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FREEDERM GEL

Active substance(s): NICOTINAMIDE

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PACKAGE LEAFLET Information for the user

nicotinamide 4% w/w
Please read all of this leaflet carefully before using this product.
Keep this leaflet. You may need to read it again.
Ask your doctor or pharmacist if you need more information or advice.

1. What Freederm Gel is and what
it is used for
2. Before you use Freederm Gel
3. How to use Freederm Gel
4. Possible side effects
5. How to store Freederm Gel
6. Further information

1. WHAT FREEDERM GEL IS
AND WHAT IT IS USED FOR
• Freederm Gel is a skin treatment for
inflamed pimples and spots.
• The medical term for this condition is mild
to moderate inflammatory acne vulgaris.
It involves inflamed pimples (papules)
and spots containing pus (pustules), often
with skin redness (erythema) and some
tenderness. The condition occurs mainly
on the face, back and chest.

Pregnancy and breast-feeding
There are no specific restrictions to using
Freederm during pregnancy or breast-feeding.
Vitamin B derivative requirements, such as
nicotinamide, are increased during pregnancy
and infancy. However, although there are no
known potential risks, as with any medicine
caution should be exercised, particularly in
the first three months of pregnancy. Ask your
doctor or pharmacist for advice before taking
any medicine.
Driving and using machinery
Using this product is not known to affect your
ability to drive or use machinery.

3. HOW TO USE FREEDERM GEL
For adults, children and the elderly:
Apply the gel twice daily over and around
the affected skin areas as follows:
• Wash the area.

• Freederm Gel is suitable for use by adults,
children and the elderly.

• Gently pat the skin dry (avoid rubbing as
this may aggravate the skin).

• The active ingredient in this product
is nicotinamide. This ingredient treats
pimples and spots by its anti-inflammatory
activity, which reduces swelling, redness
and tenderness.

• Apply a thin film of gel, and gently
massage it in.

• Nicotinamide is not an antibiotic, it is
related to an essential vitamin in our diet
(Vitamin B3 ).

2. BEFORE YOU USE
FREEDERM GEL
Do not use Freederm Gel if you are allergic
(hypersensitive) to nicotinamide or any of
the other ingredients of Freederm Gel listed in
Section 6.

Continue using the gel twice daily in this way
for as long as necessary (unless irritation
occurs - see Section 4). Depending on the
severity of your acne, it can take several
weeks for the skin’s normal repair process
to work before you see a real improvement.
If there is no improvement within 12 weeks,
or if your condition gets worse at any stage,
ask your doctor or pharmacist for advice.

• Only apply it to your skin.

If the product gets into the eyes or mouth
The product may cause irritation if it gets into
the eyes or mouth. Rinse affected areas with
plenty of water. If rinsing one eye, take care
to avoid washing product into the other eye.
If irritation persists tell your doctor or pharmacist.

• When using it on your face, keep it away
from your eyes, and avoid getting it inside
your nostrils, on your lips or inside your
mouth.

If you forget to use this product
Do not worry if you occasionally forget to use
this product, just carry on using it when you
remember.

• Depending on how sensitive your skin
tends to be, it may be a good idea initially
to test the gel on a small area, and wait 24
hours before using it on larger areas. This
is especially advisable if you have unusually
sensitive skin or if you are treating the face
(as generally applies when using any new
treatment for the first time).

If you have any further questions on the use of
this product, ask your doctor or pharmacist.

Take care when using this product:

4. POSSIBLE SIDE EFFECTS

• If you have groups of spots that are
very inflamed and painful causing lots of
damage to your skin, you may have severe
acne. Ask your doctor or pharmacist for
advice about alternative treatments.

Although Freederm Gel has been specially
designed for use on all skin types including
problem skin, it can cause side effects,
although not everybody gets them.
• Occasionally, susceptible individuals can
experience local skin dryness. If this is
unacceptable, or causes irritation or
peeling, try applying the gel only once a
day or every other day.

Using other medicines
Freederm Gel is not known to affect, or
to be affected by, any other medicines.

• Very occasionally, allergic reactions such
as itching (pruritus), redness (erythema),
swelling or burning sensations can occur.

