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PACKAGE LEAFLET: INFORMATION FOR THE USER MAXALT® MELT 10MG Oral Lyophilisates

(rizatriptan benzoate)

Your medicine is known as the above but will be referred to as Maxalt Melt throughout the remainder of this leaflet.

Read all of this leaflet carefully before you start taking this medicine

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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

-    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.

In this leaflet:

1.    What Maxalt Melt is and what it is used for

2.    Before you take Maxalt Melt

3.    How to take Maxalt Melt

4.    Possible side effects

5.    How to store Maxalt Melt

6.    Further information

Maxalt Melt belongs to a class of medicines called selective serotonin 5-HT1 b/1d receptor agonists.

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

Treatment with Maxalt Melt:

Reduces swelling of blood vessels surrounding the brain. This swelling results in the headache pain of a migraine attack.

Do not take Maxalt Melt if:

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

•    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 Melt.

Take special care with Maxalt Melt if you:

Before you take Maxalt Melt, 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 postmenopausal 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 the 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 Melt 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 Melt.

Please tell your doctor or pharmacist about your symptoms. Your doctor will decide if you have migraine. You should take Maxalt Melt only for a migraine attack. Maxalt Melt 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 Melt can affect the way some medicines work. Also, other medicines can affect Maxalt Melt.

Taking with other medicines

Do not take Maxalt Melt:

•    if you are already taking a 5-HTib/id 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 Melt may increase the risk of side effects.

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

Ask your doctor for instructions and the risks about taking Maxalt Melt

•    if you are taking propranolol (see section 3: How to take Maxalt Melt).

•    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 Melt with food and drink:

Maxalt Melt 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 Melt 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 advice before taking any medicine.

Use in children

The use of Maxalt Melt oral lyophilisates 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 Melt is amongst patients older than 65 years.

Driving or using machines

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

Important information about some of the ingredients of Maxalt Melt

Phenylketonuric patients: Contains a source of phenylalanine. May be harmful for people with phenylketonuria. Each Maxalt Melt oral lyophilisate contains 3.75 mg of aspartame (which contains phenylalanine).

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

Always take Maxalt Melt 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 Melt up to a maximum of 2 doses in a 24-hour period.

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

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