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FREEDERM TREATMENT 4% W/W GEL

Active substance(s): NICOTINAMIDE

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PACKAGE LEAFLET Information for the user

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 TREATMENT
GEL IS AND WHAT IT IS USED FOR

Driving and using machinery
Using this product is not known to affect
your ability to drive or use machinery.

• Freederm Treatment Gel is a skin treatment
for inflamed pimples and spots.

3. HOW TO USE FREEDERM
TREATMENT GEL









• Wash the area.

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.

• Freederm Treatment Gel is suitable for use
by adults, children and the elderly.
• 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.
• Nicotinamide is not an antibiotic, it is
related to an essential vitamin in our diet
(Vitamin B3 ).

2. BEFORE YOU USE
FREEDERM TREATMENT GEL
Do not use Freederm Treatment Gel if you
are allergic (hypersensitive) to nicotinamide
or any of the other ingredients of Freederm
Treatment Gel listed in Section 6.
Take care when using this product:
• Only apply it to your skin.





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.










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).

Using other medicines
Freederm Treatment Gel is not known to affect,
or to be affected by, any other medicines.
Pregnancy and breast-feeding
There are no specific restrictions to using
Freederm Treatment Gel during pregnancy
or breast-feeding. Vitamin B derivative

For adults, children and the elderly:
Apply the gel twice daily over and around
the affected skin areas as follows:
• Gently pat the skin dry (avoid rubbing
as this may aggravate the skin).
• Apply a thin film of gel, and gently
massage it in.
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
in 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.
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.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Although Freederm Treatment 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.

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

201341

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

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.

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In this leaflet:

continued...

• 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 TREATMENT GEL
What Freederm Treatment Gel contains:
The active ingredient is nicotinamide
(4% w/w).
The other ingredients are
aluminium magnesium silicate, hypromellose,
citric acid anhydrous, macrogol lauryl ether,
ethanol anhydrous and purified water.
What Freederm Treatment Gel looks like
and contents of the pack
• The product is a translucent gel.
• The product is available in tubes
containing 25g 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
May 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
for your general health). Neither is it caused
by not washing properly (although a good

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





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.
• For further independent help and advice,
contact the Acne Support Group
www.stopspots.org.

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 Treatment Gel, 00173/0398.

201341

5. HOW TO STORE FREEDERM
TREATMENT GEL

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.

This is a service provided by the Royal
National Institute of Blind People (RNIB).

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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.

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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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