Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Rizatriptan benzoate
Lupin Healthcare (UK) Ltd
N02CC04
Rizatriptan benzoate
5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04070401; GTIN: 5060346430003
PACKAGE LEAFLET: INFORMATION FOR THE USER RIZATRIPTAN 5 MG TABLETS RIZATRIPTAN 10 MG TABLETS (RIZATRIPTAN) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any 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. WHAT IS IN THIS LEAFLET: 1. WHAT RIZATRIPTAN TABLETS ARE AND WHAT THEY ARE USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RIZATRIPTAN TABLETS 3. HOW TO TAKE RIZATRIPTAN TABLETS 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE RIZATRIPTAN TABLETS 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT RIZATRIPTAN TABLETS ARE AND WHAT THEY ARE USED FOR Rizatriptan belongs to a class of medicines called serotonin 5-HT 1B/1D receptor agonists. Rizatriptan Tablets is used to treat the headache phase of the migraine attack in adults. Treatment with Rizatriptan Tablets: Reduces swelling of blood vessels surrounding the brain. This swelling results in the headache pain of a migraine attack. Rizatriptan Tablets can be used to treat migraine attacks which may or may not be associated with visual disturbances (an aura). They are not used to prevent migraine attacks. Please tell your doctor or pharmacist about your symptoms. Your doctor will decide if you suffer from migraines. You should take Rizatriptan Tablets ONLY FOR A MIGRAINE attack. This medicine should not be used to treat headaches that might be caused by other, more serious conditions. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RIZATRIPTAN TABLETS DO NOT TAKE RIZATRIPTAN TABLETS - you are allergic to rizatriptan or any of the other ingredients of this medicine (listed in section 6) - you have moderately severe or severe high blood pre Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rizatriptan 5 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 5 mg One tablet contains 7.265 mg rizatriptan benzoate, equivalent to 5 mg rizatriptan. Excipients: lactose 59.37 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet 5mg Tablet Light pink to pink coloured, capsule shaped, biconvex, un-coated tablet with “R” on one side and “5” on the other side Length – 9.50 ± 0.20 mm Width – 4.00 ± 0.20 mm 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Acute treatment of the headache phase of migraine attacks with or without aura. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _General_ Rizatriptan should not be used prophylactically. The tablets should be swallowed whole with liquid. _Effect of food: _The absorption of rizatriptan is delayed by approximately 1 hour when administered together with food. Therefore, onset of effect may be delayed when rizatriptan is administered in the fed state (see also Pharmacokinetic Properties, Absorption). Adults 18 years of age and older The recommended dose is 10 mg. _Redosing:_ Doses should be separated by at least two hours; no more than two doses should be taken in any 24-hour period. −_ For headache recurrence within 24 hours_: If headache returns after relief of the initial attack, one further dose may be taken. The above dosing limits should be observed. −_ After non-response_: The effectiveness of a second dose for treatment of the same attack, when an initial dose is ineffective, has not been examined in controlled trials. Therefore, if a patient does not respond to the first dose, a second dose should not be taken for the same attack. Clinical studies have shown that patients who do not respond to treatment of an attack are still likely to respond to treatment for subsequent attacks. Doses should be separated by at least two hours; no more than two doses should be taken in any 24-hour period. Patients older than 65 years The safety and effectiveness o Read the complete document