Land: Armenía
Tungumál: enska
Heimild: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
amlodipine (amlodipine besilate), perindopril (perindopril tert-butylamine)
Gedeon Richter PLC
C09BB04
amlodipine (amlodipine besilate), perindopril (perindopril tert-butylamine)
10mg+ 4mg
tablets
(30/3x10/), in blister
Prescription
Registered
2015-11-18
PhD002023 1 H. NAME OF THE MEDICINAL PRODUCT Amlodipine-Perindopril-Richter 4 mg/5 mg tablets Amlodipine-Perindopril-Richter 8 mg/5 mg tablets /.mlodipine-Perindopril-Richter 4 mg/1 0 mg tablets Amlodipine-Perindopril-Richter 8 mg/1 0 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Amlodipine-Perindopril-Richter 4 mg /5 mg tablet: Each tablet contains 4 mg perindopril tert-butylamine and 5 mg amlodipine (as amlodipine besilate). Amlodipine-Perindopril-Richter 8 mg _I _ 5 mg tablet: Each tablet contains 8 mg perindopril tert-butylamine and 5 mg an1lodipine (as amlodipine besilate). A1nlodipine-Perindopril-Richter 4 mg /10 mg tablet: Each tablet contains 4 mg perindopril tert-butylamine and 10 mg amlodipine (as an1lodipine besilate). Amlodipine-Perindopril-Richter s· mg _I _ 10 mg tablet: Each tablet contains 8 mg perindopril tert-butylamine and 10 mg amlodipine (as amlodipine besilate). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. 142/250 Amlodipine-Perindopril-Richter 4 mg _I _ 5 mg tablet: White or almost white, round, flat tablets of8 mm. Engraving on one side: "CH3", other side is without engraving. Amlodipine-Perindopril- Richter 8 mg _I _ 5 mg tablet: White or almost white, round, flat tablets of 8 mm .. Engraving on one side: "CH4", other side is without engraving. Amlodipine-Perindopril-Richter 4 mg /10 mg tablet: Whlte or almost white, round, flat tablets of 11 mm .. Engraving on one side: "CH5", other side is without engraving. Amlodipine-Perindopril-Richter 8 mg /10 mg tablet: White or almost white, round, flat tablets of 11 mm .. Engraving on one side: "CH6", other side is without engraving. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Amlodipine-Perindopril-Richter is indicated as substitution therapy for treatment of essential hypertension and/or stable coronary artery disease, in patients already controlled with perindopril and amlodipine given concmrently at the same dose level. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral route. One tablet per day Lestu allt skjalið