Страна: Великобритания
Язык: английский
Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Moclobemide
Tillomed Laboratories Ltd
N06AG02
Moclobemide
300mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04030200; GTIN: 5024655001668
PPaattiieenntt IInnffoorrmmaattiioonn LLeeaafflleett IInn tthhiiss lleeaafflleett:: 1. What is in Moclobemide Tablets ? 2. What is your medicine used for? 3. Before you take Moclobemide Tablets 4. How to take Moclobemide Tablets 5. Possible side effects 6. Storing your Moclobemide Tablets MOCLOBEMIDE 150 MG TABLETS MOCLOBEMIDE 300 MG TABLETS 11.. WWhhaatt iiss iinn MMoocclloobbeemmiiddee TTaabblleettss ?? Your doctor has prescribed either Moclobemide 150 mg Tablets or Moclobemide 300 mg Tablets . Each tablet contains either 150mg or 300mg of the active ingredient moclobemide. Both strengths are film-coated and contain the following inactive ingredients: lactose, maize starch, sodium starch glycollate, povidone and magnesium stearate. The 150 mg tablets also contain: lactose monohydrate, hypromellose, titanium dioxide (E171), glyceryl triacetate and ferric oxide yellow (E172). The coating for the 300 mg tablets contains: hyprolose, titanium dioxide, hypromellose and macrogol 400. The 150 mg tablets are yellow, oval tablets, scored on one side and marked 'P 150' on the other; while the 300 mg tablets are white, oval tablets, scored on one side and marked 'P 300' on the other. The tablets are scored so they can easily be broken in half. Your tablets are available in blister packs containing 30 tablets. MMaarrkkeettiinngg AAuutthhoorriissaattiioonn HHoollddeerr:: ratiopharm GmbH, Graf-Arco-Strasse 3, D-89079 Ulm, Germany MMaannuuffaaccttuurreerr:: Nordmark Arzneimittel GmbH & Co. KG, Pinnauallee 4, D-25436 Uetersen, Germany 22.. WWhhaatt iiss yyoouurr mmeeddiicciinnee uusseedd ffoorr Moclobemide belongs to a group of medicines called selective monoamine oxidase inhibitors (MAOIs) or antidepressants. Your doctor has prescribed for you this medicine in order to relieve the symptoms of depression. 33.. BBeeffoorree yyoouu ttaakkee MMoocclloobbeemmi iddee TTaabblleettss D Doo nnoott ttaakkee tthhiiss mmeeddiicciinnee iiff:: • You are allergic to moclobemide or to the ingredients listed above. Allergic reactions may inc Прочитать полный документ
PRODUCT SUMMARY 1. TRADE NAME OF THE MEDICINAL PRODUCT Moclobemide 300mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 300mg moclobemide. For excipients, see 6.1 3. PHARMACEUTICAL FORM Film-coated tablet White, coated, oval, biconvex shaped tablets with a white core, scored on one side and imprinted ”P” logo ”300” on the other side. The tablets are breakable. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Moclobemide is indicated for the treatment of major depressive episodes. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Adults: Initial usual dose 300mg, administered in divided doses after meals. The tablets should be taken with fluid. If necessary, the daily dose can be increased to 600mg per day. However, the dose should not be increased during the 1 st week of treatment, because the bioavailability increases during this time and a clinical effect may not be seen for 1-3 weeks. In individual cases, the therapeutic dose can be gradually reduced to 150 mg per day, depending on effect. Duration of treatment: Treatment with moclobemide should be continued for at least 4-6 weeks to be able to judge the efficacy of moclobemide. Treatment with moclobemide should preferably be continued for a symptom free period of 4-6 months. Then treatment can be gradually tapered off. Antidepressants, particularly MAOIs, should be withdrawn gradually to reduce the risk of withdrawal symptoms. Elderly: No special dose adjustment is required. Children: In view of the lack of clinical data available, moclobemide is not recommended for use in children. Renal/hepatic impairment: Patients with reduced renal function do not require a special dose adjustment. In patients with impaired hepatic function, the daily dose of Moclobemide should be reduced to a half or one third. 4.3. CONTRA-INDICATIONS • Hypersensitivity to moclobemide or to any of the excipients. • Acute confusion. • Patients with phaeochromocytoma. • Children under the age of 18. • Concomitant treatment with selegiline, and 5-HT re- Прочитать полный документ