Regaine for Men Extra Strength 5% scalp foam

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Minoxidil

Available from:

McNeil Products Ltd

ATC code:

D11AX01

INN (International Name):

Minoxidil

Dosage:

50mg/1gram

Pharmaceutical form:

Cutaneous foam

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13090000; GTIN: 3574660625882 3574660625851

Patient Information leaflet

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Summary of Product characteristics

OBJECT 1
REGAINE FOR MEN EXTRA STRENGTH SCALP FOAM 5%
W/W CUTANEOUS FOAM (P)
Summary of Product Characteristics Updated 14-Jan-2016 | McNeil
Products Ltd
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.
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 t