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• leaflet MAH GENERIC_PL 35533-0005

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Package leaflet: Information for the user Rizatriptan 5mg tablets Rizatriptan 10mg tablets

Rizatriptan

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 further questions, ask your doctor or pharmacist.
—	This medicine has been prescribed for you only. Do not pass it on to others. even if their symptoms are the same as yours.	It may harm them,
	If you get any side effects, talk to your doctor or pharmacist. This includes effects not listed in this leaflet. See section 4.	any possible side
What is in this leaflet:
1.	What Rizatriptan is and what it is used for
2.	What you need to know before you take Rizatriptan
3.	How to take Rizatriptan
4.	Possible side effects
5.	How to store Rizatriptan
6.	Contents of the pack and other information
1.	What Rizatriptan is and what is it used for

Rizatriptan belongs to a class of medicines called selective serotonin 5-HT_{IB/ID r}ecepto_{r a}go_nists.

Your doctor has prescribed Rizatriptan to treat the headache phase of your migraine attack. Do not use it to prevent an attack.

Treatment with Rizatriptan reduces swelling of blood vessels surrounding the brain. This swelling results in the headache pain of a migraine attack.

2. What you need to know before you take Rizatriptan

Do not take Rizatriptan if you:

•    are allergic to rizatriptan benzoate or any of the other ingredients of Rizatriptan (listed in section 6)

•    have moderately severe or severe high blood pressure, or mild high blood pressure that is not controlled by medication

•    have or have ever had heart problems including heart attack or pain on the chest(angina) or you have experienced heart disease related signs

•    have severe liver or severe kidney problems

•    have had a stroke (cerebrovascular accident CVA) or mini stroke (transient ischaemic attack TIA)

•    have blockage problems with your arteries (peripheral vascular disease)

•    are taking monoamine oxidase (MAO) inhibitors such as moclobemide, phenelzine, tranylcypromine, or pargyline (medicines against depression), or linezolid (an antibiotic), or if it has been less than two weeks since you stopped taking MAO inhibitors

•    are now taking ergotamine-type medicines, such as ergotamine or dihydro-ergotamine to treat your migraine or methysergide to prevent a migraine attack

•    are taking any other medicine in the same class, such as sumatriptan, naratriptan or zolmitriptan to treat your migraine. (See Other medicines and Rizatriptan below)

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking

Rizatriptan.

Warnings and precautions

Before you take Rizatriptan tell your doctor or pharmacist if you:

•    have any of the following risk factors for heart disease: high blood pressure, diabetes, you smoke or you are using nicotine substitution, your family has a history of heart disease, you are a man over 40 years of age, or you are a post-menopausal woman

•    have kidney or liver problems

•    have a particular problem with the way your heart beats (bundle branch block)

•    have or have had any allergies.

•    have headaches associated with dizziness, difficulty in walking, lack of co-ordination or weakness in the leg and arm

•    use any herbal preparation containing St. John’s Wort

•    have had an allergic reaction like swelling of the face, lips, tongue and/or throat which may cause difficulty breathing and/or swallowing (angioedema).

•    are taking selective serotonin reuptake inhibitors (SSRIs) such as sertraline, escitalopram oxalate, and fluoxetine or serotonin norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine, and duloxetine for depression.

•    have had short lived symptoms including chest pain and tightness.

If you take Rizatriptan too often this may result in you getting a chronic headache. In such cases you should contact your doctor as you may have to stop taking Rizatriptan.

Please tell your doctor or pharmacist about your symptoms. Your doctor will decide if you have a migraine. You should take Rizatriptan only for a migraine attack. Rizatriptan should not be used to treat headaches that might be caused by other, more serious conditions.

Other medicines and Rizatriptan

Tell your doctor if you are taking or have recently taken or plan to take, any other medicines including medicines obtained without a prescription. This includes herbal medicines and those you normally take for a migraine. This is because Rizatriptan can affect the way some medicines work. Also other medicines can affect Rizatriptan.

Do not take Rizatriptan if you are taking:

•    a 5HTib/id agonist (sometimes referred to as ‘triptans’), such as sumatriptan, naratriptan or zolmitriptan.

•    a monoamine oxidase (MAO) inhibitor such as moclobemide, phenelzine, tranylcypromine, linezolid, or pargyline or if it has been less than two weeks since you stopped taking an MAO inhibitor.

•    ergotamine-type medications such as ergotamine or dihydro-ergotamine to treat your migraine

•    methysergide to prevent a migraine attack.

The above listed medicines when taken with Rizatriptan may increase the risk of side effects.

