Riik: Austraalia
keel: inglise
Allikas: Department of Health (Therapeutic Goods Administration)
Carvedilol
Sandoz Pty Ltd
Medicine Registered
_ _ CARVEDILOL SANDOZ ® CARVEDILOL TABLETS CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Carvedilol Sandoz. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you taking Carvedilol Sandoz against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may want to read it again. WHAT CARVEDILOL SANDOZ IS USED FOR The name of your medicine is Carvedilol Sandoz. It contains the active ingredient carvedilol. Carvedilol Sandoz is used to treat heart failure. Your doctor may have prescribed Carvedilol Sandoz for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE WAS PRESCRIBED FOR YOU. _HOW CARVEDILOL SANDOZ WORKS _ Carvedilol Sandoz belongs to a group of medicines called beta-blockers. It works by slowing down the heart rate and relaxing blood vessels if they are too tight. Additionally, it works as an antioxidant. There is no evidence that Carvedilol Sandoz is addictive. This medicine is available only with a doctor’s prescription. _ _ BEFORE YOU TAKE CARVEDILOL SANDOZ _WHEN YOU MUST NOT TAKE IT _ Do not take this medicine if: • you are allergic to the active ingredient or any of the inactive ingredients mentioned at the end of this leaflet under Product Description. Symptoms of an allergic reaction may include an itchy skin rash, shortness of breath or swelling of the face or tongue. • you are pregnant or breastfeeding, unless permitted by your doctor • you have asthma or Lugege kogu dokumenti
_Product Information _ _ _ _Page 1 of _23_ _ _Carvedilol Sandoz 6.25/12.5/25mg tablets _ _02/2012_ _Sandoz Pty Ltd _ PRODUCT INFORMATION CARVEDILOL SANDOZ 6.25 / 12.5 / 25 MG TABLETS NAME OF THE MEDICINE _ _ _Carvedilol _ _ _ _ _ DESCRIPTION _Chemical Name: _(+/-)-1-(9 H-carbazol-4-yloxy)-3-{[2-(2-methoxyphenoxy) ethyl]amino}propan-2-ol. _Molecular formula_: C 24 H 26 N 2 O 4 MW: 406.5 CAS: 72956-09-3._ _ _ _ It is a white crystalline powder and has low solubility in water (0.01mg/mL). It is soluble in ethanol (22.7 mg/mL). _ _ _Carvedilol Sandoz tablets also contain inactive ingredients: _ Lactose, microcrystalline cellulose, crospovidone, povidone K 30, colloidal anhydrous silica, magnesium stearate, yellow iron oxide (6.25 mg and 12.5mg), red iron oxide (12.5mg). _ _ _Actions_ Carvedilol is a dual action cardiovascular agent. It is a vasodilating, nonselective beta-blocking agent with antioxidant properties. Vasodilation has been shown to be mediated primarily by selective blockade of alpha 1 -adrenoreceptors. _ _ PHARMACOLOGY Pharmacodynamics Carvedilol is a racemic mixture. In animal models, both enantiomers have alpha- adrenergic receptor blocking properties. The beta-adrenergic receptor blocking properties are nonselective for beta 1 and beta 2 -adrenoreceptors and are associated with the laevorotatory enantiomer of carvedilol. Carvedilol has no intrinsic sympathomimetic activity and, like propranolol, it has membrane stabilising _Product Information _ _ _ _Page 2 of _23_ _ _Carvedilol Sandoz 6.25/12.5/25mg tablets _ _02/2012_ _Sandoz Pty Ltd _ properties. Carvedilol suppresses the renin/ angiotensin/ aldosterone system through beta-blockade. The mechanism for the beneficial effects of carvedilol in congestive heart failure has not been established. Possible mechanisms include neurohormonal inhibition, beta- blockade, balanced vasodilation (red Lugege kogu dokumenti