1. what maxalt is and what it is used for

Maxalt belongs to a class of medicines called selective serotonin 5-HT1B/1D receptor agonists.

Maxalt is used to treat the headache phase of the migraine attack in adults.

Treatment with Maxalt:

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 maxalt

Do not take Maxalt if:

• – you are allergic to rizatriptan benzoate or any of the other ingredients of this medicine (listed in Section 6)

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

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

• – you have severe liver or severe kidney problems

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

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

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

• you are now taking ergotamine-type medications, such as ergotamine or dihydro-ergotamine to treat your migraine or methysergide to prevent a migraine attack
• you are taking any other drug in the same class, such as sumatriptan, naratriptan, or zolmitriptan to treat your migraine (see ‘Other medicines and Maxalt’ below).

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

Warnings and precautions

Before you take Maxalt, 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
• you have kidney or liver problems
• you have a particular problem with the way your heartbeats (bundle branch block)
• you have or have had any allergies
• your headache is associated with dizziness, difficulty in walking, lack of co-ordination or weakness in the leg and arm
• you use herbal preparation containing St.John’s wort
• you have had allergic reaction like swelling of face, lips, tongue and/or throat which may cause difficulty breathing and/or swallowing (angioedema)
• you 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
• you have had short lived symptoms including chest pain and tightness

If you take Maxalt 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 Maxalt.

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

Please 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 Maxalt can affect the way some medicines work. Also, other medicines can affect Maxalt.

Other medicines and Maxalt

Do not take Maxalt

• – if you are already taking a 5HT1B/1D agonist (sometimes referred to as ‘triptans’), such as sumatriptan, naratriptan or zolmitriptan.

• – if you are taking 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.

• – if you use ergotamine-type medications such as ergotamine or dihydro-ergotamine to treat your migraine.

• – if you use methysergide to prevent a migraine attack.

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

You should wait at least 6 hours after taking Maxalt 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 Maxalt.

Ask your doctor for instructions and the risks about taking Maxalt

• – if you are taking propranolol (see section 3: ‘

How to take Maxalt’

)

• – if you are taking SSRIs such as sertraline, escitalopram oxalate, and fluoxetine or SNRIs such as venlafaxine, and duloxetine for depression.

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

Maxalt with food and drink

Maxalt 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

If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

It is not known whether Maxalt is harmful to an unborn baby when taken by a pregnant woman. Breast-feeding should be avoided for 24 hours after treatment.

Children and adolescents

The use of Maxalt tablets 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 Maxalt is amongst patients older than 65 years.

Driving or using machines

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

Maxalt contains lactose monohydrate

The 5mg tablet contains 30.25mg of lactose monohydrate and the 10mg tablet contains 60.50mg of lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your

doctor before taking this medicinal product.

3. how to take maxalt

Maxalt is used to treat migraine attacks. Take Maxalt as soon as possible after your migraine headache has started. Do not use it to prevent an attack.

Always take Maxalt exactly as your doctor has told you. You should 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 Maxalt. You should leave at least 2 hours between taking propranolol and Maxalt up to a maximum of 2 doses in a 24-hour period.

Maxalt (rizatriptan benzoate) should be taken by mouth and swallowed whole with liquid.

Maxalt is also available as a 10mg oral lyophilisate that dissolves in the mouth. The oral lyophilisate can be used in situations in which liquids are not available, or to avoid the nausea and vomiting that may accompany the ingestion of tablets with liquids.

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

Do not take more than 2 doses of Maxalt in a 24-hour period, (for example, do not take more than two 10mg or 5mg tablets or oral lyophilisate in a 24-hour period). You should always wait at least 2 hours between doses.

If your condition worsens, seek medical attention.

If you take more Maxalt than you should:

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

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

If you have any 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 adult studies, the most common side effects reported were dizziness, sleepiness and tiredness.

Common (affects 1 to 10 users in 100)

• – tingling (paraesthesia), headache, decreased sensitivity of skin (hypoaesthesia), decreased mental sharpness, insomnia.

• – fast or irregular heartbeat (palpitation).

• – flushing (redness of the face lasting a short time).

• – throat discomfort.

• – feeling sick (nausea), dry mouth, vomiting, diarrhea, indigestion (dyspepsia).

• – feeling of heaviness in parts of the body, neck pain, stiffness.

• – pain in abdomen or chest.

Uncommon (affects 1 to 10 users in 1000)

• – bad taste in your mouth.

• – unsteadiness when walking (ataxia), dizziness (vertigo), blurred vision, tremor, fainting (syncope).

• – confusion, nervousness.

