Document: document 0 change

• document 0
• document 1

---

Migard® 2.5mg Film-coated Tablets / Frovatriptan 2.5mg Film-coated Tablets

(frovatriptan succinate)

This medicine is known by any of the above names but will be referred to as Migard throughout this leaflet.

Patient Information Leaflet

In this leaflet:

1.    What Migard is and what it is used for

2.    Before you take Migard

3.    How to take Migard

4.    Possible side effects

5.    How to store Migard

6.    Further information

1.    WHAT MIGARD IS AND WHAT IT IS USED FOR

Migard contains frovatriptan, an anti-migraine treatment belonging to the class of triptans (5-hydroxytryptamine (5HT1) selective receptor agonists).

Migard 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 should not be used to prevent a migraine attack.

2.    BEFORE YOU TAKE MIGARD

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

Do not take Migard

•    If you are allergic (hypersensitive) to frovatriptan or any of the other ingredients of Migard.

•    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).

Take special care with 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

In any of these cases ask for your doctor’s advice before taking Migard.

In very rare cases a feeling of tightness or pain in the chest can occur when taking triptans, even in patients with no history of cardio-vascular disease. If this occurs contact your doctor and do not take an additional dose of this medicine.

Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken 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. Similarly, you should not take these medicines within 24 hours following a dose of Migard.

•    especially other triptans (5-HTi 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 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, consult your doctor or pharmacist.

Taking Migard with food and drink

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

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine. Migard 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 and the migraine itself can cause drowsiness. If affected, driving or operating machinery can be dangerous and should be avoided.

Important information about some of the ingredients of Migard

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.

3. HOW TO TAKE MIGARD

Always take Migard exactly as your doctor has told you. You should check with your doctor if you are not sure.

Take Migard 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 for any following attacks.

If you obtain relief after the first dose, but later on suffer from the reappearance 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 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.

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.

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 product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

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

A feeling of tightness or pains in the chest, sometimes intense and potentially extending to the throat, can occur within minutes of taking the medicine; if this occurs contact your doctor and do not take an additional dose of this medicine.

The side-effects reported during clinical studies with Migard 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 exaggeration 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, increased blood pressure, chest pain (intense tightness or feeling of pressure in the chest),

•    feeling hot, reduced tolerance of heat and cold, pain, weakness, fever, thirst, sluggishness, increased energy, generally feeling unwell, foggy head or lightheadedness, 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 joint 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,

•    high blood pressure.

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, sore 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, earache, 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.

There have been cases of allergic reactions to Migard, with skin rash and sometimes serious whole-body allergic-type reactions (anaphylaxis), with possible sudden difficulty in breathing, fast heart beat and palpitations. If this occurs, get medical help immediately.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5.    HOW TO STORE MIGARD

Keep out of the sight and reach of children.

Store in the original package.

Do not store above 30°C.

Do not use this product after the expiry date printed on the carton. Leave your tablets in the blister pack and only remove them when required or when it is time for you to take your medicine.

If you notice that your tablets have become discoloured or show any other signs of deterioration, speak to your doctor or pharmacist. 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.

6.    FURTHER INFORMATION

What Migard contains and looks like

Each film coated tablet contains 2.5 mg frovatriptan (as succinate monohydrate).

Each tablet also contains: Anhydrous lactose, microcrystalline cellulose, magnesium stearate, sodium starch glycollate, silica colloidal anhydrous.

Film coating: OPADRY white OY-L-28906: titanium dioxide (E171), anhydrous lactose, hypromellose (E464), macrogol, triacetin.

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

Migard tablets are supplied in blister packs of either two or six.

Manufactured by Menarini Manufacturing Logistics and Services Srl, Campo Di Pile - L’Aquila, Italy. Procured from within the EU by the Product Licence holder : Caseview (PL) Ltd., 20 Alliance Court, Alliance Road, London W3 0RB. Repackaged by: OPD Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts WD24 4Pr.

PL 13826/1636

Migard

Leaflet revision date (ref) 15/10/2012

To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.