Regaine Extra Strength 5% w/v Cutaneous Solution

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Minoxidil

Fáanlegur frá:

JNTL Consumer Health I (Ireland) Limited

ATC númer:

D11AX; D11AX01

INN (Alþjóðlegt nafn):

Minoxidil

Lyfjaform:

Cutaneous solution

Lækningarsvæði:

Other dermatologicals; minoxidil

Leyfisstaða:

Marketed

Leyfisdagur:

1995-02-07

Upplýsingar fylgiseðill

REGAINE®
EXTRA STRENGTH
5 % W/V CUTANEOUS SOLUTION
Minoxidil
This medicine is used to treat hereditary hair loss in men and women
aged 18 – 65 years.
■
Do not apply to other areas of the body other than the scalp. If
accidently 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 Warnings
Relating to Regaine Extra Strength. _See section 2 _
IN THIS LEAFLET
1 What the medicine is for _page 2 _
2 Before using this medicine _page 3 _
3 How to use this medicine _page 5 _
4 Possible side-effects _page 8 _
5 Storing this medicine _page 10 _
6 Further information _page 10 _
Now read this whole leaflet carefully before you use this medicine.
Keep the leaflet: you might
need it again.
1 WHAT THE MEDICINE IS FOR
Regaine Extra Strength is a medicine used to treat common hereditary
hair loss in men and
women aged 18-65 years, by preventing further hair loss and helping
hair regrowth. It contains
minoxidil which is thought to work by aiding the blood flow to the
cells in your scalp which grow
hair.
■
The medicine is for use in men and women aged between 18 and 65 years.
■
Regaine Extra Strength works best in men and women with hair loss or
thinning at the top of
the scalp.
■
Those who are younger, have been losing hair for a short period of
time or have a small area
of baldness are likely to experience the best results.
■
You are unlikely to benefit from Regaine Extra Strength if you have
been bald for many years
or have a large area of hair loss.
HEREDITARY HAIR LOSS is recognisable because:
■
Of the pattern of hair loss (see diagrams).
■
It starts gradually and progresses.
■
You have a family history of hair loss.
■
No other symptoms ar

Vara einkenni

Health Products Regulatory Authority
02 February 2024
CRN00DHLF
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Regaine Extra Strength 5% w/v Cutaneous Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Regaine Extra Strength contains minoxidil 50 mg/ml (5% w/v).
Excipients: contains Propylene Glycol 500mg/ml and ethanol 300mg/ml.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous solution
A clear, colourless to light yellow, odourless, cutaneous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Slowing of hair loss in alopecia androgenetica.
Regrowth of hair in alopecia androgenetica.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Adult men and women between 18 and 65 years of age:
Hair and scalp should be thoroughly dry prior to topical application
of Regaine Extra Strength. A dose of 1 ml Regaine Extra
Strength should be applied to the total affected areas of the scalp
twice daily (once in the morning and once in the evening).
The total dosage should not exceed 2 ml. If fingertips are used to
facilitate drug application, hands should be washed
afterwards.
DURATION OF USE
It may take at least 2 to 4 months of twice a day treatment before
results are seen. Onset and degree of hair growth may be
variable among patients. Onset and degree of hair growth may be
variable among patients.
Continuous twice-daily usage is necessary to maintain the results of
treatment.
Relapse to pre-treatment appearance following discontinuation of
medication has been reported to occur within 3-4 months.
In the absence of any clear response in men, the treatment should be
discontinued after 12 months (8 months in women).
The method of application varies according to the disposable
applicator used:
Pump spray applicator: this is useful for large areas. Aim the pump at
the centre of the bald area, press once and spread with
fingertips over the entire bald area. Repeat for a total of 6 times to
apply a dose of 1 ml. Avoid breathing spray mist.
Extended spray tip ap