Country: Malasía
Tungumál: enska
Heimild: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
FINASTERIDE
ORGANON MALAYSIA SDN. BHD.
FINASTERIDE
28Tablet Tablets; 28 Tablet Tablets
AIAC International Pharma, LLC
PROPECIA ® TABLET Finasteride 1 mg _Consumer Medication Information Leaflet (RiMUP) _ 1 Copyright 2023 Organon group of companies. All rights reserved. _PROPECIA _ 8. Product description 9. Product Manufacturer and Product Registration Holder 10. Date of Revision Please read this leaflet carefully before you start to take your medicine, even if you have just refilled your prescription. Some of the information in the previous leaflet may have changed. Remember that this medicine is only for you. Only a doctor can prescribe it for you. Never give it to anyone else. WHAT _PROPECIA _IS USED FOR _PROPECIA _IS FOR USE BY MEN ONLY. Your doctor has prescribed _PROPECIA _ because you have male pattern hair loss (also known as androgenetic alopecia). _PROPECIA _ increases hair growth on the scalp and prevents further hair loss in men. _PROPECIA _ is for use in men only and should NOT be used by women or children. HOW _PROPECIA _WORKS _PROPECIA _ blocks an important enzyme (Type II 5-alpha reductase) involved in the regulation of the hair follicle. In the scalp, _PROPECIA _ specifically lowers the levels of DHT, a major cause of male pattern hair loss. In this way, _PROPECIA _ helps to reverse the balding process, leading to increased hair growth and prevention of further hair loss. IN WHOM IS _PROPECIA _ EXPECTED TO WORK? Men with mild to moderate, but not complete, hair loss can expect to benefit from the use of _PROPECIA_ . In women who were studied, _PROPECIA _ was not effective in the treatment of hair loss (androgenetic alopecia). BEFORE YOU TAKE _PROPECIA _ _ _ _- When you must not take it _ Do not take _PROPECIA _ if: • you are a woman who are or may potentially be pregnant (see USE IN PREGNANCY ). • you think you are allergic to any of its ingredients. • you are a woman or child • the packaging is torn and shows signs of tampering • the expiry date on the pack has passed. WHAT IS IN THIS LEAFLET What _PROPECIA _ is used for How _PROPECIA _ works Before you take _PROPECIA _ How to take _PROPECIA _ While y Lestu allt skjalið
Copyright 2023 Organon group of companies. All rights reserved. I. THERAPEUTIC CLASS II. INDICATIONS III. CLINICAL PHARMACOLOGY IIIA. PHARMACODYNAMIC PROPERTIES LPC-OG0906-PPC-1T-072023-Malaysia LOCAL PRODUCT CIRCULAR PROPECIA ® (FINASTERIDE) PROPECIA ® (finasteride) is a synthetic 4-azasteroid compound that is a specific inhibitor of Type II 5α -reductase, an intracellular enzyme that metabolizes the androgen testosterone into dihydrotestosterone (DHT). PROPECIA is indicated for the treatment of men with male pattern hair loss (androgenetic alopecia) to increase hair growth and prevent further hair loss. Safety and efficacy were demonstrated in men between 18 to 41 years of age with mild to moderate hair loss of the vertex and anterior mid-scalp area. Efficacy in bitemporal recession has not been established. PROPECIA is NOT indicated for use in women (see PREGNANCY) or children. PROPECIA is not effective in postmenopausal women with androgenetic alopecia. Finasteride is a competitive and specific inhibitor of Type II 5α -reductase. Finasteride has no affinity for the androgen receptor and has no androgenic, antiandrogenic, estrogenic, antiestrogenic, or progestational effects. Inhibition of this enzyme blocks the peripheral conversion of testosterone to the androgen dihydrotestosterone (DHT), resulting in significant decreases in serum and tissue DHT concentrations. Circulating levels of testosterone were increased by approximately 10-15% compared with placebo, yet remained within the physiologic range. Copyright 2023 Organon group of companies. All rights reserved. Finasteride produces a rapid reduction in serum DHT concentration, reaching significant suppression within 24 hours of dosing. Hair follicles contain Type II 5α -reductase. In men with male pattern hair loss, the balding scalp contains miniaturized hair follicles and increased amounts of DHT. Administration of finasteride decreases scalp and serum DHT concentrations in these men. Men with a genetic deficiency of Type II 5α -reductase do not su Lestu allt skjalið