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PACKAGE LEAFLET: INFORMATION FOR THE USER

RIZATRIPTAN 10 mg ORODISPERSIBLE 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 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:

1.    What Rizatriptan Orodispersible Tablets are and what they are used for.

2.    What you need to know before you take Rizatriptan Orodispersible Tablets.

3.    How to take Rizatriptan Orodispersible Tablets.

4.    Possible side effects.

5.    How to store Rizatriptan Orodispersible Tablets.

6.    Contents of the pack and other information.

1. WHAT RIZATRIPTAN ORODISPERSIBLE TABLETS ARE AND WHAT THEY ARE USED FOR

Rizatriptan belongs to a group of medicines called selective serotonin (5-HT_1B/1D) receptor agonists that are used to treat migraine attacks in adults.

Migraine symptoms may be caused by the temporary widening of blood vessels in the head. Rizatriptan is believed to reduce the widening of these blood vessels.

Rizatriptan is used only in the treatment of migraine headaches, with or without aura (warning signs). It should not be used for the prevention of headaches.

2.    WHAT YOU NEED TO KNOW BEFORE YOU TAKE RIZATRIPTAN ORODISPERSIBLE TABLETS

Do not take Rizatriptan Orodispersible Tablets:

•    if you are allergic to rizatriptan or to any of the other ingredients of this medicine (listed in section 6)

•    if you have severe liver or severe kidney problems

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

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

•    if 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

•    if you suffer from reduced blood flow to your arms and/or legs due to narrow or blocked arteries (Peripheral Vascular Disease)

•    if 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 Orodispersible Tablets below)

•    if 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

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

If you are not sure whether any of the above applies to you, ask your pharmacist or your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Rizatriptan Orodispersible Tablets:

•    if your headache is associated with dizziness, difficulty in walking, lack of co-ordination or weakness in the leg and arm

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

•    if you use herbal preparation containing St. John's wort

•    you have kidney or liver problems

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

•    you have or have had any allergies

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

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

Children and adolescents

The use of Rizatriptan Orodispersible Tablets in children and adolescents 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 Orodispersible Tablets is amongst patients older than 65 years.

Other medicines and Rizatriptan Orodispersible Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

This is because Rizatriptan Orodispersible Tablets can affect the way some medicines work.

Also, other medicines can affect Rizatriptan Orodispersible Tablets.

Do not take Rizatriptan Orodispersible Tablets:

•    if you are already taking a 5-HT_1B/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 Orodispersible Tablets may increase the risk of side effects.

You must wait at least six hours following use of rizatriptan before taking ergotamine-type medications (e.g. ergotamine, dihydroergotamine or methysergide).

You must wait at least 24 hours after the administration of an ergotamine-containing preparation before the administration of rizatriptan.

Ask your doctor for instructions and the risks about taking Rizatriptan Orodispersible Tablets:

•    if you are currently taking propranolol to lower blood pressure (see section 3)

•    if you are taking selective serotonin uptake inhibitors (SSRIs) e.g. sertraline, escitalopram oxalate, citalopram, fluoxetine, paroxetine, or serotonin noradrenaline uptake inhibitors (SNRIs) e.g. venlafaxine, duloxetine for depression.

Rizatriptan Orodispersible Tablets with food and drink

Rizatriptan works best on an empty stomach. You can still take it though when you have eaten but it can take longer to work.

Rizatriptan Orodispersible Tablets need not be taken with liquid.

Pregnancy and breast-feeding

If you are pregnant or breastfeeding, think you may be pregnant or are 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.

Rizatriptan is excreted in the breast milk. Do not breast-feed for 24 hours after taking Rizatriptan Orodispersible Tablets.

Driving and using machines Rizatriptan can make you feel sleepy or dizzy, in which case you should not drive or use any tools or machines.

Rizatriptan Orodispersible Tablets contain aspartame.

This medicine contains aspartame, a source of phenylalanine. This may be harmful to people with phenylketonuria.

3. HOW TO TAKE RIZATRIPTAN ORODISPERSIBLE TABLETS

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

Rizatriptan Orodispersible Tablets are used to treat migraine attacks in adults. Take Rizatriptan Orodispersible Tablets as soon as possible after your migraine headache has started. Do not use it to prevent an attack.

Adults (between 18 - 65 years)

The amount of Rizatriptan Orodispersible Tablets you take is called the dose.

The recommended dose is 10 mg.

If you are taking propranolol to lower your blood pressure, or have mild or moderate problems with your kidney or liver your doctor will tell you to take a lower (5 mg) dose. If you are taking propranolol, you must not take Rizatriptan Orodispersible Tablets within 2 hours of taking your propranolol.

