País: Malásia
Língua: inglês
Origem: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PREDNISOLONE
DUOPHARMA MANUFACTURING (BANGI) SDN BHD
PREDNISOLONE
1000 Tablet Tablets
DUOPHARMA MANUFACTURING (BANGI) SDN BHD
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ PREDNISYN TABLET ® Prednisolone (5mg) WHAT IS IN THIS LEAFLET 1. What Prednisyn is used for 2. How Prednisyn works 3. Before you use Prednisyn 4. How to use Prednisyn 5. While you are using it 6. Side effects 7. Storage and Disposal of Prednisyn 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT PREDNISYN IS USED FOR Prednisyn is used in the treatment of many different conditions. Some of these conditions include: rheumatic fever, rheumatoid arthritis, kidney disease, asthma, and other corticosteroid- indicated conditions. Ask your doctor if you have any questions about why Prednisyn has been prescribed for you. Your doctor may have prescribed it for another purpose. HOW PREDNISYN WORKS Prednisolone belongs to a group of medicines called corticosteroids which are a synthetic version of a naturally occurring body hormone called cortisol. Prednisyn works by decreasing or preventing tissue responses to inflammatory processes, thereby reducing development of symptoms of inflammation without affecting the underlying cause. This medicine is only able to prevent or reduce symptoms of your condition, it does not cure it. BEFORE YOU USE PREDNISYN - _When you must not use it _ Do not take Prednisyn if you have ever had an allergic reaction to: • prednisolone or Prednisyn • any of the ingredients listed at the end of this leaflet. Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty in breathing; swelling of the face, lips, tongue or any other parts of the body; rash, itching or hives on the skin. Do not take Prednisyn if you have: • a current serious or uncontrolled infection, including fungal infections • osteoporosis (softening of the bone) • mental disorder • active stomach or intestinal ulcer Do not take this medicine after the 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 Leia o documento completo
Prednisolone is excreted in the urine as free and conjugated metabolites, together with an appreciable proportion of unchanged prednisolone crosses the placenta and small amounts are excreted in breast milk. 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 adverse- ly 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 have received substantial doses of corticosteroids 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). Osteoporosis, active peptic ulcer, psychoses or severe psycho- neurosis. Systemic fungal infections. Acute infections unless effective, specific concurrent chemotherapy can be adminis- tered. Patients should not undergo immunisations. Tuberculosis as adjunctive treatment with tuberculostatic drug. Pregnancy and lactation. Should be used with great caution in the presence of congestive heart failure or hypertension, in patients with diabetes mellitus, epilepsy, glaucoma, infections diseases, ocular herpes simplex, chronic renal failure, and uraemia, and in elderly persons. The risk of adverse effects with pharmacologic doses of corticos- teroids generally increases with the duration of therapy and frequency of administration and, to a lesser extent, with dosage. The following side effects may occur: Cushing’s syndrome, acne, hirsutism, osteoporosis, aseptic osteonecrosis, Leia o documento completo