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NICAM 4 % W/W GEL

Active substance(s): NICOTINAMIDE

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0!#+!'%,%!&,%4Information for the user

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

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

3. HOW TO USE NICAM GEL

s Nicam Gel is a skin treatment for
inflamed pimples and spots.
s 4HEMEDICALTERMFORTHISCONDITIONIS
mild to moderate inflammatory acne
vulgaris. It involves inflamed pimples
(papules) and spots containing pus
(pustules), often with skin redness
(erythema) and some tenderness.
4HECONDITIONOCCURSMAINLYONTHE
face, back and chest.
s .
ICAM'ELISSUITABLEFORUSEBY
adults, children and the elderly.
s 4
HEactive ingredient in this product
ISNICOTINAMIDE4HISINGREDIENTTREATS
pimples and spots by its antiinflammatory activity, which reduces
swelling, redness and tenderness.
s .ICOTINAMIDEISNOTANANTIBIOTIC ITIS
related to an essential vitamin in our
diet (Vitamin B3.)

2. BEFORE YOU USE NICAM GEL
Do not use Nicam Gel if you are allergic
(hypersensitive) to nicotinamide or any
of the other ingredients of Nicam Gel
listed in Section 6.
Take care when using this product:
s Only apply it to your skin.
s 7
HENUSINGITONYOURFACE KEEPIT
away from your eyes, and avoid
getting it inside your nostrils, on your
lips or inside your mouth.
s $EPENDINGONHOWSENSITIVEYOURSKIN
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
LARGERAREAS4HISISESPECIALLY
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
Nicam Gel is not known to affect, or to
be affected by, any other medicines.
Pregnancy and breast-feeding
4HEREARENOSPECIFICRESTRICTIONSTO
using Nicam 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.

Continue using the gel twice daily in
this way for as long as necessary, (unless
irritation occurs – see Section 4).
$EPENDINGONTHESEVERITYOFYOURACNE
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
4HEPRODUCTMAYCAUSEIRRITATIONIFITGETS
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
$ONOTWORRYIFYOUOCCASIONALLYFORGETTO
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 Nicam Gel has been specially
designed for use on all skin types
including problem skin, it can cause
side effects, although not everybody
gets them.
s /CCASIONALLY SUSCEPTIBLEINDIVIDUALS
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.
s 6ERYOCCASIONALLY 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.
Reporting of side effects
If you get any side effects, talk to your
DOCTOR PHARMACISTORNURSE4HISINCLUDES
any possible side effects not listed in this
leaflet. You can also report side effects
directly (see details below). By reporting
side effects you can help provide more
information on the safety of this medicine.

continued…
Nicam PIL XP4_14_1.indd 1

Prints: Pantone 2748

XP4/14/1 201266

1. WHAT NICAM GEL IS AND
WHAT IT IS USED FOR

For adults, children and the elderly:
Apply the gel twice daily over and
around the affected skin areas as follows:
s 7ASHTHEAREA
s 'ENTLYPATTHESKINDRYAVOIDRUBBING
as this may aggravate the skin).
s !PPLYATHINFILMOFGEL ANDGENTLY
massage it in.

05/01/2015
14:38
Flat size: 140mm
x 320mm

5. HOW TO STORE NICAM GEL
s +
EEPITOUTOFTHEREACHANDSIGHTOF
children.
s !LWAYSREPLACETHECAPTIGHTLYAFTERUSE
s $ONOTSTORETHEPRODUCTABOVEª#
s $ONOTUSEAFTERTHEEXPIRYDATESHOWN
ONTHETUBEANDCARTON4HEEXPIRY
date refers to the last day of that month.
s EDICINESSHOULDNOTBEDISPOSEDOF
via wastewater or household waste.
Ask your pharmacist how to dispose
of medicines no longer required.
4HESEMEASURESWILLHELPTOPROTECT
the environment.

6. FURTHER INFORMATION
ABOUT NICAM GEL
What Nicam Gel contains:
4HEactive ingredient is nicotinamide
(4% w/w).
4HEother ingredients are aluminium
magnesium silicate, hypromellose, citric
acid anhydrous, macrogol lauryl ether,
ethanol anhydrous and purified water.
What Nicam Gel looks like and
contents of the pack
s 4HEPRODUCTISATRANSLUCENTGEL
s 4
HEPRODUCTISAVAILABLEINTUBES
containing 60g of gel.
The Marketing Authorisation holder is
$ERMAL,ABORATORIES 4ATMORE0LACE
Gosmore, Hitchin, Hertfordshire,
SG4 7QR, UK.
The Manufacturer is Aeropak Ltd,
Viking Road, Gapton Hall Industrial Estate,
Great Yarmouth, Norfolk, NR31 0NU.
This leaflet was last revised in
$ECEMBER

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
INADULTS4HEEARLYSTAGESOFACNEOFTEN
involve blackheads and whiteheads
(doctors refer to these as ‘comedones’).
4HESECANDEVELOPINTOREDORINFLAMED
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 skin care
routine is an important part of treatment).

Nicam PIL XP4_14_1.indd 2

4HEEXACTCAUSEOFACNEISNOTFULLY
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.
4HISPROCESSRELEASESCHEMICALSTHAT
cause inflammation in the surrounding
skin, and leads to redness and the
formation of ‘angry’ or inflamed-looking
PIMPLESANDSPOTS4HESEFEELSORE
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.
Important tips when treating acne
s 4
AKECARETOCLEANSEYOURSKIN
thoroughly and regularly, but try not
to clean too aggressively as this can
make matters worse.
s ANYACNEPATIENTSFINDTHEIRSKIN
becomes excessively dry. If this happens,
ask your doctor or a pharmacist about
suitable skin moisturisers.
s #AREFULLYFOLLOWTHEINSTRUCTIONS
supplied with any medication you are
using, as this will give you the best
chance of clearing your condition.
s 7
HENUSINGTREATMENTSAPPLIEDTOTHE
skin, you will need to treat all the involved
skin area, not just each individual spot.
s 4RYTOAVOIDPICKINGORSEVERELYSQUEEZING
your spots because this can make
matters worse and lead to scarring.
s 0
ERSEVEREWITHTREATMENTBECAUSEIT
can take several weeks for the skin’s
normal repair process to work.
s &ORFURTHERINDEPENDENTHELPAND
advice contact the Acne Support
Group www.stopspots.org.
Surface
of skin
Bacteria
act upon
the sebum
releasing
chemicals
that cause
inflammation

Sticky Plug
Papule/
Pustule

Pus collects
in hair follicle

4OLISTENTOORREQUESTACOPYOFTHIS
leaflet in Braille, large print or audio,
PLEASECALLFREEOFCHARGE
(UK only).
Please be ready to give the following
information: Nicam Gel, 00173/0166.
4HISISASERVICEPROVIDEDBYTHE2OYAL
National Institute of Blind People (RNIB).

Prints: Pantone 2748

XP4/14/1 201266

United Kingdom
Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance, Earlsfort
4ERRACE )2, $UBLIN4EL 
&AX 7EBSITE
WWWHPRAIE% MAILMEDSAFETY HPRAIE

Flat size: 140mm
x 320mm
05/01/2015
14:38

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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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