• – high blood pressure (hypertension); thirst, hot flushes, sweating.

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

• – feeling of tightness in parts of the body, muscle weakness.

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

• – facial pain; muscle pain.

Rare (affects 1 to 10 users in 10,000)

• – 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, post-menopausal women, particular problem with the way your heartbeats (bundle branch block)).

• – Slow heartbeat (bradycardia).

Not known (frequency cannot be estimated from the available data):

• – heart attack, spasm of the 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, man over 40 years of age, postmenopausal women, particular problem with the way your heartbeats (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.

Tell your doctor right away if you have symptoms of allergic reactions, serotonin syndrome, heart attack or stroke.

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

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 at:

or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. how to store maxalt

Keep out of the sight and reach of children.

Do not take your tablets after the expiry date which is stated on the carton label after ‘Exp’. The expiry date refers to the last day of that month.

Do not store Maxalt above 30oC.

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

Remember if your doctor tells you to stop taking this medicine, return any unused tablets to your pharmacist for safe disposal. Only keep this medicine if your doctor tells you to.

If your tablets become discoloured or show any signs of deterioration, seek the advice of your pharmacist.

REMEMBER: This medicine is for you. Do not share it with anyone else.

6. contents of the pack and other information

What Maxalt Contains

The active ingredient in Maxalt is rizatriptan (present as rizatriptan benzoate). Each tablet contains 7.265mg rizatriptan benzoate equivalent to 5mg rizatriptan.

Other ingredients: lactose monohydrate, microcrystalline cellulose (E460a), modified starch, red iron oxide (E172) and magnesium stearate (E572).

What Maxalt looks like and contents of pack

Maxalt are pale pink, capsule shaped tablets marked ‘MSD’ on one side and ‘266’ on the other. Each 5mg tablet contains 7.265mg rizatriptan benzoate equivalent to 5mg rizatriptan. The tablets are available in blister packs of 3 or 6 tablets.

Manufactured by:

Merck Sharp & Dohme BV, Waarderweg 39, 2031 BN, Haarlem, The Netherlands.

Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.

Maxalt® 5mg tablets; PL 18799/2077

How can you obtain more information about Maxalt?

This leaflet gives you some of the most important about Maxalt. If you have any questions after you have read it, ask your doctor or pharmacist who can give you further information.

Further information about migraine is available from the following organizations: Migraine Action Association, 4th Floor, 27 East Street Leicester, LE1 6NB, Tel: 0116 275 8317, Fax: 0116 254 2023 and The Migraine Trust, 52–53 Russell Square, London, WC1B 4HP, Tel: 020 7631 6970, Fax: 020 7436 2886

Leaflet date: 12.02.2020

Maxalt is a registered trademark of Merck Sharp & Dohme Corp.

Blind or partially sighted?

PACKAGE LEAFLET: INFORMATION FOR THE USER

Rizatriptan 5mg tablets

(rizatriptan benzoate)

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. 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.

The name of your medicine is Rizatriptan 5mg tablets, but will be referred to as Rizatriptan throughout this leaflet. Please note that this leaflet also contains information about another strength: Rizatriptan 10mg tablets.

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 the other information

1. what rizatriptan is and what it is used for

Rizatriptan belongs to a class of medicines called selective serotonin 5-HT1B/1D receptor agonists.

Rizatriptan is used to treat the headache phase of the migraine attack in adults.

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 this medicine (listed in Section 6)

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

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

• – you have severe liver or severe kidney problems

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

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

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

• you are now taking ergotamine-type medications, such as ergotamine or dihydro-ergotamine to treat your migraine or methysergide to prevent a migraine attack
• you are taking any other drug 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 apply 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
• you have kidney or liver problems
• you have a particular problem with the way your heartbeats (bundle branch block)
• you have or have had any allergies
• your headache is associated with dizziness, difficulty in walking, lack of co-ordination or weakness in the leg and arm
• you use herbal preparation containing St.John’s wort
• you have had allergic reaction like swelling of face, lips, tongue and/or throat which may cause difficulty breathing and/or swallowing (angioedema)
• you 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
• you 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 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.

Please 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.

Other medicines and Rizatriptan

Do not take Rizatriptan

• – if you are already taking a 5HT1B/1D agonist (sometimes referred to as ‘triptans’), such as sumatriptan, naratriptan or zolmitriptan.

• – if you are taking 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.

• – if you use ergotamine-type medications such as ergotamine or dihydro-ergotamine to treat your migraine.

• – if you use 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: ‘

How to take Rizatriptan’

)

• – if you are taking SSRIs such as sertraline, escitalopram oxalate, and fluoxetine or SNRIs such as venlafaxine, and duloxetine for depression.

