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ATRALIN 0.05% W/W GEL

Active substance(s): TRETINOIN

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Package leaflet: information for the user

Atralin 0.05% w/w
Gel
(Tretinoin)

If you have acne rosacea – which may cause
redness of the forehead, cheeks, nose and
chin
• If you have perioral dermatitis - irritation of
the skin around the mouth.
• Do not use Atralin Gel on children under 10
years of age
If any of these apply to you, go back to your
doctor without using Atralin Gel.



Take special care with Atralin Gel:



Read all of this leaflet before you start using
this medicine.





Keep this leaflet. You may need to read it
again.
If you have any further questions, please ask
your doctor or pharmacist.
This medicine has been prescribed for you. Do
not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
If any of the side effects gets severe, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

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

1. What Atralin Gel is
and what it is used for

Atralin Gel is a medicine used on the skin for the
treatment of acne.

2. Before you use Atralin Gel
Do not use Atralin Gel:





If you are allergic (hypersensitive) to tretinoin
or to any of the other ingredients of Atralin
Gel. If you experience an allergic reaction the
first time you use Atralin Gel, do not use it
again
If you have had a skin cancer, or if any other
member of your family has had one
If you suffer from eczema – inflamed, dry, itchy,
red scaly skin





If you have sunburn or red, itchy peeling
skin, don’t use Atralin Gel on those areas until
they have fully recovered.
You must avoid too much sun when you are
using Atralin Gel. You should also avoid other
sources of UV light, such as sunbeds or
ultraviolet sunlamps. If you cannot avoid
sunlight (for example, if you work outdoors)
protect skin treated with the gel:

use a sunblock or sunscreen with a sun
protection factor (SPF) of 15 or higher

wear a broad-brimmed hat.

wear clothes over treated skin that will
protect it from the sun.
Cold and windy weather may irritate skin
treated with Atralin Gel.
You can use a moisturiser during the day,
as Atralin Gel can cause a little dryness of the
skin.
You may still use other skin products like
cosmetics during the day, but make sure that
your skin is cleaned thoroughly first before
applying Atralin Gel.

Using other medicines

Do not use harsh (astringent) skin care
products such as skin peeling products, or
products which have a strong drying effect on
the skin (for example, products which contain
a lot of alcohol).
• If you have been using other skin products
for acne (including ones you may have
bought yourself without a doctor’s prescription)
or if you have been using a skin peeling
product, allow the effects of these medicines
to wear off before starting to use Atralin Gel.
Consult your doctor before you apply any other
medicines to your skin while you are using
Atralin Gel.


Pregnancy and breast-feeding

If you are pregnant or think you may be
pregnant, do not use Atralin Gel. Using Atralin
Gel whilst pregnant may be harmful to the unborn
child. Talk to your doctor, who will discuss other
treatments.
If you are breast-feeding, tell your doctor before
treatment with Atralin Gel. You may still be able to
take this medicine if your doctor considers it
necessary.

Driving and using machines

Atralin Gel is unlikely to affect your ability to drive
or operate machinery.

Important information about some of the
ingredients of Atralin Gel

Atralin Gel contains butylhydroxytoluene, which
may cause local skin reactions (eg contact
dermatitis, an inflammation of the skin) or can
cause irritation to the eyes and skin, particularly
the nostrils and the skin around the mouth. . It also
contains parahydroxybenzoates, which may cause
allergic reactions (possibly delayed).

