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REGAINE FOR WOMEN ONCE A DAY SCALP FOAM 5% W/W CUTANEOUS FOAM

Active substance(s): MINOXIDIL

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69.85mm

FOR WOMEN

O N C E A DAY

130.2mm

Regaine® for Women ONCE A DAY Scalp Foam
Minoxidil 5%
■ 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 is extremely flammable and should be
used and disposed of carefully. See Special Warning
Relating to Regaine® for Women ONCE A DAY Scalp
Foam. See section 2 c

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 8
5 How to store this medicine page 10
6 Contents of the pack and other
information page 10
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.

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1 What the medicine is and
what it is used for
Regaine® for Women ONCE A DAY Scalp Foam is a
medicine used to treat common female pattern hair
loss in women aged 18 – 65 years, by preventing
further hair loss and helping hair re-growth. It contains
minoxidil, which is thought to work by aiding the
blood flow to the hair follicles on your scalp.
■ The medicine is for use in women aged
between 18 and 65 years.
■ Regaine® for Women ONCE A DAY Scalp
Foam works best in women who have general
hair thinning of the scalp.
■ Those who are younger or have been losing
hair for a short period of time are likely to
experience the best results.
■ You are unlikely to benefit from Regaine® for
Women ONCE A DAY Scalp Foam if you have
been balding/thinning 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 are present with your
hair loss.

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2 What you need to know
before you use this medicine
This medicine is suitable for most people but a few
people should not use it. If you are in any doubt, talk
to your doctor or pharmacist.

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X Do not use this medicine…
■ If you are male.
■ More than ONCE A DAY.
■ If you are under the age of 18 or over the age
of 65.
■ If you are pregnant or breast-feeding.
■ If you have had a bad reaction to minoxidil or
any of the other ingredients.
■ If you have hair loss caused by drug treatment.
■ If you have total baldness or complete loss of
all body hair.
■ If the cause of your hair loss is unknown, is due
to childbirth, or it is sudden and unexpected.
■ If you have high blood pressure, even if it is not
being treated.
■ If you have any condition that affects your
scalp, including sunburn and psoriasis.
■ If you have a shaved scalp.
■ If you are using creams, ointments or lotions
used to treat scalp conditions, e.g.
■ Dithranol – used to treat psoriasis.
■ Tretinoin – used to treat acne or other skin
disorders.
■ Corticosteroids – a type of anti-inflammatory
■ Petrolatum - a common ingredient in hair
wax or gel.
■ If you have any kind of dressing or bandage on
your scalp.
■ Unless you know that your scalp is normal and
healthy.
If any of these bullet points apply now or in the past,
get advice from a doctor or pharmacist before using
Regaine®.

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Talk to your doctor or pharmacist…

!

If you are pregnant or breast-feeding:

■ If you are at all unsure whether your scalp is
normal and healthy.
■ If you suffer from heart disease, including
abnormal heart rhythms or rates, angina or
chest pains and / or circulation disorders.
■ If you are taking or using any other
medicines including:
■ Certain blood pressure medicines called
‘vasodilators’ e.g. hydrazaline. There is a
potential risk that minoxidil, the active
ingredient in Regaine® for Women ONCE
A DAY may interact with these medicines
and increase their effect.
If you are not sure about the medicine
you are taking or using, show the bottle or
pack to your pharmacist.
If any of these bullet points apply now or in the past,
talk to a doctor or pharmacist.

!

■ This product should NOT be used if you are
pregnant or breast-feeding.

Some of the ingredients can cause
problems
■ Regaine® for Women ONCE A DAY Scalp Foam
5% w/w Cutaneous Foam contains ethanol
(alcohol), which will cause burning and irritation
if you get it in the eye. If you get Regaine® for
Women ONCE A DAY Scalp Foam 5% w/w
Cutaneous Foam in your eye, mouth or on a cut
or damaged skin, wash the area well with lots
of cool tap water.
■ Cetyl alcohol or stearyl alcohol may cause local
skin reactions (e.g. contact dermatitis).
■ Butylated hydroxytoluene (E321) may cause
local skin reactions (e.g. contact dermatitis),
or irritation to the eyes and mucous membranes.

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Special warnings relating to Regaine®
for Women ONCE A DAY Scalp Foam
5% w/w Cutaneous Foam
■ If minoxidil passes into the blood stream it can
cause some side-effects related to low blood
pressure such as chest pain, rapid heart beat,
faintness, dizziness, swollen hands and feet,
persistent redness or irritation of the scalp.
If you experience any of these side-effects, stop
using the medicine and tell your doctor.
When Regaine® for Women ONCE A DAY Scalp
Foam 5% w/w Cutaneous Foam is used as
recommended, it is extremely unlikely that these
effects will occur. However there is a chance
the drug could get into the blood stream if it is over
used or if there is a scalp condition such as
psoriasis present. Therefore it is very important
that you use your medicine as recommended and
follow the instructions very carefully. See section 3 c
■ Avoid contact with the eyes, mouth, broken skin
and sensitive areas. If the foam is accidentally
applied to areas of the body other than the scalp,
rinse thoroughly with plenty of water.
■ Do not apply to areas of the body other than
the scalp.
■ Exceeding the recommended dose will NOT
re-grow your hair any more quickly and you have
an increased likelihood of getting side-effects.