If you still have a migraine after 2 hours

If the first dose of Rizatriptan Orodispersible Tablets did not relieve your migraine

DO NOT take a second dose for treatment of the same attack. However, there is a possibility that Rizatriptan Orodispersible Tablets may help the next time you have a migraine.

If migraine returns within 24 hours In some patients, migraine symptoms can return within a 24-hour period. If you responded to the first dose but your migraine symptoms return within 24 hours, you can take an additional dose of Rizatriptan Orodispersible Tablets. You should always wait at least 2 hours between doses.

DO NOT take more than 2 tablets of Rizatriptan Orodispersible Tablets within 24 hours, (for example, do not take more than 5 mg or 10 mg oral dispersible tablets 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 (less than 18 years of age) and older people (over 65 years)

Children, adolescents or older people should not take Rizatriptan Orodispersible Tablets because there is not enough experience with its use in these age groups.

Method and route of administration

Peel back the blister with dry hands just before dosing and place the tablet on your tongue where it will dissolve.

Rizatriptan Orodispersible Tablets 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 you take more Rizatriptan Orodispersible Tablets than you should

Contact your doctor or local hospital immediately. Take the medicine pack with you. Possible signs of overdose can include dizziness, drowsiness, vomiting, fainting and slow heart rate.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them. A list of possible side effects is given below.

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

If you get any of the following contact your doctor straight away or seek emergency help immediately:

Rare (may affect up to 1 in 1,000 people):

•    you have an allergic reaction. Such reactions may appear in the form of anaphylaxis (a severe form of allergic reaction) with symptoms such as:

*    rash,

*    swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema),

*    anaphylactoid reaction (sudden wheezing, swelling of your lips, tongue and throat or body, rash, fainting or difficulties in swallowing).

•    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 stroke, man over 40 years of age, post-menopausal women, particular problem with the way your heart beats [bundle branch block]).

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

•    seizures (convulsions/fits).

•    a widespread rash with blisters and skin peeling on much of the body surface, may be accompanied by fever (toxic epidermal necrolysis),

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

•    heart attack, spasm of blood vessels of the heart. 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, man over 40 years of age, post-menopausal women, particular problem with the way your heart beats [bundle branch block]).

In the following, please find the other side effects that may occur: Common (may affect up to 1 in 10 people):

•    tingling or numbness of the hands and feet (paraesthesia), headaches, decreased feeling or sensitivity of skin (hypoaesthesia)

•    tremor, feeling mentally less sharp

•    dizziness, drowsiness

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

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

•    sore throat, difficulty breathing (dyspnoea)

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

•    feeling tired or heavy in parts of the body

•    pain in the stomach or chest.

Uncommon (may affect up to 1 in 100 people):

•    problems with coordinating muscle movement (ataxia)

•    spinning sensation or a feeling that the ground is tilting (vertigo)

•    altered taste, bad taste in your mouth,

•    changes in the rhythm or rate of the heartbeat (arrhythmia),

•    abnormalities of the electrocardiogram (a test that records the electrical activity of your heart),

•    high blood pressure (hypertension)

•    feeling thirsty

•    indigestion (dyspepsia)

•    itchiness, red raised itchy bumps (hives)

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

•    difficulty sleeping (insomnia) confusion, nervousness

•    blurred vision

•    rash

•    muscle pain, myalgia)

•    facial pain.

Rare (may affect up to 1 in 1,000 people):

•    loss of consciousness, fainting

•    slow heartbeat (bradycardia)

•    wheezing

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

•    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

•    blockage of blood vessels

•    inflammation of the bowels

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: 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 ORODISPERSIBLE TABLETS

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date, which is stated on the label.

Do not store above 25°C. Store in the original container, in order to protect from moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.    CONTENTS OF THE PACK AND OTHER INFORMATION

What Rizatriptan Orodispersible Tablets contain:

•    The active substance is rizatriptan.

Each orodispersible tablet contains 10 mg of rizatriptan (as rizatriptan benzoate).

The other ingredients are colloidal anhydrous silica, crospovidone (Type B), crospovidone (Type A), mannitol, microcrystalline cellulose, Guar galactomannan, magnesium stearate, aspartame (E951) and peppermint flavour (contains natural flavouring, maize maltodextrin, modified corn starch).

What Rizatriptan Orodispersible Tablets look like and contents of the pack

White to off-white, round flat faced tablets with beveled edge debossed with 'M' on one side and 'RN2' on other side.

Rizatriptan Orodispersible Tablets are packed in OPA/Al/PVC perforated unit dose blisters of 2 x 1, 3 x 1, 6 x 1, 12 x 1, 18 x 1 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire, eN6 1Tl, United Kingdom.

Manufacturers

Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.

Mylan Hungary Kft., H-2900, Komarom, Mylan utca 1, Hungary.

This leaflet was last revised in 04/2014

Code No.: MH/DRUGS/25/NKD/89    470128