Country: Միացյալ Թագավորություն
language: անգլերեն
source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Tamsulosin hydrochloride
Sandoz Ltd
G04CA02
Tamsulosin hydrochloride
400microgram
Modified-release tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 07040100; GTIN: 5050650017021
OBJECT 1 FARAMSIL 400 MICROGRAM PROLONGED-RELEASE TABLETS Summary of Product Characteristics Updated 14-Feb-2018 | Sandoz Limited 1. Name of the medicinal product Faramsil 400 microgram Prolonged-release Tablets 2. Qualitative and quantitative composition Each film-coated prolonged-release tablet contains 0.4 mg tamsulosin hydrochloride. Excipient(s) with known effect: Each film-coated prolonged-release tablet contains 18.75 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated prolonged-release tablet Round, bi-convex, brown film-coated tablet with debossing “0.4” on one side and “SZ” on the other side. 4. Clinical particulars 4.1 Therapeutic indications Treatment of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). 4.2 Posology and method of administration Posology One tablet daily can be taken independently of food. Method of administration For oral use. The tablet should be swallowed whole and should not be crushed or chewed as this will interfere with the prolonged release of the active ingredient. Special populations Renal impairment: no dose adjustment is required in patients with renal impairment Hepatic impairment: no dose adjustment is required in patients with mild to moderate hepatic impairment (see also section 4.3) Paediatric population The safety and efficacy of tamsulosine in children <18 years have not been established. Currently available data are described in section 5.1 4.3 Contraindications Hypersensitivity to tamsulosin, including drug-induced angio-oedema, or to any of the excipients listed in section 6.1. A history of orthostatic hypotension. Severe hepatic insufficiency. 4.4 Special warnings and precautions for use As with other alpha1-blockers, a reduction in blood pressure can occur in individual cases during treatment with tamsulosin, leading in rare cases to syncope. At the first signs of orthostatic hypotension (dizziness, weakness), the patient should sit or lie down until the sympto read_full_document