Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
Nebivolol
Medreich Plc
C07AB12
Nebivolol
5 milligram(s)
Tablet
nebivolol
2019-11-29
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT NEBIVOLOL 5 MG TABLETS nebivolol READ ALL OF THESE 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 symptoms 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 Tablets is and what it is used for 2. What you need to know before you take Nebivolol Tablets 3. How to take Nebivolol Tablets 4. Possible side effects 5. How to store Nebivolol Tablets 6. Contents of the pack and other information 1. WHAT NEBIVOLOL TABLETS 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 blood pressure. It is used to treat raised blood pressure (hypertension). Nebivolol Tablets 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 TABLETS_ _ DO NOT TAKE NEBIVOLOL TABLETS: If you are allergic (hypersensitive) 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: o low blood pressure o serious circulation problems in the arms or legs o very slow heartbeat (less than 60 beats per minute) o certain other serious heart rhythm problems (e.g. 2nd and 3rd degree atrioventricular block, heart conduction disorders). heart failure, wh Lees het volledige document
Health Products Regulatory Authority 02 December 2019 CRN008NXK Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nebivolol 5 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg of nebivolol (as nebivolol hydrochloride). Excipient(s) with known effect: Each tablet contains 121.64mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Round, white colour tablet, cross scored on one side and debossed with "N" and "5" on either side of breakline on the other side. Dimension: 9.10mm x 3.00mm 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 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 Nebivolol 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. Health Products Regulatory Authority 02 December 2019 CRN008NXK Page 2 of 10 _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 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 Lees het volledige document