Maa: Australia
Kieli: englanti
Lähde: Department of Health (Therapeutic Goods Administration)
finasteride, Quantity: 1 mg
Accord Healthcare 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
FINASTERIDE MYLAN 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. FINASTERIDE MYLAN 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 FINASTERIDE MYLAN 1 (finasteride) film-coated tablet What is in this leaflet This leaflet answers some common questions about Finasteride Mylan 1. 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 Finasteride Mylan 1 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 Finasteride Mylan 1 is used for Finasteride Mylan 1 is for use by men only. Finasteride Mylan 1 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 Finasteride Mylan 1 works Finasteride Mylan 1 specifically lowers the levels of DHT in the scalp, thus helping to reverse the balding process. Finasteride Mylan 1 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 Finasteride Mylan 1. In women who were studied, Finasteride Mylan 1 was not effective in the treatment of hair loss (androgenetic alopecia). There should be no need to change your usual hai Lue koko asiakirja
AUSTRALIAN PRODUCT INFORMATION – FINASTERIDE MYLAN 1 (finasteride) film-coated tablet 1 NAME OF THE MEDICINE Finasteride. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Finasteride Mylan 1 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 Finasteride Mylan 1 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 Finasteride Mylan 1 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. Finasteride Mylan 1 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. Finasteride Mylan 1 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 Finasteride Mylan 1 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. Finasteride Mylan 1 v0.2 Page 2 of 15 (finasteride) film-coated tablet Finasteride Mylan 1 is not indicated for use in women or children. 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 treatmen Lue koko asiakirja