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In this leaflet:

continued...

The active ingredient is nicotinamide
(4% w/w).

for your general health). Neither is it caused
by not washing properly (although a good
skin care routine is an important part of
treatment). The exact cause of acne is not
fully understood, but we do know that it
involves the hair follicles in our skin and their
associated oil-producing glands (the so-called
“pilosebaceous units”). Often around the
onset of puberty, hormones stimulate
increased production of sebum (oil) by these
glands. Although normally this sebum flows
out to lubricate the skin, when too much of
it is produced it can become trapped within
the pilosebaceous units where it forms a
dark coloured plug or ‘blackhead’ where the
opening is wide, or a light coloured plug or
‘whitehead’ where the opening is narrow.
Inflammatory acne begins when a common
type of skin bacteria called P. acnes – which
is normally harmless – starts to break down
the trapped sebum. This process releases
chemicals that cause inflammation in the
surrounding skin, and leads to redness and
the formation of ‘angry’ or inflamed-looking
pimples and spots. These feel sore and
tender, frequently contain pus and eventually
burst open onto the skin before settling
down. If the inflammation is deep in the hair
duct, or if the spot is squeezed too early or
aggressively, the pus can rupture into the skin
and cause even more inflammation, and in
extreme cases can even cause scarring.

The other ingredients are
aluminium magnesium silicate, hypromellose,
citric acid, macrogol lauryl ether, ethanol and
purified water.

Important tips when treating acne
• Take care to cleanse your skin thoroughly
and regularly, but try not to clean too
aggressively as this can make matters worse.

What Freederm Gel looks like and
contents of the pack

• Many acne patients find their skin becomes
excessively dry. If this happens, ask your
doctor or a pharmacist about suitable skin
moisturisers.

Reporting of side effects
If you get 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 FREEDERM GEL
• Keep it out of the reach and sight of children.
• Always replace the cap tightly after use.
• Do not store the product above 25°C.
• Do not use after the expiry date shown on
the tube and carton. The expiry date refers
to the last day of that month.
• 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. FURTHER INFORMATION ABOUT
FREEDERM GEL
What Freederm Gel contains:

• The product is a translucent gel.
• The product is available in tubes
containing 10g of gel.
The Marketing Authorisation holder is
Diomed Developments Ltd, Tatmore Place,
Gosmore, Hitchin, Hertfordshire,
SG4 7QR, UK.
The Manufacturer is Aeropak,
Viking Road, Great Yarmouth, Norfolk,
NR31 0NU, UK.
This leaflet was last revised in
February 2015.
HEALTH EDUCATION INFORMATION
What is Acne?
Acne is a skin disorder that occurs mainly
on the face, back and chest. It affects a high
proportion of both sexes, most commonly
between the ages of 14 and 20, although
it can last well into adulthood or even
occur for the first time in adults. The early
stages of acne often involve blackheads
and whiteheads (doctors refer to these as
‘comedones’). These can develop into red or
inflamed pimples or spots (‘papules’) which
often contain pus (so-called ‘pustules’). In
a few severe cases, groups of spots may
become very inflamed and form cysts. Acne
is a very common skin complaint, affecting
about 70% of teenagers. Whether you have
just a few spots, or a hundred, it tends to be
regarded as acne.
What Causes Acne?
Acne is not caused by eating too many
sweets, chocolate or fatty foods (although
healthy eating and a healthy lifestyle is good

• Carefully follow the instructions supplied
with any medication you are using, as this
will give you the best chance of clearing
your condition.
• When using treatments applied to the skin,
you will need to treat all the involved skin
area, not just each individual spot.
• Try to avoid picking or severely squeezing
your spots because this can make matters
worse and lead to scarring.
• Persevere with treatment because it can
take several weeks for the skin’s normal
repair process to work.

To listen to or request a copy of this leaflet in
Braille, large print or audio, please call free of
charge: 0800 198 5000 (UK only).
Please be ready to give the following
information:
Freederm Gel, 00173/0187.
This is a service provided by the Royal
National Institute of Blind People (RNIB).

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Stop using this product and tell your doctor
or pharmacist if any side effect gets serious,
or you notice any other side effects not
mentioned in this leaflet.

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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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