País: Malàisia
Idioma: anglès
Font: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Isosorbide-5-mononitrate 70%
Duopharma Marketing Sdn. Bhd.
Isosorbide-5-mononitrate 70%
28Tablet Tablets; 28 Tablet Tablets
DUOPHARMA MANUFACTURING (BANGI) SDN BHD
_Consumer Medication Information Leaflet (RIMUP) _ IMDEX CR TABLET Isosorbide mononitrate 60mg WHAT IS IN THE LEAFLET? 1. What Imdex is used for 2. How Imdex works 3. Before you use Imdex 4. How to use Imdex 5. While you are using it 6. Side effects 7. Storage and Disposal of Imdex 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT IMDEX IS USED FOR Imdex is used to prevent angina. Angina is a pain or uncomfortable feeling in the chest, often spreading to the arms or the neck and sometimes to the shoulders and back. This is caused by too little blood and oxygen getting to the heart. The pain of angina is usually brought on by exercise or stress. HOW IMDEX WORKS Imdex belongs to a group of medicines called nitrates. It works by relaxing the blood vessels, letting more blood and oxygen reach the heart. BEFORE YOU USE IMDEX - _When you must not take it _ Do not use Imdex if you are allergic to it or medicine containing nitrates or nitrites or any ingredients listed at the end of the leaflet. Do not use Imdex if you have the following medical conditions: • Low blood pressure • Shock including those caused by low blood pressure or failing heart • Pericarditis (swelling around the heart) • Weakened muscle of the heart You must not use Imdex whilst taking sildenafil (Viagra), vardenafil (Levitra) or tadalafil (Cialis). Do not use Imdex if you are pregnant or breast feeding unless your doctor says it is safe. Ask your doctor about the risks and benefits involved. Do not give Imdex to children. There is no specific information about use in children. Always ask your doctor before giving medicines to children. Do not use after the use by (expiry) date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal. If you are not sure whether you should take this medicine, talk to your doctor. - _Before you start to use it_ _You must tell your doctor if: _ 1. you have any allergies to Llegiu el document complet
IMDEX TM Isosorbide-5-mononitrate 60 mg CR Tablet QUALITATIVE AND QUANTITATIVE COMPOSITION One controlled release tablet contains: Isosorbide mononitrate 60 mg PHARMACEUTICAL FORM Controlled release tablet 60 mg: Yellow, oval, biconvex, film coated, scored on one side and marked with IM on the other side. THERAPEUTIC INDICATIONS Prophylactic treatment of angina pectoris. POSOLOGY AND METHOD OF ADMINISTRATION is intended for prophylactic treatment. The dosage is individual and must be titrated according to clinical response. prolonged release tablets are taken once daily, in the morning. _When _ _initiating _ _treatment, _ _in _ _order _ _to _ _avoid _ _headache, _ _30 _ _mg _ _be _ _given _ _for _ _the _ _first _ _2-4 _ _days._ Normal dosage: 60 mg daily. If necessary the dose may be increased to 120mg daily. There is a risk of tolerance development with nitrate therapy. It is therefore important that is taken once daily in order to obtain intervals with low nitrate concentrations and thus reduce the risk of tolerance development. If necessary, may be combined with beta-adrenoreceptor blockers and calcium antagonists. _Administration_ The tablet is dividable. The whole or divided tablet of 60mg 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 ingredients of any excipients. Concomitant treatment with Phosphodiesterase type 5 Inhibitors (eg sildenafil). SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE Caution should be exercised in the treatment of patients with serious cerebrovascular disease, increased intracranial pressure, aortic stenosis, mitral stenosis and hypertrophic obstructive cardiomyopathy, anaemia, hypoxaemia and hypothyroidism. INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION _The following combination with must be avoided:_ Phosphodiesterase type 5 Inhibitors (eg sildenafil): Administrati Llegiu el document complet