Regaine for Men Extra Strength Scalp Foam 5% w/w Cutaneous Foam

Šalis: Malta

kalba: anglų

Šaltinis: Medicines Authority

Veiklioji medžiaga:

MINOXIDIL

Prieinama:

McNeil Products Limited

ATC kodas:

D11AX01

INN (Tarptautinis Pavadinimas):

MINOXIDIL

Vaisto forma:

CUTANEOUS FOAM

Sudėtis:

MINOXIDIL 50 milligram(s)/gram

Recepto tipas:

OTC

Gydymo sritis:

OTHER DERMATOLOGICAL PREPARATIONS

Autorizacija statusas:

Authorised

Leidimo data:

2013-09-27

Prekės savybės

Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Regaine for Men Extra Strength Scalp Foam 5% w/w Cutaneous Foam
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Minoxidil 50 mg/g (5% w/w)
Contains butylhydroxytoluene (BHT), stearyl alcohol and cetyl alcohol.
For full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Cutaneous foam
White to off-white foam
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Regaine for Men Extra Strength Scalp Foam 5% w/w Cutaneous Foam is
indicated for the treatment of alopecia androgenetica in men.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Men aged 18-49:
Hair and scalp should be thoroughly dry prior to topical application
of Regaine
for Men Extra Strength Scalp Foam 5% w/w Cutaneous Foam. A dose of 1 g
(equivalent to the volume of half a capful) Regaine for Men Extra
Strength
Scalp Foam 5% w/w Cutaneous Foam should be applied to the total
affected
areas of the scalp twice daily. The total daily dosage should not
exceed 2 g.
It may take twice-daily applications for 8 weeks or more before
evidence of
hair growth can be expected. Users should discontinue treatment if
there is no
improvement seen after 16 weeks.
If hair regrowth occurs, twice daily applications of Regaine for Men
Extra
Strength Scalp Foam 5% w/w Cutaneous Foam are necessary for continued
hair growth.
Clinical Trials have not investigated the efficacy of Regaine for Men
Extra
Strength Scalp Foam 5% w/w Cutaneous Foam beyond 16 weeks.
Page 2 of 11
SPECIAL POPULATIONS
There are no specific recommendations for use in patients with renal
or hepatic
impairment.
PAEDIATRIC AND ELDERLY POPULATIONS
Not recommended. The safety and effectiveness of Regaine for Men Extra
Strength Scalp Foam 5% w/w Cutaneous Foam in children and adolescents
below the age of 18 years or adults over 49 years has not been
established.
METHOD OF ADMINISTRATION
For topical use only.
Hold can upside down and press nozzle to dispense foam onto the hand.
Spread with fingertips over entire bald area. Hands should be wash