Država: Velika Britanija
Jezik: angleščina
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Nebivolol hydrochloride
A A H Pharmaceuticals Ltd
C07AB12
Nebivolol hydrochloride
2.5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02040000; GTIN: 5025903014843
NEBIVOLOL 2.5MG TABLETS PATIENT INFORMATION LEAFLET 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. Your medicine is called Nebivolol 2.5mg Tablets but will be referred to as Nebivolol Tablets throughout the leaflet. Please note that the leaflet also contains information about other strengths of the medicine Nebivolol 5mg Tablets. WHAT IS IN THIS LEAFLET: What Nebivolol Tablets are and what they are used for What you need to know before you take Nebivolol Tablets How to take Nebivolol Tablets Possible side effects How to store Nebivolol Tablets Contents of the pack and other information WHAT NEBIVOLOL TABLETS ARE AND WHAT THEY ARE 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 to lowering the 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NEBIVOLOL TABLETS DO NOT TAKE NEBIVOLOL TABLETS: * 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 Preberite celoten dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nebivolol 2.5 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2.5 mg of nebivolol (as nebivolol hydrochloride 2.725 mg). Excipient(s) with known effect: Each tablet contains 64mg of lactose monohydrate. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet Round, white colour tablets with breakline and debossed “N” on one side and “2.5” on the other side. Dimension: 7.00mm x 2.70mm The tablet can be divided in 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 of ≥ 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 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 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 these patients monitored closely. _Paediatric population _ The efficacy a Preberite celoten dokument