국가: 오스트레일리아
언어: 영어
출처: Department of Health (Therapeutic Goods Administration)
carvedilol, Quantity: 12.5 mg
Arrotex Pharmaceuticals Pty Ltd
Carvedilol
Tablet, film coated
Excipient Ingredients: lactose monohydrate; colloidal anhydrous silica; magnesium stearate; crospovidone; microcrystalline cellulose; povidone; titanium dioxide; macrogol 8000; hypromellose; polydextrose; triethyl citrate
Oral
60 tablets
(S4) Prescription Only Medicine
Carvedilol is indicated for the treatment of hypertension. Data have not been provided to support the use of this drug in renovascular disease. Carvedilol is indicated for the treatment of patients with symptomatic mild to severe (NYHA class II to IV) congestive heart failure (CHF) as an adjunct to conventional treatments (e.g. diuretics, digoxin, ACE inhibitors and vasodilators).
Visual Identification: White, oval shaped, film-coated tablets, imprinted '12.5' on one side and 'P' logo on the other side; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2006-11-15
APO-CARVEDILOL _Contains the active ingredient, carvedilol_ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH 1800 195 055_ WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE TAKING YOUR MEDICINE. This leaflet answers some common questions about carvedilol. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the last page. More recent information on the medicine may be available. ASK YOUR DOCTOR OR PHARMACIST: • if there is anything you do not understand in this leaflet, • if you are worried about taking your medicine, or • to obtain the most up-to-date information All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. Pharmaceutical companies cannot give you medical advice or an individual diagnosis. Keep this leaflet with the medicine. You may need to read it again WHAT THIS MEDICINE IS USED FOR The name of your medicine is APO- Carvedilol. It contains the active ingredient, carvedilol. It is used to treat high blood pressure and, together with other medicines, to help treat congestive heart failure. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor's prescription. _HOW IT WORKS_ Carvedilol belongs to a group of medicines called beta-blockers. These medicines work by relaxing tightened blood vessels and slowing the heart rate. Carvedilol has the additional effect of being an antioxidant. Heart failure occurs when the heart can no longer pump blood strongly enough for the body's needs. Often the heart grows in size to try to improve the blood flow but this can make the heart failure worse. Symptoms of heart failure include shortness of breath and swelling of the feet or legs due to fluid bu 전체 문서 읽기
1 AUSTRALIAN PRODUCT INFORMATION APO- CARVEDILOL (CARVEDILOL) TABLETS 1 NAME OF THE MEDICINE Carvedilol. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 3.125 mg, 6.25 mg, 12.5 mg or 25 mg of carvedilol as the active ingredient. EXCIPIENTS WITH KNOWN EFFECT Sugars as lactose monohydrate For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM 3.125 MG TABLETS White oval shaped, film-coated tablets, imprinted with « P » logo on one side and plain on the other side. 6.25 MG TABLETS White oval shaped, film-coated tablets, imprinted « 6.25 » on one side and « P » logo on the other side 12.5 MG TABLETS White oval shaped, film-coated tablets, imprinted « 12.5 » on one side and « P » logo on the other side 25 MG TABLETS White oval shaped, film-coated tablets, imprinted « 25 » on one side and « P » logo on the other side 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Carvedilol is indicated for the treatment of hypertension. Data have not been provided to support the use of this drug in renovascular disease. Carvedilol is indicated for the treatment of patients with symptomatic mild to severe (NYHA class II to IV) congestive heart failure (CHF) as an adjunct to conventional treatments (e.g. diuretics, digoxin, ACE inhibitors and vasodilators). 2 4.2 DOSE AND METHOD OF ADMINISTRATION APO- Carvedilol tablets are intended for oral administration. DOSAGE HYPERTENSION Once daily dosing is recommended. Adults The recommended dose for initiation of therapy is 12.5 mg once a day for the first two days. Thereafter the recommended dosage is 25 mg once a day. If necessary, the dosage may subsequently be increased at intervals of at least two weeks up to the recommended maximum daily dose of 50 mg given once a day or twice daily. Elderly The recommended dose for initiation of therapy is 12.5 mg once daily, which has provided satisfactory control in some patients. If the response is inadequate, the dose may be titrated at intervals of at least two weeks up to the reco 전체 문서 읽기