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

البلد: مالطا

اللغة: الإنجليزية

المصدر: Medicines Authority

متاح من:

JNTL Consumer Health I (Ireland) Limited Block 5, High Street, Tallaght, Dublin 24, , Ireland

ATC رمز:

D11AX01

INN (الاسم الدولي):

MINOXIDIL 50 mg/g

الشكل الصيدلاني:

CUTANEOUS FOAM

تركيب:

MINOXIDIL 50 mg/g

نوع الوصفة الطبية :

OTC

المجال العلاجي:

OTHER DERMATOLOGICAL PREPARATIONS

الوضع إذن:

Authorised

تاريخ الترخيص:

2013-09-27

نشرة المعلومات

Danger
Extremely
Flammable
Aerosol
FOR MEN
SCALP FOAM
5% W/W CUTANEOUS FOAM
MINOXIDIL
PATIENT INFORMATION
LEAFLET
EXTRA STRENGTH
EX00380
SMALLEST TEXT SIZE
AVE. TEXT SIZE
LARGEST TEXT SIZE
FONTS USED
Avenir-Black
Avenir-Heavy
Avenir-Light
Avenir-Medium
Avenir-Roman
3.50 pt
6 pt
8.53 pt
ARTWORKS ID
LANGUAGES
JOB / VERSION NO. DATE
PROJECT NAME / DESIGN
NEW COMPONENT / ITEM CODE
OLD COMPONENT / ITEM CODE
PRODUCT / EUROCODE / MAT. ID CODE
PANTONE
877 C
LITHO OFFSET
PANTONE
299 C
LITHO OFFSET
PANTONE
293 C
LITHO OFFSET
PANTONE
185 C
LITHO OFFSET
BLACK
LITHO OFFSET
VARNISH
-
IE Regaine Men Foam 5pc 1x60ml & 3x60ml
REPRESENTATION: Colours represented with a diagonal line have been
modified to aid PDF approval.
EX00380
EX00325
2822204 2822104
EMEA_2023_00083928_002
English
403497961_r0
CHILD
06-11-2023
MANUFACTURING SITE
REFERENCE
TECHNICAL CODE
SUBSTRATE
PC-SPEC
PC-028900_EX60066 / PC-038186_EX60075
WHITE
EX00380
N/A
TECHNICAL DETAILS
30-08-2023
PLANT
MASTER DIELINE
COMPONENT
DIMENSIONS
50.8 x 139.7 mm
Booklet
ASM
Print & Varnish Free
Braille Grid
Profile
Text Limit
Bleed
Fold/Technical
Tamper Evident Label Area
Varnish Free
Print Free
Stamping Area
Perforation
Coding (Silent Zone)
DATE
JJEXT_00059_V2
Seal Area
- 1 -
PACKAGE LEAFLET: INFORMATION FOR THE USER
REGAINE
® FOR MEN
EXTRA STRENGTH
SCALP FOAM 5% W/W
CUTANEOUS FOAM
MINOXIDIL
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START 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 4 months.
WHAT IS IN THIS LEAFLET
1.
What Regaine
®
Foam is and what it is
used for
2.
What you need to know before
you use Regaine
�

خصائص المنتج

Page
1
of
9
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Regaine for Men Extra Strength 5% w/w Scalp Foam 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 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 in adult men
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Regaine is for topical 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. For men aged 18
years or above a dose of 1 g (equivalent to the volume of half a
capful) of Regaine should be
applied to the total affected areas of the scalp twice daily (once in
the morning and once in the
evening). The maximum total daily recommended dose of topical
minoxidil in men is 100mg,
administered as up to 2 g foam per day.
Duration of use
It may take twice-daily applications for 2 to 4 months before evidence
of hair growth can be
expected. Users should discontinue use if there is no improvement seen
after 4 months.
If hair regrowth occurs, twice daily applications of Regaine are
necessary for continued hair growth.
SPECIAL POPULATIONS
There are no specific recommendations for use in elderly patients or
in patients with renal or hepatic
impairment.
Page
2
of
9
PEDIATRIC POPULATION
Regaine 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 the
hand. Spread with fingertips
over entire bald area. Hands should be washed thoroughly after
application.
4.3
CONTRAINDICATIONS
Hypersensitivity to min