Država: Malta
Jezik: angleščina
Source: Medicines Authority
NEBIVOLOL HYDROCHLORIDE
Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland
C07AB12
NEBIVOLOL HYDROCHLORIDE 5 mg
TABLET
NEBIVOLOL HYDROCHLORIDE 5 mg
POM
BETA BLOCKING AGENTS
Withdrawn
2008-10-10
PACKAGE LEAFLET: INFORMATION FOR THE USER NEBIVOLOL ACTAVIS 5 MG TABLETS Nebivolol 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 Actavis is and what it is used for 2. What you need to know before you take Nebivolol Actavis 3. How to take Nebivolol Actavis 4. Possible side effects 5. How to store Nebivolol Actavis 6. Contents of the pack and other information 1. WHAT NEBIVOLOL ACTAVIS IS AND WHAT IT IS USED FOR Nebivolol Actavis is a medicinal product that mainly acts on the function of your heart (beta- blocker). It decreases the blood pressure and improves the heart power. Nebivolol Actavis is used for the treatment of high blood pressure (essential hypertension) in addition to standard therapy (e.g. with diuretics, digoxin, ACE inhibitors, angiotensin II antagonists) for the treatment of stable mild or moderate chronic heart failure in patients aged 70 years or over. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NEBIVOLOL ACTAVIS DO NOT TAKE NEBIVOLOL ACTAVIS - if you are allergic to the active substance nebivolol hydrochloride or any of the other ingredients of this medicine (listed in section 6), - if you have liver function disorders or impaired liver function (hepatic insufficiency), - if you are pregnant or breast-feeding, - if you suffer from acute heart failure, cardiogenic shock or episodes of worsening heart failure (decompensation), which requires i.v. treatment with inotropic active substances, - if you suffer from sinus syndrome (a certain type of disturbance in hea Preberite celoten dokument
Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Nebivolol Actavis 5 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg of nebivolol equivalent to 5.45 mg of nebivolol hydrochloride. Excipients with known effect: 192.4 mg of lactose monohydrate/tablet For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FROM Tablet Round, white, convex, 9 mm cross-scored tablets, marked with ‘N 5’ on the 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 Method of administration: The tablet should be swallowed with a sufficient amount of liquid (e.g. one glass of water). The tablets can be taken with or without meals. 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. 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. Page 2 of 11 _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 Actavis 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 Preberite celoten dokument