Země: Malajsie
Jazyk: angličtina
Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
NEBIVOLOL HCI
A. MENARINI SINGAPORE PTE. LTD.
NEBIVOLOL HCI
28Tablet Tablets
BERLIN-CHEMIE AG
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ NEBILET 5MG TABLETS Nebivolol WHAT IS IN THIS LEAFLET 1. What is Nebilet 5mg tablets used for. 2. How Nebilet 5mg tablets works. 3. Before you take Nebilet 5mg tablets 4. How to take Nebilet 5mg tablets. 5. Side effects 6. After using Nebilet 5mg tablets 7 .Product description 8. Manufacturer 9. Product Registration Holder 10. Date of revision. WHAT IS NEBILET 5MG TABLETS USED FOR . Nebilet 5mg tablets is used to treat raised blood pressure (hypertension). Nebilet 5mg tablets is also used to treat mild and moderate chronic heart failure in patients aged 70 or over, in addition to other therapies. HOW NEBILET 5MG TABLETS WORKS Nebilet 5mg 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 BEFORE YOU TAKE NEBILET 5MG TABLETS _- When you must not take it _ Do not take Nebilet 5mg tablets • if you are allergic (hypersensitive) to nebivolol or any of the other ingredients of Nebilet 5mg tablets • 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) • certain other serious heart rhythm problems (e.g. 2 nd and 3 rd degree atrioventricular block, heart conduction disorders). • heart failure, which has just occurred or which has recently become worse, or you are receiving treatment for circulatory shock due to acute heart failure by intravenous drip feed to help your heart work • asthma or wheezing (now or in the past) • untreated phaeochromocytoma, a tumour located on top of the kidneys (in the adrenal glands) • liver function disorder • a metabolic disorder (metabolic acidosis), for example, diabetic ketoacidosis. _- Before you start to take it _ Přečtěte si celý dokument
NEBILET ® Nebivolol 5 mg COMPOSITION One Nebilet tablet contains nebivolol hydrochloride 5.45 mg (eq. to 5 mg nebivolol). _Excipients: _Polysorbate 80, hypromellose, lactose monohydrate, maize starch, croscarmellose sodium, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate. PHARMACEUTICAL FORM Tablet. Off-white, circular, biconvex tablet with one-sided dividing cross score. The tablet can be divided in equal quarters. PHARMACOLOGICAL PROPERTIES _PHARMACODYNAMIC PROPERTIES_ Beta blocking agent, selective. ATC code: C07AB12 Nebivolol is a racemate of two enantiomers, SRRR-nebivolol (or d-nebivolol) and RSSS-nebivolol (or l-nebivolol). It combines two pharmacological activities: It is a competitive and selective beta- receptor antagonist: this effect is attributed to the SRRR-enantiomer (d-enantiomer). It has mild vasodilating properties, possibly due to an interaction with the L-arginine/nitric oxide pathway. Single and repeated doses of nebivolol reduce heart rate and blood pressure at rest and during exercise, both in normotensive subjects and in hypertensive patients. The antihypertensive effect is maintained during chronic treatment. At therapeutic doses, nebivolol is devoid of alpha-adrenergic antagonism. During acute and chronic treatment with nebivolol in hypertensive patients systemic vascular resistance is decreased. Despite heart rate reduction, reduction in cardiac output during rest and exercise may be limited due to an increase in stroke volume. The clinical relevance of these haemodynamic differences as compared to other beta1 receptor antagonists has not been fully established. In hypertensive patients, nebivolol increases the NO-mediated vascular response to acetylcholine (ACh) which is reduced in patients with endothelial dysfunction. In a mortality–morbidity, placebo-controlled trial performed in 2128 patients ≥ 70 years (median age 75.2 years) with stable chronic heart failure with or without impaired left ventricular ejection fraction (mean LVEF: 36 ± 12.3%, with t Přečtěte si celý dokument