blood pressure, or if your blood pressure is not adequately controlled,

_*    if you have severe liver disease,

_*    in combination with certain other medicines also used in the treatment of migraine (ergotamine and ergotamine derivatives (including methysergide) or other triptans (5-hydroxytryptamine (5HT1) agonists).

Warning and precautions

Talk to your doctor before taking Migard:

if you are a patient at risk of coronary artery disease, including if:

_*    you are a heavy smoker or a user of nicotine substitution therapy

_*    you are a post-menopausal female or a male aged over 40 years

Stop taking Migard and talk to your doctor right away if you:

_*    experience a feeling of tightness or pain in the chest, shortness of breath and/or pain or discomfort in one or both arms, your back, shoulders, neck, jaw, or upper part of the stomach; these might be symptoms of a heart attack, which can occur when taking triptans, even in patients with no history of cardio-vascular disease (see also section 4).

*    have generalized skin rash and itching, rapid-onset swelling (especially around the lips, eyes, or of the tongue), with possible sudden difficulty in breathing and a fast heartbeat and thumping heart. These are all symptoms and signs of allergy and whole-body hypersensitivity reaction (see also section 4).

Children and adolescents

Do not give this medicine to children and adolescents (under 18 years of

age) because the safety and efficacy of Migard have not been established in

these groups.

Other medicines and Migard

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

You should not take this medicine at the same time as certain other medicines used for the treatment of migraine:

*    especially ergotamine, ergotamine derivatives (including methysergide); you should allow at least 24 hours to elapse between the discontinuation of these medicines and the administration of Migard 2.5 mg tablets. Similarly, you should not take these medicines within 24 hours following a dose of Migard 2.5 mg tablets.

*    especially other triptans (5-HT1 agonists, such as sumatriptan, almotriptan, eletriptan, naratriptan, rizatriptan or zolmitriptan).

Unless otherwise directed by your doctor, you should not take this medicine at the same time as monoamine oxidase inhibitor (MAOI) medicines used in the treatment of depression (phenelzine, isocarboxazid, tranylcypromine, moclobemide).

_*    you should also tell your doctor or pharmacist if you are taking oral contraceptives or selective serotonin-reuptake inhibitors (citalopram, fluoxetine, fluvoxamine, paroxetine, sertraline).

It is recommended that you do not take Migard 2.5 mg tablets at the same time as taking St. John's Wort (hypericum perforatum).

Concomitant use of Migard with the medicines listed above (especially monoamine oxidase inhibitors, selective serotonin-reuptake inhibitors and hypericum perforatum) may also increase the risk of serotonin syndrome (the symptoms of serotonin syndrome include: shivering, sweating, agitation, trembling and abrupt contraction of muscles, nausea, fever, confusion).

If you have any doubt about taking other medicines with Migard 2.5 mg tablets, consult your doctor or pharmacist.

Migard with food and drink

Migard 2.5 mg tablets can be taken with food or on an empty stomach, always with an adequate amount of water.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Migard 2.5 mg tablets should not be used during pregnancy or when breast feeding, unless you are told so by your doctor. In any case, you should not breastfeed for 24 hours after taking Migard and during this time any breast milk expressed should be discarded.

Driving and using machines

Migard 2.5 mg tablets and the migraine itself can cause drowsiness. If affected, driving or operating machinery can be dangerous and should be avoided.

Migard contains lactose

This product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to take Migard

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

Take Migard 2.5 mg tablets as early as possible after the onset of the migraine headache. Swallow one tablet whole with water.

If the first dose does not give you any relief, do not take a second dose during the same attack. You can use Migard 2.5 mg tablet for any following attacks. If you obtain relief after the first dose, but later on suffer from the re-appearance of a headache within 24 hours, you can take a second dose provided that at least 2 hours have elapsed between the 2 doses.

Do not exceed the maximum dose of 5 mg (two tablets) in 24 hours.

Excessive use (repeated use over several consecutive days) of Migard 2.5 mg tablets constitutes incorrect use of this medicine and may cause an increase in side effects and lead to chronic daily headaches requiring the temporary discontinuation of treatment. Consult your doctor if you start having too frequent or daily headaches as you may be suffering from medication overuse headache.

Use in children and adolescents

Migard should not be used in patients under 18 years of age.

Older people

As there is little experience in patients over 65 years, the use of MIGARD is not recommended in patients in this age group.

If you take more Migard than you should

If you accidentally take an overdose of this medicine, tell your doctor or pharmacist immediately or go to the emergency department of your nearest hospital. Please remember to take the remaining tablets or this leaflet with you.

Patient Information Leaflet (continued)

If you stop taking Migard

No special precautions are necessary when stopping the drug.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Migard and tell your doctor right away if you experience any of the following symptoms:

_*    a feeling of tightness or pain in the chest, shortness of breath and/or pain or discomfort in one or both arms, your back, shoulders, neck, jaw, or upper part of the stomach; these might be symptoms of a heart attack (myocardial infarction), which can occur when taking triptans, even

in patients with no history of cardio-vascular disease;

*    have generalized skin rash and itching, rapid-onset swelling (especially around the lips, eyes, or of the tongue and mucosa), with possible sudden difficulty in breathing and a fast heartbeat and thumping heart. These are all symptoms and signs of allergy and whole-body hypersensitivity reaction (hypersensitivity reactions, angioedema, anaphylaxis).

The side-effects reported with Migard 2.5 mg tablets were temporary, generally mild to moderate and disappeared spontaneously. Some symptoms reported may be caused by the migraine itself.

The following side-effects were commonly observed (estimated frequency is more than 1 person out of 100 and less than 1 person out of 10):

*    nausea (feeling sick), dry mouth, digestion problems, stomach pain,

*    fatigue, chest discomfort (sensation of slight heaviness, pressure or tightness in the chest),

*    headache, dizziness, sensation of pins and needles, most frequently in the arms and legs, reduction or disturbance of the sensations of touch, extreme sleepiness,

*    hot flushes,

*    tightness in the throat,

*    sight disturbances,

*    increased sweating.

The following were uncommonly observed (estimated frequency is more than 1 person out of 1000 and less than 1 person out of 100):

_*    altered sense of taste, trembling, poor concentration, lethargy, increased sensation of touch, drowsiness, involuntary muscle contractions,

_*    diarrhoea, difficulty in swallowing, gas in stomach or bowel, stomach discomfort, bloated stomach,

_*    awareness of heart beat (palpitations), fast heart beat, high blood pressure, chest pain (intense tightness or feeling of pressure in the chest),

_*    feeling hot, reduced tolerance of heat and cold, pain, weakness, thirst, sluggishness, increased energy, generally feeling unwell, sensation of spinning,

_*    anxiety, inability to sleep, confusion, nervousness, agitation, depression, loss of sense of personal identity,

_*    coldness in the hands and feet,

_*    irritation of the nose, inflamed sinus, sore throat and/or voice box,

_*    muscle stiffness, muscle and bone pain, pain in the hands and feet, back pain, painful joints,

_*    eye pain, eye irritation, painful oversensitivity to light,

_*    itchiness,

_*    ringing in the ears, earache,

_*    dehydration,

_*    passing urine frequently, production of large amounts of urine.

The following were rare (estimated frequency is more than 1 person out of

10,000 and less than 1 person out of 1000):

_*    muscle spasm, floppy muscles, diminution of reflexes (hyporeflexia), movement problems,

_*    constipation, burping, heartburn, irritable bowel syndrome, lip blisters, lip pain, spasm of the gullet, blisters in the mouth, ulcer in the stomach or upper part of the small intestine, pain in the salivary gland, inflammation of the mouth, toothache,

_*    fever,

_*    loss of memory, abnormal dreams, personality disorder,

_*    nosebleed, hiccups, overbreathing, breathing disorder, irritation in the throat,

_*    night blindness,

_*    skin reddening, sensation of hairs standing on end, purplish spots or patches on skin and mucous surfaces of the body, hives,

_*    slow heart beat,

*    ear discomfort, earorder, ear itchiness, sensitive hearing,

*    increase in bilirubin (a substance produced by the liver) in the blood, decrease of calcium in the blood, abnormal urine analysis,

*    low sugar in the blood,

*    passing urine frequently at night, pain in the kidneys,

*    self-inflicted injury (eg bite or bruising),

*    swollen lymph nodes,

*    breast pain or discomfort.

Although the frequency cannot be estimated from the available data, the following events were also reported:

*    allergic reactions (hypersensitivity) including generalized skin rash and itching, rapid-onset swelling (especially around the lips, eyes, or of the tongue), with possible sudden difficulty in breathing, that can be associated with fast heartbeat and thumping heart (anaphylaxis),

*    heart attack (myocardial infarction),

*    chest discomfort or pain that is caused by a temporary spasm (constriction) in your coronary arteries (the blood vessels that bring oxygen and nutrients to your heart, i.e. coronary artery spasm).

Reporting of side effects

If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme

at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

[5) How to store Migard

Do not use Migard 2.5 mg tablets after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Do not store above 30°C.

Store in the original package.

Keep out of the sight and reach of children

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

[£) Contents of the pack and other information

What Migard contains:

The active substance is 2.5 mg of frovatriptan as succinate monohydrate per tablet. The other ingredients are: anhydrous lactose, microcrystalline cellulose, magnesium stearate, sodium starch glycollate (type A), silica colloidal anhydrous. Film coating: OPADRY white: titanium dioxide (E171), anhydrous lactose, hypromellose (E464), macrogol 3000, triacetin.

What Migard looks like and contents of the pack

Migard 2.5 mg tablets are round biconvex white film-coated tablets, debossed with "m" on one side and "2.5" on the other.

Each blister pack contains 6 tablets.

Manufacturer and Licence Holder

This medicine is manufactured by Berlin Chemie AG, Glienicker Weg 125 - 12489 Berlin, Germany. Procured from within the EU. Product Licence Holder: LTT Pharma Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE. Repackaged by Lexon (UK) Limited, B98 0RE.

If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.

POM PL 33723/0121 Migard 2.5mg Film-coated tablets. Migard is a registered trademark of Vernalis Development Limited. Revision date: 25/02/16

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited, Tel: 01527 505414 for help.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

*    Keep this leaflet. You may need to read it again.

