Maa: Malesia
Kieli: englanti
Lähde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
HYDROCORTISONE
ORION PHARMA (MY) SDN. BHD.
HYDROCORTISONE
100 Tablets
ORION CORPORATION, ORION PHARMA
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ HYDROCORTISON ORION 10 MG TABLET Hydrocortisone (10 mg) ___________________________________________________________________________________________________________ __________________________________________________________________________________________________ 1 WHAT IS IN THIS LEAFLET 1. What Hydrocortison is used for 2. How Hydrocortison works 3. Before you start to take Hydrocortison 4. How to take Hydrocortison 5. While you are taking it 6. Side effects 7. Storage and Disposal of Hydrocortison 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT HYDROCORTISON IS USED FOR Hydrocortisone is used: - to treat low hydrocortisone levels caused by diseases of the adrenal gland (such as Addison’s disease, adrenocortical insufficiency); - in the treatment of hypopituitarism (a condition in which the pituitary gland does not produce normal amounts of some or all of its hormones); - to treat congenital adrenal hyperplasia which affects your body’s natural production of steroids; - in conditions where systemic (oral or injectable) glucocorticoid therapy is needed Your doctor will tell you for which disease or symptom (s)he has prescribed Hydrocortison for you. HOW HYDROCORTISON WORKS Hydrocortisone or cortisol is a natural glucocorticoid (corticosteroid hormone). It acts by binding to steroid receptors in the cytoplasm. It acts mainly by reducing the local inflammation reaction. It e.g. alleviates inflammation symptoms and eliminates allergic symptoms. BEFORE YOU START TO TAKE HYDROCORTISON _- When you must not take it _ Do not take Hydrocortison if you are allergic to hydrocortisone, or the ingredients listed at the end of this leaflet. _- Before you start to take _ _it _ Talk to your doctor or pharmacist before taking Hydrocortison, if you have: - bacterial, fungal, viral or parasitic infections. - gastric or duodenal ulcer - diabetes - bone loss (osteoporosis) - serious mood disorder, or psychosis - high blood pressur Lue koko asiakirja
1. NAME OF THE MEDICINAL PRODUCT Hydrocortison Orion 10mg Tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10mg hydrocortisone. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hydrocortison Orion 10mg Tablet is a white, round, flat bevelled-edged, scored uncoated tablet approx. 7 mm diameter with code ORN 45. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adrenocortical insufficiency (Addison’s disease), diminution of anterior pituitary function (hypopituitarism), congenital adrenal hyperplasia. Conditions where systemic glucocorticoid therapy is indicated. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology As replacement therapy, 20 to 30mg daily, usually approximately 2/3 of this amount in the morning and 1/3 in the early evening. If necessary, the morning dose may be taken in 2 parts. In the other indications, 40 to 200mg daily; in short-term use in special indications, even higher doses. Paediatric population In children, the dosage is individual. In adrenocortical insufficiency, 7.5 to 15mg/m2/day divided in 3 equal doses (first thing in the morning, in the afternoon, and late in the evening); the morning dose may also be larger than the other doses. In congenital adrenal hyperplasia, usually 10mg/m2/day divided in 3 doses. In hypopituitarism, 2.5mg 3 times daily. Dosing in special situations Hydrocortisone replacement therapy: In patients receiving hydrocortisone replacement therapy, the dosage of Hydrocortison should be increased 2–4-fold in stressful situations, such as in connection with injuries, infections or surgery. If necessary, the patient should be switched to parenteral treatment. Pharmacological glucocorticoid therapy: Long-term systemic glucocorticoid therapy causes adrenocortical insufficiency that may persist for months after treatment cessation. Therefore, the dosage of Hydrocortison should be increased in stressful situations such as in connection with infections. In order to avoid glucocort Lue koko asiakirja