Quốc gia: Malaysia
Ngôn ngữ: Tiếng Anh
Nguồn: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
RAMIPRIL
HEALOL PHARMACEUTICALS SDN. BHD.
RAMIPRIL
30tablet Tablets
Aurobindo Pharma Limited (Unit III),
_Consumer Medication Information Leaflet (RiMUP) _ ANGIRAM 2.5 (RAMIPRIL TABLET 2.5MG) ANGIRAM 5 (RAMIPRIL TABLET 5MG) ANGIRAM 10 (RAMIPRIL TABLET 10MG) Ramipril (2.5mg, 5mg & 10mg) 1 WHAT IS IN THIS LEAFLET 1. What ANGIRAM is used for 2. How ANGIRAM works 3. Before you use ANGIRAM 4. How to use ANGIRAM 5. While you are using it 6. Side effects 7. Storage and Disposal of ANGIRAM 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT IS ANGIRAM USED FOR The active ingredient of ANGIRAM is Ramipril. ANGIRAM is used for: • To treat high blood pressure (hypertension) • To treat your heart when it cannot pump enough blood to the rest of your body (congestive heart failure) • As treatment following heart attack (myocardial infarction) complicated with heart failure • To reduce risk of you having a heart attack or stroke • For prevention of worsening of kidney problems in patients with persistent proteinuria (presence of excess protein in urine) HOW ANGIRAM WORKS ANGIRAM contains a medicine called Ramipril. This belongs to a group of medicines called ACE inhibitors (Angiotensin Converting Enzyme inhibitors). ANGIRAM 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 BEFORE YOU USE ANGIRAM -When you must not use it • If you are allergic (hypersensitive) to Ramipril, any other ACE inhibitor medicine or any of the other ingredients of ANGIRAM. Signs of an allergic reaction may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue • If you have ever had a serious allergic reaction called ‘angioedema’. The signs include itching, hives (urticaria), red marks on the hands, feet and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing • If you are having dialysis or any other type of blo Đọc toàn bộ tài liệu
D3 - PROPOSED PACKAGE INSERT SUMMARY OF PRODUCT CHARACTERISTICS ANGIRAM RAMIPRIL TABLETS BP 2.5 MG, 5 MG, 10 MG RX ONLY QUALITATIVE AND QUANTITATIVE COMPOSITIONS: _Ramipril Tablets BP 2.5 mg:_ Each uncoated tablet contains Ramipril Ph.Eur. 2.5 mg. _Ramipril Tablets BP 5 mg:_ Each uncoated tablet contains Ramipril Ph.Eur. 5 mg. _Ramipril Tablets BP 10 mg:_ Each uncoated tablet contains Ramipril Ph.Eur. 10 mg. PHARMACEUTICAL FORM _Ramipril Tablets BP 2.5 m_g: Light yellow to yellow colored flat faced bevel edged, round uncoated tablet debossed with “H” and “18” separated by score line on one side and plain on other side. _Ramipril Tablets BP 5 mg:_ Light pink colored mottled, flat faced bevel edged round uncoated tablet debossed with “H” and “19” separated by score line on one side and plain on other side. _Ramipril Tablets BP 10 mg:_ White to off-white colored, flat faced bevel edged round uncoated tablet debossed with “H” and “20” separated by score line on one side and plain on other side. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS - Hypertension. - Congestive heart failure. - Treatment of patients who – within the first few days after an acute myocardial infarction – have demonstrated clinical signs of congestive heart failure. - For reducing the risk of myocardial infarction, stroke, cardiovascular death or the need for revascularization procedures in patients 55 years or more who have clinical evidence of coronary artery disease, stroke, or peripheral vascular disease. NAME OF THE DRUG PRODUCT: Ramipril Tablets BP 2.5 mg Ramipril Tablets BP 5 mg Ramipril Tablets BP 10 mg (TRADE) NAME OF THE PRODUCT: ANGIRAM 2.5 ANGIRAM 5 ANGIRAM 10 STRENGTH: 2.5 mg, 5 mg, 10 mg. PHARMACEUTICAL DOSAGE FORM: Tablets - For reducing the risk of myocardial infarction, stroke, cardiovascular death or revascularization procedures in diabetic patients 55 years or more with one or more of the following risk factors: systolic blood pressure > 160 mm Hg or diastolic blood pressure > 90 mm Hg (or on antihype Đọc toàn bộ tài liệu