You should wait at least 6 hours after taking Rizatriptan before you take ergotamine- type medications such as ergotamine or dihydro-ergotamine or methysergide.

You should wait at least 24 hours after taking ergotamine-type medications before taking Rizatriptan.

Ask your doctor for instructions and the risks about taking Rizatriptan if you are taking:

•    propranolol (see section 3)

•    SSRIs such as sertraline, escitalopram oxalate, and fluoxetine or

•    SNRIs such as venlafaxine, and duloxetine for depression.

Taking Rizatriptan with food and drink:

Rizatriptan can take longer to work if it is taken after food. Although it is better to take it on an empty stomach, you can still take it if you have eaten.

Pregnancy and breast-feeding

It is not known whether Rizatriptan is harmful to an unborn baby when taken by a pregnant woman.

Breast-feeding should be avoided for 24 hours after treatment.

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.

Driving or using machines

You may feel sleepy or dizzy while taking Rizatriptan. If this happens, do not drive or use any tools or machines.

3.    How to take Rizatriptan

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

The usual dose is 10 mg.

If you are currently taking propranolol or have kidney or liver problems you should use the 5 mg dose of Rizatriptan. You should leave at least 2 hours between taking propranolol and Rizatriptan up to a maximum of 2 doses in a 24-hour period.

Take Rizatriptan as soon as possible after your migraine has started.

•    Oral use.

•    Rizatriptan tablets should be taken by mouth and swallowed whole with liquid. The tablets are not intended to be divided.

If migraine returns within 24 hours

In some patients, migraine symptoms can return within a 24-hour period. If your migraine does return you can take an additional dose of Rizatriptan. You should always wait at least 2 hours between doses.

If after 2 hours you still have migraine

If you do not respond to the first dose of Rizatriptan during an attack, you should not take a second dose of Rizatriptan for treatment of the same attack. It is still likely, however, that you will respond to Rizatriptan during the next attack.

Do not take more than 2 doses of Rizatriptan in a 24-hour period. You should always wait at least 2 hours between doses.

If your condition worsens, seek medical attention.

Use in children and adolescents

The use of Rizatriptan in children under 18 years of age is not recommended.

Use in patients older than 65 years

There have been no full studies to look at how safe and effective Rizatriptan is amongst patients older than 65 years.

If you take more Rizatriptan than you should:

If you take more Rizatriptan than you should, talk to your doctor or pharmacist straight away. Take the medicine pack with you.

Signs of overdose can include dizziness, drowsiness, vomiting, fainting and slow heart rate.

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

4.    Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine.

In studies, the most common side effects reported were dizziness, sleepiness and tiredness.

Tell your doctor right away if you have symptoms of allergic reactions, serotonin syndrome, heart attack or stroke (see the list below).

In addition, tell your doctor if you experience any symptoms that suggest an allergic reaction (such as a rash or itching) after taking Rizatriptan.

Common: may affect up to 1 in 10people

•    tingling (paraesthesia), headache, decreased sensitivity of skin (hypaesthesia), decreased mental sharpness, tremor,

•    fast or irregular heart beat (palpitation), very fast heartbeat (tachycardia),

•    flushing (redness of the face lasting a short time), hot flushes, sweating,

•    throat discomfort, difficulty breathing (dyspnoea),

•    feeling sick (nausea), dry mouth, vomiting, diarrhoea,

•    feeling of heaviness in parts of the body,

•    pain in abdomen or chest

Uncommon: may affect up to 1 in 100people

•    bad taste in your mouth,

•    unsteadiness when walking (ataxia), dizziness (vertigo), blurred vision,

•    confusion, insomnia, nervousness,

•    high blood pressure (hypertension); thirst, indigestion (dyspepsia),

•    rash, itching and lumpy rash (hives), swelling of face, lips, tongue and/or throat which may cause difficulty in breathing and/or swallowing (angioedema)

•    neck pain, feeling of tightness in parts of the body, stiffness, muscle weakness

•    changes in rhythm or rate of the heartbeat (arrhythmia); abnormalities of the electrocardiogram (a test that records the electrical activity of your heart).

•    Facial pain; muscle pain.

Rare: may affect up to 1 in 1000people

•    fainting (syncope)

•    wheezing

•    allergic reaction (hypersensitivity);    sudden    life-threatening allergic reaction (anaphylaxis).

