Страна: Великобритания
Език: английски
Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Nebivolol hydrochloride
CST Pharma Ltd
C07AB12
Nebivolol hydrochloride
5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02040000; GTIN: 5055946800981
PATIENT INFORMATION LEAFLET NEBILET® 5MG TABLETS (Nebivolol hydrochloride) The name of your medicine is Nebilet 5mg Tablets, but will be referred to as Nebilet throughout the remainder of the leaflet. READ ALL THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. • 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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Nebilet is and what it is used for 2. Before you take Nebilet 3. How to take Nebilet 4. Possible side effects 5. How to store Nebilet 6. Further information 1. WHAT NEBILET IS AND WHAT IT IS USED FOR Nebilet contains nebivolol, a cardiovascular drug belonging to the group of selective beta-blocking agents (i.e. with a selective action on the cardiovascular system). It prevents increased heart rate, controls heart pumping strength. It also exerts a dilating action on blood vessels, which contributes as well to lower blood pressure. It is used to treat raised blood pressure (hypertension). Nebilet is also used to treat mild and moderate chronic heart failure in patients aged 70 or over, in addition to other therapies. 2. BEFORE YOU TAKE NEBILET DO NOT TAKE NEBILET • if you are allergic (hypersensitive) to nebivolol or any of the other ingredients of Nebilet • if you have one or more of the following disorders: - low blood pressure - serious circulation problems in the arms or legs - very slow heartbeat (less than 60 beats per minute) - certain other serious heart rhythm problems (e.g. 2nd and 3rd degree atrioventricular block, heart conduction disorders). - heart failure, which has just occurred or which has recently become worse, or you are receiving treatment for circulatory shock due to acute heart failure by intra Прочетете целия документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT NEBILET 5 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Nebilet tablet contains 5 mg of nebivolol (as nebivolol hydrochloride): 2.5 mg of SRRR-nebivolol (or d-nebivolol) and 2.5 mg of RSSS-nebivolol (or l- nebivolol). Excipients: each tablet contains 141.75 mg of lactose monohydrate (see section 4.4 and 6.1). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White, round, cross-scored tablet. The tablet can be divided in 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Hypertension _Adults_ The dose is one tablet (5 mg) daily, preferably at the same time of the day. Tablets may be taken with meals. 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. To date, an additional antihypertensive effect has been observed only when Nebilet 5 mg is combined with hydrochlorothiazide 12.5-25 mg. _Patients with renal insufficiency _ In patients with renal insufficiency, the recommended starting dose is 2.5 mg daily. If needed, the daily dose may be increased to 5 mg. _Patients with hepatic insufficiency_ Data in patients with hepatic insufficiency or impaired liver function are limited. Therefore the use of Nebilet in these patients is contra-indicated. _Elderly_ In patients over 65 years, the recommended starting dose is 2.5 mg daily. If needed, the daily dose may be increased to 5 mg. However, in view of the limited experience in patients above 75 years, caution must be exercised and these patients monitored closely. _Children_ _and ad Прочетете целия документ