Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
LOFEPRAMINE HYDROCHLORIDE
Merck Serono Limited
70 Milligram
Film Coated Tablet
1999-05-14
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gamanil 70mg Film-Coated Tablet. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains lofepramine hydrochloride 76.10mg equivalent to lofepramine 70mg. Excipents: Each tablet contains lactose 126.05mg and Ponceau 4R Aluminium Lake (E124) 1.15 mg. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Round, lacquered, brown-violet tablet, with occasional white dots, with a spindle shaped scoring on one side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the treatment of symptoms of depressive illness. This includes depression/anxiety states associated with panic disorder features. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: Oral Recommended dosage: The usual dose is 70mg twice daily (140mg) or three times daily (210mg) depending upon patient response. The daily dose should always be given in divided doses not exceeding 70 mg per dose. In the treatment of depression/anxiety states associated with panic disorder features, the initial dosage should be 70 mg daily for the first week. Paediatric patients Use in children and adolescents under the age of 18 is not recommended (see section 4.4). Elderly Elderly patients may respond to lower doses in some cases. 4.3 CONTRAINDICATIONS Lofepramine must not be used in patients hypersensitive to lofepramine, dibenzazepines, or any of the excipients. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 27/10/2010_ _CRN 2079881_ _page number: 1_ Lofepramine must not be used in patients • with mania, • with Citiți documentul complet