Country: Holland
Tungumál: hollenska
Heimild: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
NEBIVOLOLHYDROCHLORIDE SAMENSTELLING overeenkomend met ; NEBIVOLOL
Stada Arzneimittel AG
C07AB12
NEBIVOLOLHYDROCHLORIDE COMPOSITION corresponding to ; NEBIVOLOL
Tablet
CROSCARMELLOSE NATRIUM (E 468) ; CROSPOVIDON (E 1202) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; POVIDON (E 1201) ; SILICIUMDIOXIDE (E 551),
Oraal gebruik
Nebivolol
Hulpstoffen: CROSCARMELLOSE NATRIUM (E 468); CROSPOVIDON (E 1202); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEPREGELATINEERD; POVIDON (E 1201); SILICIUMDIOXIDE (E 551);
2009-02-17
1 PACKAGE LEAFLET: INFORMATION FOR THE USER NEBILOSTAD 5 MG TABLETTEN Nebivolol READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CON- TAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, please ask your doctor or your 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 Nebilostad is and what it is used for 2. What you need to know before you take Nebilostad 3. How to take Nebilostad 4. Possible side effects 5. How to store Nebilostad 6. Contents of the pack and other information 1. WHAT NEBILOSTAD IS AND WHAT IT IS USED FOR Nebilostad 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 in- creased heart rate, controls heart pumping strength. It also exerts a dilating action on blood vessels, which contributes to as well lower blood pressure. It is used to treat raised blood pressure (hypertension). Nebilostad is also used to treat stable 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 NEBILOSTAD DO NOT TAKE NEBILOSTAD if you are allergic to nebivolol or any of the other ingredients of this medicine (listed in sec- tion 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) or irregular heartbeat (sick sinus syndrome) - certain other serious heart rhythm problems (e.g. 2 nd and 3 rd degree atrioventricular block, sino-atrial block) - heart failure, which has just occurre Lestu allt skjalið
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Nebilostad 5 mg tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains nebivolol hydrochloride equivalent to 5 mg of nebivolol Excipient with known effect: 167.05 mg lactose monohydrate/tablet (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 quarter 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 _ _ _When used for the indication 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. Occasion- ally, 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 Nebilostad 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 Nebilostad 5 mg in these patients is contraindicated (see section 4.3). 2 _ _ Elderly In patients over 65 years, the recommended starting dose is 2.5 mg daily. If needed, the dai- ly 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. Paediat Lestu allt skjalið