国家: 英国
语言: 英文
来源: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ramipril
Wockhardt UK Ltd
C09AA05
Ramipril
5mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02050501; GTIN: 5012727912202
CHANGE CONTROL : Version changes due to change in: Size/Layout Regulatory Non-Regulatory Changes in detail: • New regulatory text ART WORK CHECK BOX PRODUCT : Ramipril 1.25mg; 2.5mg; 5mg; 10mg Capsules CUSTOMER : Wockhardt UK FP CODE: — PLANT LOCATION : UK supply DIMENSIONS : (w) 148 x (h) 550mm TEXT FONT SIZE : 9pt. FILE NAME : Ramipril_Leaflet_107593-3.ai SOFTWARE : Adobe Illustrator CS5 TYPEFACES : Myriad Pro Regular / Bold ARTWORK (DETAILS) 31st May, 2017 RECEIVED ON : PROOF REVISION : R 1st PDF sent on - 7TH JUNE 2017 R 2nd PDF sent on - 8TH JUNE 2017 R 3rd PDF sent on - 27TH JULY 2017 Process Black PREFOLDED SIZE : 148 X 300MM 20000XXXX FRONT _PAPER SHOULD BE BIBLE (40 GSM) _ WHAT IS IN THIS LEAFLET: 1. What Ramipril Capsules are and what they are used for 2. What you need to know before you take Ramipril Capsules 3. How to take Ramipril Capsules 4. Possible side effects 5. How to store Ramipril Capsules 6. Contents of the pack and other information 1. WHAT RAMIPRIL CAPSULES ARE AND WHAT THEY ARE USED FOR Ramipril Capsules contain a medicine called ramipril. This belongs to a group of medicines called ACE inhibitors (Angiotensin Converting Enzyme Inhibitors). Ramipril works by: • Decreasing your body’s production of substances that could raise your blood pressure • Making your blood vessels relax and widen • Making it easier for your heart to pump blood around your body. Ramipril Capsules can be used: • To treat high blood pressure (hypertension) • To reduce the risk of you having a heart attack or stroke • To reduce the risk or delay the worsening of kidney problems (whether or not you have diabetes) • To treat your heart when it cannot pump enough blood to the rest of your body (heart failure) • As treatment following heart attack (myocardial infarction) complicated with heart failure. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RAMIPRIL CAPSULES DO NOT TAKE RAMIPRIL CAPSULES: • If you are allergic to ramipril, any other ACE inhibitor medicine or any of the ingredients of this medici 阅读完整的文件
OBJECT 1 RAMIPRIL 5MG CAPSULES, HARD Summary of Product Characteristics Updated 03-Oct-2017 | Wockhardt UK Ltd 1. Name of the medicinal product Ramipril 5mg Capsules, hard 2. Qualitative and quantitative composition Each capsule, hard contains 5mg ramipril. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Capsule, hard Red opaque body and red opaque cap. The body has “RP 5” printed in black. 4. Clinical particulars 4.1 Therapeutic indications • Treatment of hypertension. • Cardiovascular prevention: reduction of cardiovascular morbidity and mortality in patients with: • manifest atherothrombotic cardiovascular disease (history of coronary heart disease or stroke, or peripheral vascular disease) or • diabetes with at least one cardiovascular risk factor (see section 5.1). • Treatment of renal disease: • Incipient glomerular diabetic nephropathy as defined by the presence of microalbuminuria, • Manifest glomerular diabetic nephropathy as defined by macroproteinuria in patients with at least one cardiovascular risk factor (see section 5.1), • 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 Capsules are taken each day at the same time of the day. Ramipril Capsules can be taken before, with or after meals, because food intake does not modify its bioavailability (see section 5.2). Ramipril Capsules have to be swallowed with liquid. It must not be chewed or crushed. _Adults _ Diuretic-Treated patients Hypotension may occur following initiation of therapy with Ramipril Capsules; this is more likely in patients who are being treated concurrently with diuretics 阅读完整的文件