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REGAINE FOR WOMEN REGULAR STRENGTH

Active substance(s): MINOXIDIL

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IFC

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PATIENT
INFORMATION LEAFLET

EX50091

®

for WOMEN

REGULAR STRENGTH
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Minoxidil 2% Scalp Solution

CUTANEOUS
SOLUTION TO BE
APPLIED TO THE SCALP
TREATS THINNING HAIR
PREVENTS
FURTHER
HAIR LOSS AND
REGROWS HAIR

Warning
Flammable Liquid

PROJECT No.
ARTWORK TYPE
CHANGE AW DRIVER
BRAND
DESCRIPTION
MARKETS/LANGUAGES
PRODUCT TYPE
PRINTER
PRINTING TECHNIQUE
PLANT
LABEL ID
SUBSTRATE
TECHNICAL SPEC

3121S2
Standard
CCDS without redesign
Regaine
Regaine 2% Sol 1*60 Leaflet UK
GB
Leaflet
Sparn Druck
offset
ASM
white paper
PC-025169

DATE: 17-Feb-16

v02

Black
150lpi 82.5degrees

PANTONE 877 C
150lpi 45degrees

Varnish
150lpi 45degrees

PANTONE 2562

PANTONE 528
150lpi 45degrees

DIELINE
150lpi 45degrees

AW CO-ORDINATOR: 150lpi 45degrees
Mickey Sandhu
OPERATOR NAME:
Liz Mathews

PANTONE 2425 C
150lpi 45degrees

STARFISH ID: 178241
FILENAME: JONHR0314AA

PANTONE 185 C
150lpi 45degrees

COMPONENT CODE: EX50091
EUROCODE 6739905

CELL SIZE
SILENT ZONE
SIZE
SYMBOL TYPE
BARCODE TYPE
CODE
BWR
MAGNIFICATION
HEIGHT
DIELINE REF
ARTWORK SIZE (w)
ARTWORK SIZE (h)

1mm
16mm x16mm
12mm x 12mm
12 by12
139.700 mm
130.200mm

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IBC
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69.85mm

FOR WOMEN
RE GULAR S T R E N GT H

130.2mm

minoxidil 2% scalp solution
cutaneous solution to be applied to the scalp
■ This medicine is used to treat hereditary hair loss in
women aged 18 – 65 years.
■ 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
■ There are 2 different ways you can apply this
product, choose the best option for you and
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 flammable and should be used and
disposed of carefully. See Special Warnings Relating
to Regaine for Women Regular Strength. 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 5
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 the leaflet: you may need to
read it again.

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69.85mm

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1 What the medicine is
and what it is used for
Regaine for Women Regular Strength is a medicine
used to treat common hereditary 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 Regular Strength 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 Regular Strength 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 pregnant or breast-feeding.
■ If you are under the age of 18 or over the age
of 65.
■ If you have had a bad reaction to minoxidil,
ethanol, or propylene glycol.
■ If you are not sure whether your hair loss is
hereditary.
■ 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 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 to you now or in the
past, get advice from a doctor or pharmacist before
using Regaine for Women Regular Strength.

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!

Talk to your doctor or pharmacist…

!

If you are pregnant or breast-feeding:

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■ 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 Regular
Strength, 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 to you 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
■ Proplylene glycol may cause skin irritation.
■ Regaine for Women Regular Strength contains
ethanol (alcohol) which will cause burning and
irritation if you get it in the eye. If you get
Regaine for Women Regular Strength in your
eye, mouth or on a cut or damaged skin, wash
the area well with lots of cool tap water.

!

Special warnings relating to Regaine
for Women Regular Strength
■ 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.

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When Regaine for Women Regular Strength 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
Warning Flammable Liquid. Keep away from
heat/sparks/open flames/ hot surfaces - No
smoking. Avoid exposure of the container
and contents to naked flames during use,
storage and disposal. Keep container tightly
closed. Store in well-ventilated place. Keep cool.
Avoid contact with the eyes, mouth, broken skin
and sensitive areas. If the solution 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.
Accidental ingestion may cause serious cardiac
adverse events. Therefore this product has to be
kept out of the reach of children.

