Country: Armenia
Bahasa: Inggeris
Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
lercanidipine (lercanidipine hydrochloride), enalapril (enalapril maleate)
Recordati Industria Chimica e Farmaceutica S.p.A.
C09BB02
lercanidipine (lercanidipine hydrochloride), enalapril (enalapril maleate)
10mg+ 20mg
tablets film-coated
(28/2x14/) blisters
Prescription
Registered
2016-07-20
CORIPREN 20 mg/10 mg rev Mar 2015 Page 1 of 21 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT CORIPREN 20 mg/10 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg enalapril maleate (equivalent to 15.29 mg enalapril) and 10 mg lercanidipine hydrochloride (equivalent to 9.44 mg lercanidipine). Excipient with known effect: each tablet contains 92.0 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Yellow, circular, biconvex tablets of 8.5 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension in patients whose blood pressure is not adequately controlled by enalapril 20 mg alone. Fixed combination CORIPREN 20 mg/10 mg should not be used for initial treatment of hypertension. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Patients whose blood pressure is not adequately controlled by treatment with enalapril 20 mg alone could either be titrated up to the higher dose of enalapril monotherapy or switched to fixed combination CORIPREN 20mg/10mg. Individual dose titration with the components can be recommended. When clinically appropriate, direct switch from monotherapy to the fixed combination may be considered. Posology The recommended dose is one tablet once a day at least 15 minutes before meals. _ELDERLY PATIENTS:_ The dose should depend on the patient's renal function (see "Use in renal impairment"). _PATIENTS WITH RENAL IMPAIRMENT:_ CORIPREN is contraindicated in patients with severe renal dysfunction (creatinine clearance <30 ml/min) or in patients undergoing haemodialysis (see section 4.3 and 4.4). Particular caution is needed when initiating treatment in patients with mild to moderate renal dysfunction. _PATIENTS WITH HEPATIC IMPAIRMENT: _ CORIPREN is contraindicated in severe hepatic dysfunction. Particular caution is needed when initiating treatment in patients with mild to moderate hepatic dysfunction. _PAEDIATRIC POPULATION:_ There is Baca dokumen lengkap