Land: Malta
Sprog: engelsk
Kilde: Medicines Authority
LABETALOL HYDROCHLORIDE
Generics UK Limited Station Close, Potters Bar, Herts, EN6 1TL, United Kingdom
C07AG01
LABETALOL HYDROCHLORIDE 200 mg
TABLET
LABETALOL HYDROCHLORIDE 200 mg
POM
BETA BLOCKING AGENTS
Suspended
2006-12-14
111222111 BEFORE YOU TAKE YOUR MEDICINE PLEASE READ THIS LEAFLET CAREFULLY. This leaflet contains a summary of the information about your medicine, Labetalol Tablets BP. YOUR MEDICINE Your medicine is in the form of a tablet. There are three different strengths of Labetalol Tablets BP available. Each tablet contains either 100 mg, 200 mg or 400 mg of the active ingredient Labetalol Hydrochloride. Each tablet also contains microcrystalline cellulose, pregelatinised starch, sucrose, sodium starch glycollate Type A, colloidal anhydrous silica, silicon dioxide, magnesium stearate, hypromellose, diethyl phthalate, ethylcellulose, sunset yellow (E110), titanium dioxide (E171) and carnauba wax. The 400 mg tablet also contains talc and quinoline yellow aluminium lake (E104). The 100 mg tablet is marked ‘LL 100’; the 200 mg tablet ‘LL 200’ whilst the 400 mg tablet is marked ‘LL 400’. Labetalol Tablets BP are available in containers of 56 tablets. Your pharmacist will dispense the number of tablets prescribed by your doctor. HOW DOES YOUR MEDICINE WORK ? Labetalol belongs to a group of medicines called BETA-BLOCKERS. Labetalol helps to block the effects of naturally occurring substances within your body (Catecholamines). In some patients Catecholamines may cause high blood pressure or worsen angina. By blocking these effects, Labetalol can reduce blood pressure and reduce angina pain. Product Licence Holder and Manufacturer: Generics [UK] Limited, Station Close, Potters Bar, Herts, EN6 1TL. WHY DO YOU NEED TO TAKE YOUR MEDICINE ? Labetalol Tablets BP can help treat the following conditions: • High blood pressure (hypertension), including hypertension in pregnancy. • Angina (pain in the chest, arms, shoulders or neck caused by effort, Læs hele dokumentet
_ _ _ _ Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS PRODUCT SUMMARY 1. TRADE NAME OF THE MEDICINAL PRODUCT Labetalol Tablets BP 200mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200 mg Labetalol Hydrochloride 3. PHARMACEUTICAL FORM Orange biconvex film-coated tablets marked “LL 200” on one side and blank on the other. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Labetalol is a combined alpha and beta-adrenoceptor blocker indicated for: - Hypertension, including hypertension in pregnancy. - Angina pectoris with existing hypertension. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION For oral administration only. Labetalol tablets should be taken with food. Adults: Hypertension: Initially, 100mg twice daily, increased at intervals of 14 days to usual dose of 200mg twice daily. If necessary up to 800mg daily may be given, as a twice daily regimen. In severe refractory hypertension, daily doses of up to 2400mg have been given, divided into three or four times a day regimens. Hypertension in Pregnancy: An initial dosage of 100mg twice daily may be increased, if necessary at weekly intervals by 100mg twice daily. During the second and third trimesters, the severity of hypertension may necessitate a further dose titration to a three times daily regimen ranging from 100mg – 400mg three times a day. The total daily dosage should not exceed 2400mg. Angina Co-Existing with Hypertension: The recommended dose is that which is necessary to control the hypertension. _ _ _ _ Page 2 of 8 Children: Dosage has not been established. Elderly: An initial dose of 50mg twice daily is recommended and this has been sufficient in some cases to control hypertension. 4.3. CONTRA-INDICATIONS Labetalol is contraindicated in patients with hypersensitivity to Labetalol, Læs hele dokumentet