NICAM 4 % W/W GEL
Active substance(s): 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
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 4HE 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.
4HE CONDITION OCCURS MAINLY ON THE
face, back and chest.
s .ICAM 'EL IS SUITABLE FOR USE BY
adults, children and the elderly.
s 4HE active ingredient in this product
IS NICOTINAMIDE 4HIS INGREDIENT TREATS
pimples and spots by its antiinflammatory activity, which reduces
swelling, redness and tenderness.
s .ICOTINAMIDE IS NOT AN ANTIBIOTIC IT IS
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 7HEN 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.
s $EPENDING 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 4HIS 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
Nicam Gel is not known to affect, or to
be affected by, any other medicines.
Pregnancy and breast-feeding
4HERE ARE NO SPECIFIC RESTRICTIONS TO
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).
$EPENDING 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
4HE 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
$O 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
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
s /CCASIONALLY 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.
s 6ERY 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.
Reporting of side effects
If you get any side effects, talk to your
DOCTOR PHARMACIST OR NURSE 4HIS INCLUDES
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.
Nicam PIL XP4_14_1.indd 1
Prints: Pantone 2748
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 7ASH THE AREA
s 'ENTLY PAT THE SKIN DRY AVOID RUBBING
as this may aggravate the skin).
s !PPLY A THIN FILM OF GEL AND GENTLY
massage it in.
Flat size: 140mm
5. HOW TO STORE NICAM GEL
s +EEP IT OUT OF THE REACH AND SIGHT OF
s !LWAYS REPLACE THE CAP TIGHTLY AFTER USE
s $O NOT STORE THE PRODUCT ABOVE ª#
s $O NOT USE AFTER THE EXPIRY DATE SHOWN
ON THE TUBE AND CARTON 4HE EXPIRY
date refers to the last day of that month.
s -EDICINES SHOULD NOT BE DISPOSED OF
via wastewater or household waste.
Ask your pharmacist how to dispose
of medicines no longer required.
4HESE MEASURES WILL HELP TO PROTECT
6. FURTHER INFORMATION
ABOUT NICAM GEL
What Nicam Gel contains:
4HE active ingredient is nicotinamide
4HE other 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 4HE PRODUCT IS A TRANSLUCENT GEL
s 4HE PRODUCT IS AVAILABLE IN TUBES
containing 60g of gel.
The Marketing Authorisation holder is
$ERMAL ,ABORATORIES 4ATMORE 0LACE
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
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 4HE EARLY STAGES OF ACNE OFTEN
involve blackheads and whiteheads
(doctors refer to these as ‘comedones’).
4HESE 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 skin care
routine is an important part of treatment).
Nicam PIL XP4_14_1.indd 2
4HE 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.
4HIS 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 4HESE 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.
Important tips when treating acne
s 4AKE CARE TO CLEANSE YOUR SKIN
thoroughly and regularly, but try not
to clean too aggressively as this can
make matters worse.
s -ANY ACNE PATIENTS FIND THEIR SKIN
becomes excessively dry. If this happens,
ask your doctor or a pharmacist about
suitable skin moisturisers.
s #AREFULLY FOLLOW THE INSTRUCTIONS
supplied with any medication you are
using, as this will give you the best
chance of clearing your condition.
s 7HEN USING TREATMENTS APPLIED TO THE
skin, you will need to treat all the involved
skin area, not just each individual spot.
s 4RY TO AVOID PICKING OR SEVERELY SQUEEZING
your spots because this can make
matters worse and lead to scarring.
s 0ERSEVERE WITH TREATMENT BECAUSE IT
can take several weeks for the skin’s
normal repair process to work.
s &OR FURTHER INDEPENDENT HELP AND
advice contact the Acne Support
in hair follicle
4O LISTEN TO OR REQUEST A COPY OF THIS
leaflet in Braille, large print or audio,
PLEASE CALL FREE OF CHARGE
Please be ready to give the following
information: Nicam Gel, 00173/0166.
4HIS IS A SERVICE PROVIDED BY THE 2OYAL
National Institute of Blind People (RNIB).
Prints: Pantone 2748
Yellow Card Scheme at:
HPRA Pharmacovigilance, Earlsfort
4ERRACE )2, $UBLIN 4EL
WWWHPRAIE % MAIL MEDSAFETY HPRAIE
Flat size: 140mm
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.