*    If you have any further questions, ask your doctor or pharmacist.

*    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

*    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

What Migard is and what it is used for ^ What you need to know before you take Migard ,3 How to take Migard Possible side effects How to store Migard

_l6 j Contents of the pack and other information

^ What Migard is and what is it used for

Migard 2.5 mg tablets contain frovatriptan, an anti-migraine treatment belonging to the class of triptans (5-hydroxytryptamine (5HT1) selective receptor agonists). Migard 2.5 mg tablets is a medicine for the treatment of the headache phase of a migraine attack with or without aura (a temporary strange feeling before a migraine, which varies from person to person but can affect, for example, vision, smell, hearing).

Migard 2.5 mg tablets should not be used to prevent a migraine attack.

Migard is used to treat migraine attacks in adults.

^ What you need to know before you take Migard

The diagnosis of migraine must have been clearly established by your doctor

Do not take Migard

*    If you are allergic to frovatriptan or any of the other ingredients of this medicine (listed in section 6.1).

_*    if you have had a heart attack, or suffer or have suffered from certain cardiovascular diseases such as angina pectoris (characterised by crushing pain in the chest which can extend into the left arm), or circulation disorders of the legs or arms (especially in the fingers and toes),

*    if you have had a stroke or a transient ischaemic attack (TIA),

_*    if you have severely or moderately high blood pressure, or if your blood pressure is not adequately controlled,

_*    if you have severe liver disease,

_*    in combination with certain other medicines also used in the treatment of migraine (ergotamine and ergotamine derivatives (including methysergide) or other triptans (5-hydroxytryptamine (5HT1) agonists).

Warning and precautions

Talk to your doctor before taking Migard:

if you are a patient at risk of coronary artery disease, including if:

_*    you are a heavy smoker or a user of nicotine substitution therapy

_*    you are a post-menopausal female or a male aged over 40 years

Stop taking Migard and talk to your doctor right away if you:

_*    experience a feeling of tightness or pain in the chest, shortness of breath and/or pain or discomfort in one or both arms, your back, shoulders, neck, jaw, or upper part of the stomach; these might be symptoms of a heart attack, which can occur when taking triptans, even in patients with no history of cardio-vascular disease (see also section 4).

*    have generalized skin rash and itching, rapid-onset swelling (especially around the lips, eyes, or of the tongue), with possible sudden difficulty in breathing and a fast heartbeat and thumping heart. These are all symptoms and signs of allergy and whole-body hypersensitivity reaction (see also section 4).

Children and adolescents

Do not give this medicine to children and adolescents (under 18 years of

age) because the safety and efficacy of Migard have not been established in

these groups.

Other medicines and Migard

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

You should not take this medicine at the same time as certain other medicines used for the treatment of migraine:

*    especially ergotamine, ergotamine derivatives (including methysergide); you should allow at least 24 hours to elapse between the discontinuation of these medicines and the administration of Migard 2.5 mg tablets. Similarly, you should not take these medicines within 24 hours following a dose of Migard 2.5 mg tablets.

*    especially other triptans (5-HT1 agonists, such as sumatriptan, almotriptan, eletriptan, naratriptan, rizatriptan or zolmitriptan).

Unless otherwise directed by your doctor, you should not take this medicine at the same time as monoamine oxidase inhibitor (MAOI) medicines used in the treatment of depression (phenelzine, isocarboxazid, tranylcypromine, moclobemide).

_*    you should also tell your doctor or pharmacist if you are taking oral contraceptives or selective serotonin-reuptake inhibitors (citalopram, fluoxetine, fluvoxamine, paroxetine, sertraline).

It is recommended that you do not take Migard 2.5 mg tablets at the same time as taking St. John's Wort (hypericum perforatum).

Concomitant use of Migard with the medicines listed above (especially monoamine oxidase inhibitors, selective serotonin-reuptake inhibitors and hypericum perforatum) may also increase the risk of serotonin syndrome (the symptoms of serotonin syndrome include: shivering, sweating, agitation, trembling and abrupt contraction of muscles, nausea, fever, confusion).

If you have any doubt about taking other medicines with Migard 2.5 mg tablets, consult your doctor or pharmacist.

Migard with food and drink

Migard 2.5 mg tablets can be taken with food or on an empty stomach, always with an adequate amount of water.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Migard 2.5 mg tablets should not be used during pregnancy or when breast feeding, unless you are told so by your doctor. In any case, you should not breastfeed for 24 hours after taking Migard and during this time any breast milk expressed should be discarded.

Driving and using machines

Migard 2.5 mg tablets and the migraine itself can cause drowsiness. If affected, driving or operating machinery can be dangerous and should be avoided.

Migard contains lactose

This product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to take Migard

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

Take Migard 2.5 mg tablets as early as possible after the onset of the migraine headache. Swallow one tablet whole with water.

If the first dose does not give you any relief, do not take a second dose during the same attack. You can use Migard 2.5 mg tablet for any following attacks. If you obtain relief after the first dose, but later on suffer from the re-appearance of a headache within 24 hours, you can take a second dose provided that at least 2 hours have elapsed between the 2 doses.

Do not exceed the maximum dose of 5 mg (two tablets) in 24 hours.

Excessive use (repeated use over several consecutive days) of Migard 2.5 mg tablets constitutes incorrect use of this medicine and may cause an increase in side effects and lead to chronic daily headaches requiring the temporary discontinuation of treatment. Consult your doctor if you start having too frequent or daily headaches as you may be suffering from medication overuse headache.

Use in children and adolescents

Migard should not be used in patients under 18 years of age.

Older people

As there is little experience in patients over 65 years, the use of MIGARD is not recommended in patients in this age group.

If you take more Migard than you should

If you accidentally take an overdose of this medicine, tell your doctor or pharmacist immediately or go to the emergency department of your nearest hospital. Please remember to take the remaining tablets or this leaflet with you.

Patient Information Leaflet (continued)

If you stop taking Migard

No special precautions are necessary when stopping the drug.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Migard and tell your doctor right away if you experience any of the following symptoms:

_*    a feeling of tightness or pain in the chest, shortness of breath and/or pain or discomfort in one or both arms, your back, shoulders, neck, jaw, or upper part of the stomach; these might be symptoms of a heart attack (myocardial infarction), which can occur when taking triptans, even

in patients with no history of cardio-vascular disease;

*    have generalized skin rash and itching, rapid-onset swelling (especially around the lips, eyes, or of the tongue and mucosa), with possible sudden difficulty in breathing and a fast heartbeat and thumping heart. These are all symptoms and signs of allergy and whole-body hypersensitivity reaction (hypersensitivity reactions, angioedema, anaphylaxis).

The side-effects reported with Migard 2.5 mg tablets were temporary, generally mild to moderate and disappeared spontaneously. Some symptoms reported may be caused by the migraine itself.

The following side-effects were commonly observed (estimated frequency is more than 1 person out of 100 and less than 1 person out of 10):

*    nausea (feeling sick), dry mouth, digestion problems, stomach pain,

*    fatigue, chest discomfort (sensation of slight heaviness, pressure or tightness in the chest),

*    headache, dizziness, sensation of pins and needles, most frequently in the arms and legs, reduction or disturbance of the sensations of touch, extreme sleepiness,

*    hot flushes,

*    tightness in the throat,

*    sight disturbances,

*    increased sweating.

The following were uncommonly observed (estimated frequency is more than 1 person out of 1000 and less than 1 person out of 100):

_*    altered sense of taste, trembling, poor concentration, lethargy, increased sensation of touch, drowsiness, involuntary muscle contractions,

_*    diarrhoea, difficulty in swallowing, gas in stomach or bowel, stomach discomfort, bloated stomach,

_*    awareness of heart beat (palpitations), fast heart beat, high blood pressure, chest pain (intense tightness or feeling of pressure in the chest),

_*    feeling hot, reduced tolerance of heat and cold, pain, weakness, thirst, sluggishness, increased energy, generally feeling unwell, sensation of spinning,

_*    anxiety, inability to sleep, confusion, nervousness, agitation, depression, loss of sense of personal identity,

_*    coldness in the hands and feet,

_*    irritation of the nose, inflamed sinus, sore throat and/or voice box,

_*    muscle stiffness, muscle and bone pain, pain in the hands and feet, back pain, painful joints,

_*    eye pain, eye irritation, painful oversensitivity to light,

_*    itchiness,

_*    ringing in the ears, earache,

_*    dehydration,

_*    passing urine frequently, production of large amounts of urine.

The following were rare (estimated frequency is more than 1 person out of

10,000 and less than 1 person out of 1000):

_*    muscle spasm, floppy muscles, diminution of reflexes (hyporeflexia), movement problems,

_*    constipation, burping, heartburn, irritable bowel syndrome, lip blisters, lip pain, spasm of the gullet, blisters in the mouth, ulcer in the stomach or upper part of the small intestine, pain in the salivary gland, inflammation of the mouth, toothache,

_*    fever,

_*    loss of memory, abnormal dreams, personality disorder,

_*    nosebleed, hiccups, overbreathing, breathing disorder, irritation in the throat,

_*    night blindness,

_*    skin reddening, sensation of hairs standing on end, purplish spots or patches on skin and mucous surfaces of the body, hives,

_*    slow heart beat,

*    ear discomfort, earorder, ear itchiness, sensitive hearing,

*    increase in bilirubin (a substance produced by the liver) in the blood, decrease of calcium in the blood, abnormal urine analysis,

*    low sugar in the blood,

*    passing urine frequently at night, pain in the kidneys,

*    self-inflicted injury (eg bite or bruising),

*    swollen lymph nodes,

*    breast pain or discomfort.

Although the frequency cannot be estimated from the available data, the following events were also reported:

*    allergic reactions (hypersensitivity) including generalized skin rash and itching, rapid-onset swelling (especially around the lips, eyes, or of the tongue), with possible sudden difficulty in breathing, that can be associated with fast heartbeat and thumping heart (anaphylaxis),

*    heart attack (myocardial infarction),

*    chest discomfort or pain that is caused by a temporary spasm (constriction) in your coronary arteries (the blood vessels that bring oxygen and nutrients to your heart, i.e. coronary artery spasm).

Reporting of side effects

If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme

at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

[5) How to store Migard

Do not use Migard 2.5 mg tablets after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Do not store above 30°C.

