Država: Velika Britanija
Jezik: angleščina
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Nebivolol hydrochloride
Milpharm Ltd
C07AB12
Nebivolol hydrochloride
5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02040000; GTIN: 08901175041800
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 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 Nebivolol is and what it is used for 2. What you need to know before you take Nebivolol 3. How to take Nebivolol 4. Possible side effects 5. How to store Nebivolol 6. Contents of the pack and other information 1. WHAT NEBIVOLOL IS AND WHAT IT IS USED FOR Nebivolol tablets 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 the blood pressure. It is used to treat raised blood pressure (hypertension). Nebivolol is also used to treat mild and moderate chronic heart failure in patients aged 70 years or over, in addition to other therapies. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NEBIVOLOL DO NOT TAKE NEBIVOLOL • 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 heart beats per minute) - certain other serious heart rhythm problems (e.g. 2 nd and 3 rd 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 intrav Preberite celoten dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nebivolol 5 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5.45 mg nebivolol hydrochloride equivalent to 5 mg nebivolol. Excipients with known effect Each tablet contains 153.480 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White to off white, round shaped (diameter is 9.1 mm), biconvex uncoated tablets debossed with ‘NL 5’ separated by cross score line side of the tablet and plain on another side. The tablet can be divided into equal doses (halves). 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 5 mg (one tablet) 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 nebivolol 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 Nebivolol 2.5 mg or Nebivolol 5 mg tablets 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 th Preberite celoten dokument