Regaine for Men Extra Strength

البلد: مالطا

اللغة: الإنجليزية

المصدر: Medicines Authority

العنصر النشط:

MINOXIDIL

متاح من:

McNeil Products Limited

ATC رمز:

D11AX01

INN (الاسم الدولي):

MINOXIDIL

الشكل الصيدلاني:

CUTANEOUS SOLUTION

تركيب:

MINOXIDIL 50 milligram(s)/millilitre

نوع الوصفة الطبية :

OTC

المجال العلاجي:

OTHER DERMATOLOGICAL PREPARATIONS

الوضع إذن:

Authorised

تاريخ الترخيص:

2006-02-07

خصائص المنتج

Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Regaine for Men Extra Strength
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Minoxidil 50 mg/ml (5% w/v).
Contains propylene glycol.
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Cutaneous Solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Regaine for Men Extra Strength is indicated for the treatment of
alopecia
androgenetica in men.
Onset and degree of hair regrowth may be variable among users.
Although trends
in the data suggest that those users who are younger, who have been
balding for a
shorter period of time or who have a smaller area of baldness on the
vertex are
more likely to respond to Regaine for Men Extra Strength, individual
responses
cannot be predicted.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Men aged 18-65:
Hair and scalp should be thoroughly dry prior to topical application
of Regaine for
Men Extra Strength. A dose of 1 ml Regaine for Men Extra Strength
cutaneous
solution should be applied to the total affected areas of the scalp
twice daily. The
total dosage should not exceed 2 ml. If fingertips are used to
facilitate drug
application, hands should be washed afterwards.
It may take twice daily applications for 2 months or more before
evidence of hair
growth can be expected.
Page 2 of 13
If hair re-growth occurs, twice daily applications of Regaine for Men
Extra
Strength are necessary for continued hair growth. Anecdotal reports
indicate that
re-grown hair may disappear three to four months after stopping
Regaine for Men
Extra Strength application and the balding process will continue.
Users should discontinue treatment if there is no improvement after
one year.
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 in children and adolescents below the age of 18 years or
adults over the
age of 65 years has not bee