Store in the original package.

Keep out of the sight and reach of children

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

[£) Contents of the pack and other information

What Migard contains:

The active substance is 2.5 mg of frovatriptan as succinate monohydrate per tablet. The other ingredients are: anhydrous lactose, microcrystalline cellulose, magnesium stearate, sodium starch glycollate (type A), silica colloidal anhydrous. Film coating: OPADRY white: titanium dioxide (E171), anhydrous lactose, hypromellose (E464), macrogol 3000, triacetin.

What Migard looks like and contents of the pack

Migard 2.5 mg tablets are round biconvex white film-coated tablets, debossed with "m" on one side and "2.5" on the other.

Each blister pack contains 6 tablets.

Manufacturer and Licence Holder

This medicine is manufactured by A. Menarini Manufacturing Logistics and Services s.r.l. Via Campo di Pile - L'Aquila, Italy. Procured from within the EU. Product Licence Holder: LTT Pharma Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE. Repackaged by Lexon (UK) Limited, B98 0RE.

If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.

POM PL 33723/0121 Migard 2.5mg Film-coated tablets. Migard is a registered trademark of Vernalis Development Limited. Revision date: 25/02/16

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited, Tel: 01527 505414 for help.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

*    Keep this leaflet. You may need to read it again.

*    If you have any further questions, ask your doctor or pharmacist.

*    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

*    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

What Migard is and what it is used for ^ What you need to know before you take Migard ,3 How to take Migard Possible side effects How to store Migard

_l6 j Contents of the pack and other information

^ What Migard is and what is it used for

Migard 2.5 mg tablets contain frovatriptan, an anti-migraine treatment belonging to the class of triptans (5-hydroxytryptamine (5HT1) selective receptor agonists). Migard 2.5 mg tablets is a medicine for the treatment of the headache phase of a migraine attack with or without aura (a temporary strange feeling before a migraine, which varies from person to person but can affect, for example, vision, smell, hearing).

Migard 2.5 mg tablets should not be used to prevent a migraine attack.

Migard is used to treat migraine attacks in adults.

^ What you need to know before you take Migard

The diagnosis of migraine must have been clearly established by your doctor

Do not take Migard

*    If you are allergic to frovatriptan or any of the other ingredients of this medicine (listed in section 6.1).

_*    if you have had a heart attack, or suffer or have suffered from certain cardiovascular diseases such as angina pectoris (characterised by crushing pain in the chest which can extend into the left arm), or circulation disorders of the legs or arms (especially in the fingers and toes),

*    if you have had a stroke or a transient ischaemic attack (TIA),

_*    if you have severely or moderately high blood pressure, or if your blood pressure is not adequately controlled,

_*    if you have severe liver disease,

_*    in combination with certain other medicines also used in the treatment of migraine (ergotamine and ergotamine derivatives (including methysergide) or other triptans (5-hydroxytryptamine (5HT1) agonists).

Warning and precautions

Talk to your doctor before taking Migard:

if you are a patient at risk of coronary artery disease, including if:

_*    you are a heavy smoker or a user of nicotine substitution therapy

_*    you are a post-menopausal female or a male aged over 40 years

Stop taking Migard and talk to your doctor right away if you:

_*    experience a feeling of tightness or pain in the chest, shortness of breath and/or pain or discomfort in one or both arms, your back, shoulders, neck, jaw, or upper part of the stomach; these might be symptoms of a heart attack, which can occur when taking triptans, even in patients with no history of cardio-vascular disease (see also section 4).

*    have generalized skin rash and itching, rapid-onset swelling (especially around the lips, eyes, or of the tongue), with possible sudden difficulty in breathing and a fast heartbeat and thumping heart. These are all symptoms and signs of allergy and whole-body hypersensitivity reaction (see also section 4).

Children and adolescents

Do not give this medicine to children and adolescents (under 18 years of

age) because the safety and efficacy of Migard have not been established in

these groups.

Other medicines and Migard

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

You should not take this medicine at the same time as certain other medicines used for the treatment of migraine:

*    especially ergotamine, ergotamine derivatives (including methysergide); you should allow at least 24 hours to elapse between the discontinuation of these medicines and the administration of Migard 2.5 mg tablets. Similarly, you should not take these medicines within 24 hours following a dose of Migard 2.5 mg tablets.

*    especially other triptans (5-HT1 agonists, such as sumatriptan, almotriptan, eletriptan, naratriptan, rizatriptan or zolmitriptan).

Unless otherwise directed by your doctor, you should not take this medicine at the same time as monoamine oxidase inhibitor (MAOI) medicines used in the treatment of depression (phenelzine, isocarboxazid, tranylcypromine, moclobemide).

_*    you should also tell your doctor or pharmacist if you are taking oral contraceptives or selective serotonin-reuptake inhibitors (citalopram, fluoxetine, fluvoxamine, paroxetine, sertraline).

It is recommended that you do not take Migard 2.5 mg tablets at the same time as taking St. John's Wort (hypericum perforatum).

Concomitant use of Migard with the medicines listed above (especially monoamine oxidase inhibitors, selective serotonin-reuptake inhibitors and hypericum perforatum) may also increase the risk of serotonin syndrome (the symptoms of serotonin syndrome include: shivering, sweating, agitation, trembling and abrupt contraction of muscles, nausea, fever, confusion).

If you have any doubt about taking other medicines with Migard 2.5 mg tablets, consult your doctor or pharmacist.

Migard with food and drink

Migard 2.5 mg tablets can be taken with food or on an empty stomach, always with an adequate amount of water.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Migard 2.5 mg tablets should not be used during pregnancy or when breast feeding, unless you are told so by your doctor. In any case, you should not breastfeed for 24 hours after taking Migard and during this time any breast milk expressed should be discarded.

Driving and using machines

Migard 2.5 mg tablets and the migraine itself can cause drowsiness. If affected, driving or operating machinery can be dangerous and should be avoided.

Migard contains lactose

This product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to take Migard

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

Take Migard 2.5 mg tablets as early as possible after the onset of the migraine headache. Swallow one tablet whole with water.

If the first dose does not give you any relief, do not take a second dose during the same attack. You can use Migard 2.5 mg tablet for any following attacks. If you obtain relief after the first dose, but later on suffer from the re-appearance of a headache within 24 hours, you can take a second dose provided that at least 2 hours have elapsed between the 2 doses.

Do not exceed the maximum dose of 5 mg (two tablets) in 24 hours.

Excessive use (repeated use over several consecutive days) of Migard 2.5 mg tablets constitutes incorrect use of this medicine and may cause an increase in side effects and lead to chronic daily headaches requiring the temporary discontinuation of treatment. Consult your doctor if you start having too frequent or daily headaches as you may be suffering from medication overuse headache.

Use in children and adolescents

Migard should not be used in patients under 18 years of age.

Older people

As there is little experience in patients over 65 years, the use of MIGARD is not recommended in patients in this age group.

If you take more Migard than you should

If you accidentally take an overdose of this medicine, tell your doctor or pharmacist immediately or go to the emergency department of your nearest hospital. Please remember to take the remaining tablets or this leaflet with you.

Patient Information Leaflet (continued)

If you stop taking Migard

No special precautions are necessary when stopping the drug.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Migard and tell your doctor right away if you experience any of the following symptoms:

_*    a feeling of tightness or pain in the chest, shortness of breath and/or pain or discomfort in one or both arms, your back, shoulders, neck, jaw, or upper part of the stomach; these might be symptoms of a heart attack (myocardial infarction), which can occur when taking triptans, even

in patients with no history of cardio-vascular disease;

*    have generalized skin rash and itching, rapid-onset swelling (especially around the lips, eyes, or of the tongue and mucosa), with possible sudden difficulty in breathing and a fast heartbeat and thumping heart. These are all symptoms and signs of allergy and whole-body hypersensitivity reaction (hypersensitivity reactions, angioedema, anaphylaxis).

The side-effects reported with Migard 2.5 mg tablets were temporary, generally mild to moderate and disappeared spontaneously. Some symptoms reported may be caused by the migraine itself.

The following side-effects were commonly observed (estimated frequency is more than 1 person out of 100 and less than 1 person out of 10):

*    nausea (feeling sick), dry mouth, digestion problems, stomach pain,

*    fatigue, chest discomfort (sensation of slight heaviness, pressure or tightness in the chest),

*    headache, dizziness, sensation of pins and needles, most frequently in the arms and legs, reduction or disturbance of the sensations of touch, extreme sleepiness,

*    hot flushes,

*    tightness in the throat,

*    sight disturbances,

*    increased sweating.

The following were uncommonly observed (estimated frequency is more than 1 person out of 1000 and less than 1 person out of 100):

_*    altered sense of taste, trembling, poor concentration, lethargy, increased sensation of touch, drowsiness, involuntary muscle contractions,

_*    diarrhoea, difficulty in swallowing, gas in stomach or bowel, stomach discomfort, bloated stomach,

_*    awareness of heart beat (palpitations), fast heart beat, high blood pressure, chest pain (intense tightness or feeling of pressure in the chest),

_*    feeling hot, reduced tolerance of heat and cold, pain, weakness, thirst, sluggishness, increased energy, generally feeling unwell, sensation of spinning,

_*    anxiety, inability to sleep, confusion, nervousness, agitation, depression, loss of sense of personal identity,

_*    coldness in the hands and feet,

_*    irritation of the nose, inflamed sinus, sore throat and/or voice box,

_*    muscle stiffness, muscle and bone pain, pain in the hands and feet, back pain, painful joints,

_*    eye pain, eye irritation, painful oversensitivity to light,

_*    itchiness,

_*    ringing in the ears, earache,

_*    dehydration,

_*    passing urine frequently, production of large amounts of urine.

