País: Malàisia
Idioma: anglès
Font: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PREDNISOLONE
KOTRA PHARMA (M) SDN. BHD.
PREDNISOLONE
100Tablet Tablets; 300 Tablet Tablets; 100 Tablet Tablets
KOTRA PHARMA (M) SDN. BHD.
AXCEL PREDNISOLONE-5MG EC TABLET Prednisolone (5mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ WHAT IS IN THIS LEAFLET 1. What Axcel Prednisolone-5mg EC Tablet is used for. 2. How Axcel Prednisolone-5mg EC Tablet works. 3. Before you use Axcel Prednisolone-5mg EC Tablet. 4. How to use Axcel Prednisolone- 5mg EC Tablet. 5. While you are using it. 6. Side effects. 7. Storage and disposal of Axcel Prednisolone-5mg EC Tablet. 8. Product description. 9. Manufacturer and Product Registration Holder. 10. Date of revision. WHAT AXCEL PREDNISOLONE-5MG EC TABLET IS USED FOR Axcel Prednisolone-5mg EC Tablet is used for the treatment of inflammatory condition such as • Rheumatic fever. • Rheumatoid arthritis (joint pain and inflammation). • Allergic diseases. • Nephritic syndrome. • Asthma. • Other corticosteroid-indicated conditions. HOW AXCEL PREDNISOLONE-5MG EC TABLET WORK Axcel Prednisolone-5mg EC Tablet is an anti-inflammatory agent. It is a steroid that decrease or prevent tissue responses to inflammatory processes, thereby reducing symptoms of inflammation without affecting the underlying cause. It is also prevent production and /or release of several chemical that initiate inflammation. BEFORE YOU USE AXCEL PREDNISOLONE- 5MG EC TABLET _-When you must not use it _ Do not take Axcel Prednisolone-5mg EC Tablet if: • You are having allergy to any component of this medication. • You are having active osteoporosis (fragile bone), active ulcer on your stomach, esophagus or small intestine or mental disorder. • It is not prescribed by a qualified doctor or pharmacist for you. • You are having acute infections. • You are taking medicines to treat tuberculosis (bacterial infection that mainly affects the lungs). • You are pregnant, trying to get pregnant or think you may be pregnant. • You are having systemic fungal infections. • You are having vaccination. • You are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine. _-Before you start to use it _ Tell y Llegiu el document complet
relatively low doses. Prolonged therapy may produce posterior sub-capsular cataracts. Glaucoma with possible damage to optic nerve. Steroid myopathy and Cushing’s habitus may develop with long term therapy. Hepatic cirrhosis and hypothyroidism may enhance corticosteroid effects. Withdrawal syndrome (abdominal or back pain, dizziness, fainting, low grade fever, prolonged loss of appetite, muscle or joint pain, nausea, vomiting, shortness of breath, frequent or continuing unexplained headaches, unusual tiredness or weakness, rapid weight loss, reappearance of disease symptoms). Caution is required in patients with systemic sclerosis because of an increased incidence of (possibly fatal) scleroderma renal crisis with hypertension and decreased urinary output observed with a daily dose of 15mg or more prednisolone. _Use in Pregnancy and Lactation:_ _Pregnancy / Reproduction:_ Fertility: Corticosteroids have been reported to increase or decrease the number or motility of spermatozoa. However, it is not known whether reproductive capacity in humans is adversely affected. Pregnancy: Corticosteroids cross the placenta. Although adequate studies have not been done in humans, there is some evidence that pharmacologic doses of corticosteroids may increase the risk of placental insufficiency, decreased birthweight, or stillbirth. However, teratogenic effects in humans have not been confirmed. Infants born to mothers who received substantial doses or corticosteroid during pregnancy should be carefully observed for signs of hypoadrenalism and replacement therapy administered as required. Studies in animals have shown that corticosteroids increase the incidence of cleft palate, placental insufficiency, spontaneous absorption and intrauterine growth retardation. (FDA Pregnancy Category C). SIDE EFFECTS: The risk of adverse effects with pharmacologic doses of corticosteroid generally increases with the duration of therapy and frequency of administration and to a lesser extent, with dosage. The following side effects may occur: C Llegiu el document complet