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3 How to use this medicine
Regaine® for Women ONCE A DAY Scalp Foam 5% w/w
Cutaneous Foam is for topical and external use only.
It should only be applied directly to the scalp area.
■ Do not apply to areas of the body other than the scalp.
■ Wash your hands thoroughly before and after applying
the foam and rinse other areas that have come into
contact with the foam.
■ Make sure your hair and scalp are completely dry
before applying the foam.
■ To open container: Match arrow on can ring with
arrow on cap. Pull off cap.
■ Hold the can upside down and press nozzle to
dispense the foam onto your fingers. The total amount
of foam applied should not exceed 1 g (equivalent to
the volume of half a capful).
■ The foam may begin to melt on contact if your
fingers are warm. Rinse your fingers in cold water
first before dispensing. Be sure to dry them
thoroughly before handling the foam.
■ Use a comb to part your hair. Remember the foam
needs to be applied to your scalp, NOT your hair.
■ As you may need to part your hair several times during
the application, you may find it convenient to dispense
the foam onto a non-absorbent surface, such as a
dish or saucer. The total amount of foam applied
should not exceed half a cap.
■ Within your hair thinning areas, make a centre parting
to help maximise scalp exposure. Part your hair at
least 2 more times on each side of the centre parting.
■ Using your fingertips, spread just enough foam over
the hair loss areas and gently massage the foam into
the scalp starting from the back to front (forehead)
direction. Use until all the foam is gone.
■ After each use, thoroughly clean and dry the dish or
saucer if used.
■ Wash your hands well with soap and water after
applying the foam.
■ Allow the foam to dry completely, especially if applied
before going to bed.
■ To close container: place cap on container and snap
into place. Make sure that the arrows do not line up so
that the cap remains child-resistant.

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1

2

OPEN CONTAINER

HOLD CAN STRAIGHT
UPSIDE DOWN

3

4

USE YOUR FINGERS

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PART THE HAIR

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Daily dose for Adult Women:
Age

Dose

Female Adults
aged 18 to 65
years



On a completely dry scalp and
hair, apply a dose of 1 g
(equivalent to the volume of half
a capful) to the total affected
area once daily.
■ Do NOT apply more than ONCE
a day.
■ Do not exceed 1 g per day.
■ This product should NOT be
used by men.

Continued use of Regaine®
■ You may need to use this medicine ONCE a day
for at least 12 - 24 weeks before you see new hair
growth. This is because hair growth is a slow
process. Some women may need to use this
product for at least 24 weeks before seeing results.
■ Hair growth may be soft and downy at the start
but should eventually become the same as
normal hair.

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■ Once the hair has begun to re-grow, you need to
continue using this medicine ONCE daily for the
growth to continue.
■ Clinical trials on Regaine® Foam efficacy have not
been carried out beyond 24 weeks.
■ If at any time during your treatment you are
concerned you should consult your doctor or
pharmacist.
■ Do not use more than once a day.
■ This product should NOT be used by men.

If anyone uses too much
■ Seek immediate medical advice if anyone, including
a child, uses too much of this medicine. Take the
medicine and container with you.

If you forget to apply a dose of the
foam

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If you miss one or two applications, just carry on as
normal, as if you had not missed the dose(s) - do not
use twice as much or twice as often.

If you accidentally swallow the solution
If anyone, including a child, swallows any of the foam,
take them to a hospital immediately with the Regaine®
for Women ONCE A DAY Scalp Foam pack if possible,
as the doctor may like to have some idea of how much
they have swallowed.

4 Possible side-effects
Like all medicines, this medicine can cause side-effects,
although not everybody gets them.

If you experience any of the following,
stop using the medicine and seek
immediate medical help:
■ Chest pain.
■ Swelling of the face, lips, mouth, tongue or
throat which may cause difficulty in swallowing
or breathing.

If you experience any of the following,
stop using the medicine and talk to your
doctor:
■ Allergic reactions including swollen face, skin
redness or itching or throat tightness.

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■ Low blood pressure.
■ Fast heart beat or an increased awareness of
the heart beat (palpitations).
■ Faintness or dizziness.
■ Swollen hands or feet, shortness of
breath, high blood pressure.
■ Sudden unexplained weight gain.
■ Persistent local redness or rash.

