Negara: Inggris
Bahasa: Inggris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ergotamine tartrate; Cyclizine hydrochloride; Caffeine hydrate
Wockhardt UK Ltd
N02CA52
Ergotamine tartrate; Cyclizine hydrochloride; Caffeine hydrate
2mg ; 50mg ; 100mg
Oral tablet
Oral
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: 04070401; GTIN: 5012727903545
PACKAGE LEAFLET: INFORMATION FOR THE USER MIGRIL® TABLETS Ergotamine Tartrate 2mg, Cyclizine Hydrochloride 50mg and Caffeine Hydrate 100mg 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 Migril® Tablets are and what they are used for 2. What you need to know before you take Migril® Tablets 3. How to use Migril® Tablets 4. Possible side effects 5. How to store Migril® Tablets 6. Contents of the pack and other information _ARE AND WHAT THEY ARE USED F_ 1. WHAT MIGRIL® TABLETS ARE AND WHAT THEY ARE USED FOR The name of your medicine is Migril® Tablets. Migril® Tablets contain the active substances ergotamine tartrate, cyclizine hydrochloride and caffeine hydrate. These tablets belong to a group of medicines called vasoconstrictors and anti-emetics. Vasoconstrictors cause narrowing of the blood vessels and anti-emetics stop you feeling and being sick. Migril® Tablets are used in the treatment of migraines to relieve the symptoms and to stop the attack getting worse. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MIGRIL® TABLETS DO NOT TAKE MIGRIL® TABLETS IF: • you are allergic (hypersensitive) to ergotamine tartrate, cyclizine hydrochloride, caffeine hydrate or to any of the other ingredients in this medicine (see section 6, Contents of the pack and other information) • you are suffering from kidney or liver disease • you are suffering from angina, coronary heart disease or high blood pressure • you are suffering from temporal arteritis • you are suffering from a condition called por Baca dokumen lengkapnya
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Migril Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Ergotamine tartrate 2.0mg, cyclizine hydrochloride 50.0mg and caffeine equivalent to caffeine hydrate 100mg. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Tablet White, round, biconvex compression-coated tablets with a pink core, scored and impressed ‘CP A4A’. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Migril is indicated for the relief of acute migraine attack 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults: _Migril should be taken as soon as possible after the first warning of an attack of migraine and repeated if necessary at the prescribed intervals. The usual initial dose is one tablet. Additional doses of a half to one tablet may then be required at half-hourly intervals. No more than 3 tablets (6 mg ergotamine) should be taken in any 24 hours or 4 tablets (8mg ergotamine) during any one attack. The recommended minimum interval between successive courses is 4 days. No more than 6 tablets (12 mg ergotamine) should be given in any one week. No more than two courses of treatment should be administered in a month. Use the minimum effective dosage of Migril necessary, since individual sensitivity to the arterial effects of ergotamine varies considerably. _Children_: The use of Migril in children is not recommended. _Use in the elderly: _There are no absolute contra-indications to the use of Migril in the elderly, but see Section 4.3 _'Contra-indications' _and Section 4.4 _'Precautions'._ 4.3 CONTRAINDICATIONS Co-administration of ergotamine with potent CYP3A4 inhibitors (ritonavir, nelfinavir, indinavir, amprenavir, azithromycin, erythromycin, clarithromycin) has been associated with acute ergot toxicity (ergotism) characterised by vasospasm and ischaemia of the extremities, with some cases resulting in amputation. There have been rare reports of cerebral ischaemia in patients on protease inhibitor therapy when ergotamine was co-administered, at least one resulting in death. Baca dokumen lengkapnya