국가: 오스트레일리아
언어: 영어
출처: Department of Health (Therapeutic Goods Administration)
finasteride, Quantity: 1 mg
Arrotex Pharmaceuticals Pty Ltd
Finasteride
Tablet, film coated
Excipient Ingredients: pregelatinised maize starch; sodium starch glycollate type A; magnesium stearate; lauroyl macrogolglycerides; microcrystalline cellulose; lactose monohydrate; titanium dioxide; hypromellose; iron oxide yellow; macrogol 6000; iron oxide red
Oral
28 tablets
(S4) Prescription Only Medicine
FINAPEN is indicated for the treatment of male pattern hair loss (androgenetic alopecia) to increase hair growth and prevent further hair loss in men 18 years or older. Efficacy has not been demonstrated in men over the age of 41 years. FINAPEN is not indicated for use in women (see Use in Pregnancy and Clinical Studies) or children.
Visual Identification: Reddish brown, 7 mm, round, biconvex, film-coated tablet, marked 'F1' on one side and plain on the other.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2012-10-17
FINAPEN CONSUMER MEDICINE INFORMATION Version 2 -1- FINAPEN Finasteride Tablets 1 mg CONSUMER MEDICINE INFORMATION _ _ _WHAT IS IN THIS LEAFLET _ This leaflet answers some common questions about Finapen. 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 Finapen 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 FINAPEN IS USED _ _FOR _ Finapen is for use by men only. Finapen is used to treat men with male pattern hair loss to increase hair growth on the scalp and to prevent further hair loss. Male pattern hair loss (also known as androgenetic alopecia) is a common condition in which men experience thinning of the hair on the scalp. This often results in a receding hair line and/or balding on the top of the head. These changes typically start to occur in some men in their 20s and become more common with age. Once hair loss has occurred over a long period of time, the hair may be permanently lost. Male pattern hair loss is thought to be caused by a combination of family history (heredity) and production of a particular male hormone, called dihydrotestosterone (DHT). Men with male pattern hair loss have more DHT in the balding part of their scalp than in other parts, resulting in increased hair loss. _HOW FINAPEN WORKS _ Finapen specifically lowers the levels of DHT in the scalp, thus helping to reverse the balding process. Finapen does not affect hair on other parts of the body. Men with mild to moderate, but not complete, hair loss can expect to benefit from the use of Finapen. In women who were studied, Finapen was not effective in the treatment of hair loss (androgenetic alopecia). There should be no need to change your usual hair care routine (for example, shampooing or haircuts) because you are tak 전체 문서 읽기
1 AUSTRALIAN PRODUCT INFORMATION – FINAPEN(FINASTERIDE) FILM COATED TABLET 1 NAME OF THE MEDICINE Finasteride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains finasteride 1mg For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Finapen comes as a reddish brown, round, biconvex, film-coated tablets, marked ‘F1’ on one side and plain on the other 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Finapen is indicated for the treatment of male pattern hair loss (androgenetic alopecia) to increase hair growth and prevent further hair loss in men 18 years or older. Efficacy has not been demonstrated in men over the age of 41 years. Finapen is not indicated for use in women (see section 4.6 FERTILITY, PREGANCY AND LACTATION- Use in Pregnancy and Clinical Studies) or children. 4.2 D OSE AND METHOD OF ADMINISTRATION The recommended dosage is one 1-mg tablet daily. Finapen may be taken with or without food. In general, daily use for 3 months or more is necessary before increased hair growth and/or prevention of further hair loss is observed. Continued use is recommended to obtain maximum benefit. 4.3 C ONTRAINDICATIONS Finapen is contraindicated in the following: section 4.6 FERTILITY, PREGNANCY AND LACTATION- • Hypersensitivity to any component of this product • Finapen is not indicated for use in women or children. 4.4 S PECIAL WARNINGS AND PRECAUTIONS FOR USE IDENTIFIED PRECAUTIONS In clinical studies with finasteride in men 18-41 years of age, the mean value of serum prostate- specific antigen (PSA) decreased from 0.7 ng/mL at baseline to 0.5 ng/mL at Month 12. When finasteride is used for treatment of male pattern hair loss in older men who also have benign 2 prostatic hyperplasia (BPH), consideration should be given to the fact that, in older men with BPH, PSA levels are decreased by approximately 50%. INCREASED RISK OF HIGH-GRADE PROSTATE CANCER Men aged 55 and over with a normal digital rectal examination and PSA ≤ 3.0 ng/mL at baseline taking finas 전체 문서 읽기