Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
Minoxidil
McNeil Healthcare (Ireland) Ltd
D11AX; D11AX01
Minoxidil
5 percent weight/weight
Cutaneous foam
Medicinal product not subject to medical prescription
Other dermatologicals; minoxidil
Marketed
2016-01-29
PACKAGE LEAFLET: INFORMATION FOR THE USER REGAINE FOR WOMEN EXTRA STRENGTH SCALP FOAM 5% W/W CUTANEOUS FOAM MINOXIDIL READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you . - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. - You must talk to a doctor if your symptoms worsen or do not improve after 6 months. IN THIS LEAFLET: 1. What Regaine for Women is and what it is used for 2. What you need to know before you use Regaine for Women 3. How to use Regaine for Women 4. Possible side effects 5. How to store Regaine for Women 6. Contents of the pack and other information 1. WHAT IS REGAINE FOR WOMEN AND WHAT IT IS USED FOR Regaine for Women contains minoxidil. Minoxidil regrows hair in women by revitalization of hair follicles. What is female pattern baldness: Hair thins on the crown of the scalp. It usually starts with a widening through the parting. The front hairline remains unaffected except for normal receding of hair, which happens to everyone as time passes. Regaine for Women is used to treat women with common hereditary thinning or hair loss in the parting (also called androgenetic alopecia, female type). 2. WHAT YOU NEED TO KNOW BEFORE YOU USE REGAINE FOR WOMEN Before the start of the treatment with Regaine for Women you should consult a doctor. Hairloss due to disorders of the hormonal system (endocrinological disorders), underlying diseases or malnutrion has to be excluded. In this case you will need a specific treatment. DO NOT USE REGAINE FOR WOMEN IF YOU: - are allergic to minoxidil or any of the other ingredients of this medicine (listed in section 6). WARNING AND PRECAUTIONS Talk to your doctor or your pharmaci Lugege kogu dokumenti
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Regaine for Women Extra Strength Scalp Foam 5%w/w Cutaneous Foam 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Minoxidil 50 mg/ g Each gram of cutaneous foam contains 50 mg of Minoxidil (5% w/w). Excipient(s) with known effect: 1 g of cutaneous foam contains 1 mg of butylhydroxytoluene, 5.30 mg of stearyl alcohol and 11.60 mg of cetyl alcohol. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cutaneous foam. White to yellowish, unscented foam. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of androgenetic alopecia, female type (characteristic thinning of the hair in the parietal area) in women. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Regaine for Women Extra Strength Scalp Foam is for external use only. Do not apply to areas of the body other than the scalp. Hair and scalp should be thoroughly dry prior to topical application of the foam. A dose of 1 g (equivalent to the volume of half a capful) of Regaine for Women Extra Strength Scalp Foam should be applied on the affected areas on the top of the scalp once daily. The total dosage should not exceed 1 g. Generally it will take a once-daily application for 12 weeks before evidence of hair growth can be expected. Users should discontinue use if there is no improvement seen after 24 weeks. CONTINUED USE IS NECESSARY TO MAINTAIN HAIR REGROWTH, OR HAIR LOSS/HAIR THINNING WILL BEGIN AGAIN. SPECIAL POPULATIONS There are no specific recommendations for use in elderly patients or in patients with renal or hepatic impairment. PAEDIATRIC POPULATION Regaine for Women Extra Strength Scalp Foam is not recommended for use in children below the age of 18 years due to lack of data on safety and efficacy. METHOD OF ADMINISTRATION Hold can upside down and press the nozzle to dispense foam onto a non-absorbent surface like a clean dish or saucer. Within your hair thinning areas, make a center part to help maximize scalp exposure. Spread over the affected areas at H E A L T H Lugege kogu dokumenti