•    stroke (this generally occurs in patients with    risk    factors for heart and blood vessel    disease (high

blood pressure, diabetes, smoking, use of nicotine substitution, family history of heart disease or stroke, man over 40 years of age, postmenopausal women, particular problem with the way your heart beats [bundle branch block])

•    slow heartbeat (bradycardia)

Not known: frequency cannot be estimated from the available data

•    heart attack, spasm of blood vessels of the heart. These generally occur in patients with risk factors for heart and blood vessel disease (high blood pressure, diabetes, smoking, use of nicotine substitution, family history of heart disease or stroke, men over 40 years of age, post-menopausal women, particular problem with the way your heart beats [bundle branch block]).

•    a syndrome called “serotonin syndrome” that may cause side effects like coma, unstable blood pressure, extremely high body temperature, lack of muscle co-ordination, agitation, and hallucinations

•    severe shedding of the skin with or without fever (toxic epidermal necrolysis)

•    seizure (convulsions/fits)

•    spasm of blood vessels of the extremities including coldness and numbness of the hands or feet

•    spasm of the blood vessels of the colon (large bowel), which can cause abdominal pain.

Reporting of side effects

If you get any side effects, talk to your doctor pharmacist. This includes any possible side effects not

listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (website:

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 Rizatriptan

Keep out of the sight and reach of children.

Do not use Rizatriptan after the expiry date which is stated on the container after EXP. The expiry date refers to the last day of the month.

Do not store above 30^oC.

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.    Contents of the pack and other information What Rizatriptan contains

The active substance is rizatriptan.

One Rizatriptan 5mg tablet contains 5mg rizatriptan as 7.26 mg of rizatriptan benzoate.

One Rizatriptan 10mg tablet contains 10mg rizatriptan as 14.53 mg of rizatriptan benzoate.

The other ingredients are: microcrystalline cellulose, maize starch, pregelatinised, starch (maize), iron oxide red (E172), magnesium stearate.

What Rizatriptan looks like and contents of pack

5mg tablets are pale pink, round biconvex tablets with dimensions 6.0±0.1mm and 3.0±0.2mm in thickness.

10mg tablets are pale pink, round biconvex tablets, with a score line in one side and dimensions 8.0±0.1mm and 3.5±0.2mm in thickness.

Pack sizes: Packs with 2, 3, 6, 12 or 18 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

Aspire Pharma Ltd Bellamy House Winton Road Petersfield Hampshire GU32 3HA United Kingdom

Manufacturer:

Pharmathen S.A.

6 Dervenakion str 15351 Pallini Attiki Greece

Or

Pharmathen International S.A

Industrial Park Sapes Rodopi Prefecture Block No 5 Rodopi 69300 Greece

This leaflet was last revised in 05/2014

Package Leaflet: Information for the User

Rizatriptan 5mg tablets Rizatriptan 10mg tablets

Rizatriptan

Read all ofthis 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 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 symptoms 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:

1.    What Rizatriptan is and what it is used for

2.    What you need to know before you take Rizatriptan

3.    How to take Rizatriptan

4.    Possible side effects

5.    How to store Rizatriptan

6.    Contents of the pack and other information

1.    What Rizatriptan is and what it is used for

Rizatriptan belongs to a class of medicines called selective serotonin 5-HTib/id receptor agonists.

Your doctor has prescribed Rizatriptan to treat the headache phase of your migraine attack. Do not use it to prevent an attack.

Treatment with Rizatriptan reduces swelling of blood vessels surrounding the brain. This swelling results in the headache pain of a migraine attack.

2.    What you need to know before you take Rizatriptan

Do not take Rizatriptan if you:

•    are allergic to rizatriptan benzoate or any of the other ingredients of Rizatriptan (listed in section 6)

•    have moderately severe or severe high blood pressure, or mild high blood pressure that is not controlled by medication

•    have or have ever had heart problems including heart attack or pain on the chest (angina) or you have experienced heart disease related signs

•    have severe liver or severe kidney problems

•    have had a stroke (cerebrovascular accident CVA) or mini stroke (transient ischaemic attack TIA)

•    have blockage problems with your arteries (peripheral vascular disease)

•    are taking monoamine oxidase (MAO) inhibitors such as moclobemide, phenelzine, tranylcypromine, or pargyline (medicines against depression), or linezolid (an antibiotic), or if it has been less than two weeks since you stopped taking MAO inhibitors

•    are now taking ergotamine-type medicines, such as ergotamine or dihydro-ergotamine to treat your migraine or methysergide to prevent a migraine attack

•    are taking any other medicine in the same class, such as sumatriptan, naratriptan or zolmitriptan to treat your migraine. (See Other medicines and Rizatriptan below)

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Rizatriptan.

