Nchi: Australia
Lugha: Kiingereza
Chanzo: Department of Health (Therapeutic Goods Administration)
finasteride, Quantity: 5 mg
Pharmacor Pty Ltd
Finasteride
Tablet, film coated
Excipient Ingredients: lactose monohydrate; magnesium stearate; lauroyl macrogolglycerides; pregelatinised maize starch; sodium starch glycollate type A; microcrystalline cellulose; titanium dioxide; hypromellose; macrogol 6000; indigo carmine aluminium lake
Oral
30 tablets
(S4) Prescription Only Medicine
Pharmacor 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
Version 3.0 1 PHARMACOR FINASTERIDE 5 Finasteride Tablets 5 mg CONSUMER MEDICINE INFORMATION _WHAT IS IN THIS LEAFLET _ This leaflet answers some common questions about Pharmacor Finasteride 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 Pharmacor Finasteride 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 _ _PHARMACOR _ _FINASTERIDE 5 IS USED FOR _ Pharmacor Finasteride 5 is for use by men only. Pharmacor Finasteride 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 streamof urine Feeling that you cannotempty your bladdercompletely A delay before you start topass urine Needing to pass urine often,especially at night Feeling that you must passurine 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. Pharmacor Finasteride 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. Pharmacor Finasteride 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. Soma hati kamili
1 AUSTRALIAN PRODUCT INFORMATION – PHARMACOR 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 Pharmacor 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 T HERAPEUTIC INDICATIONS Pharmacor Finasteride 5 is indicated for the treatment of patients with symptomatic benign prostatic hyperplasia (BPH) with an enlarged prostate. 4.2 D OSE AND METHOD OF ADMINISTRATION 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. 4.3 C ONTRAINDICATIONS Pharmacor 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 Pharmacor Finasteride 5 is not indicated for use in women or children. 2 4.4 S PECIAL WARNINGS AND PRECAUTIONS FOR USE GENERAL Since the beneficial response to Pharmacor 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. Pharmacor Finasteride 5 may not reduce inconvenience to patients arising from benign prostatic hyperplasia symptoms in patients with mild to moderate enlarg Soma hati kamili