Country: Аустралија
Језик: Енглески
Извор: Department of Health (Therapeutic Goods Administration)
finasteride, Quantity: 5 mg
Dr Reddys Laboratories Australia Pty Ltd
Finasteride
Tablet, film coated
Excipient Ingredients: lactose monohydrate; pregelatinised maize starch; microcrystalline cellulose; sodium starch glycollate type A; magnesium stearate; docusate sodium; titanium dioxide; hypromellose; indigo carmine aluminium lake; macrogol 400
Oral
28 tablets, 30 Tablets
(S4) Prescription Only Medicine
Treatment of patients with symptomatic benign prostatic hyperplasia (BPH) with an enlarged prostate.
Visual Identification: Blue coloured, oval shaped, biconvex, film-coated tablet, debossed with 'FIN' on one side and '5' on the other side; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2010-06-18
FINPRO ® _Finasteride_ _ _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about FINPRO. 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 FINPRO 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 FINPRO IS USED FOR FINPRO is for use by men only. FINPRO 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 • 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. FINPRO 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. FINPRO 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 FINPRO for another reason. Ask your doctor if you have any questions about why FINPRO has been prescribed for you. FINPRO is not Прочитајте комплетан документ
AUSTRALIAN PRODUCT INFORMATION – FINPRO (FINASTERIDE) FILM-COATED TABLETS 1 NAME OF THE MEDICINE Finasteride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg of finasteride. Also contains lactose. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Finpro 5 mg tablets are blue colored, oval shaped, biconvex, film-coated tablets, debossed with ‘FIN’ on one side and ‘5’ on the other side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS 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. IMPAIRED RENAL FUNCTION_ _ Adjustments in dosage are not necessary in patients with varying degrees of renal insufficiency (creatinine clearances as low as 9 mL/minute) as pharmacokinetic studies did not indicate any change in the disposition of finasteride. USE IN THE ELDERLY No adjustment in dosage is required although pharmacokinetic studies indicated that the elimination of finasteride is somewhat decreased in patients aged over 70 years. 4.3 C ONTRAINDICATIONS Finasteride is contraindicated in the following: • Use in women when they are or may potentially be pregnant (see 4.6 FERTILITY, PREGNANCY AND LACTATION, USE IN PREGNANCY, RISK TO A MALE FETUS OF EXPOSURE TO FINASTERIDE and 6.4 SPECIAL PRECAUTIONS FOR STORAGE). • Hypersensitivity to any component of this product. • Use in women or children. 1 4.4 S PECIAL WARNINGS AND PRECAUTIONS FOR USE IDENTIFIED PRECAUTIONS GENERAL Since the beneficial response to finasteride may not be manifested immediately, patients with large residual urine volume and/or severely diminished urinary flow should be carefully monitored for obstructive uropathy. Finasteride may not reduce inconvenience to patients arising from benign prostatic hyperplasia (BPH) symptoms in patients with mild to moderate enlargement in prostate (< 40 mL size). EFFECTS ON PROS Прочитајте комплетан документ