Land: Storbritannia
Språk: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Rizatriptan benzoate
DE Pharmaceuticals
N02CC04
Rizatriptan benzoate
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04070401
The active ingredient in this medicine, rizatriptan belongs to a group of medicines called selective serotonin 5-HT 1B/1D receptor agonists. Rizatriptan is used to treat the headache phase of the migraine attack in adults. DO NOT TAKE RIZATRIPTAN IF YOU: • are allergic (hypersensitive) to rizatriptan or any of the other ingredients of Rizatriptan _(see Section 6 and end of _ _ Section 2)._ • are currently taking monoamine oxidase (MAO) inhibitors such as moclobemide, phenelzine, tranylcypromine (used to treat depression) or linezolid (drug used to treat bacterial infections), or have taken MAO inhibitors within the last two weeks (see section ‘_Other medicines _ _ and Rizatriptan_’) • have severely impaired liver or kidney function. • have had a previous stroke (cerebrovascular accident or CVA) or symptoms similar to a stroke which wear off after a day or two (transient ischaemic attack or TIA). • have moderately severe or severe high blood pressure, or mild high blood pressure that is NOT controlled by medication. • have ever suffered from heart disease (poor blood flow in the arteries of the heart), heart attack or a particular type of chest pain known as Prinzmetal’s angina. • have had problems with the blood supply to your legs (peripheral vascular disease). • are taking any other medicine for your migraine such as ergotamine, ergotamine-type medicines (dihidroergotamine, methysergide), or another medicine in the same class (i.e. 5-HT 1B/1D receptor agonists, such as sumatriptan, naratriptan or zolmitriptan) (_see section ‘Other medicines and _ _ Rizatriptan_’). TAKE SPECIAL CARE WITH RIZATRIPTAN Talk to your doctor before taking Rizatriptan if you have: • any of the following risk factors for heart disease: - high blood pressure or diabetes - you smoke or are using a nicotine substitute - a family history of heart disease - you are a man over 40 years, or a post-menopausal woman. • kidney or liver problems. • a particular problem with the way your heart beats (bundle branch bl Les hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rizatriptan 10 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 10 mg tablet contains 10 mg of rizatriptan (as rizatriptan benzoate). Excipients: Aspartame 8 mg. For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Tablet 10 mg tablets are white to off white, approximately 9 mm round, flat, beveled edged uncoated tablets, engraved with ‘468’ on one side and plain on other side 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Acute treatment of the headache phase of migraine attacks, with or without aura in adults. Rizatriptan should not be used prophylactically. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 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 Rizatriptan, in particular the following patient groups: − patients on propranolol. Administration of rizatriptan should be separated by at least two hours from administration of propranolol. (See section 4.5) − patients with mild or moderate renal insufficiency. − patients with mild to moderate hepatic insufficiency. 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 s Les hele dokumentet