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Consumer Medicine Information

MAXALT®
MAXALT® Melt

rizatriptan benzoate

5 mg & 10 mg tablets
5 mg & 10 mg wafers
(Only MAXALT Melt 10 mg wafer is available in New Zealand)

What is in this leaflet

This leaflet answers some common questions about MAXALT (tablet) and MAXALT Melt (wafer). It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking MAXALT or MAXALT Melt against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What MAXALT and MAXALT Melt is used for

MAXALT and MAXALT Melt is used to relieve the headache pain and other symptoms of migraine attacks. MAXALT and MAXALT Melt does not work for other types of headaches.

Migraine is an intense, throbbing, typically one-sided headache. It often includes nausea, vomiting, sensitivity to light, and sensitivity to sound. Some people may have visual symptoms before the headache, called an aura. An aura can include flashing lights or wavy lines.

Migraine attacks last anything from two hours to two days and they can return frequently. The severity and frequency of migraine attacks may vary.

Migraine occurs in about one out of every 10 people. It is three times more common in women than men. Six out of ten migraine sufferers have their first attack before the age of 20.

There is no single cause of migraine. It tends to run in families. Certain things, singly or in combination, can trigger migraine attacks in some people. Some of these triggers are:

If you understand what triggers your attacks, you may be able to prevent migraine attacks or reduce their frequency. Keeping a headache diary will help you identify and monitor all of the possible migraine triggers you encounter. Once the triggers are identified, you and your doctor can modify your treatment and lifestyle appropriately.

How MAXALT and MAXALT Melt works

During a migraine attack, blood vessels in the brain dilate, or widen, resulting in a throbbing pain. MAXALT and MAXALT Melt decreases this widening, returning the blood vessels to their normal size, and therefore helps to relieve the pain. MAXALT and MAXALT Melt also blocks the release of certain chemicals from nerve endings that cause more pain and other symptoms of migraine.

Before you take MAXALT or MAXALT Melt

When you must not take it

Do not take MAXALT or MAXALT Melt if:

If you are not sure whether you should start taking MAXALT or MAXALT Melt, talk to your doctor.

Do not give MAXALT or MAXALT Melt to children under 18 years of age. The safety and effectiveness of MAXALT and MAXALT Melt in children under 18 years have not been established.

Phenylketonuric patients: You should be aware that this product contains phenylalanine (a component of aspartame). Each 5 mg MAXALT Melt wafer contains 1.05 mg phenylalanine, and each 10 mg MAXALT Melt wafer contains 2.10 mg phenylalanine.

Before you start to take it

Tell your doctor if:

  1. you are pregnant or intend to become pregnant
    Like most medicines, MAXALT and MAXALT Melt is not recommended for use during pregnancy. If there is a need to consider MAXALT or MAXALT Melt during pregnancy, your doctor will discuss with you the risks and benefits of taking it during pregnancy.
  2. you are breast-feeding or plan to breast-feed
    It is not known whether MAXALT and MAXALT Melt passes into breast milk. Your doctor will discuss with you the risks and benefits of taking it while breast-feeding.
  3. you have any risk factors for heart disease, including:
    • high blood pressure
    • diabetes
    • smoking
    • a high cholesterol level
    • a family history of heart disease
  4. your headache is more severe than your 'usual' migraine, or it behaves differently
  5. you have or have had any other medical conditions
  6. you have any allergies to any other medicines or any other substances, such as foods, preservatives or dyes
  7. you are intolerant to lactose (this applies to the tablet only).

Each MAXALT tablet contains a small quantity of lactose, but this quantity is probably not enough to cause specific symptoms of intolerance.

If you have not told your doctor about any of the above, tell them before you take any MAXALT or MAXALT Melt.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines should not be taken with MAXALT or MAXALT Melt.

These include:

Some medicines and MAXALT or MAXALT Melt may interfere with each other.

These include:

These medicines may be affected by MAXALT or MAXALT Melt, or may affect how well it works. You may need different amounts of your medicine, you may need to take different medicines or you may need to be careful of the timing of some of these medicines.

Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking MAXALT or MAXALT Melt.

How to take MAXALT and MAXALT Melt

How much to take

Take MAXALT and MAXALT Melt only when prescribed by your doctor.

Wafer

The usual dose to treat a migraine is one 10 mg wafer.

