Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
Carvedilol
KRKA, d.d., Novo mesto
C07AG; C07AG02
Carvedilol
12.5 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
Alpha and beta blocking agents; carvedilol
Marketed
2003-08-22
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CARVEDILOL KRKA 3.125 MG TABLETS CARVEDILOL KRKA 6.25 MG TABLETS CARVEDILOL KRKA 12.5 MG TABLETS CARVEDILOL KRKA 25 MG TABLETS carvedilol READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN this leaflet 1. What Carvedilol Krka is and what it is used for 2. What you need to know before you take Carvedilol Krka 3. How to take Carvedilol Krka 4. Possible side effects 5. How to store Carvedilol Krka 6. Contents of the pack and other information 1. WHAT CARVEDILOL KRKA IS AND WHAT IT IS USED FOR Carvedilol Krka contains a medicine called carvedilol. This belongs to a group of medicines called ‘betablockers’. Carvedilol Krka 3.125 mg and 6.25 mg tablets are used to treat the following: - Congestive heart failure. - High blood pressure (hypertension). Carvedilol Krka 12.5 mg and 25 mg tablets are used to treat the following: - Congestive heart failure. - High blood pressure (hypertension). - Angina (chest pain or discomfort that happens when your heart isn’t getting enough oxygen). Carvedilol Krka works by making your blood vessels relax and widen. - This helps to lower your blood pressure. - If you have congestive heart failure, this makes it easier for your heart to pump blood around your body. - If you have angina, this will help stop the chest pain. Your doctor may give you other medicines as well as Carvedilol Krka to help treat your condition. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CARVEDILOL KRKA DO NOT TAKE CARVEDILOL KRKA - if you are allergic (hypersensitive) to carved Läs hela dokumentet
Health Products Regulatory Authority 18 October 2019 CRN008JX7 Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Carvedilol Krka 12.5 mg Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 12.5 mg carvedilol. Excipients: Each tablet contains 144.50 mg lactose monohydrate and 10 mg sucrose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablets. Appearance: Oval slightly biconvex, white tablet, marked S3 on one side, scored on the reverse. The tablets can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adjunctive therapy for the treatment of symptomatic congestive heart failure to reduce morbidity and increase patient well-being. Treatment of hypertension. Long-term management of stable angina pectoris 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ _ _SYMPTOMATIC CONGESTIVE HEART FAILURE_ The dosage must be titrated to individual requirements and patients' clinical status should be monitored for 2 - 3 hours after initiation and any dose increase during up-titration. For those patients receiving diuretics and/or digoxin and/or ACE inhibitors, dosing of these other drugs should be stabilised prior to initiation of Carvedilol Krka treatment. _ _ _ADULTS_ The recommended dose for the initiation of therapy is 3.125 mg 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 85 kg (187 lbs) and 50 mg twice daily in patients weighing more than 85 kg. During up-titration of the dose in patients with systolic blood pressure < 100 mmHg, deterioration of renal and/or cardiac functions may occur. Therefore, before each dose increase, these patients should be evaluated by the physici Läs hela dokumentet