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

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

If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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.

Children and adolescents

The use of Rizatriptan tablets 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.

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.

Rizatriptan contains lactose monohydrate

The 5mg tablet contains 30.25mg of lactose monohydrate and the 10mg tablet contains 60.50mg of lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your

doctor before taking this medicinal product.

3. how to take rizatriptan

Rizatriptan is used to treat migraine attacks. Take Rizatriptan as soon as possible after your migraine headache has started. Do not use it to prevent an attack.

Always take Rizatriptan exactly as your doctor has told you. You should 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.

Rizatriptan (rizatriptan benzoate) should be taken by mouth and swallowed whole with liquid.

Rizatriptan is also available as a 10mg oral lyophilisate that dissolves in the mouth. The oral lyophilisate can be used in situations in which liquids are not available, or to avoid the nausea and vomiting that may accompany the ingestion of tablets with liquids.

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, (for example, do not take more than two 10mg or 5mg tablets or oral lyophilisate in a 24-hour period). You should always wait at least 2 hours between doses.

If your condition worsens, seek medical attention.

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 overdosage can include dizziness, drowsiness, vomiting, fainting and slow heart rate.

If you have any 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 adult studies, the most common side effects reported were dizziness, sleepiness and tiredness.

Common (affects 1 to 10 users in 100)

• – tingling (paraesthesia), headache, decreased sensitivity of skin (hypoaesthesia), decreased mental sharpness, insomnia.

• – fast or irregular heartbeat (palpitation).

• – flushing (redness of the face lasting a short time).

• – throat discomfort.

• – feeling sick (nausea), dry mouth, vomiting, diarrhea, indigestion (dyspepsia).

• – feeling of heaviness in parts of the body, neck pain, stiffness.

• – pain in abdomen or chest.

Uncommon (affects 1 to 10 users in 1000)

• – bad taste in your mouth.

• – unsteadiness when walking (ataxia), dizziness (vertigo), blurred vision, tremor, fainting (syncope).

• – confusion, nervousness.

• – high blood pressure (hypertension); thirst, hot flushes, sweating.

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

• – feeling of tightness in parts of the body, muscle weakness.

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

• – facial pain; muscle pain.

Rare (affects 1 to 10 users in 10,000)

• – 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, post-menopausal women, particular problem with the way your heartbeats (bundle branch block)).

• – Slow heartbeat (bradycardia).

Not known (frequency cannot be estimated from the available data):

• – heart attack, spasm of the 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, man over 40 years of age, postmenopausal women, particular problem with the way your heartbeats (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.

5. how to store rizatriptan

Keep out of the sight and reach of children.

Do not take your tablets after the expiry date which is stated on the carton label after ‘Exp’. The expiry date refers to the last day of that month.

Do not store Rizatriptan above 30oC.

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

Remember if your doctor tells you to stop taking this medicine, return any unused tablets to your pharmacist for safe disposal. Only keep this medicine if your doctor tells you to.

If your tablets become discoloured or show any signs of deterioration, seek the advice of your pharmacist.

REMEMBER: This medicine is for you. Do not share it with anyone else.

6. contents of the pack and other information

What Rizatriptan contains

The active ingredient in Maxalt is Rizatriptan (present as rizatriptan benzoate). Each tablet contains 7.265mg rizatriptan benzoate equivalent to 5mg rizatriptan.

Other ingredients: lactose monohydrate, microcrystalline cellulose (E460a), modified starch, red iron oxide (E172) and magnesium stearate (E572).

What Rizatriptan looks like and contents of pack

Rizatriptan are pale pink, capsule shaped tablets marked ‘MSD’ on one side and ‘266’ on the other. Each 5mg tablet contains 7.265mg rizatriptan benzoate equivalent to 5mg rizatriptan. The tablets are available in blister packs of 3 or 6 tablets.

Manufactured by:

Merck Sharp & Dohme BV, Waarderweg 39, 2031 BN, Haarlem, Netherlands.

Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.

Rizatriptan 5mg tablets PL 18799/2077

How can you obtain more information about Rizatriptan?

This leaflet gives you some of the most important about Rizatriptan. if you have any questions after you have read it, ask your doctor or pharmacist who can give you further information.

Further information about migraine is available from the following organizations: Migraine Action Association, 4th Floor, 27 East Street Leicester, LE1 6NB, Tel: 0116 275 8317, Fax: 0116 254 2023 and The Migraine Trust, 52–53 Russell Square, London, WC1B 4HP, Tel: 020 7631 6970, Fax: 020 7436 2886

Leaflet date: 12.02.2020

Blind or partially sighted?

