Regaine for Women Regular Strength

Ország: Málta

Nyelv: angol

Forrás: Medicines Authority

Aktív összetevők:

MINOXIDIL

Beszerezhető a:

McNeil Products Limited Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG, United Kingdom

ATC-kód:

D11AX01

INN (nemzetközi neve):

MINOXIDIL 20 mg/ml

Gyógyszerészeti forma:

CUTANEOUS SOLUTION

Összetétel:

MINOXIDIL 20 mg/ml

Recept típusa:

OTC

Terápiás terület:

OTHER DERMATOLOGICAL PREPARATIONS

Engedélyezési státusz:

Withdrawn

Engedély dátuma:

2006-02-07

Betegtájékoztató

PATIENT INFORMATION LEAFLET
REGAINE FOR WOMEN REGULAR STRENGTH
Minoxidil 2% scalp solution
Cutaneous solution to be applied to the scalp
Treats thinning hair
Prevents further hair loss and regrows hair
McNeil Products Ltd
Warning Flammable Liquid
REGAINE FOR WOMEN REGULAR STRENGTH
MINOXIDIL 2% SCALP SOLUTION CUTANEOUS SOLUTION TO BE APPLIED TO THE
SCALP

This medicine is used to treat hereditary hair loss in women aged
18-65 years.

Do not apply to other areas of the body other than the scalp. If
accidentally applied rinse
thoroughly with plenty of water. See section 2 >

THERE ARE 2 DIFFERENT WAYS YOU CAN APPLY THIS PRODUCT; CHOOSE THE BEST
OPTION FOR YOU AND
FOLLOW THE INSTRUCTIONS ON HOW TO USE THIS PRODUCT CAREFULLY. See
section 3 >

THIS MEDICINE IS FOR EXTERNAL USE ONLY AND SHOULD ONLY BE APPLIED TO
YOUR SCALP. See section
3>

THIS PRODUCT IS FLAMMABLE AND SHOULD BE USED AND DISPOSED OF
CAREFULLY. See Special
Warning Relating to Regaine for Women Regular Strength. See section 2
>
IN THIS LEAFLET
1.
What the medicine is and what it is used for _PAGE 2_
2.
What you need to know before you use this medicine _PAGE 3_
3.
How to use this medicine _PAGE 5_
4.
Possible side-effects _PAGE 8_
5.
How to store this medicine _PAGE 10_
6.
Contents of the pack and other information _PAGE 10_
NOW READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU. Keep the leaflet: you may need
to read it again.
1.
WHAT THE MEDICINE IS AND WHAT IT IS USED FOR
Regaine for Women Regular Strength is a medicine used to treat common
hereditary
hair loss in women aged 18-65 years, by preventing further hair loss
and helping hair re-
growth. It contains minoxidil which is thought to work by aiding the
blood flow to the
hair follicles on your scalp.

The medicine is for use in men aged between 18 and 65 years.

Regaine for Women Regular Strength works best in men with hair loss or
thinning at the top of the scalp.

Those who are younger, have been losing

Termékjellemzők

Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Regaine for Women Regular Strength
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Minoxidil 20 mg/ml (2% w/v).
Contains propylene glycol.
For full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Cutaneous Solution (to be applied to the scalp).
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Regaine for Women Regular Strength is indicated for the treatment of
alopecia
androgenetica in women aged between 18 and 65.
Onset and degree of hair regrowth may be variable among users.
Although trends
in the data suggest that those users who are younger, whose hair has
been thinning
for a shorter period of time or who have a smaller area of thinning on
the vertex
are more likely to respond to Regaine for Women Regular Strength,
individual
responses cannot be predicted.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Women aged 18-65:
Hair and scalp should be thoroughly dry prior to topical application
of Regaine for
Women Regular Strength. A dose of 1 ml Regaine for Women Regular
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 four months or more before
evidence of
hair growth can be expected.
Page 2 of 12
If hair re-growth occurs, twice daily applications of Regaine for
Women Regular
Strength are necessary for continued hair growth. Anecdotal reports
indicate that
re-grown hair may disappear three to four months after stopping
Regaine for
Women Regular 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 Women
Regular
Strength in