Страна: Вірменія
мова: англійська
Джерело: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
nebivolol (nebivolol hydrochloride)
STADA Arzneimittel AG
nebivolol (nebivolol hydrochloride)
5mg
tablets
Prescription
SmPC Nebivolol NL803+4 CSP+QRD adaption 2014-04-29/AR 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Nebivolol STADA 5 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains nebivolol hydrochlorideequivalent to 5 mg of nebivolol Excipient with known effect: 167.05 mg lactose monohydrate/tablet (see section 4.4 and 6.1). For thefull 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. Occasio- nally, 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 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 Nebivolol STADA 5 mg in these patients is contraindicated (see section 4.3). SmPC Nebivolol NL803+4 CSP+QRD adaption 2014-04-29/AR 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 limit Прочитайте повний документ