Maxalt Melt 10 mg Oral Lyophilisates

• 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 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.

1. What MAXALT MELT is and what it is used for
2. What you need to know before you take MAXALT MELT
3. How to take MAXALT MELT
4. Possible side effects
5. How to store MAXALT MELT
6. Contents of the pack and other information

• you are allergic (hypersensitive) to rizatriptan benzoate or any of the other ingredients of this medicine (listed in section 6)
• 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 Other medicines and MAXALT MELT below).

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

Talk to your doctor or pharmacist before taking MAXALT MELT, 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 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) 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.

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.

Tell your doctor or pharmacist if you are taking, have recently taken or might 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.

Do not take MAXALT MELT:

• 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 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.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

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.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Available data on the safety of rizatriptan when used during the first 3 months of pregnancy do not suggest an increased risk of birth defects. It is not known whether MAXALT MELT is harmful to an unborn baby when taken by a pregnant woman after the first 3 months of pregnancy.

If you are breastfeeding, you may postpone breastfeeding for 12 hours after treatment to avoid exposure in your baby.

The use of MAXALT MELT oral lyophilisates in children under 18 years of age is not recommended.

There have been no full studies to look at how safe and effective MAXALT MELT is amongst patients older than 65 years.

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

This medicine contains 3.75 mg aspartame in each 10 mg oral lyophilisate which is equivalent to 2.1 mg phenylalanine.

Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.

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 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.

If your condition worsens, seek medical attention.

• MAXALT MELT (rizatriptan benzoate) is available as a 5 or 10 mg oral lyophilisate that dissolves in the mouth.
• Open the MAXALT MELT oral lyophilisate blister pack with dry hands.
• The oral lyophilisate should be placed on your tongue, where it dissolves and can be swallowed with the saliva.
• 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.

MAXALT MELT is also available as a tablet to be taken with liquids.

If you take more MAXALT MELT 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 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

The active substance of the MAXALT MELT is rizatriptan. One oral lyophilisate contains 10 mg rizatriptan as 14.53 mg of rizatriptan benzoate.

The other ingredients of MAXALT MELT oral lyophilisates are: gelatin, mannitol (E421), glycine, aspartame (E951) and peppermint flavour (composed of peppermint oil, maltodextrin and dextrin).

10 mg oral lyophilisates are white to off-white, round with a modified square on one side, with a peppermint flavour.

Pack sizes: Packs with 2, 3, 6, 12 or 18 oral lyophilisates.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Manufacturer