Land: Malta
Taal: Engels
Bron: Medicines Authority
MINOXIDIL
Johnson & Johnson (Ireland) Limited Airton Road Tallaght, Dublin 24, Dublin, Ireland
D11AX01
MINOXIDIL 50 mg/g
CUTANEOUS FOAM
MINOXIDIL 50 mg/g
OTC
OTHER DERMATOLOGICAL PREPARATIONS
Authorised
2013-09-27
PACKAGE LEAFLET: INFORMATION FOR THE USER REGAINE FOR MEN 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 4 months. WHAT IS IN THIS LEAFLET 1. What Regaine Foam is and what it is used for 2. What you need to know before you use Regaine Foam 3. How to use Regaine Foam 4. Possible side effects 5. How to store Regaine Foam 6. Content of the pack and other information 1. WHAT REGAINE FOAM IS AND WHAT IT IS USED FOR Regaine contains minoxidil. Minoxidil regrows hair and stabilizes hair loss in men with a receding hairline and crown balding by revitalization of hair follicles. Regaine is used to treat men with common hereditary hair loss (also called androgenetic alopecia). It is to be used only on the scalp (head) 2. WHAT YOU NEED TO KNOW BEFORE YOU USE REGAINE FOAM DO NOT USE REGAINE FOAM 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 pharmacist before using Regaine Foam - If you suffer from heart disease including abnormal heart rhythms or rates, angina or chest pains and/or circulation disorders. - When minoxidil passes into the blood stream it can cause some side-effects related to low blood pressure such as chest pain, rapid heartbeat, faintness, dizziness, sudden unexplained Document ID: Version: Status: 1.0 J0449565 Approved weight gain or swollen hands and feet. It can also cause persistent redness or irritation of the scalp. If you ex Lees het volledige document
Version 2, Draft SNAS 2245 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Regaine for Men Extra Strength 5% w/w Scalp Foam 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 in adult men 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Regaine is for topical 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. For men aged 18 years or above a dose of 1 g (equivalent to the volume of half a capful) of Regaine should be applied to the total affected areas of the scalp twice daily (once in the morning and once in the evening). The maximum total daily recommended dose of topical minoxidil in men is 100mg, administered as up to 2 g foam per day. Duration of use It may take twice-daily applications for 2 to 4 months before evidence of hair growth can be expected. Users should discontinue use if there is no improvement seen after 4 months. If hair regrowth occurs, twice daily applications of Regaine are necessary for continued hair growth. SPECIAL POPULATIONS Page 2 of 10 There are no specific recommendations for use in elderly patients or in patients with renal or hepatic impairment. PEDIATRIC POPULATION Regaine 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 the hand. Spread with fingertips over entire bald area. Hands should be washed thoroughly after application. 4.3 CONTRAINDICATIONS Hypersensitivity to minox Lees het volledige document