País: Austràlia
Idioma: anglès
Font: Department of Health (Therapeutic Goods Administration)
finasteride, Quantity: 1 mg
Sandoz Pty Ltd
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
FINASTA 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. FINASTA 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: 4 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2020-05-04
CONSUMER MEDICINE INFORMATION FINASTA® 1 MG (FINASTERIDE) FILM-COATED TABLET WHAT IS IN THIS LEAFLET This leaflet answers some common questions about FINASTA 1 mg. 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 FINASTA 1 mg 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 FINASTA 1 MG IS USED FOR FINASTA 1 mg is for use by men only. FINASTA 1 mg 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 FINASTA 1 MG WORKS _ FINASTA 1 mg specifically lowers the levels of DHT in the scalp, thus helping to reverse the balding process. FINASTA 1 mg 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 FINASTA. In women who were studied, FINASTA 1 mg 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 taking F Llegiu el document complet
AUSTRALIAN PRODUCT INFORMATION – FINASTA® (FINASTERIDE) 1 MG FILM-COATED TABLET 1 NAME OF THE MEDICINE Finasteride. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION FINASTA 1 mg film-coated tablets contain 1 mg of finasteride. List of excipients with known effects: lactose monohydrate. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM FINASTA 1 mg film-coated tablets are reddish-brown, round, biconvex, film-coated tablet, marked ‘F1’ on one side and plain on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS FINASTA 1 mg 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. FINASTA 1 mg is not indicated for use in women (see SECTION 4.6 FERTILITY, PREGNANCY AND LACTATION – USE IN PREGNANCY and SECTION 5.1 PHARMACODYNAMIC PROPERTIES – CLINICAL TRIALS) or children. 4.2 DOSE AND METHOD OF ADMINISTRATION The recommended dosage is one 1 mg tablet daily. FINASTA 1 mg 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 CONTRAINDICATIONS FINASTA 1 mg is contraindicated in the following: Use in women when they are or may potentially be pregnant (see SECTION 4.6 FERTILITY, PREGNANCY AND LACTATION – USE IN PREGNANCY). Hypersensitivity to any component of this product. FINASTA 1 mg is not indicated for use in women or children. FINASTA® 1 mg v1 Page 2 of 13 (finasteride) film-coated tablet 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE 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 Llegiu el document complet