Country: United Kingdom
Bahasa: Inggeris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Nebivolol hydrochloride
Torrent Pharma (UK) Ltd
C07AB12
Nebivolol hydrochloride
5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02040000; GTIN: 5060623371487
PACKAGE LEAFLET: INFORMATION FOR THE USER NEBIVOLOL 5 MG TABLETS (Nebivolol hydrochloride) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If you get any side effects talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Nebivolol 5 mg Tablets are and what is it used for 2. What you need to know before you take Nebivolol 5 mg Tablets 3. How to take Nebivolol 5 mg Tablets 4. Possible side effects 5. How to store Nebivolol 5 mg Tablets 6. Contents of the pack and other information 1. WHAT NEBIVOLOL 5 MG TABLETS ARE AND WHAT IS IT USED FOR Nebivolol 5 mg Tablets contains nebivolol hydrochloride, belong to a group of medicines known as beta-blockers. They work by blocking the activity of specific proteins in the heart, lungs, pancreas, liver, and blood circulation system. Nebivolol 5 mg Tablets are used to treat. high blood pressure (hypertension). chronic heart failure in patients aged 70 years or older. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NEBIVOLOL 5 MG TABLETS DO NOT TAKE NEBIVOLOL 5 MG TABLETS IF: you are allergic (hypersensitive) to Nebivolol or any of the other ingredients of Nebivolol 5 mg Tablets (Listed in section 6). you suffer from liver problems. you have low blood pressure or poor circulation in the arms or legs. you have a very slow heart beat (less than 60 beats per minute). you have certain serious heart rhythm problems (e.g. 2nd and 3rd degree atrioventricular block, heart conduction disorders). you have the condition heart failure which has just occurred or which has recently become worse, or you are receiving treatment f Baca dokumen lengkap
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nebivolol 5mg Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Nebivolol 5mg Tablet contains 5mg of nebivolol (as hydrochloride) Excipients with known effects Lactose monohydrate each tablet contains 192.4 mg of lactose monohydrate For a full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Tablets. White, round, biconvex, 9mm diameter tablet, cross-scored on one side and marked with “N5” on the other side. The tablet can be divided into equal quarters. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension Treatment of essential hypertension. Chronic heart failure (CHF) Treatment of stable mild and moderate chronic heart failure in addition to standard therapies in elderly patients 70 years old or above. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Hypertension _Adults _ _ _ The usual dose is one tablet (5mg) daily, preferably taken at the same time of the day. The blood pressure lowering effect becomes evident after 1-2 weeks of treatment. Occasionally, the optimal effect is reached only after 4 weeks. _Combination with other antihypertensive agents _ Beta-blockers can be used alone or concomitantly with other antihypertensive agents. An additional antihypertensive effect has been observed when Nebivolol 5mg Tablets are combined with hydrochlorothiazide 12.5mg-25mg. _Patients with renal insufficiency _ _ _ The recommended starting dose for patients with renal insufficiency is 2.5mg daily. If needed, the daily dose may be increased to 5mg. _Patients with hepatic insufficiency _ _ _ Data in patients with hepatic insufficiency or impaired liver function are limited. Therefore the use of nebivolol in these patients is contraindicated. _Elderly _ _ _ In patients over 65 years, the recommended starting dose is 2.5mg daily. If needed, the daily dose may be increased to 5mg. However, in view of the limited experience in patients above 75 years, caution must be exercised and these patients monitored closely. _Paediatr Baca dokumen lengkap