Quốc gia: Vương quốc Anh
Ngôn ngữ: Tiếng Anh
Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)
Nebivolol hydrochloride
A. Menarini Farmaceutica Internazionale SRL
C07AB12
Nebivolol hydrochloride
5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02040000; GTIN: 5038227000263
1 Package leaflet: Information for the user HYPOLOC 5 mg tablets Nebivolol READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Hypoloc is and what it is used for 2. What you need to know before you take Hypoloc 3. How to take Hypoloc 4. Possible side effects 5. How to store Hypoloc 6. Contents of the pack and other information 1. WHAT HYPOLOC IS AND WHAT IT IS USED FOR Hypoloc 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). Hypoloc is also used to treat mild and moderate chronic heart failure in patients aged 70 or over, in addition to other therapies. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE HYPOLOC DO NOT TAKE HYPOLOC • if you are allergic to nebivolol or any of the other ingredients of this medicine (listed in section 6). • 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. 2 nd and 3 rd degree atrioventricular block, heart conduction disorders). 2 − heart failure, which has just occurred or which has recently become worse, or you are receiving treatment for circula Đọc toàn bộ tài liệu
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT HYPOLOC 5 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Hypoloc 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). Excipient with known effect: each tablet contains 141.75 mg of lactose monohydrate (see section 4.4 and 6.1). For the 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 Posology Hypertension _Adults_ The dose is one tablet (5 mg) daily, preferably 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. To date, an additional antihypertensive effect has been observed only when Hypoloc 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 Hypoloc in these patients is contra-indicated. _Older people_ 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. _Paediatric popu Đọc toàn bộ tài liệu