Quốc gia: New Zealand
Ngôn ngữ: Tiếng Anh
Nguồn: Medsafe (Medicines Safety Authority)
Finasteride 1mg
Viatris Limited
Finasteride 1 mg
1 mg
Film coated tablet
Active: Finasteride 1mg Excipient: Docusate sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry brown OY-S-36500 Polyvidone 30 Pregelatinised maize starch Sodium starch glycolate
Blister pack, PVC/aluminium; 28 tablets, 28 tablets
Prescription
Prescription
Cipla Ltd
· ReGen is indicated for the treatment of men with male pattern hair loss (androgenetic alopecia) to increase hair growth and prevent further hair loss. · ReGen is not indicated for use in women (see WARNINGS AND PRECAUTIONS, PREGNANCY) or children. ReGen is not effective in postmenopausal women with androgenetic alopecia.
Package - Contents - Shelf Life: Blister pack, PVC/aluminium - 28 tablets - 36 months from date of manufacture stored at or below 25°C
2008-04-30
Page 1 of 3 NEW ZEALAND CONSUMER MEDICINE INFORMATION REGEN _FINASTERIDE FILM-COATED TABLET 1 MG_ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about ReGen. 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 ReGen 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 REGEN IS USED FOR ReGen 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 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 twenties 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 of the hormone (DHT) in the balding part of their scalp than in other parts, resulting in increased hair loss. ReGen contains the active ingredient finasteride. It works by lowering the levels of DHT in the scalp, thus helping to reverse the balding process. ReGen 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 ReGen. REGEN IS FOR USE BY MEN ONLY. It is NOT effective in the treatment of hair loss in women (androgenetic alopecia). ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. Đọc toàn bộ tài liệu
Page 1 of 8 NEW ZEALAND DATA SHEET REGEN 1. PRODUCT NAME ReGen, 1 mg, film coated tablet. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablet contains 1 mg of finasteride. ReGen tablets contain lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM ReGen tablets are brown, round, biconvex film-coated tablets, 7.6 mm in diameter. ReGen tablets should not be halved. Dose equivalence when the tablet is divided has not been established. 4. CLINICAL PARTICULARS _4.1 _ _THERAPEUTIC INDICATIONS _ • ReGen is indicated for the treatment of men with male pattern hair loss (androgenetic alopecia) to increase hair growth and prevent further hair loss. • ReGen is NOT indicated for use in women (see section 4.6) or children. ReGen is not effective in postmenopausal women with androgenetic alopecia. _4.2 _ _DOSE AND METHOD OF ADMINISTRATION _ The recommended dosage is one 1 mg tablet daily. 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. Withdrawal from the treatment leads to reversibility of effect within 12 months. METHOD OF ADMINISTRATION ReGen may be taken with or without food. _4.3 _ _CONTRAINDICATIONS _ Finasteride is contraindicated in the following: • Use in women when they are or may potentially be pregnant (see section 4.6) • Hypersensitivity to any component of this product listed in section 6.1. • Finasteride is not indicated for use in women or children. Page 2 of 8 _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 nanograms/mL at baseline to 0.5 nanograms/mL at Month 12. When finasteride is used for treatment of male pattern hair loss in older men who also have benign prostatic hyperplasia (BPH), consideration should be given to the fact that, in older men with BPH, PSA levels are Đọc toàn bộ tài liệu