ISOTREXIN GEL

Active substance: ISOTRETINOIN

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PATIENT INFORMATION LEAFLET
®

ISOTREXIN GEL

(isotretinoin 0.05% w/w, erythromycin 2.0% w/w)
Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or
pharmacist.
This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their symptoms signs
of illness are the same as yours.
If you get any side effects, talk to your doctor, or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
The name of your medicine is Isotrexin Gel but will be referred to
as Isotrexin in this leaflet.
What is in this leaflet:
1. What Isotrexin is and what it is used for
2. What you need to know before you use Isotrexin
3. How to use Isotrexin
4. Possible side effects
5. How to store Isotrexin
6. Contents of the pack and other information

1. What Isotrexin is and what it is used for
The name of this medicine is Isotrexin Gel (called Isotrexin in
this leaflet), which is used to treat moderate acne. Isotrexin
contains two different medicines called erythromycin and
isotretinoin.
Erythromycin is an antibiotic. It works by fighting bacteria
that can cause acne (spots).
Isotretinoin belongs to a family of medicines called retinoids,
like vitamin A. It works by helping the skin so that blocked
pores are less likely. This helps prevent spots.
Isotrexin helps to:
make your skin less oily
loosen blackheads and whiteheads so that they come out
more easily
stop new blackheads, whiteheads and spots from forming
lower the number of bacteria which can cause acne
lower the number of red, inflamed acne spots.

2. What you need to know before you use Isotrexin
Do not use Isotrexin if:
you are allergic to erythromycin, isotretinoin or any of the
other ingredients of Isotrexin (listed in Section 6).
you are pregnant, if you think you could be pregnant, or if
you are planning to become pregnant
you are breast-feeding.
➔ Don’t use Isotrexin if the above applies to you. If you are not
sure, ask your doctor or pharmacist before using this
medicine.
Warnings and precautions
Talk to your doctor or pharmacist before using Isotrexin.
Before you use Isotrexin tell your doctor if:
you have a history of inflammatory bowel disease or
antibiotic-associated colitis (severe, prolonged or bloody
diarrhoea following antibiotic use).
Antibiotics may cause a condition that result in severe diarrhoea
and stomach cramps. This is unlikely to happen with antibiotics
applied to the skin.
➔ If you develop stomach cramps or diarrhoea that does not
improve or is severe, stop using Isotrexin and contact your
doctor immediately.
Before you use Isotrexin your doctor needs to know if:
you or any of your close family have had skin cancer
you have had problems tolerating this or similar medicines in
the past (you have found them too irritating for your skin)
you have:
- eczema
- redness of the skin, broken blood vessels and tiny
pimples usually in the centre of the face (rosacea)

- redness and soreness around your mouth (perioral
dermatitis)
Isotrexin may further irritate these conditions.
you have skin reactions in the sunlight
➔ Check with your doctor if you think any of these may apply
to you.
Only use Isotrexin on your skin. Keep it away from areas
such as your mouth, lips, and eyes.
Don’t use Isotrexin on any irritated areas of skin. For
example if you have cuts or grazes, or sunburn.
Don’t use too much Isotrexin on sensitive areas of skin such
as the neck.
Don’t use Isotrexin on skin that has had cosmetic treatment
recently such as depilation, chemical hair treatment,
chemical peel, dermabrasion or laser resurfacing.
Take care not to use too much Isotrexin especially where it
could run into your eyes or build up in the angles of your
nose, skin folds, or other areas of the skin that do not require
treatment.
Avoid skin products that contain alcohol, spices or lime.
These products may irritate your skin more if used with
Isotrexin.
Sunlight
Using Isotrexin can make your skin more sensitive to sunlight.
When you are using Isotrexin you need to:
protect your skin from the sun. You can do this by using a
sunscreen product which provides broad protection (protects
against UVA and UVB rays) and wearing clothes to stop you
getting sunburnt
avoid using sun beds (sun lamps) or spending a long time in
the sun
➔ If you do get sunburnt, stop using Isotrexin until your skin is
better.
Very cold or windy weather may also irritate your skin while you
are using Isotrexin.
Children
Isotrexin is for use by adults and adolescents with acne. It is not
for use by children under 12 years.
Other medicines and Isotrexin
Tell your doctor or pharmacist if you are using, have recently
used, or might use any other medicines.
If you have recently taken or used other medicines that contain
erythromycin or clindamycin, there is an increased chance that
Isotrexin will not work as well as it should.
➔ Tell your doctor or pharmacist if you have used or taken any
other medicines that contain erythromycin or clindamycin
recently.
Tell your doctor or pharmacist before using your medicine if:
you are using benzoyl peroxide (another acne treatment). If
used at the same time, it may make Isotrexin less effective.
You may need to use these medicines at different times of
the day (for example, one in the morning and the other at
bedtime)
you are using any other acne treatment. If used at the same
time, it may make skin irritation worse. If your skin becomes
very irritated, you may need to use a moisturiser, use
Isotrexin less often or stop using it for a short period to allow
your skin to recover and then re-start treatment. Stop
treatment and see your doctor if skin irritation does not
improve
➔ If you are not sure if the above applies to you, check with
your doctor or pharmacist before using Isotrexin.
Pregnancy and breast-feeding
Don’t use Isotrexin if:
you are pregnant or might become pregnant (you should
stop using Isotrexin one menstrual cycle (period) before
trying to get pregnant).
you are breast-feeding. Discuss with your doctor whether
you choose to breast-feed or to use Isotrexin.