The following were rare (estimated frequency is more than 1 person out of

10,000 and less than 1 person out of 1000):

_*    muscle spasm, floppy muscles, diminution of reflexes (hyporeflexia), movement problems,

_*    constipation, burping, heartburn, irritable bowel syndrome, lip blisters, lip pain, spasm of the gullet, blisters in the mouth, ulcer in the stomach or upper part of the small intestine, pain in the salivary gland, inflammation of the mouth, toothache,

_*    fever,

_*    loss of memory, abnormal dreams, personality disorder,

_*    nosebleed, hiccups, overbreathing, breathing disorder, irritation in the throat,

_*    night blindness,

_*    skin reddening, sensation of hairs standing on end, purplish spots or patches on skin and mucous surfaces of the body, hives,

_*    slow heart beat,

*    ear discomfort, earorder, ear itchiness, sensitive hearing,

*    increase in bilirubin (a substance produced by the liver) in the blood, decrease of calcium in the blood, abnormal urine analysis,

*    low sugar in the blood,

*    passing urine frequently at night, pain in the kidneys,

*    self-inflicted injury (eg bite or bruising),

*    swollen lymph nodes,

*    breast pain or discomfort.

Although the frequency cannot be estimated from the available data, the following events were also reported:

*    allergic reactions (hypersensitivity) including generalized skin rash and itching, rapid-onset swelling (especially around the lips, eyes, or of the tongue), with possible sudden difficulty in breathing, that can be associated with fast heartbeat and thumping heart (anaphylaxis),

*    heart attack (myocardial infarction),

*    chest discomfort or pain that is caused by a temporary spasm (constriction) in your coronary arteries (the blood vessels that bring oxygen and nutrients to your heart, i.e. coronary artery spasm).

Reporting of side effects

If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme

at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

[5) How to store Migard

Do not use Migard 2.5 mg tablets after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Do not store above 30°C.

Store in the original package.

Keep out of the sight and reach of children

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

[£) Contents of the pack and other information

What Migard contains:

The active substance is 2.5 mg of frovatriptan as succinate monohydrate per tablet. The other ingredients are: anhydrous lactose, microcrystalline cellulose, magnesium stearate, sodium starch glycollate (type A), silica colloidal anhydrous. Film coating: OPADRY white: titanium dioxide (E171), anhydrous lactose, hypromellose (E464), macrogol 3000, triacetin.

What Migard looks like and contents of the pack

Migard 2.5 mg tablets are round biconvex white film-coated tablets, debossed with "m" on one side and "2.5" on the other.

Each blister pack contains 6 tablets.

Manufacturer and Licence Holder

This medicine is manufactured by Laboratorios Menarini S.A Alfonso XII, 587-08918 Barcelona Spain. Procured from within the EU. Product Licence Holder: LTT Pharma Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE. Repackaged by Lexon (UK) Limited, B98 0RE.

If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.

POM PL 33723/0121 Migard 2.5mg Film-coated tablets. Migard is a registered trademark of Vernalis Development Limited. Revision date: 25/02/16

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited, Tel: 01527 505414 for help.

Patient Information Leaflet

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

*    Keep this leaflet. You may need to read it again.

*    If you have any further questions, ask your doctor or pharmacist.

*    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

*    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Your medicine is called Frovatriptan 2.5mg Film-coated tablets and will be referred to as Frovatriptan throughout the rest of this leaflet

What is in this leaflet

^ What Frovatriptan is and what it is used for

What you need to know before you take Frovatriptan How to take Frovatriptan ^ Possible side effects

How to store Frovatriptan [m Contents of the pack and other information

^ What Frovatriptan is and what is it used for

Frovatriptan 2.5 mg tablets contain frovatriptan, an anti-migraine treatment belonging to the class of triptans (5-hydroxytryptamine (5HT1) selective receptor agonists). Frovatriptan 2.5 mg tablets is a medicine for the treatment of the headache phase of a migraine attack with or without aura (a temporary strange feeling before a migraine, which varies from person to person but can affect, for example, vision, smell, hearing). Frovatriptan 2.5 mg tablets should not be used to prevent a migraine attack.

Frovatriptan is used to treat migraine attacks in adults.

[2| What you need to know before you take Frovatriptan

The diagnosis of migraine must have been clearly established by your doctor Do not take Frovatriptan

*    If you are allergic to frovatriptan or any of the other ingredients of this medicine (listed in section 6.1).

_*    if you have had a heart attack, or suffer or have suffered from certain cardiovascular diseases such as angina pectoris (characterised by crushing pain in the chest which can extend into the left arm), or circulation disorders of the legs or arms (especially in the fingers and toes),

*    if you have had a stroke or a transient ischaemic attack (TIA),

_*    if you have severely or moderately high blood pressure, or if your blood pressure is not adequately controlled,

_*    if you have severe liver disease,

_*    in combination with certain other medicines also used in the treatment of migraine (ergotamine and ergotamine derivatives (including methysergide) or other triptans (5-hydroxytryptamine (5HT1) agonists).

Warning and precautions

Talk to your doctor before taking Frovatriptan:

if you are a patient at risk of coronary artery disease, including if:

_*    you are a heavy smoker or a user of nicotine substitution therapy

_*    you are a post-menopausal female or a male aged over 40 years

Stop taking Frovatriptan and talk to your doctor right away if you:

_*    experience a feeling of tightness or pain in the chest, shortness of breath and/or pain or discomfort in one or both arms, your back, shoulders, neck, jaw, or upper part of the stomach; these might be symptoms of a heart attack, which can occur when taking triptans, even in patients with no history of cardio-vascular disease (see also section 4).

*    have generalized skin rash and itching, rapid-onset swelling (especially around the lips, eyes, or of the tongue), with possible sudden difficulty in breathing and a fast heartbeat and thumping heart. These are all symptoms and signs of allergy and whole-body hypersensitivity reaction (see also section 4).

Children and adolescents

Do not give this medicine to children and adolescents (under 18 years of age) because the safety and efficacy of Frovatriptan have not been established in these groups.

Other medicines and Frovatriptan

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

You should not take this medicine at the same time as certain other medicines used for the treatment of migraine:

*    especially ergotamine, ergotamine derivatives (including methysergide); you should allow at least 24 hours to elapse between the discontinuation of these medicines and the administration of Frovatriptan 2.5 mg tablets. Similarly, you should not take these medicines within 24 hours following a dose of Frovatriptan 2.5 mg tablets.

*    especially other triptans (5-HT1 agonists, such as sumatriptan, almotriptan, eletriptan, naratriptan, rizatriptan or zolmitriptan).

Unless otherwise directed by your doctor, you should not take this medicine at the same time as monoamine oxidase inhibitor (MAOI) medicines used in the treatment of depression (phenelzine, isocarboxazid, tranylcypromine, moclobemide).

_*    you should also tell your doctor or pharmacist if you are taking oral contraceptives or selective serotonin-reuptake inhibitors (citalopram, fluoxetine, fluvoxamine, paroxetine, sertraline).

It is recommended that you do not take Frovatriptan 2.5 mg tablets at the same time as taking St. John's Wort (hypericum perforatum).

Concomitant use of Frovatriptan with the medicines listed above (especially monoamine oxidase inhibitors, selective serotonin-reuptake inhibitors and hypericum perforatum) may also increase the risk of serotonin syndrome (the symptoms of serotonin syndrome include: shivering, sweating, agitation, trembling and abrupt contraction of muscles, nausea, fever, confusion).

If you have any doubt about taking other medicines with Frovatriptan 2.5 mg tablets, consult your doctor or pharmacist.

Frovatriptan with food and drink

Frovatriptan 2.5 mg tablets can be taken with food or on an empty stomach, always with an adequate amount of water.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Frovatriptan 2.5 mg tablets should not be used during pregnancy or when breast feeding, unless you are told so by your doctor. In any case, you should not breastfeed for 24 hours after taking Frovatriptan and during this time any breast milk expressed should be discarded.

Driving and using machines

Frovatriptan 2.5 mg tablets and the migraine itself can cause drowsiness. If affected, driving or operating machinery can be dangerous and should be avoided.

Frovatriptan contains lactose

This product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to take Frovatriptan

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

Take Frovatriptan 2.5 mg tablets as early as possible after the onset of the migraine headache. Swallow one tablet whole with water.

If the first dose does not give you any relief, do not take a second dose during the same attack. You can use Frovatriptan 2.5 mg tablet for any following attacks. If you obtain relief after the first dose, but later on suffer from the

re-appearance of a headache within 24 hours, you can take a second dose provided that at least 2 hours have elapsed between the 2 doses.

Do not exceed the maximum dose of 5 mg (two tablets) in 24 hours.

Excessive use (repeated use over several consecutive days) of Frovatriptan

2.5 mg tablets constitutes incorrect use of this medicine and may cause an increase in side effects and lead to chronic daily headaches requiring the temporary discontinuation of treatment. Consult your doctor if you start having too frequent or daily headaches as you may be suffering from medication overuse headache.

Use in children and adolescents

Frovatriptan should not be used in patients under 18 years of age.

Older people

As there is little experience in patients over 65 years, the use of Frovatriptan is not recommended in patients in this age group.

If you take more Frovatriptan than you should

If you accidentally take an overdose of this medicine, tell your doctor or pharmacist immediately or go to the emergency department of your nearest hospital. Please remember to take the remaining tablets or this leaflet with you.

Patient Information Leaflet (continued)

If you stop taking Frovatriptan

No special precautions are necessary when stopping the drug.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Frovatriptan and tell your doctor right away if you experience any of the following symptoms:

_*    a feeling of tightness or pain in the chest, shortness of breath and/or pain or discomfort in one or both arms, your back, shoulders, neck, jaw, or upper part of the stomach; these might be symptoms of a heart attack (myocardial infarction), which can occur when taking triptans, even

in patients with no history of cardio-vascular disease;

_*    have generalized skin rash and itching, rapid-onset swelling (especially around the lips, eyes, or of the tongue and mucosa), with possible sudden difficulty in breathing and a fast heartbeat and thumping heart. These are all symptoms and signs of allergy and whole-body hypersensitivity reaction (hypersensitivity reactions, angioedema, anaphylaxis).

The side-effects reported with Frovatriptan 2.5 mg tablets were temporary, generally mild to moderate and disappeared spontaneously. Some symptoms reported may be caused by the migraine itself.

The following side-effects were commonly observed (estimated frequency is more than 1 person out of 100 and less than 1 person out of 10):

*    nausea (feeling sick), dry mouth, digestion problems, stomach pain,

*    fatigue, chest discomfort (sensation of slight heaviness, pressure or tightness in the chest),

*    headache, dizziness, sensation of pins and needles, most frequently in the arms and legs, reduction or disturbance of the sensations of touch, extreme sleepiness,

*    hot flushes,

*    tightness in the throat,

*    sight disturbances,

*    increased sweating.