Warnings and precautions

Before you take Rizatriptan tell your doctor or pharmacist if you:

•    have any of the following risk factors for heart disease: high blood pressure, diabetes, you smoke or you are using nicotine substitution, your family has a history of heart disease, you are a man over 40 years of age, or you are a post-menopausal woman

•    have kidney or liver problems

•    have a particular problem with the way your heart beats (bundle branch block)

•    have or have had any allergies

•    have headaches associated with dizziness, difficulty in walking, lack of co-ordination or weakness in the leg and arm

•    use any herbal preparation containing St. John's Wort

•    have had an allergic reaction like swelling of the face, lips, tongue and/or throat which may cause difficulty breathing and/or swallowing (angioedema)

•    are taking selective serotonin reuptake inhibitors (SSRIs) such as sertraline, escitalopram oxalate, and fluoxetine or serotonin norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine, and duloxetine for depression

•    have had short lived symptoms including chest pain and tightness

If you take Rizatriptan too often this may result in you getting a chronic headache. In such cases you should contact your doctor as you may have to stop taking Rizatriptan.

Please tell your doctor or pharmacist about your symptoms. Your doctor will decide if you have a migraine. You should take Rizatriptan only for a migraine attack. Rizatriptan should not be used to treat headaches that might be caused by other, more serious conditions. Other medicines and Rizatriptan

Tell your doctor if you are taking or have recently taken or plan to take, any other medicines including medicines obtained without a prescription. This includes herbal medicines and those you normally take for a migraine. This is because Rizatriptan can affect the way some medicines work. Also other medicines can affect Rizatriptan.

Do not take Rizatriptan if you are taking:

•    a 5-HTib/id agonist (sometimes referred to as ‘triptans'), such as sumatriptan, naratriptan or zolmitriptan.

•    a monoamine oxidase (MAO) inhibitor such as moclobemide, phenelzine, tranylcypromine, linezolid, or pargyline or if it has been less than two weeks since you stopped taking a MAO inhibitor.

•    ergotamine-type medications such as ergotamine or dihydro-ergotamine to treat your migraine

•    methysergide to prevent a migraine attack.

The above listed medicines when taken with Rizatriptan may increase the risk of side effects.

You should wait at least 6 hours after taking Rizatriptan before you take ergotamine- type medications such as ergotamine or dihydro-ergotamine or methysergide.

You should wait at least 24 hours after taking ergotamine-type medications before taking Rizatriptan.

Ask your doctor for instructions and the risks about taking Rizatriptan if you are taking:

•    propranolol (see section 3)

•    SSRIs such as sertraline, escitalopram oxalate, and fluoxetine or

•    SNRIs such as venlafaxine, and duloxetine for depression.

Taking Rizatriptan with food and drink

Rizatriptan can take longer to work if it is taken after food. Although it is better to take it on an empty stomach, you can still take it if you have eaten.

Pregnancy and breast-feeding

It is not known whether Rizatriptan is harmful to an unborn baby when taken by a pregnant woman.

Breast-feeding should be avoided for 24 hours after treatment.

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.

Driving or using machines

You may feel sleepy or dizzy while taking Rizatriptan. If this happens, do not drive or use any tools or machines.

3. How to take Rizatriptan

Always take this medicine exactly as your doctor has told you.

Check with your doctor or your pharmacist if you are not sure.

The usual dose is 10mg.

If you are currently taking propranolol or have kidney or liver problems you should use the 5mg dose of Rizatriptan. You should leave at least 2 hours between taking propranolol and Rizatriptan up to a maximum of 2 doses in a 24-hour period.

Take Rizatriptan as soon as possible after your migraine has started.

•    Oral use

•    Rizatriptan tablets should be taken by mouth and swallowed whole with liquid. The tablets are not intended to be divided.

If migraine returns within 24 hours

In some patients, migraine symptoms can return within a 24-hour period. If your migraine does return you can take an additional dose of Rizatriptan. You should always wait at least 2 hours between doses. If after 2 hours you still have a migraine

If you do not respond to the first dose of Rizatriptan during an attack, you should not take a second dose of Rizatriptan for treatment of the same attack. It is still likely, however, that you will respond to Rizatriptan during the next attack.

Do not take more than 2 doses of Rizatriptan in a 24-hour period. You should always wait at least 2 hours between doses.

If your condition worsens, seek medical attention.

Use in children and adolescents

The use of Rizatriptan in children under 18 years of age is not recommended.

Use in patients older than 65 years

There have been no full studies to look at how safe and effective Rizatriptan is amongst patients older than 65 years.

If you take more Rizatriptan than you should

If you take more Rizatriptan than you should, talk to your doctor or pharmacist straight away. Take the medicine pack with you.

