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

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Minoxidil

Available from:

McNeil Healthcare (Ireland) Ltd

ATC code:

D11AX; D11AX01

INN (International Name):

Minoxidil

Dosage:

5 percent weight/weight

Pharmaceutical form:

Cutaneous foam

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Other dermatologicals; minoxidil

Authorization status:

Marketed

Authorization date:

2012-08-03

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 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 weight gain or
swollen hands and feet. It can also cause persistent redness or
irritation of the scalp. If you experience
any of these side effects stop using the medicine

Summary of Product characteristics

Health Products Regulatory Authority
10 October 2018
CRN008JND
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Regaine for Men 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 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
Health Products Regulatory Authority
10 October 2018
CRN008JND
Page 2 of 14
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.
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 ba