The following were uncommonly observed (estimated frequency is more than 1 person out of 1000 and less than 1 person out of 100):

_*    altered sense of taste, trembling, poor concentration, lethargy, increased sensation of touch, drowsiness, involuntary muscle contractions,

_*    diarrhoea, difficulty in swallowing, gas in stomach or bowel, stomach discomfort, bloated stomach,

_*    awareness of heart beat (palpitations), fast heart beat, high blood pressure, chest pain (intense tightness or feeling of pressure in the chest),

_*    feeling hot, reduced tolerance of heat and cold, pain, weakness, thirst, sluggishness, increased energy, generally feeling unwell, sensation of spinning,

_*    anxiety, inability to sleep, confusion, nervousness, agitation, depression, loss of sense of personal identity,

_*    coldness in the hands and feet,

_*    irritation of the nose, inflamed sinus, sore throat and/or voice box,

_*    muscle stiffness, muscle and bone pain, pain in the hands and feet, back pain, painful joints,

_*    eye pain, eye irritation, painful oversensitivity to light,

_*    itchiness,

_*    ringing in the ears, earache,

_*    dehydration,

_*    passing urine frequently, production of large amounts of urine.

The following were rare (estimated frequency is more than 1 person out of

10,000 and less than 1 person out of 1000):

_*    muscle spasm, floppy muscles, diminution of reflexes (hyporeflexia), movement problems,

_*    constipation, burping, heartburn, irritable bowel syndrome, lip blisters, lip pain, spasm of the gullet, blisters in the mouth, ulcer in the stomach or upper part of the small intestine, pain in the salivary gland, inflammation of the mouth, toothache,

_*    fever,

_*    loss of memory, abnormal dreams, personality disorder,

_*    nosebleed, hiccups, overbreathing, breathing disorder, irritation in the throat,

_*    night blindness,

_*    skin reddening, sensation of hairs standing on end, purplish spots or patches on skin and mucous surfaces of the body, hives,

_*    slow heart beat,

_*    ear discomfort, earorder, ear itchiness, sensitive hearing,

_*    increase in bilirubin (a substance produced by the liver) in the blood, decrease of calcium in the blood, abnormal urine analysis,

_*    low sugar in the blood,

_*    passing urine frequently at night, pain in the kidneys,

_*    self-inflicted injury (eg bite or bruising),

_*    swollen lymph nodes,

*    breast pain or discomfort.

Although the frequency cannot be estimated from the available data, the following events were also reported:

*    allergic reactions (hypersensitivity) including generalized skin rash and itching, rapid-onset swelling (especially around the lips, eyes, or of the tongue), with possible sudden difficulty in breathing, that can be associated with fast heartbeat and thumping heart (anaphylaxis),

_*    heart attack (myocardial infarction),

_*    chest discomfort or pain that is caused by a temporary spasm (constriction) in your coronary arteries (the blood vessels that bring oxygen and nutrients to your heart, i.e. coronary artery spasm).

Reporting of side effects

If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme

at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

[a How to store Frovatriptan

Do not use Frovatriptan 2.5 mg tablets after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Do not store above 30°C.

Store in the original package.

Keep out of the sight and reach of children

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

[£) Contents of the pack and other information

What Frovatriptan contains:

The active substance is 2.5 mg of frovatriptan as succinate monohydrate per tablet. The other ingredients are: anhydrous lactose, microcrystalline cellulose, magnesium stearate, sodium starch glycollate (type A), silica colloidal anhydrous. Film coating: OPADRY white: titanium dioxide (E171), anhydrous lactose, hypromellose (E464), macrogol 3000, triacetin.

What Frovatriptan looks like and contents of the pack

Frovatriptan 2.5 mg tablets are round biconvex white film-coated tablets, debossed with "m" on one side and "2.5" on the other.

Each blister pack contains 6 tablets.

Manufacturer and Licence Holder

This medicine is manufactured by, Almac Pharma Services Limited, Almac House, 20 Seagoe Industrial Estate, Craigavon, Co Armagh, Northern Ireland, BT63 5UA. Procured from within the EU. Product Licence Holder: LTT Pharma Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE. Repackaged by Lexon (UK) Limited, B98 0RE.

If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.

POM PL 33723/0121 Frovatriptan 2.5mg Film-coated tablets. Frovatriptan is a registered trademark of Vernalis Development Limited. Revision date: 25/02/16

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited, Tel: 01527 505414 for help.

Patient Information Leaflet

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

*    Keep this leaflet. You may need to read it again.

*    If you have any further questions, ask your doctor or pharmacist.

*    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

*    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Your medicine is called Frovatriptan 2.5mg Film-coated tablets and will be referred to as Frovatriptan throughout the rest of this leaflet

What is in this leaflet

^ What Frovatriptan is and what it is used for

What you need to know before you take Frovatriptan How to take Frovatriptan ^ Possible side effects

How to store Frovatriptan [m Contents of the pack and other information

^ What Frovatriptan is and what is it used for

Frovatriptan 2.5 mg tablets contain frovatriptan, an anti-migraine treatment belonging to the class of triptans (5-hydroxytryptamine (5HT1) selective receptor agonists). Frovatriptan 2.5 mg tablets is a medicine for the treatment of the headache phase of a migraine attack with or without aura (a temporary strange feeling before a migraine, which varies from person to person but can affect, for example, vision, smell, hearing). Frovatriptan 2.5 mg tablets should not be used to prevent a migraine attack.

Frovatriptan is used to treat migraine attacks in adults.

[2| What you need to know before you take Frovatriptan

The diagnosis of migraine must have been clearly established by your doctor Do not take Frovatriptan

*    If you are allergic to frovatriptan or any of the other ingredients of this medicine (listed in section 6.1).

_*    if you have had a heart attack, or suffer or have suffered from certain cardiovascular diseases such as angina pectoris (characterised by crushing pain in the chest which can extend into the left arm), or circulation disorders of the legs or arms (especially in the fingers and toes),

*    if you have had a stroke or a transient ischaemic attack (TIA),

_*    if you have severely or moderately high blood pressure, or if your blood pressure is not adequately controlled,

_*    if you have severe liver disease,

_*    in combination with certain other medicines also used in the treatment of migraine (ergotamine and ergotamine derivatives (including methysergide) or other triptans (5-hydroxytryptamine (5HT1) agonists).

Warning and precautions

Talk to your doctor before taking Frovatriptan:

if you are a patient at risk of coronary artery disease, including if:

_*    you are a heavy smoker or a user of nicotine substitution therapy

_*    you are a post-menopausal female or a male aged over 40 years

Stop taking Frovatriptan and talk to your doctor right away if you:

_*    experience a feeling of tightness or pain in the chest, shortness of breath and/or pain or discomfort in one or both arms, your back, shoulders, neck, jaw, or upper part of the stomach; these might be symptoms of a heart attack, which can occur when taking triptans, even in patients with no history of cardio-vascular disease (see also section 4).

*    have generalized skin rash and itching, rapid-onset swelling (especially around the lips, eyes, or of the tongue), with possible sudden difficulty in breathing and a fast heartbeat and thumping heart. These are all symptoms and signs of allergy and whole-body hypersensitivity reaction (see also section 4).

Children and adolescents

Do not give this medicine to children and adolescents (under 18 years of age) because the safety and efficacy of Frovatriptan have not been established in these groups.

Other medicines and Frovatriptan

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

You should not take this medicine at the same time as certain other medicines used for the treatment of migraine:

*    especially ergotamine, ergotamine derivatives (including methysergide); you should allow at least 24 hours to elapse between the discontinuation of these medicines and the administration of Frovatriptan 2.5 mg tablets. Similarly, you should not take these medicines within 24 hours following a dose of Frovatriptan 2.5 mg tablets.

*    especially other triptans (5-HT1 agonists, such as sumatriptan, almotriptan, eletriptan, naratriptan, rizatriptan or zolmitriptan).

Unless otherwise directed by your doctor, you should not take this medicine at the same time as monoamine oxidase inhibitor (MAOI) medicines used in the treatment of depression (phenelzine, isocarboxazid, tranylcypromine, moclobemide).

_*    you should also tell your doctor or pharmacist if you are taking oral contraceptives or selective serotonin-reuptake inhibitors (citalopram, fluoxetine, fluvoxamine, paroxetine, sertraline).

It is recommended that you do not take Frovatriptan 2.5 mg tablets at the same time as taking St. John's Wort (hypericum perforatum).

Concomitant use of Frovatriptan with the medicines listed above (especially monoamine oxidase inhibitors, selective serotonin-reuptake inhibitors and hypericum perforatum) may also increase the risk of serotonin syndrome (the symptoms of serotonin syndrome include: shivering, sweating, agitation, trembling and abrupt contraction of muscles, nausea, fever, confusion).

If you have any doubt about taking other medicines with Frovatriptan 2.5 mg tablets, consult your doctor or pharmacist.

Frovatriptan with food and drink

Frovatriptan 2.5 mg tablets can be taken with food or on an empty stomach, always with an adequate amount of water.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Frovatriptan 2.5 mg tablets should not be used during pregnancy or when breast feeding, unless you are told so by your doctor. In any case, you should not breastfeed for 24 hours after taking Frovatriptan and during this time any breast milk expressed should be discarded.

Driving and using machines

Frovatriptan 2.5 mg tablets and the migraine itself can cause drowsiness. If affected, driving or operating machinery can be dangerous and should be avoided.

Frovatriptan contains lactose

This product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to take Frovatriptan

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

Take Frovatriptan 2.5 mg tablets as early as possible after the onset of the migraine headache. Swallow one tablet whole with water.

If the first dose does not give you any relief, do not take a second dose during the same attack. You can use Frovatriptan 2.5 mg tablet for any following attacks. If you obtain relief after the first dose, but later on suffer from the

re-appearance of a headache within 24 hours, you can take a second dose provided that at least 2 hours have elapsed between the 2 doses.

Do not exceed the maximum dose of 5 mg (two tablets) in 24 hours.

