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

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

MINOXIDIL

Available from:

Johnson & Johnson (Ireland) Limited Airton Road Tallaght, Dublin 24, Dublin, Ireland

ATC code:

D11AX01

INN (International Name):

MINOXIDIL 50 mg/g

Pharmaceutical form:

CUTANEOUS FOAM

Composition:

MINOXIDIL 50 mg/g

Prescription type:

OTC

Therapeutic area:

OTHER DERMATOLOGICAL PREPARATIONS

Authorization status:

Authorised

Authorization date:

2013-09-27

Patient Information leaflet

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 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 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 Foam
3.
How to use Regaine Foam
4.
Possible side effects
5.
How to store Regaine Foam
6.
Content of the pack and other information
1. WHAT REGAINE FOAM IS AND WHAT IT IS USED FOR
Regaine contains minoxidil. Minoxidil regrows hair and stabilizes hair
loss in men with a receding
hairline and crown balding by revitalization of hair follicles.
Regaine is used to treat men with common hereditary hair loss (also
called androgenetic alopecia). It
is to be used only on the scalp (head)
2. WHAT YOU NEED TO KNOW BEFORE YOU USE REGAINE FOAM
DO NOT USE REGAINE FOAM 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 pharmacist before using Regaine Foam
-
If you suffer from heart disease including abnormal heart rhythms or
rates, angina or chest
pains and/or circulation disorders.
-
When minoxidil passes into the blood stream it can cause some
side-effects related to low
blood pressure such as chest pain, rapid heartbeat, faintness,
dizziness, sudden unexplained
Document ID:
Version:
Status:
1.0
J0449565
Approved
weight gain or swollen hands and feet. It can also cause persistent
redness or irritation of the
scalp. If you ex

Summary of Product characteristics

Version 2, Draft
SNAS 2245
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 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
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2
of
10
There are no specific recommendations for use in elderly patients or
in patients with renal or hepatic
impairment.
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 minox