Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Carvedilol
Almus Pharmaceuticals Ltd
C07AG02
Carvedilol
6.25mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02040000; GTIN: 05060057402726
Accord Logo CARVEDILOL 3.125MG TABLETS CARVEDILOL 6.25MG TABLETS CARVEDILOL 12.5MG TABLETS CARVEDILOL 25MG TABLETS READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU . • Keep the leaflet. You may need to read it again. • If you have any further questions, ask your doctor, pharmacist or nurse. • 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 ARE CARVEDILOL TABLETS AND WHAT THEY ARE USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CARVEDILOL TABLETS 3. HOW TO TAKE CARVEDILOL TABLETS 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE CARVEDILOL TABLETS 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT CARVEDILOL TABLETS IS AND WHAT IT IS USED FOR Carvedilol Tablets contain the active ingredient carvedilol. Carvedilol is one of a group of medicines called beta-blockers. These medicines work by widening blood vessels (vasodilation). This lowers blood pressure and makes it easier for the heart to pump blood around the body by lessening the strain on the heart muscles. Carvedilol Tablets may be used to treat: • High blood pressure (hypertension) • Angina pectoris • Heart failure. Carvedilol Tablets are normally taken at the same time as other medicines for heart failure. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE Carvedilol Tablets DO NOT TAKE Carvedilol Tablets : • If you have ever had an allergic reaction to Carvedilol Tablets or any of the ingredients in the tablet. An allergic reaction may include a rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue. • If you have a history of wheezing due to asthma, emphysema or bronchitis. • If you have severe liver problems. • If you suffer from a weak heart (cardiogenic shock) or sec Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Carvedilol 6.25 mg tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains 6.25 mg carvedilol. Excipient with known effect: Each tablet contains 25mg lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet White, oval, scored on both sides and marked "6.25" on one side. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Essential hypertension. Chronic stable angina pectoris Adjunctive treatment in moderate to severe stable heart failure._ _ _4.2 _ _POSOLOGY AND METHOD OF ADMINISTRATION _ Posology Carvedilol is available in 4 strengths: 3.125 mg, 6.25 mg, 12.5 mg and 25 mg _Essential hypertension _ Carvedilol may be used for the treatment of hypertension alone or in combination with other antihypertensives, especially thiazide diuretics. Once daily dosing is recommended, however the recommended maximum single dose is 25 mg and the recommended maximum daily dose is 50 mg. _Adults _ The recommended initial dose is 12.5 mg once a day for the first two days. Thereafter, the treatment is continued at the dose 25 mg/day. If necessary, the dose may be further increased gradually at intervals of two weeks or more rarely. _Elderly_ The recommended initial dose in hypertension is 12.5 mg once a day, which may also be sufficient for continued treatment. However, if the therapeutic response is inadequate at this dose, the dose may be further increased gradually at intervals of two weeks or more rarely. _Chronic stable angina pectoris _ _Adults_ The recommended initial dose is 12.5 mg twice daily for two days. Thereafter, the treatment is continued at the dose 25 mg twice daily. If necessary, the dose may be further increased gradually at intervals of two weeks or more rarely. The recommended maximum daily dose is 100 mg in divided doses (50mg twice daily). _Elderly_ The recommended initial dose is 12.5 mg twice daily for two days. There Read the complete document