Excessive use (repeated use over several consecutive days) of Frovatriptan

2.5 mg tablets constitutes incorrect use of this medicine and may cause an increase in side effects and lead to chronic daily headaches requiring the temporary discontinuation of treatment. Consult your doctor if you start having too frequent or daily headaches as you may be suffering from medication overuse headache.

Use in children and adolescents

Frovatriptan should not be used in patients under 18 years of age.

Older people

As there is little experience in patients over 65 years, the use of Frovatriptan is not recommended in patients in this age group.

If you take more Frovatriptan than you should

If you accidentally take an overdose of this medicine, tell your doctor or pharmacist immediately or go to the emergency department of your nearest hospital. Please remember to take the remaining tablets or this leaflet with you.

Patient Information Leaflet (continued)

If you stop taking Frovatriptan

No special precautions are necessary when stopping the drug.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Frovatriptan and tell your doctor right away if you experience any of the following symptoms:

_*    a feeling of tightness or pain in the chest, shortness of breath and/or pain or discomfort in one or both arms, your back, shoulders, neck, jaw, or upper part of the stomach; these might be symptoms of a heart attack (myocardial infarction), which can occur when taking triptans, even

in patients with no history of cardio-vascular disease;

_*    have generalized skin rash and itching, rapid-onset swelling (especially around the lips, eyes, or of the tongue and mucosa), with possible sudden difficulty in breathing and a fast heartbeat and thumping heart. These are all symptoms and signs of allergy and whole-body hypersensitivity reaction (hypersensitivity reactions, angioedema, anaphylaxis).

The side-effects reported with Frovatriptan 2.5 mg tablets were temporary, generally mild to moderate and disappeared spontaneously. Some symptoms reported may be caused by the migraine itself.

The following side-effects were commonly observed (estimated frequency is more than 1 person out of 100 and less than 1 person out of 10):

*    nausea (feeling sick), dry mouth, digestion problems, stomach pain,

*    fatigue, chest discomfort (sensation of slight heaviness, pressure or tightness in the chest),

*    headache, dizziness, sensation of pins and needles, most frequently in the arms and legs, reduction or disturbance of the sensations of touch, extreme sleepiness,

*    hot flushes,

*    tightness in the throat,

*    sight disturbances,

*    increased sweating.

The following were uncommonly observed (estimated frequency is more than 1 person out of 1000 and less than 1 person out of 100):

_*    altered sense of taste, trembling, poor concentration, lethargy, increased sensation of touch, drowsiness, involuntary muscle contractions,

_*    diarrhoea, difficulty in swallowing, gas in stomach or bowel, stomach discomfort, bloated stomach,

_*    awareness of heart beat (palpitations), fast heart beat, high blood pressure, chest pain (intense tightness or feeling of pressure in the chest),

_*    feeling hot, reduced tolerance of heat and cold, pain, weakness, thirst, sluggishness, increased energy, generally feeling unwell, sensation of spinning,

_*    anxiety, inability to sleep, confusion, nervousness, agitation, depression, loss of sense of personal identity,

_*    coldness in the hands and feet,

_*    irritation of the nose, inflamed sinus, sore throat and/or voice box,

_*    muscle stiffness, muscle and bone pain, pain in the hands and feet, back pain, painful joints,

_*    eye pain, eye irritation, painful oversensitivity to light,

_*    itchiness,

_*    ringing in the ears, earache,

_*    dehydration,

_*    passing urine frequently, production of large amounts of urine.

The following were rare (estimated frequency is more than 1 person out of

10,000 and less than 1 person out of 1000):

_*    muscle spasm, floppy muscles, diminution of reflexes (hyporeflexia), movement problems,

_*    constipation, burping, heartburn, irritable bowel syndrome, lip blisters, lip pain, spasm of the gullet, blisters in the mouth, ulcer in the stomach or upper part of the small intestine, pain in the salivary gland, inflammation of the mouth, toothache,

_*    fever,

_*    loss of memory, abnormal dreams, personality disorder,

_*    nosebleed, hiccups, overbreathing, breathing disorder, irritation in the throat,

_*    night blindness,

_*    skin reddening, sensation of hairs standing on end, purplish spots or patches on skin and mucous surfaces of the body, hives,

_*    slow heart beat,

_*    ear discomfort, earorder, ear itchiness, sensitive hearing,

_*    increase in bilirubin (a substance produced by the liver) in the blood, decrease of calcium in the blood, abnormal urine analysis,

_*    low sugar in the blood,

_*    passing urine frequently at night, pain in the kidneys,

_*    self-inflicted injury (eg bite or bruising),

_*    swollen lymph nodes,

*    breast pain or discomfort.

Although the frequency cannot be estimated from the available data, the following events were also reported:

*    allergic reactions (hypersensitivity) including generalized skin rash and itching, rapid-onset swelling (especially around the lips, eyes, or of the tongue), with possible sudden difficulty in breathing, that can be associated with fast heartbeat and thumping heart (anaphylaxis),

_*    heart attack (myocardial infarction),

_*    chest discomfort or pain that is caused by a temporary spasm (constriction) in your coronary arteries (the blood vessels that bring oxygen and nutrients to your heart, i.e. coronary artery spasm).

Reporting of side effects

If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme

at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

[a How to store Frovatriptan

Do not use Frovatriptan 2.5 mg tablets after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Do not store above 30°C.

Store in the original package.

Keep out of the sight and reach of children

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

[£) Contents of the pack and other information

What Frovatriptan contains:

The active substance is 2.5 mg of frovatriptan as succinate monohydrate per tablet. The other ingredients are: anhydrous lactose, microcrystalline cellulose, magnesium stearate, sodium starch glycollate (type A), silica colloidal anhydrous. Film coating: OPADRY white: titanium dioxide (E171), anhydrous lactose, hypromellose (E464), macrogol 3000, triacetin.

What Frovatriptan looks like and contents of the pack

Frovatriptan 2.5 mg tablets are round biconvex white film-coated tablets, debossed with "m" on one side and "2.5" on the other.

Each blister pack contains 6 tablets.

Manufacturer and Licence Holder

This medicine is manufactured by Berlin Chemie AG, Glienicker Weg 125 - 12489 Berlin, Germany. Procured from within the EU. Product Licence Holder: LTT Pharma Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE. Repackaged by Lexon (UK) Limited, B98 0RE.

If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.

POM PL 33723/0121 Frovatriptan 2.5mg Film-coated tablets. Frovatriptan is a registered trademark of Vernalis Development Limited. Revision date: 25/02/16

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited, Tel: 01527 505414 for help.

Patient Information Leaflet

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

*    Keep this leaflet. You may need to read it again.

*    If you have any further questions, ask your doctor or pharmacist.

*    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

*    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Your medicine is called Frovatriptan 2.5mg Film-coated tablets and will be referred to as Frovatriptan throughout the rest of this leaflet

What is in this leaflet

^ What Frovatriptan is and what it is used for

What you need to know before you take Frovatriptan How to take Frovatriptan ^ Possible side effects

How to store Frovatriptan [m Contents of the pack and other information

^ What Frovatriptan is and what is it used for

Frovatriptan 2.5 mg tablets contain frovatriptan, an anti-migraine treatment belonging to the class of triptans (5-hydroxytryptamine (5HT1) selective receptor agonists). Frovatriptan 2.5 mg tablets is a medicine for the treatment of the headache phase of a migraine attack with or without aura (a temporary strange feeling before a migraine, which varies from person to person but can affect, for example, vision, smell, hearing). Frovatriptan 2.5 mg tablets should not be used to prevent a migraine attack.

Frovatriptan is used to treat migraine attacks in adults.

[2| What you need to know before you take Frovatriptan

The diagnosis of migraine must have been clearly established by your doctor Do not take Frovatriptan

*    If you are allergic to frovatriptan or any of the other ingredients of this medicine (listed in section 6.1).

_*    if you have had a heart attack, or suffer or have suffered from certain cardiovascular diseases such as angina pectoris (characterised by crushing pain in the chest which can extend into the left arm), or circulation disorders of the legs or arms (especially in the fingers and toes),

*    if you have had a stroke or a transient ischaemic attack (TIA),

_*    if you have severely or moderately high blood pressure, or if your blood pressure is not adequately controlled,

_*    if you have severe liver disease,

_*    in combination with certain other medicines also used in the treatment of migraine (ergotamine and ergotamine derivatives (including methysergide) or other triptans (5-hydroxytryptamine (5HT1) agonists).

Warning and precautions

Talk to your doctor before taking Frovatriptan:

if you are a patient at risk of coronary artery disease, including if:

_*    you are a heavy smoker or a user of nicotine substitution therapy

_*    you are a post-menopausal female or a male aged over 40 years

Stop taking Frovatriptan and talk to your doctor right away if you:

_*    experience a feeling of tightness or pain in the chest, shortness of breath and/or pain or discomfort in one or both arms, your back, shoulders, neck, jaw, or upper part of the stomach; these might be symptoms of a heart attack, which can occur when taking triptans, even in patients with no history of cardio-vascular disease (see also section 4).

*    have generalized skin rash and itching, rapid-onset swelling (especially around the lips, eyes, or of the tongue), with possible sudden difficulty in breathing and a fast heartbeat and thumping heart. These are all symptoms and signs of allergy and whole-body hypersensitivity reaction (see also section 4).

Children and adolescents

Do not give this medicine to children and adolescents (under 18 years of age) because the safety and efficacy of Frovatriptan have not been established in these groups.

Other medicines and Frovatriptan

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

You should not take this medicine at the same time as certain other medicines used for the treatment of migraine:

*    especially ergotamine, ergotamine derivatives (including methysergide); you should allow at least 24 hours to elapse between the discontinuation of these medicines and the administration of Frovatriptan 2.5 mg tablets. Similarly, you should not take these medicines within 24 hours following a dose of Frovatriptan 2.5 mg tablets.

*    especially other triptans (5-HT1 agonists, such as sumatriptan, almotriptan, eletriptan, naratriptan, rizatriptan or zolmitriptan).

Unless otherwise directed by your doctor, you should not take this medicine at the same time as monoamine oxidase inhibitor (MAOI) medicines used in the treatment of depression (phenelzine, isocarboxazid, tranylcypromine, moclobemide).

