Nazione: Australia
Lingua: inglese
Fonte: Department of Health (Therapeutic Goods Administration)
finasteride, Quantity: 5 mg
Pharmacor Pty Ltd
Finasteride
Tablet, film coated
Excipient Ingredients: lactose monohydrate; lauroyl macrogolglycerides; microcrystalline cellulose; pregelatinised maize starch; sodium starch glycollate type A; magnesium stearate; titanium dioxide; hypromellose; macrogol 6000; indigo carmine aluminium lake
Oral
30 tablets
(S4) Prescription Only Medicine
APO-FINASTERIDE 5 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: 4 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2010-03-26
APO-Finasteride 5 1 APO-FINASTERIDE 5 _Finasteride _ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about finasteride. 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 using this medicine 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 want to read it again. WHAT THIS MEDICINE IS USED FOR FINASTERIDE IS FOR USE BY MEN ONLY. Finasteride is used to treat a medical condition in men called benign prostatic hyperplasia (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. The prostate gland takes years to grow. Therefore, the symptoms of BPH take a long time to develop. In some men, BPH can lead to serious problems, including urinary tract infections and the sudden inability to pass urine at all (acute urinary retention). BPH may also require surgery to improve the flow of urine. _HOW IT WORKS _ Finasteride 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 also helps reduce the risk of developing a sudden inability to pass urine and the need for surgery. This may happen whether or not you notice any improvement or change in your symptoms. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THI Leggi il documento completo
1 AUSTRALIAN PRODUCT INFORMATION APO-FINASTERIDE 5 (FINASTERIDE) FILM-COATED TABLETS 1 NAME OF THE MEDICINE Finasteride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Finasteride 5 mg. EXCIPIENTS WITH KNOWN EFFECT Lactose monohydrate. For the full list of excipients see section 6.1 LIST OF EXCIPIENTS 3 PHARMACEUTICAL FORM APO-Finasteride 5 comes as a blue, round, biconvex, film-coated tablets, marked ‘F5’ on one side and plain on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS APO-Finasteride 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 DOSAGE The recommended dosage is one 5 mg tablet daily with or without food. RENAL IMPAIRMENT 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. 2 4.3 CONTRAINDICATIONS APO-Finasteride 5 is contraindicated in the following: • Use in women when they are or may potentially be pregnant (see sections 4.6 FERTILITY, PREGNANCY AND LACTATION - USE IN PREGNANCY; EXPOSURE TO FINASTERIDE - RISK TO A MALE FOETUS) • Hypersensitivity to any component of this product APO-Finasteride 5 is not indicated for use in women or children. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE GENERAL Since the beneficial response to APO-Finasteride 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. APO-Finasteride 5 may not reduce inconvenience to patients arising from benign prostatic hyperplasia symptoms in patients with mild to moderate enlargement in prostate (< 40 mL size). EFFECTS ON PSA Leggi il documento completo