Pays: Australie
Langue: anglais
Source: Department of Health (Therapeutic Goods Administration)
finasteride, Quantity: 5 mg
Generic Health Pty Ltd
Finasteride
Tablet, film coated
Excipient Ingredients: magnesium stearate; lauroyl macrogolglycerides; lactose monohydrate; pregelatinised maize starch; microcrystalline cellulose; sodium starch glycollate type A; titanium dioxide; hypromellose; macrogol 6000; indigo carmine aluminium lake
Oral
30 tablets
(S4) Prescription Only Medicine
FINASTERIDE GH 5 5 mg is indicated for the treatment of patients with symptomatic benign prostatic hyperplasia (BPH) with an enlarged prostate.
Visual Identification: Blue, 7 mm, round, biconvex, film-coated tablet, marked 'F5' on one side and plain on the other.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
2012-10-17
CONSUMER MEDICINE INFORMATION FINASTERIDE GH 5 (FINASTERIDE) FILM-COATED TABLET WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Finasteride GH 5. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Finasteride GH 5 against the benefits they expect it will have for you. 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 FINASTERIDE GH 5 IS USED FOR Finasteride GH 5 is for use by men only. Finasteride GH 5 is used to treat a medical condition in men called benign prostatic hyperplasia or BPH. BPH is a condition where your prostate gland (which is near your bladder) has become bigger making it more difficult for you to pass urine. This can lead to symptoms such as: • Weak or interrupted stream of urine. • Feeling that you cannot empty your bladder completely. • A delay before you start to pass urine. • Needing to pass urine often, especially at night. • Feeling that you must pass urine right away. BPH occurs only in men and is common over the age of 50 years. In some men, BPH can lead to serious problems, including urinary tract infections and the sudden inability to pass urine at all. BPH can also lead to the need for surgery such as procedures to improve the flow of urine. The prostate gland takes years to grow. Therefore, the symptoms of BPH take a long time to develop. Finasteride GH 5 works by slowly reducing the size of your prostate gland. This may lead to gradual improvement in your urine flow and other symptoms over several months. Finasteride GH 5 also helps reduce the risk of developing a sudden inability to pass urine (acute urinary retention) and the need for surgery. This may happen whether or not you notice any improvement or change in your symptoms. Your doctor may have prescribed Finasteride GH 5 for another r Lire le document complet
AUSTRALIAN PRODUCT INFORMATION – FINASTERIDE GH 5 (FINASTERIDE) FILM-COATED TABLET 1 NAME OF THE MEDICINE Finasteride. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Finasteride GH 5 film-coated tablets contain 5 mg of finasteride. List of excipients with known effects: lactose monohydrate. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Finasteride GH 5 film-coated tablets are blue, round, biconvex, film-coated tablets, marked ‘F5’ on one side and plain on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Finasteride GH 5 is indicated for the treatment of patients with symptomatic benign prostatic hyperplasia (BPH) with an enlarged prostate. 4.2 DOSE AND METHOD OF ADMINISTRATION The recommended dosage is one 5 mg tablet daily with or without food. DOSAGE IN RENAL INSUFFICIENCY Adjustments in dosage are not necessary in patients with varying degrees of renal insufficiency (creatinine clearances as low as 9 mL/min) as pharmacokinetic studies did not indicate any change in the disposition of finasteride. DOSAGE IN THE ELDERLY No adjustment in dosage is required although pharmacokinetic studies indicated the elimination of finasteride is somewhat decreased in patients more than 70 years of age. Finasteride GH 5 v4.0 Page 2 of 15 (finasteride) film-coated tablet 4.3 CONTRAINDICATIONS Finasteride GH 5 is contraindicated in the following: • Use in women when they are or may potentially be pregnant (see SECTION 4.6 FERTILITY, PREGNANCY AND LACTATION – USE IN PREGNANCY, EXPOSURE TO FINASTERIDE – RISK TO A MALE FOETUS and SECTION 6.4 SPECIAL PRECAUTIONS FOR STORAGE). • Hypersensitivity to any component of this product. Finasteride GH 5 is not indicated for use in women or children. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE GENERAL Since the beneficial response to Finasteride GH 5 may not be manifested immediately, patients with large residual urine volume and/or severely diminished urinary flow should be carefully monitored for obstructive uropathy. Finas Lire le document complet