3. How to use Atralin Gel
When and how much to use

Always use Atralin Gel as your doctor has
instructed you. Check with your doctor or
pharmacist if you are unsure.
Normally your doctor will tell you to apply Atralin
Gel once a day, in the evening, after washing,
to the affected areas of the skin. All of the affected
area should be treated, not just the spots.
• Thoroughly wash and dry the area to be
treated, before applying Atralin Gel
• Apply a small amount of Atralin Gel, usually
about the size of a pea, using clean finger tips,
cotton wool or gauze.
• Lightly cover the affected area. Applying
more Atralin Gel will not make it work more
effectively. If you use too much then it may
make the skin red, causing peeling and
discomfort. If this happens, you should stop
using Atralin Gel until these symptoms have
gone away.
• Keep away from your eyes, nostrils and
mouth when applying Atralin Gel. Wash them
with water if the gel gets into them. Do not
allow the gel to collect in the folds of skin
around your eyes or nose.
After you have applied Atralin Gel, your skin may
feel warm or sting slightly for a while. If these
feelings persist, or if they get worse, consult your
doctor.
Do not apply Atralin Gel to skin that is cracked and
weeping or eczematous.

When your acne has improved (this may take
more than 4 weeks) your doctor may tell you that
you can apply Atralin Gel less frequently.

Children

Do not use Atralin Gel on children under 10 years
of age

If you forget to apply Atralin Gel

If you accidentally forget an application, just make
the next application as normal. Do not apply an
extra dose to make up for the missed one.

If you swallow Atralin Gel

Atralin Gel is only for use on the skin. If any gel is
swallowed, contact your doctor or nearest hospital
casualty department immediately.

If you use more Atralin Gel than you
should

If you accidentally apply too much Atralin Gel, it is
unlikely to do you any harm. However, always
try to exactly follow the instructions for use.

4. Possible side effects

Like all medicines, Atralin Gel can cause side
effects although not everybody gets them.

Common effects

(seen in between one in 10 and one in 100 users)
Reddening, peeling or scaling of the skin, which
may be swollen. Dry skin, itching, warmth or a
burning sensation, rashes, pain or a stinging
sensation may occur. Temporary changes
(increase or decrease) in skin pigmentation may
occur.
If any of these symptoms is severe, or if you get
crusts, blisters, swelling or a burning sensation on
the skin, stop using the gel and consult your
doctor immediately.

Uncommon effects

(seen in between one in 1,000 and one in 100
users)
Irritation of the eye and swelling, blistering and
crusting of the skin.

Very rare effects

(seen in up to one in 10,000 users)
Contact allergy has been reported with medicines
containing tretinoin.
If any of the side effects gets severe, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

5. How to store Atralin Gel

Keep out of the reach and sight of children.
Do not use Atralin Gel after the expiry date which
is stated on the carton and the crimp of the tube.
The expiry date refers to the last day of that
month.
After first opening the gel should be stored for a
maximum of three months. It is important that you
record the date of opening on the container
labelling.
Do not store above 25°C.
Medicines should not be disposed of in waste
water or household rubbish. Ask your pharmacist
how to dispose of medicines no longer required.
These measures will help to protect the
environment.

6. Further information
What Atralin Gel contains

The active substance is tretinoin.
Atralin Gel contains 0.05% tretinoin by weight.
The other ingredients are water, glycerol, soluble
collagen, sodium hyaluronate, carbomer 940,
butylhydroxytoluene (E321), octoxynol 9,
trolamine, methyl parahydroxybenzoate (E218),
propyl parahydroxybenzoate (E216), ethyl
parahydroxybenzoate (E214), butyl
parahydroxybenzoate, isobutyl
parahydroxybenzoate, benzyl alcohol and
phenoxyethanol.

What Atralin Gel looks like and
contents of the pack

Atralin Gel is a transparent yellow gel available in
tubes of 20 g and 45 g.
Marketing Authorisation Holder:
Beechmere Pharmaceuticals Ltd.
Merlin Place
Milton Road
Cambridge
CB4 0DP
United Kingdom
Manufacturer:
DPT Laboratories, Ltd
San Antonio
Texas 78215
USA

The Manufacturer responsible for batch
release in Europe is:
Brecon Pharmaceuticals Ltd
Pharos House
Wye Valley Business Park
Hay-on-Wye
Hereford
HR3 5PG
This leaflet was last approved in: 11/2012

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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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