País: Austrália
Língua: inglês
Origem: Department of Health (Therapeutic Goods Administration)
finasteride, Quantity: 5 mg
Arrotex Pharmaceuticals Pty Ltd
Finasteride
Tablet, film coated
Excipient Ingredients: magnesium stearate; purified talc; lactose monohydrate; hypromellose; pregelatinised maize starch; titanium dioxide; hyprolose; sodium starch glycollate; microcrystalline cellulose; macrogol 6000
Oral
30 tablets
(S4) Prescription Only Medicine
Treatment of patients with symptomatic benign prostatic hyperplasia (BPH) with an enlarged prostate.
Visual Identification: White rounded triangle tablet with "R\G" on one side; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 4 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2008-12-17
FINNACAR- Consumer Medicine Information Page 1 of 3 FINNACAR finasteride CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about FINNACAR. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking FINNACAR against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. Keep this leaflet with your medicine. You may need to read it again. WHAT FINNACAR IS USED FOR FINNACAR is for use in men only. It must not be taken by women. FINNACAR is used to treat benign prostatic hyperplasia (BPH). BPH is a condition where your prostate gland (which is near your bladder) has become bigger making it difficult to pass urine. This can cause symptoms such as: • a weak or interrupted stream of urine • the feeling that you cannot completely empty your bladder • a delay before you start to pass urine • the need to pass urine often, especially at night • the urgent feeling that you need to 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 so the symptoms of BPH can take a long time to develop. FINNACAR 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. FINNACAR 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 FINNACAR for another reason. Ask your doctor if you have Leia o documento completo
1 AUSTRALIAN PRODUCT INFORMATION – FINNACAR (FINASTERIDE) TABLETS 1 NAME OF THE MEDICINE Finasteride. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION FINNACAR tablets contain 5 mg of finasteride. Excipients with known effect: Lactose monohydrate For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM _FINNACAR _ White, rounded triangle tablet marked with R/G on one 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. Handling Crushed or broken tablets of FINNACAR should not be handled by women when they are or may potentially be pregnant (see section 4.6 FERTILITY, PREGNANCY AND LACTATION, Use in pregnancy, Risk to a male fetus of exposure to finasteride). 2 4.3 C ONTRAINDICATIONS Use in women when they are or may potentially be pregnant (see section 4.6 FERTILITY, PREGNANCY AND LACTATION, Use in pregnancy, Risk to a male fetus of exposure to finasteride and s e c t i o n 4 . 2 DOSE AND METHOD OF ADMINISTRATION Handling). Hypersensitivity to any component of this product. Use in women or children. 4.4 S PECIAL WARNINGS AND PRECAUTIONS FOR USE 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 Leia o documento completo