Regaine for Women Once a Day 5% scalp foam

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Minoxidil

Beschikbaar vanaf:

McNeil Products Ltd

ATC-code:

D11AX01

INN (Algemene Internationale Benaming):

Minoxidil

Dosering:

50mg/1gram

farmaceutische vorm:

Cutaneous foam

Toedieningsweg:

Cutaneous

klasse:

No Controlled Drug Status

Prescription-type:

Valid as a prescribable product

Product samenvatting:

BNF: 13090000; GTIN: 3574661202808 3574661365879

Bijsluiter

DANGER EXTREMELY
FLAMMABLE AEROSOL
SCALP FOAM
5% W/W CUTANEOUS FOAM
MINOXIDIL
Once-a-Day
Foam For Women
O N C E A D AY
_FOR WOMEN_
EX70015
69.85MM
139.7MM
130.2MM
69.85MM
OBC
OFC
69.85MM
139.7MM
130.2MM
69.85MM
OBC
OFC
36112N1_1
PROJECT NO.
BRAND
DESCRIPTION
MARKETS/LANGUAGES
PRODUCT TYPE
PRINTER
PRINTING TECHNIQUE
PLANT
LABEL ID
SUBSTRATE
TECHNICAL SPEC
STARFISH ID:
CELL SIZE
SILENT ZONE
SIZE
SYMBOL TYPE
BARCODE TYPE
CODE
BWR
MAGNIFICATION
HEIGHT
DIELINE REF
ARTWORK SIZE (W)
JONHR0282AE
EX70015
V03
ARTWORK SIZE (H)
FILENAME:
DATE: 05-APR-18
OPERATOR NAME:
Regaine
Womens 5% Foam Leaflet Shared GB
GB
Leaflet
Sparndruck
Offset
ASM
-
White Paper
PC-025169
David Alston
1mm x 1mm
16mm x 16mm
12mm x 12mm
12 by 12
-
-
-
-
-
-
139.700 mm
130.200mm
205006
AW CO-ORDINATOR:
Mickey Sandhu
COMPONENT CODE:
EUROCODE
9202500_9202400
PANTONE 312 C
150lpi 0degrees
PANTONE 185 C
150lpi 0degrees
PANTONE 7657 C
150lpi 0degrees
Black
150lpi 0degrees
Varnish
150lpi 0degrees
ARTWORK TYPE
CHANGE AW DRIVER
2 in 1
Local Market Change
t: [phone] w: www.starfishbrandsolutions.com
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 6_
4 POSSIBLE SIDE-EFFECTS _page 9_
5 HOW TO STORE THIS MEDICINE _page 11_
6 CONTENTS OF THE PACK AND OTHER
INFORMATION _page 11_
Now read all of this leaflet carefully before you start using
this medicine because it contains important information
for you. Keep this leaflet. You may need to read it again.
1
■
■
■
■
■
■
This medicine is used to treat female pattern hair
loss in women aged 18 – 65 years.
This product should ONLY be used ONCE A DAY.
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 _c
FOLLOW THE INSTRUCTIONS ON HOW TO USE THIS
PRODUCT CAREFULLY. _See section 3 _c
THIS MEDICINE IS FOR EXTERNAL USE ONLY AND SHOULD
ONLY BE APPLIED TO YOUR SCALP. _See section 3 _c
THIS PRODUCT

Productkenmerken

OBJECT 1
REGAINE FOR WOMEN ONCE A DAY SCALP FOAM 5%
W/W CUTANEOUS FOAM
Summary of Product Characteristics Updated 19-Jun-2018 | McNeil
Products Ltd
1. Name of the medicinal product
Regaine for Women Once a Day 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
This product is indicated for the treatment of alopecia androgenetica
in women (also known as female
pattern hair loss) 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 the product, 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 this product. A dose of 1 g
(equivalent to the volume of half a capful) of this product should be
applied to the total affected areas of
the scalp once daily. The total daily dosage should not exceed 1 g.
It may take once-daily applications for 12 to 24 weeks before evidence
of hair growth can be expected.
Users should discontinue treatment if there is no improvement seen
after 24 weeks.
If hair regrowth occurs, once daily applications of this product are
necessary for continued hair growth.
Clinical Trials have not investigated the efficacy of this product
beyond 24 weeks. Further secondary
results and safety were assessed up to 52 weeks (see section 5.1).
SPECIAL POPULATIONS
There are no specific recommendations for use in older people or in
patients with renal or hepatic
impairment.
PAEDIATRIC POPULATION
Not recommended. The safety and effectiveness of this product in
child