Maxalt

• For migraine headache
• Tablet or lyophilisate (orodispersible tablet) for oral use
• May cause dizziness or sleepiness

MAXALT is a medicine specifically used to relieve migraine attacks. Migraine is a type of headache characterised by:

• Pounding pain, usually to one side of the head.
• Nausea, vomiting.
• Hypersensitivity to light or sound.

The headache is sometimes preceded by visual disturbances such as flashing lights, zigzag patterns, stars or patches (aura).

The active substance of MAXALT is rizatriptan. This medicine relieves migraine headaches by reducing the swelling of blood vessels surrounding the brain.

MAXALT is available as tablets and lyophilisates (orodispersible tablets). The regular tablets should be taken with a drink of water. The lyophilisates are designed to dissolve on the tongue.

MAXALT should be taken as early as possible after the migraine headache has started. MAXALT is not to be used to prevent migraine attacks.

If your migraine returns, you can take an additional dose of MAXALT. However, you should always wait at least two hours between doses. If MAXALT does not relieve your migraine, do NOT take a second dose for the same attack.

If your migraine gets worse, contact your doctor.

Dosage

Dosage varies per person and is determined by a doctor depending on the symptoms. The general dosage guidelines are as follows:

• Adults: the recommended dose is 10 mg.

Patients with kidney or liver problems or who take propranolol-containing medicines, the recommended dose is 5 mg. You should leave at least two hours between taking propranolol and MAXALT.

Do not take more than a maximum of two doses in a 24-hour period (for example, do not take more than two tablets or lyophilisates of 10 mg or 5 mg per 24-hour period). Always leave at least two hours between doses.

This medicine is not recommended for children under 18 years of age.

Alcohol/driving

There are no known interactions between alcohol and MAXALT.

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

If you use 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.

MAXALT is not suitable for everyone. Do not take this medicine if:

• You are allergic to any of the ingredients in this medicine (see section ‘What MAXALT contains').
• You have moderately severe or severe high blood pressure or mild high blood pressure that is not controlled by medication.
• You have, or have had, heart problems including heart attack or pain on the chest (angina pectoris) or you have experienced heart diseaserelated signs.
• You have severe liver or 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 use certain antidepressants or other migraine medicines (see section ‘Other medicines and MAXALT).
• You are taking an antibiotic called linezolid.

When should this medicine be used with caution?

Talk to your doctor or pharmacist before taking using MAXALT if:

• You have a risk factor for heart disease (see the package leaflet for more information).
• You have kidney or liver problems.
• You have a particular problem with the way your heart beats (bundle branch block).
• You have or have ever had any allergies.
• Your headache is associated with dizziness, difficulty in walking, lack of coordination 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) or serotonin norepinephrine reuptake inhibitors (SNRIs) for depression.
• You have had short lived symptoms including chest pain and tightness.

See the package leaflet for more warnings associated with the use of MAXALT.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, talk to your doctor or pharmacist before taking using MAXALT.

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

Breastfeeding should be avoided for 24 hours after treatment.

Other medicines and MAXALT

Tell your doctor if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines.

Do not take MAXALT if:

• You are already taking a 5HT1B/1D agonist (e.g., sumatriptan, naratriptan or zolmitriptan).
• You are taking a monoamine oxidase (MAO) inhibitor (see the package leaflet), or if it has been less than two weeks since you stopped taking an MAO inhibitor.
• You use ergotaminetype medications to treat your migraine.
• 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 six 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 'How to use MAXALT').
• You are taking SSRIs for depression (see the package leaflet).

Please refer to the package leaflet for more information.

Like all medicines, MAXALT can cause side effects, although not everybody gets them. In adult studies, the most common side effects reported were dizziness, sleepiness and tiredness. Other side effects include:

Common (may affect up to 1 in 10 people):

• 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.
• Abdominal pain.
• Chest pain.

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

• 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), shortness of breath (dyspnoea).
• Feeling of tightness in parts of the body, muscle weakness.
• Changes in the rhythm or rate of the heartbeat (arrhythmia).
• Facial pain, muscle pain.

For a list of all possible side effects, see the package leaflet. If you experience side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Tell your doctor right away if you have symptoms of allergic reactions, serotonin syndrome, heart attack or stroke.

The active substance is rizatriptan. One tablet contains 5 or 10 mg rizatriptan as 7.265 or 14.53 mg of rizatriptan benzoate.

Read the package leaflet before use. The official package leaflet of MAXALT is available for download here.