国家: 以色列
语言: 英文
来源: Ministry of Health
CARVEDILOL
DEXCEL LTD, ISRAEL
C07AG02
TABLETS
CARVEDILOL 6.25 MG
PER OS
Required
DEXCEL LTD, ISRAEL
CARVEDILOL
CARVEDILOL
Treatment of symptomatic congestive heart failure. Carvedexxon may be used as adjunct to standard therapy, but may also be used in those patients unable to tolerate an ACE inhibitor, or those who are not receiving digitalis, hydralazine or nitrate therapy.
2022-11-30
1 PATIENT PACKAGE INSERT ACCORDING TO PHARMACISTS' REGULATIONS (PREPARATIONS) – 1986 This medicine can be sold with a physician’s prescription only. CARVEDEXXON TABLETS 6.25, 12.5 MG ACTIVE INGREDIENT: each tablet contains Carvedilol at dose of 6.25 and 12.5 mg respectively. Inactive ingredients and allergens in the medicine – see section 6 "Additional information" and in section 2 "Important information about some of the ingredients of the medicine". READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, ask the doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if you think that their medical condition is the same as yours. 1. WHAT IS THE MEDICINE INTENDED FOR? CARVEDEXXON is used for the treatment of congestive heart failure. THERAPEUTIC GROUP: Alpha 1 and beta receptor blockers. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF YOU: • Are hypersensitive (allergic) to the active ingredient (carvedilol), or to any of the other ingredients this medicine contains (see section 6). • Have ever had wheezing or asthma. • Have severe heart failure (swelling of your hands, ankles and feet) which is being treated by medicines given into one of your veins (intravenously). • Have problems with your liver. • Have problems with your heart (for example: ‘heart block’ or slow heartbeat). CARVEDEXXON is not suitable for some people with certain types of heart problems. • Have very low blood pressure. If any of the above applies to you, do not take this medicine. If you are not sure, talk to the doctor or pharmacist before taking this medicine. SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE • BEFORE THE TREATMENT WITH CARVEDEXXON, TELL THE DOCTOR IF YOU: o Have problems with your lungs. o Have problems with your kidneys. o Have diabetes (high blood sugar). o Wear contact lenses. o Have problems with your blood vessels (peripher 阅读完整的文件
1 SUMMARY OF PRODUCT CHARACTERITICS 1. NAME OF THE MEDICINAL PRODUCT CARVEDEXXON 6.25 CARVEDEXXON 12.5 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Carvedilol 6.25 mg or 12.5 mg respectively. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. White to off white, round, biconvex tablets, scored on one side. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of symptomatic congestive heart failure. CARVEDEXXON may be used as adjunct to standard therapy, but may also be used in those patients unable to tolerate an ACE inhibitor, or those who are not receiving digitalis, hydralazine or nitrate therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The tablets should be taken with fluid. CARVEDEXXON should be given with food to slow the rate of absorption and reduce the incidence of orthostatic effects. SYMPTOMATIC CONGESTIVE HEART FAILURE The dosage must be titrated to individual requirements and monitored during up-titration. For those patients receiving diuretics and/or digoxin and/or ACE inhibitors, dosing of these other medicinal products should be stabilized prior to initiation of CARVEDEXXON treatment. ADULTS The recommended dose for the initiation of therapy is 3.125 mg (half a 6.25mg tablet) twice a day for two weeks. If this dose is tolerated, the dosage should be increased subsequently, at intervals of not less than two weeks, to 6.25 mg twice daily, followed by 12.5 mg twice daily and thereafter 25 mg twice daily. Dosing should be increased to the highest level tolerated by the patient. The recommended maximum daily dose is 25 mg given twice daily in patients weighing less than 85kg. and 50 mg twice daily in patients weighing more than 85 kg. Before each dose increase the patient should be evaluated by the physician for symptoms of worsening heart failure or vasodilation. Transient worsening of heart failure, vasodilation or fluid retention may be treated with increased doses of diuretics or ACE inhibitors 阅读完整的文件