Држава: Арменија
Језик: Енглески
Извор: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
carvedilol
Arpimed LLC
C07AG02
carvedilol
12,5mg
tablets
(40/1x40/), in blister
Prescription
Registered
2016-06-08
SUMMARY PRODUCT CHARACTERISTIC (SPC) CARVEDILOL TABLETS 1. NAME OF THE MEDICINAL PRODUCT 1.1 TRADE NAME – Carvedilol 1.2 INTERNATIONAL NON-PROPERTY NAME – Carvedilol 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ACTIVE INGREDIENT:_ Carvedilol Each 6.25 mg tablet contains 6.25 mg carvedilol. Each 12.5 mg tablet contains 12.5 mg carvedilol. Each 25 mg tablet contains 25 mg carvedilol. _For a full list of excipients, see section 6.1._ _ _ 3. PHARMACEUTICAL FORM 6.25 mg tablet: light greenish flat scored tablets, odorless 12.5 mg tablet: white flat scored tablets, odorless 25 mg tablet: light pink flat scored tablets, odorless 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _HYPERTENSION _ Carvedilol is indicated for the management of essential hypertension. It can be used alone or in combination with other anti-hypertensive agents (e.g. calcium channel blockers, diuretics). _ANGINA PECTORIS _ Carvedilol is indicated in the management of chronic stable angina. _CHRONIC HEART FAILURE _ Unless a contraindication exists, carvedilol is indicated for the treatment of all patients with stable and symptomatic, mild, moderate and severe chronic heart failure (CHF) of ischemic or non-ischemic etiology in combination with standard therapy (including ACE inhibitors and diuretics with or without digitalis). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Method of administration _ The tablets should be taken with the adequate supply of fluid. It is recommended that heart failure patients take their carvedilol medication with food to allow the absorption to be slower and the risk of orthostatic hypotension to be reduced. _Duration of treatment _ Treatment with carvedilol is a long-term therapy. As with all β-blockers, treatment should not be stopped abruptly but rather gradually reduced at weekly intervals. This is particularly important in the case of patients with concomitant coronary heart disease. _CHRONIC HEART FAILURE _ For CHF patients Carvedilol should be given with food. Symptomatic chronic heart failure. Initiation o Прочитајте комплетан документ