Land: Armenien
Sprog: engelsk
Kilde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
fenofibrate
Recipharm Fontaine
C10AB05
fenofibrate
145mg
tablets film-coated
(30/3x10/) in blister
Prescription
Registered
2023-02-06
MASTER OF SUMMARY OF PRODUCT CHARACTERISTIC (SMPC) FENOFIBRATE This Information is Confidential Page 1 of 11 1. NAME OF THE MEDICINAL PRODUCT Tricor® 145 mg, film-coated tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Tricor® 145 mg: Each tablet contains 145.0 mg fenofibrate (nanoparticles). For a full list of excipients, see Section 6.1. 3. PHARMACEUTICAL FORM Film coated tablet. Tricor® 145 mg: White, oblong, film-coated tablets engraved “145” on one side and “Fournier logo” on the other side. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Tricor® is indicated as an adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight reduction) for the following: - Treatment of severe hypertriglyceridaemia with or without low HDL cholesterol. - Mixed hyperlipidaemia when a statin is contraindicated or not tolerated. - Mixed hyperlipidaemia in patients at high cardiovascular risk in addition to a statin when triglycerides and HDL cholesterol are not adequately controlled. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Response to therapy should be monitored by determination of serum lipid values. If an adequate response has not been achieved after several months (e.g. 3 months), complementary or different therapeutic measures should be considered. Film-coated tablet may be given at any time of the day, with or without food (see section 5.2. Pharmacokinetic properties). Tablet should be swallowed whole with a glass of water. The recommended dose is one tablet containing 145 mg fenofibrate taken once daily. Patients currently taking one 200 mg capsule (or one 160 mg tablet) can be changed to one 145 mg fenofibrate tablet without further dose adjustment. In case of missing the next dose, the next dose should be taken at the usual time the next day. Do not take a double dose to make up for a forgotten dose. _Geriatric population _ In elderly patients, without renal impairment, the usual adult dose is recommended. _Pediatric population _ The safety and efficacy of fenofibrate in children an Læs hele dokumentet