_*    you should also tell your doctor or pharmacist if you are taking oral contraceptives or selective serotonin-reuptake inhibitors (citalopram, fluoxetine, fluvoxamine, paroxetine, sertraline).

It is recommended that you do not take Frovatriptan 2.5 mg tablets at the same time as taking St. John's Wort (hypericum perforatum).

Concomitant use of Frovatriptan with the medicines listed above (especially monoamine oxidase inhibitors, selective serotonin-reuptake inhibitors and hypericum perforatum) may also increase the risk of serotonin syndrome (the symptoms of serotonin syndrome include: shivering, sweating, agitation, trembling and abrupt contraction of muscles, nausea, fever, confusion).

If you have any doubt about taking other medicines with Frovatriptan 2.5 mg tablets, consult your doctor or pharmacist.

Frovatriptan with food and drink

Frovatriptan 2.5 mg tablets can be taken with food or on an empty stomach, always with an adequate amount of water.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Frovatriptan 2.5 mg tablets should not be used during pregnancy or when breast feeding, unless you are told so by your doctor. In any case, you should not breastfeed for 24 hours after taking Frovatriptan and during this time any breast milk expressed should be discarded.

Driving and using machines

Frovatriptan 2.5 mg tablets and the migraine itself can cause drowsiness. If affected, driving or operating machinery can be dangerous and should be avoided.

Frovatriptan contains lactose

This product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to take Frovatriptan

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

Take Frovatriptan 2.5 mg tablets as early as possible after the onset of the migraine headache. Swallow one tablet whole with water.

If the first dose does not give you any relief, do not take a second dose during the same attack. You can use Frovatriptan 2.5 mg tablet for any following attacks. If you obtain relief after the first dose, but later on suffer from the

re-appearance of a headache within 24 hours, you can take a second dose provided that at least 2 hours have elapsed between the 2 doses.

Do not exceed the maximum dose of 5 mg (two tablets) in 24 hours.

Excessive use (repeated use over several consecutive days) of Frovatriptan

2.5 mg tablets constitutes incorrect use of this medicine and may cause an increase in side effects and lead to chronic daily headaches requiring the temporary discontinuation of treatment. Consult your doctor if you start having too frequent or daily headaches as you may be suffering from medication overuse headache.

Use in children and adolescents

Frovatriptan should not be used in patients under 18 years of age.

Older people

As there is little experience in patients over 65 years, the use of Frovatriptan is not recommended in patients in this age group.

If you take more Frovatriptan than you should

If you accidentally take an overdose of this medicine, tell your doctor or pharmacist immediately or go to the emergency department of your nearest hospital. Please remember to take the remaining tablets or this leaflet with you.

Patient Information Leaflet (continued)

If you stop taking Frovatriptan

No special precautions are necessary when stopping the drug.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Frovatriptan and tell your doctor right away if you experience any of the following symptoms:

_*    a feeling of tightness or pain in the chest, shortness of breath and/or pain or discomfort in one or both arms, your back, shoulders, neck, jaw, or upper part of the stomach; these might be symptoms of a heart attack (myocardial infarction), which can occur when taking triptans, even

in patients with no history of cardio-vascular disease;

_*    have generalized skin rash and itching, rapid-onset swelling (especially around the lips, eyes, or of the tongue and mucosa), with possible sudden difficulty in breathing and a fast heartbeat and thumping heart. These are all symptoms and signs of allergy and whole-body hypersensitivity reaction (hypersensitivity reactions, angioedema, anaphylaxis).

The side-effects reported with Frovatriptan 2.5 mg tablets were temporary, generally mild to moderate and disappeared spontaneously. Some symptoms reported may be caused by the migraine itself.

The following side-effects were commonly observed (estimated frequency is more than 1 person out of 100 and less than 1 person out of 10):

*    nausea (feeling sick), dry mouth, digestion problems, stomach pain,

*    fatigue, chest discomfort (sensation of slight heaviness, pressure or tightness in the chest),

*    headache, dizziness, sensation of pins and needles, most frequently in the arms and legs, reduction or disturbance of the sensations of touch, extreme sleepiness,

*    hot flushes,

*    tightness in the throat,

*    sight disturbances,

*    increased sweating.

The following were uncommonly observed (estimated frequency is more than 1 person out of 1000 and less than 1 person out of 100):

_*    altered sense of taste, trembling, poor concentration, lethargy, increased sensation of touch, drowsiness, involuntary muscle contractions,

_*    diarrhoea, difficulty in swallowing, gas in stomach or bowel, stomach discomfort, bloated stomach,

_*    awareness of heart beat (palpitations), fast heart beat, high blood pressure, chest pain (intense tightness or feeling of pressure in the chest),

_*    feeling hot, reduced tolerance of heat and cold, pain, weakness, thirst, sluggishness, increased energy, generally feeling unwell, sensation of spinning,

_*    anxiety, inability to sleep, confusion, nervousness, agitation, depression, loss of sense of personal identity,

_*    coldness in the hands and feet,

_*    irritation of the nose, inflamed sinus, sore throat and/or voice box,

_*    muscle stiffness, muscle and bone pain, pain in the hands and feet, back pain, painful joints,

_*    eye pain, eye irritation, painful oversensitivity to light,

_*    itchiness,

_*    ringing in the ears, earache,

_*    dehydration,

_*    passing urine frequently, production of large amounts of urine.

The following were rare (estimated frequency is more than 1 person out of

10,000 and less than 1 person out of 1000):

_*    muscle spasm, floppy muscles, diminution of reflexes (hyporeflexia), movement problems,

_*    constipation, burping, heartburn, irritable bowel syndrome, lip blisters, lip pain, spasm of the gullet, blisters in the mouth, ulcer in the stomach or upper part of the small intestine, pain in the salivary gland, inflammation of the mouth, toothache,

_*    fever,

_*    loss of memory, abnormal dreams, personality disorder,

_*    nosebleed, hiccups, overbreathing, breathing disorder, irritation in the throat,

_*    night blindness,

_*    skin reddening, sensation of hairs standing on end, purplish spots or patches on skin and mucous surfaces of the body, hives,

_*    slow heart beat,

_*    ear discomfort, earorder, ear itchiness, sensitive hearing,

_*    increase in bilirubin (a substance produced by the liver) in the blood, decrease of calcium in the blood, abnormal urine analysis,

_*    low sugar in the blood,

_*    passing urine frequently at night, pain in the kidneys,

_*    self-inflicted injury (eg bite or bruising),

_*    swollen lymph nodes,

*    breast pain or discomfort.

Although the frequency cannot be estimated from the available data, the following events were also reported:

*    allergic reactions (hypersensitivity) including generalized skin rash and itching, rapid-onset swelling (especially around the lips, eyes, or of the tongue), with possible sudden difficulty in breathing, that can be associated with fast heartbeat and thumping heart (anaphylaxis),

_*    heart attack (myocardial infarction),

_*    chest discomfort or pain that is caused by a temporary spasm (constriction) in your coronary arteries (the blood vessels that bring oxygen and nutrients to your heart, i.e. coronary artery spasm).

Reporting of side effects

If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme

at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

[a How to store Frovatriptan

Do not use Frovatriptan 2.5 mg tablets after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Do not store above 30°C.

Store in the original package.

Keep out of the sight and reach of children

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

[£) Contents of the pack and other information

What Frovatriptan contains:

The active substance is 2.5 mg of frovatriptan as succinate monohydrate per tablet. The other ingredients are: anhydrous lactose, microcrystalline cellulose, magnesium stearate, sodium starch glycollate (type A), silica colloidal anhydrous. Film coating: OPADRY white: titanium dioxide (E171), anhydrous lactose, hypromellose (E464), macrogol 3000, triacetin.

What Frovatriptan looks like and contents of the pack

Frovatriptan 2.5 mg tablets are round biconvex white film-coated tablets, debossed with "m" on one side and "2.5" on the other.

Each blister pack contains 6 tablets.

Manufacturer and Licence Holder

This medicine is manufactured by A. Menarini Manufacturing Logistics and Services s.r.l. Via Campo di Pile - L'Aquila, Italy. Procured from within the EU. Product Licence Holder: LTT Pharma Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE. Repackaged by Lexon (UK) Limited, B98 0RE.

If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.

POM PL 33723/0121 Frovatriptan 2.5mg Film-coated tablets. Frovatriptan is a registered trademark of Vernalis Development Limited. Revision date: 25/02/16

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited, Tel: 01527 505414 for help.

Patient Information Leaflet

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

*    Keep this leaflet. You may need to read it again.

*    If you have any further questions, ask your doctor or pharmacist.

*    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

*    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Your medicine is called Frovatriptan 2.5mg Film-coated tablets and will be referred to as Frovatriptan throughout the rest of this leaflet

What is in this leaflet

^ What Frovatriptan is and what it is used for

What you need to know before you take Frovatriptan How to take Frovatriptan ^ Possible side effects

How to store Frovatriptan [m Contents of the pack and other information

^ What Frovatriptan is and what is it used for

Frovatriptan 2.5 mg tablets contain frovatriptan, an anti-migraine treatment belonging to the class of triptans (5-hydroxytryptamine (5HT1) selective receptor agonists). Frovatriptan 2.5 mg tablets is a medicine for the treatment of the headache phase of a migraine attack with or without aura (a temporary strange feeling before a migraine, which varies from person to person but can affect, for example, vision, smell, hearing). Frovatriptan 2.5 mg tablets should not be used to prevent a migraine attack.

Frovatriptan is used to treat migraine attacks in adults.

[2| What you need to know before you take Frovatriptan

The diagnosis of migraine must have been clearly established by your doctor Do not take Frovatriptan

*    If you are allergic to frovatriptan or any of the other ingredients of this medicine (listed in section 6.1).

_*    if you have had a heart attack, or suffer or have suffered from certain cardiovascular diseases such as angina pectoris (characterised by crushing pain in the chest which can extend into the left arm), or circulation disorders of the legs or arms (especially in the fingers and toes),

*    if you have had a stroke or a transient ischaemic attack (TIA),

_*    if you have severely or moderately high blood pressure, or if your blood pressure is not adequately controlled,

_*    if you have severe liver disease,

_*    in combination with certain other medicines also used in the treatment of migraine (ergotamine and ergotamine derivatives (including methysergide) or other triptans (5-hydroxytryptamine (5HT1) agonists).

