Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
Dexamethasone
Activase Pharmaceuticals Limited
H02AB02
Dexamethasone
Tablet
dexamethasone
2022-06-03
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DEXAMETHASONE ACTIVASE 0.5 MG TABLETS DEXAMETHASONE ACTIVASE 2 MG TABLETS (dexamethasone) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. WHAT DEXAMETHASONE TABLETS IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DEXAMETHASONE TABLETS 3. HOW TO TAKE DEXAMETHASONE TABLETS 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE DEXAMETHASONE TABLETS 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT DEXAMETHASONE TABLETS IS AND WHAT IT IS USED FOR The name of your medicine is Dexamethasone. This belongs to a group of medicines called corticosteroids. Corticosteroids are hormones that are found naturally in your body that help to keep you healthy and well. Taking extra corticosteroids, such as Dexamethasone, is used to treat various illnesses involving inflammation in the body. Dexamethasone lowers inflammation, which could otherwise go on making your condition worse. You must take this medicine regularly to get maximum benefit from it. Dexamethasone can be used to: Reduce inflammation Treat a number of different diseases of the immune system including: • Rheumatism (pain, stiffness or limitation of motion in the joints, muscles and tendons) • Inflammations including inflammation of the joints and tissue around the joint (rheumatoid arthritis), inflammation of the skin (such as contact dermatitis), the eye, blood vessels and other parts of the body • Allergic conditions which cause joint pain, skin rashes and fever • Hypersen Прочитайте повний документ
Health Products Regulatory Authority 03 June 2022 CRN00C380 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dexamethasone Activase 0.5 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 0.5 mg dexamethasone Excipients with known effect Each tablet contains 72.5 mg lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White, round, flat bevelled tablets of about 6.0 mm in diameter and 2.5-2.8mm, thickness, debossed 'D' on top and '0.5' underneath on one side and plain on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dexamethasone tablets are used for the treatment of various inflammatory and autoimmune diseases e.g.: RHEUMATISM, as pain, stiffness or limitation of motion, especially in the joints and related structures, including muscles, bursae, tendons, fibrous tissue; COLLAGEN DISEASE, as lupus erythematosus, dermatomyositis, polyarteritis nodosa, thrombotic purpura and rheumatoid arthritis; ALLERGIES, as status asthmaticus, bronchial asthma, contact dermatitis, inflammatory processes of the eye and its adnexa, severe hypersensitivity reactions to drugs or insect stings, anaphylactic shock, impending allograft rejection; PRIMARY OR SECONDARY ADRENOCORTICAL INSUFFICIENCY, AND ADRENOGENITAL SYNDROMES. Besides Dexamethasone is used as an adjunct in the control of CEREBRAL OEDEMA (not in those cases where the oedema is caused by head injury), for treatment of LYMPHOCYTIC LEUKAEMIA, as ANTI-EMETIC in antineoplastic regimens and for palliative treatment in terminal stages of NEOPLASTIC DISEASE. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Method of administration Glucocorticoids may be administered by a number of routes, depending on the nature of the disease and the condition of the patient. Localised therapy is generally preferred because it minimises adverse effects. When systemic administration is required, the oral route is preferred for ease in regulation of dose and the variety in regimens. Dex Прочитайте повний документ