Signs of overdose can include dizziness, drowsiness, vomiting, fainting and slow heart rate.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine.

In studies, the most common side effects reported were dizziness, sleepiness and tiredness.

Tell your doctor right away if you have symptoms of allergic reactions, serotonin syndrome, heart attack or stroke (see the list below).

In addition, tell your doctor if you experience any symptoms that suggest an allergic reaction (such as a rash or itching) after taking Rizatriptan.

Common: may affect up to 1 in 10 people

•    tingling (paraesthesia), headache, decreased sensitivity of skin (hypaesthesia), decreased mental sharpness, tremor,

•    fast or irregular heartbeat (palpitation), very fast heartbeat (tachycardia),

•    flushing (redness of the face lasting a short time), hot flushes, sweating,

•    throat discomfort, difficulty breathing (dyspnoea),

•    feeling sick (nausea), dry mouth, vomiting, diarrhoea,

•    feeling of heaviness in parts of the body,

•    pain in abdomen or chest

Uncommon: may affect up to 1 in 100 people

•    bad taste in your mouth,

•    unsteadiness when walking (ataxia), dizziness (vertigo), blurred vision,

•    confusion, insomnia, nervousness,

•    high blood pressure (hypertension); thirst, indigestion (dyspepsia),

•    rash, itching and lumpy rash (hives), swelling of face, lips, tongue and/or throat which may cause difficulty breathing and/or swallowing (angioedema)

•    neck pain, feeling of tightness in parts of the body, stiffness, muscle weakness

•    changes in rhythm or rate of the heartbeat (arrhythmia); abnormalities of the electrocardiogram (a test that records the electrical activity of your heart).

•    facial pain; muscle pain.

Rare: may affect up to 1 in 1000 people

•    fainting (syncope),

•    wheezing.

•    allergic reaction (hypersensitivity); sudden life-threatening allergic reaction (anaphylaxis).

•    stroke (this generally occurs in patients with risk factors for heart and blood vessel disease (high blood pressure, diabetes, smoking, use of nicotine substitution, family history of heart disease or stroke, men over 40 years of age, postmenopausal women, particular problem with the way your heart beats [bundle branch block]).

•    slow heartbeat (bradycardia).

Not known: frequency cannot be estimated from the available data

•    heart attack, spasm of blood vessels of the heart. These generally occur in patients with risk factors for heart and blood vessel disease (high blood pressure, diabetes, smoking, use of nicotine substitution, family history of heart disease or stroke, men over 40 years of age, post-menopausal women, particular problem with the way your heart beats [bundle branch block]).

•    a syndrome called ‘serotonin syndrome' that may cause side effects like coma, unstable blood pressure, extremely high body temperature, lack of muscle co-ordination, agitation, and hallucinations.

•    severe shedding of the skin with or without fever (toxic epidermal necrolysis).

•    seizure (convulsions/fits).

•    spasm of blood vessels of the extremities including coldness and numbness of the hands or feet.

•    spasm of the blood vessels of the colon (large bowel), which can cause abdominal pain.

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 the Yellow Card Scheme (website: 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 Rizatriptan

Keep out of the sight and reach of children.

Do not use Rizatriptan after the expiry date which is stated on the container after EXP. The expiry date refers to the last day of the month. Do not store above 30°C.

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.    Contents of the pack and other information

What Rizatriptan contains

The active substance is rizatriptan.

One Rizatriptan 5mg tablet contains 5mg rizatriptan as 7.26mg of rizatriptan benzoate.

One Rizatriptan 10mg tablet contains 10mg rizatriptan as 14.53mg of rizatriptan benzoate.

The other ingredients are: microcrystalline cellulose, maize starch, pregelatinised, starch (maize), iron oxide red (E172), magnesium stearate.

What Rizatriptan looks like and contents of pack

5mg tablets are pale pink, round biconvex tablets with dimensions 6.0±0.1mm and 3.0±0.2mm in thickness.

10mg tablets are pale pink, round biconvex tablets, with a score line in one side and dimensions 8.0±0.1mm and 3.5±0.2mm in thickness. Pack sizes: Packs with 2, 3, 6, 12 or 18 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:

Aspire Pharma Ltd Bellamy House,

Winton Road,

Petersfield,

Hampshire,

GU32 3HA,

United Kingdom Manufacturer:

Pharmathen S.A.

6 Dervenakion str,

15351 Pallini, Attiki,

Greece

or

Pharmathen International S.A Industrial Park Sapes,

Rodopi Prefecture, Block No 5,

Rodopi 69300,

Greece

This leaflet was last revised in

05/2014

1010072-P4.1