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

Země: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktivní složka:

MINOXIDIL

Dostupné s:

McNeil Products Limited

ATC kód:

D11AX01

INN (Mezinárodní Name):

MINOXIDIL

Léková forma:

CUTANEOUS FOAM

Složení:

MINOXIDIL 50 milligram(s)/gram

Druh předpisu:

OTC

Terapeutické oblasti:

OTHER DERMATOLOGICAL PREPARATIONS

Stav Autorizace:

Authorised

Datum autorizace:

2013-09-27

Charakteristika produktu

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