Kraj: Australia
Język: angielski
Źródło: Department of Health (Therapeutic Goods Administration)
prednisolone, Quantity: 5 mg
iNova Pharmaceuticals (Australia) Pty Ltd
Tablet, uncoated
Excipient Ingredients: magnesium stearate; wheat starch; maize starch; propyl hydroxybenzoate; lactose monohydrate; Gelatin
Oral
1000 tablets, 1000 tablets (E), 30 tablets, 60 tablets, 100 tablets
Medicine Registered
(S4) Prescription Only Medicine, Not scheduled. Not considered by committee
INDICATIONS AS AT 26 MARCH 1997 : Wherever corticosteroid therapy is indicated.
Visual Identification: A white round, biconvex tablet with breakline on one side and marking 'L' on other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Registered
1991-08-30
SOLONE _Prednisolone (Pred-NISS-oh-lone)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about SOLONE (prednisolone tablets). It does not contain all the available information about SOLONE tablets. It does not replace talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you or your child taking SOLONE against the benefits he or she expects it will have. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT IS SOLONE The name of your medicine is SOLONE and is available in 5 mg and 25 mg tablet strengths. The active ingredient is called prednisolone. Prednisolone belongs to a group of medicines called corticosteroids. Corticosteroids are used to help reduce inflammation in your body or suppress your immune system, when a disease may be due to an auto- immune reaction (where your body fights against itself). WHAT SOLONE IS USED FOR SOLONE is used to treat a number of medical conditions. Your doctor will be able to help decide if SOLONE is suitable for your condition. Ask your doctor if you have any questions about why SOLONE has been prescribed for you. If you have any concerns, you should discuss this with your doctor. This medicine is only available with a doctor's prescription. BEFORE YOU TAKE SOLONE _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE SOLONE IF YOU ARE ALLERGIC TO: • Prednisolone or other cortisone type medications, or any of the ingredients listed at the end of this leaflet including lactose monohydrate. Some of the symptoms of an allergic reaction to SOLONE may include urticaria and other skin rashes, difficulty breathing, swelling of the face or throat or faintness. DO NOT TAKE SOLONE IF YOU: • have a peptic ulcer • suffer from osteoporosis (brittle bones) • have severe disturbances in thoughts, feelings and behaviours (psychoneuroses) • have tuberculosis. DO NOT TAKE SOLONE IF YOU ARE Przeczytaj cały dokument
1 AUSTRALIAN PRODUCT INFORMATION – SOLONE (PREDNISOLONE) TABLET 1 NAME OF THE MEDICINE Prednisolone 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Solone tablets contain 5 mg or 25 mg prednisolone as the active ingredient. List of excipients with known effect: Contains sugars as lactose monohydrate and hydroxybenzoates. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Tablet, uncoated. 5 mg tablet: – White, round, biconvex tablet with a breakline on one side and marking ‘L’ on other side. 25 mg tablet: – White, round, biconvex tablet with a breakline on one side and plain on other side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Wherever corticosteroid therapy is indicated. 4.2 D OSE AND METHOD OF ADMINISTRATION Adults: 10 to 100 mg daily in divided doses. Children: 1 to 5 years: 2.5 to 10 mg twice daily. 6 to 12 years: 5 to 20 mg twice daily. 4.3 C ONTRAINDICATIONS Systemic fungal infections and known hypersensitivity to prednisolone or any of the excipients. Peptic ulcer, osteoporosis, psychoses or severe psychoneuroses. Patients with active or doubtfully quiescent tuberculosis should not be given these hormones except as adjuncts to treatment with tuberculostatic drugs. 4.4 S PECIAL WARNINGS AND PRECAUTIONS FOR USE Corticosteroids should be used with caution in the presence of diminished cardiac reserve or congestive heart failure, in patients with diabetes mellitus, infectious diseases, chronic renal failure, uraemia and in elderly persons. 2 In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is indicated. Corticosteroids may mask some signs of infection, and new infections may appear during their use. Infections with any pathogen including viral, bacterial, fungal, protozoan or helminthic infections, in any location of the body, may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents Przeczytaj cały dokument