Țară: Malta
Limbă: engleză
Sursă: Medicines Authority
MINOXIDIL
McNeil Healthcare (Ireland) Limited Airton Road, Tallaght, Dublin 24, Ireland
D11AX01
MINOXIDIL 50 mg/ml
CUTANEOUS SOLUTION
MINOXIDIL 50 mg/ml
OTC
OTHER DERMATOLOGICAL PREPARATIONS
Authorised
2006-02-07
REGAINE® EXTRA STRENGTH 5 % W/V CUTANEOUS SOLUTION Minoxidil This medicine is used to treat hereditary hair loss in men and women aged 18 – 65 years. ■ Do not apply to other areas of the body other than the scalp. If accidently applied rinse thoroughly with plenty of water. _See section 2 _ ■ THERE ARE 2 DIFFERENT WAYS YOU CAN APPLY THIS PRODUCT, CHOOSE THE BEST OPTION FOR YOU AND FOLLOW THE INSTRUCTIONS ON HOW TO USE THIS PRODUCT CAREFULLY. _See section 3 _ ■ THIS MEDICINE IS FOR EXTERNAL USE ONLY AND SHOULD ONLY BE APPLIED TO YOUR SCALP. _See section 3 _ ■ THIS PRODUCT IS FLAMMABLE AND SHOULD BE USED AND DISPOSED OF CAREFULLY. See Special Warnings Relating to Regaine Extra Strength. _See section 2 _ IN THIS LEAFLET 1 What the medicine is for _page 2 _ 2 Before using this medicine _page 3 _ 3 How to use this medicine _page 5 _ 4 Possible side-effects _page 8 _ 5 Storing this medicine _page 10 _ 6 Further information _page 10 _ Now read this whole leaflet carefully before you use this medicine. Keep the leaflet: you might need it again. 1 WHAT THE MEDICINE IS FOR Regaine Extra Strength is a medicine used to treat common hereditary hair loss in men and women aged 18-65 years, by preventing further hair loss and helping hair regrowth. It contains minoxidil which is thought to work by aiding the blood flow to the cells in your scalp which grow hair. ■ The medicine is for use in men and women aged between 18 and 65 years. ■ Regaine Extra Strength works best in men and women with hair loss or thinning at the top of the scalp. ■ Those who are younger, have been losing hair for a short period of time or have a small area of baldness are likely to experience the best results. ■ You are unlikely to benefit from Regaine Extra Strength if you have been bald for many years or have a large area of hair loss. HEREDITARY HAIR LOSS is recognisable because: ■ Of the pattern of hair loss (see diagrams). ■ It starts gradually and progresses. ■ You have a family history of hair loss. ■ No other symptoms ar Citiți documentul complet
Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1. TRADE NAME OF THE MEDICINAL PRODUCT Regaine Extra Strength 5% w/v Cutaneous Solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Regaine Extra Strength contains minoxidil 50 mg/ml (5% w/v). Excipients: contains Propylene Glycol 500mg/ml and ethanol 300mg/ml. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Cutaneous solution. A clear, colourless to light yellow, odourless cutaneous solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Slowing of hair loss in alopecia androgenetica. Regrowth of hair in alopecia androgenetica. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Adult men and women between 18 and 65 years of age: Hair and scalp should be thoroughly dry prior to topical application of Regaine Extra Strength. A dose of 1 ml Regaine Extra Strength should be applied to the total affected areas of the scalp twice daily (once in the morning and once in the evening). The total dosage should not exceed 2 ml. If fingertips are used to facilitate drug application, hands should be washed afterwards. DURATION OF USE It may take at least 2 to 4 months of twice a day treatment before results are seen. Onset and degree of hair growth may be variable among patients. Onset and degree of hair growth may be variable among patients. Continuous twice-daily usage is necessary to maintain the results of treatment. Page 2 of 10 Relapse to pre-treatment appearance following discontinuation of medication has been reported to occur within 3-4 months. In the absence of any clear response in men, the treatment should be discontinued after 12 months (8 months in women). The method of application varies according to the disposable applicator used: Pump spray applicator: this is useful for large areas. Aim the pump at the centre of the bald area, press once and spread with fingertips over the entire bald area. Repeat for a total of 6 times to apply a dose of 1 ml. Avoid breathing spray mist. Extended spray tip applicator: this is useful for small areas Citiți documentul complet