Warning and precautions

Talk to your doctor before taking Frovatriptan:

if you are a patient at risk of coronary artery disease, including if:

_*    you are a heavy smoker or a user of nicotine substitution therapy

_*    you are a post-menopausal female or a male aged over 40 years

Stop taking Frovatriptan and talk to your doctor right away if you:

_*    experience a feeling of tightness or pain in the chest, shortness of breath and/or pain or discomfort in one or both arms, your back, shoulders, neck, jaw, or upper part of the stomach; these might be symptoms of a heart attack, which can occur when taking triptans, even in patients with no history of cardio-vascular disease (see also section 4).

*    have generalized skin rash and itching, rapid-onset swelling (especially around the lips, eyes, or of the tongue), with possible sudden difficulty in breathing and a fast heartbeat and thumping heart. These are all symptoms and signs of allergy and whole-body hypersensitivity reaction (see also section 4).

Children and adolescents

Do not give this medicine to children and adolescents (under 18 years of age) because the safety and efficacy of Frovatriptan have not been established in these groups.

Other medicines and Frovatriptan

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

You should not take this medicine at the same time as certain other medicines used for the treatment of migraine:

*    especially ergotamine, ergotamine derivatives (including methysergide); you should allow at least 24 hours to elapse between the discontinuation of these medicines and the administration of Frovatriptan 2.5 mg tablets. Similarly, you should not take these medicines within 24 hours following a dose of Frovatriptan 2.5 mg tablets.

*    especially other triptans (5-HT1 agonists, such as sumatriptan, almotriptan, eletriptan, naratriptan, rizatriptan or zolmitriptan).

Unless otherwise directed by your doctor, you should not take this medicine at the same time as monoamine oxidase inhibitor (MAOI) medicines used in the treatment of depression (phenelzine, isocarboxazid, tranylcypromine, moclobemide).

_*    you should also tell your doctor or pharmacist if you are taking oral contraceptives or selective serotonin-reuptake inhibitors (citalopram, fluoxetine, fluvoxamine, paroxetine, sertraline).

It is recommended that you do not take Frovatriptan 2.5 mg tablets at the same time as taking St. John's Wort (hypericum perforatum).

Concomitant use of Frovatriptan with the medicines listed above (especially monoamine oxidase inhibitors, selective serotonin-reuptake inhibitors and hypericum perforatum) may also increase the risk of serotonin syndrome (the symptoms of serotonin syndrome include: shivering, sweating, agitation, trembling and abrupt contraction of muscles, nausea, fever, confusion).

If you have any doubt about taking other medicines with Frovatriptan 2.5 mg tablets, consult your doctor or pharmacist.

Frovatriptan with food and drink

Frovatriptan 2.5 mg tablets can be taken with food or on an empty stomach, always with an adequate amount of water.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Frovatriptan 2.5 mg tablets should not be used during pregnancy or when breast feeding, unless you are told so by your doctor. In any case, you should not breastfeed for 24 hours after taking Frovatriptan and during this time any breast milk expressed should be discarded.

Driving and using machines

Frovatriptan 2.5 mg tablets and the migraine itself can cause drowsiness. If affected, driving or operating machinery can be dangerous and should be avoided.

Frovatriptan contains lactose

This product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to take Frovatriptan

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

Take Frovatriptan 2.5 mg tablets as early as possible after the onset of the migraine headache. Swallow one tablet whole with water.

If the first dose does not give you any relief, do not take a second dose during the same attack. You can use Frovatriptan 2.5 mg tablet for any following attacks. If you obtain relief after the first dose, but later on suffer from the

re-appearance of a headache within 24 hours, you can take a second dose provided that at least 2 hours have elapsed between the 2 doses.

Do not exceed the maximum dose of 5 mg (two tablets) in 24 hours.

Excessive use (repeated use over several consecutive days) of Frovatriptan

2.5 mg tablets constitutes incorrect use of this medicine and may cause an increase in side effects and lead to chronic daily headaches requiring the temporary discontinuation of treatment. Consult your doctor if you start having too frequent or daily headaches as you may be suffering from medication overuse headache.

Use in children and adolescents

Frovatriptan should not be used in patients under 18 years of age.

Older people

As there is little experience in patients over 65 years, the use of Frovatriptan is not recommended in patients in this age group.

If you take more Frovatriptan than you should

If you accidentally take an overdose of this medicine, tell your doctor or pharmacist immediately or go to the emergency department of your nearest hospital. Please remember to take the remaining tablets or this leaflet with you.

Patient Information Leaflet (continued)

If you stop taking Frovatriptan

No special precautions are necessary when stopping the drug.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Frovatriptan and tell your doctor right away if you experience any of the following symptoms:

_*    a feeling of tightness or pain in the chest, shortness of breath and/or pain or discomfort in one or both arms, your back, shoulders, neck, jaw, or upper part of the stomach; these might be symptoms of a heart attack (myocardial infarction), which can occur when taking triptans, even

in patients with no history of cardio-vascular disease;

_*    have generalized skin rash and itching, rapid-onset swelling (especially around the lips, eyes, or of the tongue and mucosa), with possible sudden difficulty in breathing and a fast heartbeat and thumping heart. These are all symptoms and signs of allergy and whole-body hypersensitivity reaction (hypersensitivity reactions, angioedema, anaphylaxis).

The side-effects reported with Frovatriptan 2.5 mg tablets were temporary, generally mild to moderate and disappeared spontaneously. Some symptoms reported may be caused by the migraine itself.

The following side-effects were commonly observed (estimated frequency is more than 1 person out of 100 and less than 1 person out of 10):

*    nausea (feeling sick), dry mouth, digestion problems, stomach pain,

*    fatigue, chest discomfort (sensation of slight heaviness, pressure or tightness in the chest),

*    headache, dizziness, sensation of pins and needles, most frequently in the arms and legs, reduction or disturbance of the sensations of touch, extreme sleepiness,

*    hot flushes,

*    tightness in the throat,

*    sight disturbances,

*    increased sweating.

The following were uncommonly observed (estimated frequency is more than 1 person out of 1000 and less than 1 person out of 100):

_*    altered sense of taste, trembling, poor concentration, lethargy, increased sensation of touch, drowsiness, involuntary muscle contractions,

_*    diarrhoea, difficulty in swallowing, gas in stomach or bowel, stomach discomfort, bloated stomach,

_*    awareness of heart beat (palpitations), fast heart beat, high blood pressure, chest pain (intense tightness or feeling of pressure in the chest),

_*    feeling hot, reduced tolerance of heat and cold, pain, weakness, thirst, sluggishness, increased energy, generally feeling unwell, sensation of spinning,

_*    anxiety, inability to sleep, confusion, nervousness, agitation, depression, loss of sense of personal identity,

_*    coldness in the hands and feet,

_*    irritation of the nose, inflamed sinus, sore throat and/or voice box,

_*    muscle stiffness, muscle and bone pain, pain in the hands and feet, back pain, painful joints,

_*    eye pain, eye irritation, painful oversensitivity to light,

_*    itchiness,

_*    ringing in the ears, earache,

_*    dehydration,

_*    passing urine frequently, production of large amounts of urine.

The following were rare (estimated frequency is more than 1 person out of

10,000 and less than 1 person out of 1000):

_*    muscle spasm, floppy muscles, diminution of reflexes (hyporeflexia), movement problems,

_*    constipation, burping, heartburn, irritable bowel syndrome, lip blisters, lip pain, spasm of the gullet, blisters in the mouth, ulcer in the stomach or upper part of the small intestine, pain in the salivary gland, inflammation of the mouth, toothache,

_*    fever,

_*    loss of memory, abnormal dreams, personality disorder,

_*    nosebleed, hiccups, overbreathing, breathing disorder, irritation in the throat,

_*    night blindness,

_*    skin reddening, sensation of hairs standing on end, purplish spots or patches on skin and mucous surfaces of the body, hives,

_*    slow heart beat,

_*    ear discomfort, earorder, ear itchiness, sensitive hearing,

_*    increase in bilirubin (a substance produced by the liver) in the blood, decrease of calcium in the blood, abnormal urine analysis,

_*    low sugar in the blood,

_*    passing urine frequently at night, pain in the kidneys,

_*    self-inflicted injury (eg bite or bruising),

_*    swollen lymph nodes,

*    breast pain or discomfort.

Although the frequency cannot be estimated from the available data, the following events were also reported:

*    allergic reactions (hypersensitivity) including generalized skin rash and itching, rapid-onset swelling (especially around the lips, eyes, or of the tongue), with possible sudden difficulty in breathing, that can be associated with fast heartbeat and thumping heart (anaphylaxis),

_*    heart attack (myocardial infarction),

_*    chest discomfort or pain that is caused by a temporary spasm (constriction) in your coronary arteries (the blood vessels that bring oxygen and nutrients to your heart, i.e. coronary artery spasm).

Reporting of side effects

If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme

at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

[a How to store Frovatriptan

Do not use Frovatriptan 2.5 mg tablets after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Do not store above 30°C.

Store in the original package.

Keep out of the sight and reach of children

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

[£) Contents of the pack and other information

What Frovatriptan contains:

The active substance is 2.5 mg of frovatriptan as succinate monohydrate per tablet. The other ingredients are: anhydrous lactose, microcrystalline cellulose, magnesium stearate, sodium starch glycollate (type A), silica colloidal anhydrous. Film coating: OPADRY white: titanium dioxide (E171), anhydrous lactose, hypromellose (E464), macrogol 3000, triacetin.

What Frovatriptan looks like and contents of the pack

Frovatriptan 2.5 mg tablets are round biconvex white film-coated tablets, debossed with "m" on one side and "2.5" on the other.

Each blister pack contains 6 tablets.

Manufacturer and Licence Holder

This medicine is manufactured by Laboratorios Menarini S.A Alfonso XII, 587-08918 Barcelona Spain. Procured from within the EU. Product Licence Holder: LTT Pharma Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE. Repackaged by Lexon (UK) Limited, B98 0RE.

If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.

POM PL 33723/0121 Frovatriptan 2.5mg Film-coated tablets. Frovatriptan is a registered trademark of Vernalis Development Limited. Revision date: 25/02/16

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited, Tel: 01527 505414 for help.