If the first MAXALT Melt wafer does help your migraine, but it comes back later, you may take another wafer. Take the second wafer at least 2 hours after the first. Do not take more than 30 mg (3 wafers) in a 24 hour period.

If the first MAXALT Melt wafer does not help your migraine, do not take another wafer for the same attack, as it is unlikely to help. It is still likely, however, that you will respond to MAXALT Melt during your next attack.

If you are taking propranolol, the usual dose to treat a migraine is one 5 mg wafer. Since the 5 mg wafer is not available in New Zealand, you should not take MAXALT Melt while you are taking propranolol.

Follow all directions given to you by your doctor carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions on the box, ask your doctor or pharmacist for help.

How to take it

With dry hands place the wafer on your tongue.

The wafer will dissolve rapidly and be swallowed with your saliva. No water is needed for taking the wafer.

It does not matter if you take MAXALT Melt before or after food.

If you take too much (overdose)

Immediately telephone your doctor or National Poisons Centre (in Australia telephone 13 11 26, or New Zealand telephone 0800 POISON or 0800 764 766) for advice, or go to accident and emergency at your nearest hospital, if you think that you or anyone else may have taken too much MAXALT. Do this even if there are no signs of discomfort or poisoning.

If you take too many tablets, you may feel sleepy, dizzy, faint or have a slow heart beat.

While you are using MAXALT and MAXALT Melt

Things you must do

If your headache is more severe than your 'usual' migraine or it behaves differently, tell your doctor.

If you are about to be started on any new medicine, tell your doctor and pharmacist that you take MAXALT or MAXALT Melt for migraines.

If you become pregnant while taking MAXALT or MAXALT Melt, tell your doctor immediately.

Things you must not do

Do not give MAXALT or MAXALT Melt to anyone else, even if they have the same condition as you.

Things to be careful of

Be careful driving or operating machinery until you know how MAXALT and MAXALT Melt affects you.

Migraine or treatment with MAXALT and MAXALT Melt may cause sleepiness or dizziness in some people. Make sure you know how you react to MAXALT and MAXALT Melt before you drive a car, operate machinery, or do anything else that could be dangerous if you are sleepy or dizzy. If you drink alcohol, sleepiness or dizziness may be worse.

Adverse Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking MAXALT or MAXALT Melt.

MAXALT and MAXALT Melt helps most people with migraine headaches, but it may have unwanted adverse effects in a few people. All medicines can have adverse effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the adverse effects.

Ask your doctor or pharmacist to answer any questions you may have. Tell your doctor if you notice any of the following and they worry you:

Difficulty thinking or working because of:

Stomach or bowel problems

Changes in your sight, or taste such as:

Skin problems

Changes in the way your body feels, such as:

Tell your doctor immediately or go to accident and emergency at your nearest hospital if you notice any of the following:

As with other medicines in this class, there have been very rare reports of heart attack and stroke generally occurring in patients who are at risk of heart and blood vessel disease (high blood pressure, diabetes, smoking, family history of heart disease or stroke).

These are serious adverse effects. You may need urgent medical attention. Serious adverse effects are rare. Other adverse effects not listed above may also occur in some patients. Tell your doctor if you notice any other effects.

Do not be alarmed by this list of possible adverse effects. You may not experience any of them.

After using MAXALT or MAXALT Melt

Storage

Keep your tablets in the container provided until it is time to take them. If you take the medicine out of the container provided, they may not keep well.

Keep MAXALT and MAXALT Melt in a cool dry place where the temperature stays below 30°C. Do not store it or any other medicine in the bathroom or near a sink. Do not leave it in the car or on window sills. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking the tablets, or the tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.

Product description

Availability

Only MAXALT Melt 10 mg wafer is available in New Zealand.

What it looks like

Wafer

Ingredients

Active ingredient:

MAXALT Melt 10 mg - 10 mg rizatriptan benzoate per wafer

Inactive ingredients:

MAXALT Melt does not contain gluten, lactose, sucrose, tartrazine or any other azo dyes.

Supplier

MAXALT is supplied in New Zealand by:

Merck Sharp & Dohme (New Zealand) Limited
P O Box 99 851
Newmarket
Auckland
NEW ZEALAND
Tel: 0800 500 673

This leaflet was prepared in March 2008

CP-MXT-0208(100308)

®Registered Trademark of Merck & Co Inc., Whitehouse Station, NJ, USA
Copyright© 2008 Merck & Co., Inc. All rights reserved