国: マレーシア
言語: 英語
ソース: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CARVEDILOL
DKSH MALAYSIA SDN BHD
CARVEDILOL
30Tablet Tablets; 100Tablet Tablets
Delpharm Milano s.r.l
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ DILATREND _®_ _ _ Carvedilol (6.25mg, 25mg) 1 WHAT IS IN THIS LEAFLET 1. What Dilatrend is used for 2. How Dilatrend words 3. Before you take Dilatrend 4. How to take Dilatrend 5. While you are using Dilatrend 6. Side effects 7. After using Dilatrend 8. Product Description 9. Manufacturer 1. WHAT DILATREND IS USED FOR Dilatrend contains a medicine called carvedilol. This belongs to a group of medicines called ‘beta-blockers’. Dilatrend is used to treat the following: • Chronic heart failure. • High blood pressure (hypertension). • Angina (chest pain or discomfort that happens when your heart isn’t getting enough oxygen). 2. HOW DILATREND WORKS Dilatrend works by making your blood vessels relax and widen. • This helps to lower your blood pressure. • If you have chronic 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 Dilatrend to help treat your condition 3. BEFORE YOU TAKE DILATREND _- When you must not use it _ • You are allergic (hypersensitive) to carvedilol or any of the other ingredients of Dilatrend (listed in Section 8: Product Description). • You have ever had wheezing due to asthma or other lung diseases. • You have severe fluid retention (swelling of your hands, ankles and feet) which is being treated by medicines given into one of your veins (intravenously). • You have problems with your liver. • You have problems with your heart (for example ‘heart block’ or slow heart beat). Dilatrend is not suitable for some people with certain types of heart problem. • You have very low blood pressure. • You have a problem with the acid levels in your blood (‘metabolic acidosis’). • You have a growth on one of your adrenal glands (‘phaeochromocytoma’). If you are not sure, talk to your doctor or pharmacist before taking Dilatrend. _ _ _ _ _- Before you start to use it _ Chec 完全なドキュメントを読む
KOEPCKE.PUBLISHING Leaflet Dilatrend (MY) - FOR REG SUBMISSION ONLY DRAFT (DATE) 24.06.2022 [11:30 uhr] (4) COLOURS Black linework DIMENSIONS 210 x 600 mm MATERIAL NUMBER 90001869/13 FONT SIZE 7,5 pt PRODUCT CODE DP xxxxxxxx MY-CP PACK INSERT FOR MALAYSIA DILATREND ® Carvedilol 1. DESCRIPTION 1.1 THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG Alpha (α) and beta (β) adrenergic receptor blocking agents. ATC code: C07AG02. 1.2 TYPE OF DOSAGE FORM Tablets. The tablet(s) can be divided into equal doses. 1.3 ROUTE OF ADMINISTRATION Oral. The tablets are to be swallowed with sufficient fluid. 1.4 STERILE / RADIOACTIVE STATEMENT Not applicable. 1.5 QUALITATIVE AND QUANTITATIVE COMPOSITION _Active ingredient: _carvedilol. _Tablets_ One 6.25 mg tablet contains 6.25 mg carvedilol. One 25 mg tablet contains 25 mg carvedilol. The tablets are uncoated, round, and biconvex with a bilateral scorelines, and either yellow (6.25 mg) or white to pale yellowish-beige (25 mg). 2. CLINICAL PARTICULARS 2.1 THERAPEUTIC INDICATION(S) _Hypertension_ Dilatrend is indicated for the management of essential hypertension. It can be used alone or in combination with other antihypertensive agents (e.g. calcium channel blockers, diuretics). _Treatment of angina pectoris _ _Dilatrend is indicated for the treatment of angina pectoris._ _Chronic heart failure_ Unless a contraindication exists, carvedilol is indicated for the treatment of all patients with stable and symptomatic, mild, moderate and severe chronic heart failure of ischemic or non-ischemic etiology in combination with standard therapy (including ACE inhibitors and diuretics with or without digitalis). 2.2 DOSAGE AND ADMINISTRATION _Hypertension_ 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 to the recommended maximum daily dose of 50 mg, given once or twice daily. _Coronary heart disease_ The recomm 完全なドキュメントを読む