Land: Armenía
Tungumál: enska
Heimild: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
lisinopril (lisinopril dihydrate), hydrochlorothiazide
Alkaloid AD Skopje
C09BA03
lisinopril (lisinopril dihydrate), hydrochlorothiazide
20mg+ 12,5mg
tablets
(20/2x10/) in blister, (30/3x10/) in blister
Prescription
Registered
2023-04-07
Skopryl plus 20 mg/12.5 mg tablets Summary of Product Characteristics 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Skopryl plus ® 20 mg/12.5 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg of lisinopril (as lisinopril dihydrate 21.78 mg) and 12.5 mg hydrochlorothiazide. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets Round, biconvex, ochre-violet tablets with bisection line on one side. The score line is not intended for breaking the tablet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Skopryl Plus is indicated in the management of mild to moderate hypertension in patients who have been stabilised on the individual components given in the same proportions. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION PRIMARY HYPERTENSION The usual dosage is 1 tablet, administered once daily. As with all other medication taken once daily, Skopryl Plus should be taken at approximately the same time each day. In general, if the desired therapeutic effect cannot be achieved in a period of 2 to 4 weeks at this dose level, the dose can be increased to 2 tablets administered once daily. RENAL IMPAIRMENT Thiazides may not be appropriate diuretics for use in patients with renal impairment and are ineffective at creatinine clearance values of 30 ml/min or below (i.e. moderate or severe renal insufficiency). Skopryl Plus is not to be used as initial therapy in any patient with renal insufficiency. Skopryl plus 20 mg/12.5 mg tablets Summary of Product Characteristics 2 In patients with creatinine clearance of >30 and <80 ml/min, Skopryl Plus may be used, but only after titration of the individual components. The recommended dose of lisinopril, when used alone, in mild renal insufficiency, is 5 to 10 mg. PRIOR DIURETIC THERAPY Symptomatic hypotension may occur following the initial dose of Skopryl Plus: this is more likely in patients who are volume and/or salt depleted as a result of prior diuretic therapy. The diuretic therapy should be Lestu allt skjalið