3 How to use this medicine
Regaine for Women Regular Strength is for topical and
external use only. It should only be applied directly to the
scalp area.
■ Avoid breathing in the spray whilst applying to the scalp.
■ Do not apply to areas of the body other than the scalp.
■ Wash your hands thoroughly before and after
applying the solution and rinse other areas that
have come into contact with the solution.
■ Make sure your hair and scalp are completely dry
before applying the solution.
■ Choose an appropriate applicator to apply the
medicine (see ‘Which applicator to use?’).
Each applicator is designed to accurately release a
1 ml dose when used as described.

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Daily dose for Adult Women:
Age

Dose

On a completely dry scalp and
hair, apply a 1 ml dose to the
total affected area twice daily
using the best applicator for you.
■ The solution should be
massaged lightly into the
scalp after application.
■ Leave at least 12 hours between each use.
■ Do not exceed 2 ml in a day.
■ Do not use more than twice a day.

Female Adults
aged 18 to 65
years



Continued use of Regaine

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Which applicator to use

130.2mm

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■ You may need to use this medicine twice daily for
at least 4 months before you see new hair growth,
this is because hair growth is a slow process.
■ Hair growth may be soft and downy at the start
but should eventually become the same as
normal hair.
■ Once the hair has begun to re-grow, you need to
continue using this medicine twice a day for the
growth to continue. In clinical trials 3 out of every
5 women reported hair re-growth after 8 months
of continual use of this product.
■ When you stop using the medicine, the hair that
has re-grown may disappear after 3-4 months and
the balding / hair loss process will continue.
■ If you have no improvement in your hair growth
after one year of use, you should discontinue
treatment.
■ If at any time during your treatment you are
concerned you should consult your doctor or
pharmacist.

The way you apply the solution to your scalp depends
on the amount of baldness / thinning you have and
the type of applicator you use (see the options and
diagrams following). Choose which option is best
for you.

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Option 1 - Pump spray Applicator

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1. This applicator works best for applying the solution
to large areas of the scalp.
2. Remove large outer cap and put it to one side;
remove smaller inner cap and throw it away.
3. Insert the spray applicator into the bottle and screw
on firmly.

4. After aiming the pump toward the centre of the
bald area of the scalp, press the pump once and
spread the solution with fingertips to cover all
the bald area. Repeat a further 5 times. Avoid
breathing spray mist. Place outer cap back on
bottle when not in use.
5. The total of 6 sprays will deliver the 1 ml dose of
minoxidil that is required.
6. Wash your hands and any other areas other than
your scalp which may have come in contact with
this medicine.

Option 2 - Extended Spray-tip Applicator
1. This applicator works best for applying the solution
to small areas of the scalp, or under hair.

2. The pump spray applicator must be on the bottle
to use the extended tip applicator. Follow steps
2 and 3 for the pump spray applicator first.
3. Then remove small spray head from top of pump
spray applicator; fit the extended spray-tip

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applicator onto the spray shaft and push down
firmly. Remove the small cap on the end of the
extended tip and put to one side.
4. After aiming the applicator toward the centre of
the bald area of the scalp, press the pump once
and spread the solution with fingertips to cover
all of the bald area. Repeat a further 5 times.
Avoid breathing spray mist. Replace the small
cap of extended tip when not in use.
5. The total of 6 sprays will deliver the 1 ml dose of
minoxidil that is required.
6. Wash your hands and any other areas other than
your scalp which may have come in contact with
this medicine.

If anyone uses too much

130.2mm

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
solution

If you miss one or two applications just carry on as
normal as if you had not missed the dose - 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
solution, take them to a hospital immediately (with
Regaine for Women Regular Strength bottle 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.

