Nchi: Malesia
Lugha: Kiingereza
Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ISOSORBIDE DINITRATE
SM PHARMACEUTICALS SDN. BHD.
ISOSORBIDE DINITRATE
1000Tablet Tablets; 10Tablet Tablets; 1000Tablet Tablets; 100Tablet Tablets; 2500 Tablet Tablets; 100 Tablet Tablets; 5000 Tablet Tablets
SM PHARMACEUTICALS SDN. BHD.
_Consumer Medication Information Leaflet (RiMUP) _ SOLBID TABLET Isosorbide Dinitrate (10mg) __________________________________________________________________________________________________________________________ _______________________________________________________________________________________________________________ 1 WHAT IN THIS LEAFLET 1. WHAT SOLBID TABLET IS USED FOR 2.HOW SOLBID TABLET WORKS 3.BEFORE YOU USE SOLBID TABLET 4.HOW TO USE SOLBID TABLET 5.WHILE YOU ARE USING SOLBID TABLET 6.SIDE EFFECTS 7. STORAGE AND DISPOSAL OF SOLBID TABLET 8.PRODUCT DESCRIPTION 9.MANUFACTURER AND PRODUCT REGISTRATION HOLDER 10.DATE OF REVISION WHAT SOLBID TABLET IS USED FOR Isosorbide dinitrate is used as a preventive measure in the treatment of angina pectoris. (described as pressure, squeezing, burning, or tightness in the chest). HOW SOLBID TABLET WORKS Solbid Tablet is an anti-anginal agent which relaxes the blood vessels in the body, allowing them to widen. This lets more blood flow through the blood vessels, which reduces the work the heart has to do to pump blood. This reduces the oxygen needs of the heart and decreases chest pain. BEFORE YOU USE SOLBID TABLET _WHEN YOU MUST NOT TAKE IT _ If you are hypersensitive to isosorbide dinitrate or other nitrates or nitrites. _BEFORE YOU START TO TAKE IT _ Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes. Tell your doctor if you have any of following medical conditions: • Severe hypotension(low blood pressure). • Hypovolaemia (a state of decreased blood volume). • Anaemia (a decrease in the amount of red blood cells). • Constrictive pericarditis (inflammation of the pericardium - sac-like membrane that surrounds the heart). • Raised intracranial pressure (pressure inside the skull). • Closed-angle glaucoma (buildup of pressure inside the eye). It should be used with caution if you have: • Severely impaired kidney or liver function. • Hypothyroidism (reduced level of thyroid hormone). • Malnutrition (lack o Soma hati kamili
additional measures unnecessary. However, if additional correction of severe hypotension is required, administration of an intravenous alpha - adrenergic agonist such as methoxamine or phenylephrine may be considered; epinephrine should be avoided since it aggravates the shock - like reaction. The administration of oxygen, with assisted respiration may be necessary in the severe poisoning; if methaemoglobinaemia occurs give methylene blue 1 mg per kg of body weight by slow intravenous injection. The circulation may be maintained with infusions of plasma or suitable electrolyte solutions. In the case of severe poisoning with tablets the stomach should be emptied by lavage STORAGE CONDITIONS, USER INSTRUCTIONS AND PHARMACEUTICAL PRECAUTIONS: Store below 25°C, in a well closed container. USER INSTRUCTIONS: Avoid alcoholic beverages. PHARMACEUTICAL PRECAUTIONS: Loss of potency is accelerated by exposure to heat and moisture PACKING / PACK SIZES: Plastic container of 100 tablets and 1000 tablets. Blister pack of 10 tablets, 100 x 100’s / box and 500 x 10’s/box. SHELF LIFE: 3 Years NAME AND ADDRESS OF MANUFACTURER: SM PHARMACEUTICALS SDN BHD (218620-M) Lot 88, Sungai Petani Industrial Estate 08000 Sungai Petani, Kedah Darul Aman, Malaysia. SM PHARMACEUTICALS SDN. BHD. SOLBID TABLET 10 MG _(ISOSORBIDE DINITRATE 10 MG)_ DESCRIPTION: Yellowish Orange, clean, dry, uniform capsule shaped with flat surface and breakline, uncoated tablet. ACTIONS AND MODE OR MECHANISMS OF ACTION: Anti-anginal or cardiac load – reducing agent – Not specifically known but thought to cause a reduction of myocardial oxygen demand. This is attributed to a reduction in left ventricular pre-load and after-load because of venous (predominantly) and arterial dilation with a more efficient redistribution of blood flow within the myocardium PHARMACOLOGY: Protein Binding: Moderate Metabolism: Hepatic (very rapid and nearly complete) and in blood (enzymatically). Oral dosage form undergoes extensive first – pass metabolism. Onset of action: Not Soma hati kamili