Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
Nebivolol
Glenmark Arzneimittel GmbH
C07AB; C07AB12
Nebivolol
10 milligram(s)
Tablet
Beta blocking agents, selective; nebivolol
Not marketed
2014-01-17
V 2.1 Draft – 08-Jul-2022 1 IE/H/0815/001/IB/013 – Safety (Brand Leader) Update PACKAGE LEAFLET V 2.1 Draft – 08-Jul-2022 2 IE/H/0815/001/IB/013 – Safety (Brand Leader) Update PACKAGE LEAFLET: INFORMATION FOR THE USER NEBIVOLOL 10 MG TABLETS Nebivolol (as 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 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, 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 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 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 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 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 hear Lire le document complet
Health Products Regulatory Authority 23 December 2022 CRN00D7KL Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nebivolol 10mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tabletcontains 10.90 mg nebivolol hydrochloride corresponding to 10 mg nebivolol Excipient(s) with known effect: 139.55 mg of lactose monohydrate/tablet For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Circular, white, shallow, biconvex uncoated tablets engraved with ‘G’ and ‘N’ on either side of break line on one side and plain on other side. The tablet can be divided into equal doses. 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 (two 2.5 mg tablets, one 5 mg tablet or half a 10 mg tablet) daily, preferably at the same time of the day. Nebivolol 2.5 mg and 5 mg tablets are also available on the market. 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 tablets in these patients is contra-indicated. Health Products Regulatory Authority 23 December 2022 CRN00D7KL Page 2 of 10 _Elderly_ In pa Lire le document complet