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REGAINE FOR MEN EXTRA STRENGTH 5% CUTANEOUS SOLUTION

Active substance(s): MINOXIDIL

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EX50089

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Scalp
Solution
5% w/v
Minoxidil
Cutaneous solution

PATIENT INFORMATION LEAFLET

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

3122S2
Standard
CCDS & Yellow Card No redesign
Regaine
Regaine 5% Sol 1*60 Leaflet UK
GB
Leaflet
Sparndruck
Offset
ASM
white paper
PC-025169

DATE: 18-Feb-16

v02

Black
120lpi 82.5degrees

PANTONE 8382 C
120lpi 45degrees

PANTONE 185 C

Varnish
150lpi 45degrees

AW CO-ORDINATOR: 120lpi 45degrees
Mickey Sandhu
OPERATOR NAME:
Mike Crabb

PANTONE 300 C
120lpi 45degrees

STARFISH ID: 178237
FILENAME: JONHR0306AA

DIELINE
120lpi 45degrees

COMPONENT CODE: EX50089
EUROCODE 6741104

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

1mm
16 x 16mm
12 x 12mm
12 x 12
139.700 mm
130.200mm

scalp solution 5% w/v minoxidil
cutaneous solution to be applied to the scalp
■ This medicine is used to treat hereditary hair loss in
men aged 18 – 65 years.
■ This product is for men only and should NOT be
used by women.
■ 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 Men Extra Strength Scalp Solution
5% w/v. 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.

1

1 What the medicine is and
what it is used for
Regaine for Men Extra Strength Scalp Solution 5% w/v
is a medicine used to treat common hereditary hair loss
in men 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 only for use in men aged
between 18 and 65 years.
■ Regaine for Men Extra Strength Scalp Solution
5% w/v works best in men with hair loss or
thinning at the top of the scalp.
■ Those who are younger, have been losing hair for
a short period of time or have a small area of
baldness are likely to experience the best results.
■ You are unlikely to benefit from Regaine for
Men Extra Strength Scalp Solution 5% w/v if
you have been bald 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.

2

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.

X Do not use this medicine…

■ If you are female.
■ 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 if 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, 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 to you now or in the past,
get advice from a doctor or pharmacist before
using Regaine.

3

!

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
potential risk that minoxidil, the active
ingredient in Regaine for Men Extra Strength
Scalp Solution 5% w/v 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 is for men and should NOT be
used by women. It 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 Men Extra Strength Scalp Solution 5%
w/v contains ethanol (alcohol) which will cause
burning and irritation if you get it in the eye. If you
get Regaine for Men Extra Strength Scalp Solution
5% w/v 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
Men Extra Strength Scalp Solution 5% w/v
■ 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.

4









When Regaine for Men Extra Strength Scalp
Solution 5% w/v 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 Men Extra Strength Scalp Solution 5% w/v 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?’ over the
page). Each applicator is designed to accurately release
a 1 ml dose when used as described.

5

i

Daily dose for Adult Men:
Age

Dose

Male Adults
aged 18 to
65 years










i

i

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.
This product should NOT be used by women.

Continued use of Regaine
■ You may need to use this medicine twice daily for
at least 2 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 men reported hair re-growth after 48 weeks 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.

Which applicator to use

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 below). Choose which option is best for you.

Option 1

Option 2

6

Option 1 - Pump spray Applicator
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
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.

7

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
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
Men Extra Strength Scalp Solution 5% w/v 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.

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.

8

■ 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.

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 is should stop within a couple of weeks.
If this hair loss continues for longer than two
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.

9

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.
By reporting side-effects, you can help provide more
information on the safety of this medicine.

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 is Minoxidil 50 mg.
Other ingredients are: Ethanol (alcohol), propylene
glycol and water.

What the medicine looks like
Regaine for Men Extra Strength Scalp Solution 5% w/v
is a solution contained in a 60 ml bottle, enough for
1 month of treatment.
Packs contain 1 or 3 bottles, 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.

10

Regaine for Men Extra Strength Scalp Solution 5% w/v
is a registered trade mark.

i

FURTHER INFORMATION ABOUT
REGAINE FOR MEN EXTRA STRENGTH
SCALP SOLUTION 5% w/v

Q If my hair growth is restored using Regaine for Men
Extra Strength Scalp Solution 5% w/v, 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 Men Extra Strength Scalp Solution 5% w/v?
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 Men Extra Strength Scalp
Solution 5% w/v.
Q If I do shampoo, how long must I wait before applying
Regaine for Men Extra Strength Scalp Solution 5% w/v?
A To be sure the scalp is thoroughly dry, it is recommended
that Regaine for Men Extra Strength Scalp Solution
5% w/v be applied one hour after shampooing.
Q Can I use a hair dryer with Regaine for Men Extra
Strength Scalp Solution 5% w/v?
A Yes, but not to dry the solution itself.
Q Can I use common hair styling preparations such as
hair gels or hair sprays while using Regaine for Men
Extra Strength Scalp Solution 5% w/v?
A Yes, but Regaine for Men Extra Strength Scalp
Solution 5% w/v 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 Men Extra
Strength Scalp Solution 5% w/v. To minimise breakage
of existing hair, just ask that any massaging of your

11

scalp be gentle, and that a comb with widely spaced,
round teeth be used to avoid excessive pulling.
Q Can Regaine for Men Extra Strength Scalp Solution
5% w/v be used with a sun-blocking agent?
A No. If you are planning to be in the sun after applying
Regaine for Men Extra Strength Scalp Solution 5%
w/v, use headwear.
Q Can I apply Regaine for Men Extra Strength Scalp
Solution 5% w/v after swimming?
A Yes, as long as hair is dry. However, Regaine for Men
Extra Strength Scalp Solution 5% w/v should not be
applied more frequently than twice daily.
Q How long will each bottle of Regaine for Men Extra
Strength Scalp Solution 5% w/v last?
A One bottle of Regaine for Men Extra Strength Scalp
Solution 5% w/v 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 or damaged over time.

12

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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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