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Maxalt® 5mg Tablets/Rizatriptan 5mg Tablets Maxalt® 10mg Tablets/Rizatriptan 10mg Tablets

(rizatriptan benzoate)

In this leaflet:

1)    What Maxalt is and what it is used for

2)    Before you take Maxalt

3)    How to take Maxalt

4)    Possible side effects

5)    How to store Maxalt

6)    Further information

1)    What Maxalt is and what it is used for

Maxalt belongs to a class of medicines called selective serotonin 5-HT_1B/id 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)    Before you take Maxalt Do not take Maxalt if:

•    you are allergic (hypersensitive) to rizatriptan benzoate or any of the other ingredients of Maxalt

•    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 Taking with other medicines below).

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

Take special care with Maxalt if you:

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 heart beats (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.

Taking with other medicines

Do not take Maxalt

•    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 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.

Taking 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

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

Talk to your doctor before taking this medicine if you are pregnant, planning to get pregnant or are breastfeeding. Breastfeeding should be avoided for 24 hours after treatment.

Ask your doctor or pharmacist for advise before taking any medicine.

Use in children

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.

Important information about some of the ingredients of Maxalt

The 5-mg tablet contains 30.25 mg of lactose monohydrate and the 10-mg tablet contains 60.50 mg 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 10 mg.

If you are currently taking propranolol or have kidney or liver problems you should use the 5-mg 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) tablets should be taken by mouth and swallowed whole with liquid.

Maxalt is also available as a 10-mg 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 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 10 mg or 5 mg 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, Maxalt 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, 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,

•    rash

Uncommon (affects 1 to 10 users in 1000)

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

•    confusion, insomnia, nervousness,

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

•    itching and lumpy rash (hives), allergic reaction (hypersensitivity); swelling of face, lips, tongue and/or throat which may cause difficulty breathing and/or swallowing (angiodema),

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

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

•    bad taste in your mouth,

•    fainting (syncope), 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,

•    facial pain, wheezing,

•    sudden life-threatening allergic reaction (anaphylaxis) severe shedding of the skin with or without fever (toxic epidermal necrolysis),

•    heart attack, spasm of blood vessels of the heart, stroke. They 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 heart beats [bundle branch block]).

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

•    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,

•    muscle pain,

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

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.

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

5)    How to store Maxalt

•    Keep all medicines out of the sight and reach of children.

•    Do not use Maxalt after the expiry date which is printed on the carton label and blister strip 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 medicines no longer required. These measures will help to protect the environment.

6)    Further information What Maxalt contains:

The active substance of the Maxalt is rizatriptan.

Each tablet contains 5 mg rizatriptan as 7.265mg of rizatriptan benzoate and

Each tablet contains 10mg rizatriptan as 14.53mg of rizatriptan benzoate.

The other ingredients of Maxalt are lactose monohydrate, microcrystalline cellulose (E460a), pregelatinized maize starch, iron oxide (E172) and magnesium stearate (E572).

What Maxalt looks like and contents of the pack

Each capsule shaped, pink tablet is marked ‘MSD' on one side; ‘266' on the reverse for the 5mg tablets.

Each capsule shaped, pink tablet is marked ‘MSD267' on one side; ‘MAXALT' on the reverse for the 10mg tablets.

Maxalt 5mg Tablets are available as blister packs of 3 or 6 tablets.

Maxalt 10mg Tablets are available as blister packs of 3, 6, 12 and 18 tablets.

PL10383/1980 Maxalt 5mg Tablets/Rizatriptan 5mg Tablets |POM| PL10383/1981 Maxalt 10mg Tablets/Rizatriptan 10mg Tablets

Who makes and repackages your medicine?

Your medicine is manufactured by Merck Sharp and Dohme BV, Waarderweg 39, 2031 BN, Haarlem, The Netherlands. Procured from within the EU and repackaged by Product Licence Holder: Primecrown Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.

Leaflet date: 01.10.2012

How can you obtain more information about Maxalt?

This leaflet gives you some of the most important information 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 organisations:

Migraine Action Association 27 East Street Leicester LE1 6NB

Tel: 0116 275 8317 Fax: 0116 254 2023

and

The Migraine Trust

55-56 Russell Square

London

WC1B 4HP

Tel: 020 7436 1336

Fax: 020 7436 2880

Helpline: 020 7462 6601, Monday to Friday 10am-5pm

(Migraine Action and The Migraine Trust are independent organisations and are not associated with Merck Sharp & Dohme Limited or Primecrown Ltd.)

Maxalt ® is a trademark of Merck & Co., Inc., Whitehouse Station, NJ, U.S.A.