- rizatriptan benzoate
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL16363/0321.
Rizatriptan 10 mg orodispersible tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Rizatriptan 10 mg orodispersible tablets
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet:
1. What Rizatriptan is and what it is used for
2. What you need to know before you take Rizatriptan
3. How to take Rizatriptan
4. Possible side effects
5. How to store Rizatriptan
6. Contents of the pack and other information
1. WHAT RIZATRIPTAN IS AND WHAT IT IS USED FOR
Rizatriptan belongs to a class of medicines called selective serotonin 5-HT1B/1D receptor agonists.
Rizatriptan is used to treat the headache phase of the migraine attack in adults.
Treatment with Rizatriptan:
Reduces swelling of blood vessels surrounding the brain. This swelling results in the headache pain of a migraine attack.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RIZATRIPTAN
Do not take Rizatriptan:
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Rizatriptan.
Warnings and precautions
Talk to your doctor or pharmacist before taking Rizatriptan if:
If you take Rizatriptan 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 Rizatriptan.
Please tell your doctor or pharmacist about your symptoms. Your doctor will decide if you have migraine. You should take Rizatriptan only for a migraine attack. Rizatriptan 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 Rizatriptan can affect the way some medicines work. Also other medicines can affect Rizatriptan.
Other medicines and Rizatriptan
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take Rizatriptan:
The above listed medicines when taken with Rizatriptan may increase the risk of side effects.
You should wait at least 6 hours after taking Rizatriptan 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 Rizatriptan.
Ask your doctor for instructions and the risks about taking Rizatriptan
Rizatriptan with food and drink
Rizatriptan 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 breast-feeding and fertility
It is not known whether Rizatriptan 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.
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.
Use in children
The use of Rizatriptan 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 Rizatriptan is amongst patients older than 65 years.
Driving or using machines
You may feel sleepy or dizzy while taking Rizatriptan. If this happens, do not drive or use any tools or machines.
Rizatriptan contains Aspartame
Rizatriptan contains aspartame, a source of phenylalanine. This may be harmful for people with phenylketonuria.
3. HOW TO TAKE RIZATRIPTAN
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Rizatriptan is used to treat migraine attacks. Take Rizatriptan as soon as possible after your migraine headache has started. Do not use it to prevent an attack.
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 rizatriptan. You should leave at least 2 hours between taking propranolol and Rizatriptan 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 Rizatriptan. 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 Rizatriptan during an attack, you should not take a second dose of Rizatriptan for treatment of the same attack. It is still likely, however, that you will respond to Rizatriptan during the next attack.
Do not take more than 2 doses of Rizatriptan in a 24-hour period, (for example, do not take more than two 10-mg or 5 mg orodispersible tablets or tablets in a 24-hour period). You should always wait at least 2 hours between doses.
If your condition worsens, seek medical attention.
How to administer Rizatriptan orodispersible tablets
Rizatriptan is also available as a tablet to be taken with liquids.
If you take more Rizatriptan than you should
If you take more Rizatriptan than you should, talk to your doctor or pharmacist straight away. Take the medicine pack with you.
Signs of over-dosage can include dizziness, drowsiness, vomiting, fainting and slow heart rate.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
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 (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
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 Rizatriptan.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
5. HOW TO STORE RIZATRIPTAN
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 blister, carton and bottle label after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
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.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Rizatriptan contains
What Rizatriptan looks like and contents of pack
White to off-white coloured, circular, biconvex, uncoated tablets debossed with 'F25' on one side and plain on other side with a peppermint flavor.
Rizatriptan orodispersible tablets are available in Polyamide/ Aluminium/ PVC - Aluminium foil blister packs of: 2, 3, 6, 10, 12 and 18 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
This leaflet was last revised in 09/2012.
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