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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.
■ 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.
■ Sudden unexplained weight gain.
■ Persistent local redness or rash.

130.2mm

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, dryness,
flaky skin have all been reported. This may be
due to propylene glycol 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 been reported
(including facial hair growth in women). Always
wash your hands thoroughly after application
and if you accidentally apply the solution to
parts of the body other than the scalp, rinse
thoroughly with plenty of water.
■ Temporary hair loss may occur during the 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.

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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-effects directly via the Yellow Card
Scheme at www.mhra.gov.uk/yellowcard.
And in Malta directly via ADR Reporting,
The Medicines Authority, Post-Licensing Directorate,
3L]LS9\L+(YNLUZ.ǎ9.ǏPYH
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt
By reporting side-effects, you can help provide more
information on the safety of this medicine.

130.2mm

5 How to store this 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 box.
Warning Flammable Liquid. Keep away from
heat/sparks/open flames/ hot surfaces - No smoking.
Avoid exposure of the container and contents to naked
flames during use, storage and disposal. Keep container
tightly closed. Store in well-ventilated place. Keep cool.
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 protect the environment.

6 Contents of the pack
and other information
What this medicine contains
The active substance in 1 ml of Regaine for
Women Regular Strength is Minoxidil 20 mg.
Other ingredients are: ethanol (alcohol), propylene
glycol and water.

What the medicine looks like
Regaine for Women Regular Strength is a solution
contained in a 60 ml bottle, enough for 1 month of

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treatment. Packs contain 1 bottle, a pump spray
applicator and spray-tip applicator.
The pump spray and extended spray-tip applicators
are CE registered components (CE 0120).
The legal manufacturer is: ASM, Aerosol-Service AG,
Industriestrasse 11, 4313 Möhlin, Switzerland.
Product Licence holder: McNeil Products Ltd,
Maidenhead, Berkshire, SL6 3UG, UK.
Manufacturer: Janssen-Cilag,
Domaine de Maigremont, 27100 Val de Reuil, France.
This leaflet was revised February 2016.
Regaine is a registered trade mark.

130.2mm

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FURTHER INFORMATION ABOUT
REGAINE FOR WOMEN REGULAR
STRENGTH

Q If my hair growth is restored using Regaine for
Women Regular Strength, 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 hair
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 Regular Strength?
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
Regular Strength.
Q If I do shampoo, how long must I wait before
applying Regaine for Women Regular Strength?
A To be sure the scalp is thoroughly dry, it is
recommended that Regaine for Women Regular
Strength be applied one hour after shampooing.
Q Can I use a hair dryer with Regaine for Women
Regular Strength?
A Yes, but not to dry the solution itself.

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69.85mm

Q Can I use common hair styling products such as
hair gels or hair sprays while using Regaine for
Women Regular Strength?
A Most hair gels and hair sprays are ok to use with
Regaine for Women Regular Strength. However if
they contain petrolatum (petroleum jelly) they
should not be used. If you do use hair products
with Regaine for Women Regular Strength make
sure you apply to a dry scalp before applying any
other products.
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
Regular Strength. 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 Regular Strength be used
with a sun-blocking agent?
A No. if you are planning to be in the sun after applying
Regaine for Women Regular Strength, use headwear.
Q Can I apply Regaine for Women Regular Strength
after swimming?
A Yes, as long as hair is dry. However, Regaine for
Women Regular Strength should not be applied
more frequently than twice daily.
Q How long will each bottle of Regaine for Women
Regular Strength last?
A One bottle of Regaine for Women Regular Strength
should last for 30 days (one month), if applied
twice a day according to directions. As you near
the end of a month's supply, you should plan to
renew it so that you do not miss a daily application.
Q Why do boxes always include new applicators?
Why not make refills available?
A Each pack comes with new applicators. So you
can be assured that the metering device is always
delivering the correct amount of solution and that it
has not become clogged of damaged over time.

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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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