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The product code(s) for this leaflet are: PL 00025/0369, PL 00025/0370.
Maxalt 5mg and 10mg Tablets
MAXALT® 10 mg Tablets/5 mg Tablets
rizatriptan
1. What MAXALT is and what it is used for
2. What you need to know before you take MAXALT
3. How to take MAXALT
4. Possible side effects
5. How to store MAXALT
6. Contents of the pack and other information
MAXALT belongs to a class of medicines called selective serotonin 5-HT1B/1D 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.
If you are not sure if any of the above apply to you talk to your doctor or pharmacist before taking MAXALT.
Talk to your doctor or pharmacist before taking MAXALT, if:
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.
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.
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 can affect the way some medicines work. Also, other medicines can affect MAXALT.
Do not take MAXALT
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
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 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.
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.
The use of MAXALT tablets in children under 18 years of age is not recommended.
There have been no full studies to look at how safe and effective MAXALT is amongst patients older than 65 years.
You may feel sleepy or dizzy while taking MAXALT. If this happens, do not drive or use any tools or machines.
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.
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 this medicine exactly as your doctor has told you. Check with your doctor or 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.
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 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, 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.
Like all medicines, this medicine 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)
Uncommon (affects 1 to 10 users in 1000)
Rare (affects 1 to 10 users in 10,000)
Not known (frequency cannot be estimated from the available data):
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 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 Website 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.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton/blister after "EXP". The expiry date refers to the last day of the month.
Do not store MAXALT above 30°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance of MAXALT is rizatriptan. One tablet contains 5 or 10 mg rizatriptan as 7.265 or 14.53 mg of rizatriptan benzoate.
The other ingredients of MAXALT tablets are lactose monohydrate, microcrystalline cellulose (E460a), starch, pregelatinised; iron oxide red (E172) and magnesium stearate (E572).
MAXALT 5 mg tablets
5 mg tablets are pale pink, capsule shaped, coded MSD on one side and 266 on the other.
MAXALT 10 mg tablets
10 mg tablets are pale pink, capsule-shaped, coded MAXALT on one side and MSD 267 on the other.
Pack sizes: Packs with 2, 3, 6, 12 or 18 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
This medicinal product is authorised in the Member States of the EEA under the following names:
Maxalt 5 mg Tablets
Austria , Finland, France, Greece, Iceland, The Netherlands, Norway, Poland, Sweden, United Kingdom MAXALT
Belgium and Luxemburg MAXALT 5 mg
Czech Republic MAXALT 5mg, tablety
Denmark MAXALT, tabletter
Germany MAXALT 5 mg Tabletten
Ireland Rizatriptan MSD 5 mg Tablets
Italy MAXALT 5 mg compresse
Romania MAXALT 5 mg comprimate
Maxalt 10 mg Tablets
Austria, Finland, France, Greece Iceland, The Netherlands, Norway, Poland, Portugal, Sweden, United Kingdom MAXALT
Belgium, Luxemburg and Spain MAXALT 10 mg
Czech Republic MAXALT 10 mg, tablety
Denmark MAXALT, tabletter
Germany MAXALT 10 mg Tabletten
Ireland Rizatriptan MSD 10 mg Tablets
Italy MAXALT 10 mg compresse
Romania MAXALT 10 mg comprimate
This leaflet was last revised in April 2022.
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:
and
(Migraine Action Association and The Migraine Trust are independent organizations and are not associated with Organon Pharma (UK) Limited.)
© 2022 Organon group of companies. All rights reserved.
PIL.MXT.22.UK.0078.IA-ORG-LDN.NORCN