PACKAGE LEAFLET: INFORMATION FOR THE USER

Rizatriptan 5mg tablets

(rizatriptan benzoate)

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. 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.

The name of your medicine is Rizatriptan 5mg tablets, but will be referred to as Rizatriptan throughout this leaflet. Please note that this leaflet also contains information about another strength: Rizatriptan 10mg tablets.

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 the other information

1. what rizatriptan is and what it is used for

Rizatriptan belongs to a class of medicines called selective serotonin 5-HT1B/1D receptor agonists.

Rizatriptan is used to treat the headache phase of the migraine attack in adults.

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 this medicine (listed in Section 6)

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

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

• – you have severe liver or severe kidney problems

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

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

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

• you are now taking ergotamine-type medications, such as ergotamine or dihydro-ergotamine to treat your migraine or methysergide to prevent a migraine attack
• you are taking any other drug 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 apply 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
• you have kidney or liver problems
• you have a particular problem with the way your heartbeats (bundle branch block)
• you have or have had any allergies
• your headache is associated with dizziness, difficulty in walking, lack of co-ordination or weakness in the leg and arm
• you use herbal preparation containing St.John’s wort
• you have had allergic reaction like swelling of face, lips, tongue and/or throat which may cause difficulty breathing and/or swallowing (angioedema)
• you 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
• you 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 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.

Please 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.

Other medicines and Rizatriptan

Do not take Rizatriptan

• – if you are already taking a 5HT1B/1D agonist (sometimes referred to as ‘triptans’), such as sumatriptan, naratriptan or zolmitriptan.

• – if you are taking 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.

• – if you use ergotamine-type medications such as ergotamine or dihydro-ergotamine to treat your migraine.

• – if you use 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: ‘

  How to take Rizatriptan’

  )

• – if you are taking SSRIs such as sertraline, escitalopram oxalate, and fluoxetine or SNRIs such as venlafaxine, and duloxetine for depression.

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

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

If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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.

Children and adolescents

The use of Rizatriptan tablets 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.

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.

Rizatriptan contains lactose monohydrate

The 5mg tablet contains 30.25mg of lactose monohydrate and the 10mg tablet contains 60.50mg of lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your

doctor before taking this medicinal product.

3. how to take rizatriptan

Rizatriptan is used to treat migraine attacks. Take Rizatriptan as soon as possible after your migraine headache has started. Do not use it to prevent an attack.

Always take Rizatriptan exactly as your doctor has told you. You should 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.

Rizatriptan (rizatriptan benzoate) should be taken by mouth and swallowed whole with liquid.

Rizatriptan is also available as a 10mg oral lyophilisate that dissolves in the mouth. The oral lyophilisate can be used in situations in which liquids are not available, or to avoid the nausea and vomiting that may accompany the ingestion of tablets with liquids.

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, (for example, do not take more than two 10mg or 5mg tablets or oral lyophilisate in a 24-hour period). You should always wait at least 2 hours between doses.

If your condition worsens, seek medical attention.

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 overdosage can include dizziness, drowsiness, vomiting, fainting and slow heart rate.

If you have any 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 adult studies, the most common side effects reported were dizziness, sleepiness and tiredness.

Common (affects 1 to 10 users in 100)

• – tingling (paraesthesia), headache, decreased sensitivity of skin (hypoaesthesia), decreased mental sharpness, insomnia.

• – fast or irregular heartbeat (palpitation).

• – flushing (redness of the face lasting a short time).

• – throat discomfort.

• – feeling sick (nausea), dry mouth, vomiting, diarrhea, indigestion (dyspepsia).

• – feeling of heaviness in parts of the body, neck pain, stiffness.

• – pain in abdomen or chest.

Uncommon (affects 1 to 10 users in 1000)

• – bad taste in your mouth.

• – unsteadiness when walking (ataxia), dizziness (vertigo), blurred vision, tremor, fainting (syncope).

• – confusion, nervousness.

• – high blood pressure (hypertension); thirst, hot flushes, sweating.

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

• – feeling of tightness in parts of the body, muscle weakness.

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

• – facial pain; muscle pain.

Rare (affects 1 to 10 users in 10,000)

• – 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, post-menopausal women, particular problem with the way your heartbeats (bundle branch block)).

• – Slow heartbeat (bradycardia).

Not known (frequency cannot be estimated from the available data):

• – heart attack, spasm of the 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, man over 40 years of age, postmenopausal women, particular problem with the way your heartbeats (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.