Country: United Kingdom
Bahasa: Inggeris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Captopril
Actavis UK Ltd
C09AA01
Captopril
25mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02050501
PATIENT INFORMATION LEAFLET ECOPACE 12.5MG, 25MG AND 50MG TABLETS READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • Keep this leaflet. You may need to read it again. • If you have further questions, please ask your doctor or your pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. • The name of your medicine is Ecopace 12.5mg, 25mg and 50mg Tablets, but will be referred to as ‘Ecopace Tablets’ throughout the remainder of the Leaflet. IN THIS LEAFLET: 1. What Ecopace Tablets are and what they are used for 2. Before you take Ecopace Tablets 3. How to take Ecopace Tablets 4. Possible side effects 5. Storing Ecopace Tablets 6. Further information 1. WHAT ECOPACE TABLETS ARE AND WHAT THEY ARE USED FOR Ecopace Tablets belong to a group of medicines known as ACE inhibitors (Angiotensin Converting Enzyme Inhibitors). Captopril works by making your blood vessels wider. This helps your blood pressure to fall. It also makes it easier for your heart to pump blood around your body. ECOPACE TABLETS CAN BE USED TO TREAT • High blood pressure – also called hypertension • Heart failure - where the heart has difficulty pumping blood around your body. • Heart attack (Myocardial infarction) - where the heart has difficulty pumping blood around your body. 2. BEFORE YOU TAKE ECOPACE TABLETS DO NOT TAKE ECOPACE TABLETS IF: • You are PREGNANT, planning to become pregnant or are breast-feeding. • You have ever had an allergic (hypersensitivity) reaction to Captopril, any other ACE inhibitor medicine, or any of the ingredients in these tablets (see Section 6: Further Information). Signs of an allergic reaction include: rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue. If you are not sure about taking Captopril, talk Baca dokumen lengkap
1. NAME OF THE MEDICINAL PRODUCT Captopril 25mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 25 mg of Captopril. Excipient with known effect: Also contains 25mg of lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets White to almost white, round, flat, bevelled edged, uncoated tablets with score line on one side and “25” embossed on the other side. 4.1 THERAPEUTIC INDICATIONS HYPERTENSION: The management of mild to moderate hypertension. In severe hypertension it should be used where standard therapy is ineffective or inappropriate. CONGESTIVE HEART FAILURE: Captopril is indicated for the treatment of congestive heart failure. The drug should be used together with diuretics and, when appropriate, digitalis and beta-blockers. In patients on doses of over 100 mg daily plus or minus a diuretic, in those with severe renal impairment or those with severe congestive heart failure use of captopril should be under specialist supervision. MYOCARDIAL INFARCTION: - _Short-term (4 weeks) treatment_: Captopril is indicated in any clinically stable patient within the first 24 hours of an infarction. - _Long-term prevention of symptomatic heart failure:_ Captopril is indicated in clinically stable patients with asymptomatic left ventricular dysfunction (ejection fraction ≤ 40%) following myocardial infarction to improve survival, delay the onset of symptomatic heart failure, reduce hospitalisations for heart failure and reduce recurrent myocardial infarction and coronary revascularisation procedures. Before starting therapy, cardiac function should be determined by radionuclide ventriculography or echocardiography. TYPE I DIABETIC NEPHROPATHY: Captopril is indicated in insulin dependent diabetics for the treatment of macroproteinuric diabetic nephropathy (microalbuminuria greater than 30 mg/day) (See Section 5.1). Captopril may prevent the progression of the renal disease and reduce associated clinical events e.g. dialysis, renal transplantation and death. C Baca dokumen lengkap