Land: Vereinigtes Königreich
Sprache: Englisch
Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ramipril
IVAX Pharmaceuticals UK Ltd
C09AA05
Ramipril
5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02050501
● You have had certain types of heart problems e.g. aortic and mitral stenosis (narrowing of the inlet valve into the left ventricle of the heart), hypertrophic cardiomyopathy (disease of the heart muscle) and cardiac arrhythmias (irregular heart beat). TAKE SPECIAL CARE WITH RAMIPRIL TABLETS IF: ● You have heart problems (particularly if you are taking medicine for it), or if you have any kidney or liver disease. Your doctor may need to change the dose of your medicine. ● If you are dehydrated or have a salt imbalance. ● You are taking diuretic medication (water tablets). Your doctor may discontinue diuretic therapy and correct volume and/or salt depletion before starting treatment with ramipril. ● You have severe high blood pressure. ● You are taking any medications which may affect your blood picture. Your doctor can advise you of this. ● You are taking medication for low potassium levels. ● You are taking allopurinol and/or other immunosuppressants as this may increase the likelihood of blood picture changes. Alcohol can increase the effect of ramipril, this can be dangerous and you should speak to your doctor if you are unsure. You need to tell your doctor or dentist that you are taking ramipril if you are about to undergo a surgical / dental procedure where an aesthetic might be used. PREGNANCY: Ramipril should not be used in the first trimester of pregnancy. When pregnancy is planned/confirmed switch to an alternative treatment. Do not take blood pressure lowering drugs as this may cause defects to the unborn baby. Ask your doctor or pharmacist for advice before taking any medicine. LACTATION: Ramipril Tablets should not be taken by women who are breast-feeding as Ramipril passes into breast milk and may be harmful to the baby. DRIVING AND USING MACHINES: It is not advisable to drive or operate machinery for several hours after the first dose of Ramipril Tablets or after an increase in dose. Do not take alcohol.You should not drive or operate machinery if you feel dizzy or tired while takin Lesen Sie das vollständige Dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ramipril 5mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Ramipril 5 mg: one tablet contains 5 mg ramipril Excipient with known effect: lactose monohydrate 96.47 mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablets. Ramipril 5 mg: pink, capsule-shaped, un-coated, flat tablets, 8.8 x 4.4 mm, scored on one side and side walls, marked R3. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS • Treatment of hypertension. • Treatment of renal disease. o Incipient glomerular diabetic nephropathy as defined by the presence of microalbuminuria, o Manifest glomerular diabetic nephropathy as defined by macroproteinuria in patients with at least one cardiovascular risk factor (see section 5.1), o Manifest glomerular non diabetic nephropathy as defined by macroproteinuria ≥ 3 g/day (see section 5.1). • Treatment of symptomatic heart failure. • Secondary prevention after acute myocardial infarction: reduction of mortality from the acute phase of myocardial infarction in patients with clinical signs of heart failure when started > 48 hours following acute myocardial infarction. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology It is recommended that ramipril is taken each day at the same time of the day. Ramipril tablets can be taken before, with or after meals, because food intake does not modify its bioavailability (see section 5.2). Ramipril tablets have to be swallowed with liquid. _ _ _Adults _ _Diuretic-Treated patients _ _ _ Hypotension may occur following initiation of therapy with ramipril; this is more likely in patients who are being treated concurrently with diuretics. Caution is therefore recommended since these patients may be volume and/or salt depleted. If possible, the diuretic should be discontinued 2 to 3 days before beginning therapy with ramipril (see section 4.4). In hypertensive patients in whom the diuretic is not discontinued, therapy with ramipril should be initiated with a 1.25mg dose. Renal Lesen Sie das vollständige Dokument