Ország: Egyesült Királyság
Nyelv: angol
Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)
Rizatriptan benzoate
DE Pharmaceuticals
N02CC04
Rizatriptan benzoate
5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04070401
PACKAGE LEAFLET: INFORMATION FOR THE USER MAXALT ® 5MG TABLETS (RIZATRIPTAN) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE, BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • The name of your medicine is Maxalt 5mg tablets, and will be referred to as Maxalt throughout this leaflet. Maxalt Tablets are also available in 10mg strengths. • 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. WHAT IS IN THIS LEAFLET 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 1) WHAT MAXALT IS AND WHAT IT IS USED FOR Maxalt belongs to a class of medicines called selective serotonin 5-HT 1B/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. 2) WHAT YOU NEED TO KNOW BEFORE YOU TAKE MAXALT DO NOT TAKE MAXALT IF: • you are allergic 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 arteri Olvassa el a teljes dokumentumot
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT MAXALT ® 5 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 7.265 mg of rizatriptan benzoate (corresponding to 5 mg of the rizatriptan). Excipients with known effect: lactose monohydrate 30.25 mg in the 5 mg tablet. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet 5 mg tablets are pale pink, capsule-shaped, coded MSD on one side and 266 on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Acute treatment of the headache phase of migraine attacks with or without aura in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Method of administration MAXALT should not be used prophylactically. The oral 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). MAXALT is also available as an alternative oral lyophilisate. Posology 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. Some patients should receive the lower (5 mg) dose of MAXALT, in particular the following patient groups: − pa Olvassa el a teljes dokumentumot