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Other effects which may occur include:
Very common (may affect more than 1 in 10 people)
■ Headache.
Common (may affect up to 1 in 10 people)
■ Itching, dermatitis or excessive hair growth.
Uncommon (may affect up to 1 in 100 people)
■ Eye irritation.
■ Vomiting or nausea.
■ Scalp irritation such as local redness, itchiness,
dryness, flaky skin have all been reported.
This may be due to the hydroxybutylated
toluene, cetyl alcohol and/or stearyl alcohol in
the product. This is usually only a temporary
effect, but if it is persistent you should stop
using this product.
■ Acne-like rash, itchy rash, blistering, bleeding
or ulceration.
■ Unwanted non-scalp hair has occasionally been
reported. Always wash your hands thoroughly
after application and if you accidentally apply
the foam to parts of the body other than the
scalp, rinse thoroughly with plenty of water.
Allow sufficient drying time before going to bed.
■ Temporary hair loss may occur during first 2 - 6
weeks of use. This is likely to be as a result of a
change within the growth cycle and it should
stop within a couple of weeks. If this hair loss
continues for longer than 2 weeks, stop using
the product and talk to your doctor.
■ Change in hair colour and/or texture may occur.
If this happens you should stop using Regaine®.

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If you experience any side-effects talk to your doctor,
pharmacist or nurse. This includes any possible
side-effects not listed in this leaflet. You can also report
side-effect directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard. By reporting side-effects,
you can help provide more information on the safety of
this medicine.

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5 How to store the
medicine
Keep out of the sight and reach of children.
Do not store above 25°C.
Do not use after the expiry date on the base of the can.
The product in this pressurised container is extremely
flammable, therefore you should keep it away from
heat, hot surfaces, sparks, open flames and other
ignition sources. No smoking. Do not spray
on an open flame or other ignition source.
Do not pierce or burn, even after use.
Keep out of reach of children. Protect from
sunlight. Do not expose to temperatures
exceeding 50°C.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose
of medicines no longer required. These measures will
help to protect the environment.

6 Contents of the pack and
other information
What this medicine contains
The active substance in 1 g of Regaine® is minoxidil 50 mg.
Other ingredients are: ethanol anhydrous, purified water,
butylated hydroxytoluene (E321), lactic acid anhydrous,
glycerol, cetyl alcohol, stearyl alcohol, polysorbate 60,
propane, butane, isobutane.

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What the medicine looks like
Regaine® for Women ONCE A DAY Scalp Foam 5%
w/w Cutaneous Foam is a foam contained in a 73 ml
(equivalent to 60 g) can, enough for 2 months of
treatment. Packs contain 1 or 2 cans.

Product Licence holder:
McNeil Products Ltd, Maidenhead, Berkshire,
SL6 3UG, UK.
Manufacturer:
Janssen-Cilag.
Domaine de Maigremont, 27100, Val de Reuill,
France

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This leaflet was prepared January 2016.
Regaine® is a registered trade mark.

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FURTHER INFORMATION ABOUT
REGAINE® FOR WOMEN ONCE A DAY
SCALP FOAM

Q If my hair growth is restored using Regaine® for
Women ONCE A DAY Scalp foam, what will the new
hair look like?
A If you respond to treatment, your initial re-growth
may at first be soft, downy (“vellus”) hair and may be
barely visible.
After further treatment, your re-growth may change
and become the same colour and thickness as the
rest of your hair.
Q Is shampooing necessary before applying Regaine®
for Women ONCE A DAY Scalp Foam?
A No, but if you do choose to shampoo, we
recommend the use of a shampoo, with a gentle
cleansing and conditioning action that does not
impede the absorption of Regaine® for Women
ONCE A DAY Scalp Foam.

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Q Can I use a hair dryer with Regaine® for Women
ONCE A DAY Scalp Foam?
A Yes, but not to dry the foam itself.

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Q Can I use common hair styling preparations such as
hair gels or hair sprays while using Regaine® for
Women ONCE A DAY Scalp Foam?
A Yes, but Regaine® for Women ONCE A DAY Scalp
Foam should be applied to the dry scalp before
these other preparations are applied.
Q Can I have my hair dyed?
A Yes, you may, there is no need to change your hair
care routine. However, you should tell your hair care
professional that you are using Regaine® for Women
ONCE A DAY Scalp Foam. To minimise breakage of
existing hair, just ask that any massaging of your
scalp be gentle and that a comb with widely spaced,
round teeth be used to avoid excessive pulling.
Q Can Regaine® for Women ONCE A DAY Scalp Foam
be used with a sun-blocking agent?
A No, if you are planning to be in the sun after applying
Regaine® for Women ONCE A DAY Scalp Foam, use
headwear.
Q Can I apply Regaine® for Women ONCE A DAY Scalp
Foam after swimming?
A Yes, as long as hair is dry. However, Regaine® for
Women ONCE A DAY Scalp Foam should not be
applied more than ONCE a day.
Q How long will each can of Regaine® for Women
ONCE A DAY Scalp Foam last?
A One can of Regaine® for Women ONCE A DAY Scalp
Foam should last for 60 days (2 months), if applied
ONCE a day according to the directions.
As you near the end of the 2 months’ supply, you
should plan to renew it so that you do not miss a
daily application.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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