Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CARVEDILOL
IMEKS PHARMA SDN. BHD.
CARVEDILOL
30Tablet Tablets; 50Tablet Tablets; 100Tablet Tablets
Salutas pharma GmbH
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ CARVEDILOL HEXAL _® _ 6.25/ 12.5/25MG TABLET _ _ _ _ Carvedilol (6.25/12.5/25mg) Page no. WHAT IS IN THIS LEAFLET 1. What CARVEDILOL HEXAL is used for 2. How CARVEDILOL HEXAL works 3. Before you take CARVEDILOL HEXAL 4. How to take CARVEDILOL HEXAL 5. While you are using CARVEDILOL HEXAL 6. Possible side effects 7. After using CARVEDILOL HEXAL 8. Product description 9. Marketing authorization holder and manufacturer WHAT CARVEDILOL HEXAL IS USED FOR CARVEDILOL HEXAL is used to treat High blood pressure (hypertension) Chest pain (angina pectoris) Chronic heart failure HOW CARVEDILOL HEXAL WORKS CARVEDILOL HEXAL contains the active ingredient carvedilol. It belongs to the group of medicines called ‘beta blockers’. These medicines works by relaxing the blood vessels and slowing down the heart rate. Carvedilol also possesses antioxidant effect. BEFORE YOU USE CARVEDILOL HEXAL _- When you must not use it _ Do not take CARVEDILOL HEXAL if you: Have ever had allergic reaction to carvedilol, the active ingredient, or to any other ingredients in CARVEDILOL HEXAL Have severe heart failure Have asthma or other conditions that causes breathing difficulties Have liver problems, including liver failure Have a slow heart beat or serious problems with the heart rhythm (second or third degree heart block) Suffering from cardiogenic shock (second or third degree heart block) Suffering from cardiogenic shock (a state where heart is damaged and unable to supply sufficient blood to organs in body) Have very low blood pressure Have metabolic acidosis (excessive acidity in the body fluid) Have Prinzmetal’s angina, a type of chest pain Untreated phaeochromocytoma (a rare tumor in adrenal gland) Have poor circulation to your fingers and/or toes (peripheral vascular disease) Taking injectables medicine of verapamil or diltiazem. _If you are not sure whether you should _ _start taking this medicine, consult your _ _d Baca dokumen lengkap
DIRECTIONS FOR USE PLEASE READ CAREFULLY! CONTENT Each CARVEDILOL HEXAL ® 6.25MG, CARVEDILOL HEXAL ® 12.5MG and CARVEDILOL HEXAL ® 25MG TABLET contains 6.25mg, 12.5mg and 25mg carvedilol respectively for the purpose of oral administration. bisected tablet with a pressure-sensitive scoring notch, encoded C2. CARVEDILOL HEXAL ® 12.5MG TABLET: Red/brown, round, convex, bisected tablet with a pressure-sensitive scoring notch, encoded C3. CARVEDILOL HEXAL ® 25MG TABLET: White, round, convex, bisected tablet with a pressure-sensitive scoring notch, encoded C4. PHARMACODYNAMICS Carvedilol is a vasodilative non-selective beta-blocker which reduces the peripheral vascular resistance by selective alpha 1- receptor blockade and suppresses the renin-angiotensin system through non- selective beta-blockade. Plasma renin activity is reduced, and fluid retention is rare. Carvedilol has no intrinsic sympathomimetic activity (ISA). Like propranolol, it has membrane-stabilizing properties. Carvedilol is a racemate of two stereoisomers. Both enantiomers were found to have alpha-adrenergic blocking activity. Non- selective beta 1 - and beta 2 -adrenoceptor blockade is attributed mainly to the S (-) enantiomer. Carvedilol is a potent antioxidant, a scavenger of reactive oxygen radicals and anti-proliferative agent. The antioxidant properties of carvedilol and its metabolites have been demonstrated in _ in vitro _ and _in vivo _ animal studies and _ in vitro _ in a number of human cell types. In hypertensive patients, a reduction in blood pressure is not associated with a concomitant increase in peripheral resistance, as observed with pure beta-blocking agents. Heart rate is slightly decreased. Stroke volume remains unchanged. Renal blood flow and renal function remain normal, as does peripheral blood flow, therefore, cold extremities, often observed with beta-blockers, are only rarely seen. In hypertensive patients, carvedilol increases the plasma concentration of norepinephrine. In prolonged treatment of patients with angina pec Baca dokumen lengkap