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

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Minoxidil

متاح من:

Johnson & Johnson (Ireland) Limited

ATC رمز:

D11AX; D11AX01

INN (الاسم الدولي):

Minoxidil

جرعة:

5 percent weight/weight

الشكل الصيدلاني:

Cutaneous foam

نوع الوصفة الطبية :

Product not subject to medical prescription

المجال العلاجي:

Other dermatologicals; minoxidil

الوضع إذن:

Marketed

تاريخ الترخيص:

2016-01-29

نشرة المعلومات

PACKAGE LEAFLET: INFORMATION FOR THE USER
REGAINE FOR WOMEN EXTRA STRENGTH SCALP FOAM 5% W/W CUTANEOUS FOAM
MINOXIDIL
READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told
you
.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
-
You must talk to a doctor if your symptoms worsen or do not improve
after 6 months.
IN THIS LEAFLET:
1.
What Regaine for Women is and what it is used for
2.
What you need to know before you use Regaine for Women
3.
How to use Regaine for Women
4.
Possible side effects
5.
How to store Regaine for Women
6.
Contents of the pack and other information
1. WHAT IS REGAINE FOR WOMEN AND WHAT IT IS USED FOR
Regaine for Women contains minoxidil. Minoxidil regrows hair in women
by revitalization of hair
follicles.
What is female pattern baldness:
•
Hair thins on the crown of the scalp. It usually starts with a
widening through the parting.
•
The front hairline remains unaffected except for normal receding of
hair, which happens to
everyone as time passes.
Regaine for Women is used to treat women with common hereditary
thinning or hair loss in the
parting (also called androgenetic alopecia, female type).
2. WHAT YOU NEED TO KNOW BEFORE YOU USE REGAINE FOR WOMEN
Before the start of the treatment with Regaine for Women you should
consult a doctor. Hairloss due
to disorders of the hormonal system (endocrinological disorders),
underlying diseases or malnutrion
has to be excluded. In this case you will need a specific treatment.
DO NOT USE REGAINE FOR WOMEN IF YOU:
-
are allergic to minoxidil or any of the other ingredients of this
medicine (listed in section 6).
WARNING AND PRECAUTIONS
Talk to your doctor or your pharmaci

خصائص المنتج

Health Products Regulatory Authority
08 June 2023
CRN00D8JN
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Regaine for Women Extra Strength Scalp Foam 5%w/w Cutaneous Foam
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Minoxidil 50 mg/ g
Each gram of cutaneous foam contains 50 mg of Minoxidil (5% w/w).
Excipient(s) with known effect: 1 g of cutaneous foam contains 564.6
mg of ethanol, 1 mg of butylhydroxytoluene, 5.30 mg of
stearyl alcohol and 11.60 mg of cetyl alcohol.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous foam.
White to yellowish, unscented foam.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of androgenetic alopecia, female type (characteristic
thinning of the hair in the parietal area) in women.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Regaine for Women Extra Strength Scalp Foam is for external use only.
Do not apply to areas of the body other than the scalp.
Hair and scalp should be thoroughly dry prior to topical application
of the foam. A dose of 1 g (equivalent to the volume of
half a capful) of Regaine for Women Extra Strength Scalp Foam should
be applied on the affected areas on the top of the scalp
once daily. The total dosage should not exceed 1 g.
Generally it will take a once-daily application for 12 weeks before
evidence of hair growth can be expected. Users should
discontinue use if there is no improvement seen after 24 weeks.
CONTINUED USE IS NECESSARY TO MAINTAIN HAIR REGROWTH, OR HAIR
LOSS/HAIR THINNING WILL BEGIN AGAIN.
SPECIAL POPULATIONS
There are no specific recommendations for use in elderly patients or
in patients with renal or hepatic impairment.
PAEDIATRIC POPULATION
Regaine for Women Extra Strength Scalp Foam is not recommended for use
in children below the age of 18 years due to lack
of data on safety and efficacy.
METHOD OF ADMINISTRATION
Hold can upside down and press the nozzle to dispense foam onto a
non-absorbent surface like a clean dish or saucer.
Within your hair thinning areas, make