Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ISOSORBIDE-5-MONONITRATE
ZUELLIG PHARMA SDN BHD
ISOSORBIDE-5-MONONITRATE
28Tablet Tablets; 30 Tablet Tablets; 105 Tablet Tablets
AstraZeneca Pharmaceutical Co. Ltd.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ IMDUR ® Isosorbide-5-mononitrate 30mg, 60mg 1 WHAT IS IN THIS LEAFLET 1. What Imdur ® is used for 2. How Imdur ® works 3. Before you use Imdur ® 4. How to use Imdur ® 5. While you are using it 6. Side Effects 7. Storage and disposal of Imdur ® 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT IMDUR ® IS USED FOR Imdur is used as preventive treatment of vascular spasm in the heart (angina pectoris). HOW IMDUR ® WORKS Imdur works by widening the blood vessels and so making the work of the heart easier in the case of vascular spasm in the heart. BEFORE YOU TAKE IMDUR ® - _When you must not take it_ You must not use Imdur in the following cases : • in shock • in low blood pressure • in disease of the heart muscles (constrictive cardiomyopathy) • in certain diseases of the pericardium (constrictive pericarditis, pericardial tamponade) • at the same time as phosphodiesterase type 5 inhibitors, such as Viagra (sildenafil), Cialis (tadalafil) and Levitra (vardenafil) • if you are hypersensitive to any of the ingredients - _Before you start use it_ Talk to your doctor before you start using Imdur if you suffer from any of the following: • brain damage • heart disease • reduced oxygen level in the blood (hypoxaemia) • blood deficiency (anaemia) • reduced thyroid gland function (hypothyroidism) - _Taking other medicines_ Inform your doctor if you are taking any other medication at the same time as Imdur. Certain medicines may affect or be affected by treatment with Imdur. When you are treated with Imdur you must not use phosphodiesterase type 5 inhibitors, such as Viagra (sildenafil), Cialis (tadalafil) and Levitra (vardenafil), which are used for impotence (erectile dysfunction). HOW TO TAKE IMDUR ® - _How much to take_ Your doctor will determine the dose that is suitable for you. The usual dose is 60 mg once daily. - _When to take it_ The tablets for the lower strengths, 30 mg and 60 mg, are di Baca dokumen lengkap
Imdur Isosorbide-5-mononitrate Tablets 30 mg & 60 mg Qualitative and Quantitative Composition One prolonged release tablet contains: isosorbide mononitrate 30 mg or 60 mg. For excipients see List of excipients. Pharmaceutical Form Prolonged release tablet 30 mg: Pink, oval with score, marked A/II, 7x13 mm. 60 mg: Pale yellow, oval with score, marked A/ID, 7 x 13 mm. Therapeutic indications Prophylactic treatment of angina pectoris. Posology and method of administration Imdur is intended for prophylactic treatment. The dosage is individual and must be titrated according to clinical response. Imdur prolonged release tablets are taken once daily, in the morning. When initiating treatment, in order to avoid headache, 30 mg may be given for the first 2-4 days. Normal dosage: 60 mg daily. If necessary the dose may be increased to 120 mg daily. There is a risk of tolerance development with nitrate therapy. It is therefore important that Imdur is taken once daily in order to obtain intervals with low nitrate concentrations and thus reduce the risk of tolerance development. If necessary, Imdur may be combined with beta-adrenoreceptor blockers and calcium antagonists. Administration The tablets for the lower strengths, 30 and 60 mg, are dividable. The whole or divided tablet should not be chewed or crushed and should be swallowed together with ½ glass of fluid. Contraindications Shock, hypotension, constrictive cardiomyopathy, constrictive pericarditis and pericardial tamponade. Hypersensitivity to the active ingredient or any excipients. Concomitant treatment with Phospodiesterase type 5 Inhibitors (e.g. sildenafil). Baca dokumen lengkap