Use a reliable method of contraception properly to prevent
pregnancy while you are using Isotrexin
➔ If you do become pregnant during treatment with Isotrexin,
tell your doctor. Ask your doctor or pharmacist for advice before
using any medicine, if you are pregnant or breast-feeding.
medicine, if you are pregnant or breast-feeding.
Important information about some of the ingredients of
Isotrexin
Isotrexin contains butylated hydroxytoluene (E321). This can
cause local skin reactions (e.g. contact dermatitis). It can also
cause irritation to your eyes and mucous membranes such as
the lining of your nose.
3.

How to use Isotrexin

Always use Isotrexin exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
Use Isotrexin once or twice each day. Your doctor will tell
you how many times to use the medicine.
It can take 6 to 8 weeks before you see the full effect of
Isotrexin.
You should keep using the medicine until your doctor tells
you otherwise.
How to apply Isotrexin
1. Wash your hands.
2. Completely remove any make-up, wash the area with a mild
soap and warm water, and dry gently.
3. Put a thin film of gel on the affected skin, using your
fingertips.
4. Apply to all of the area of your skin which has acne, not just
each spot.
Take care not to apply too much Isotrexin especially
where the excess could run into the eyes, the angles of
the nose or other areas of the skin that do not require
treatment.
5. Wash your hands after using the gel.
6. After it has dried, you can use non-greasy make-up.
What else you need to know when applying Isotrexin
Due to the flammable nature of Isotrexin, you should avoid
smoking or being near an open flame while you’re applying
Isotrexin, and immediately after you’ve used it.
If you use more Isotrexin than you should
If you use more Isotrexin than you should, it may cause redness,
peeling or irritation of your skin. If this happens, stop using the
medicine for a few days. Using more Isotrexin than you should
will not help your spots clear up more quickly.
If you accidentally swallow Isotrexin
The ingredients of Isotrexin should not be harmful if swallowed
in small amounts. If you accidentally get Isotrexin in your mouth,
rinse at once with plenty of water. Talk to a doctor if you swallow
a lot of Isotrexin.
If you forget to use Isotrexin
Do not apply a double dose to make up for the forgotten
doses.
Apply the next dose at the usual time.
If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.
4.

Possible side effects

Like all medicines, Isotrexin can cause side effects, although not
everybody gets them. The following side effects may happen
with this medicine:
Stop using Isotrexin and see a doctor straight away if:
you have an allergic reaction: difficulty breathing or
swallowing caused by sudden swelling of the throat, face,
lips or mouth. A sudden swelling of hands, feet and ankles,
or an itchy rash (hives)
you have severe burning, peeling or itching of your skin
you develope severe or prolonged diarrhoea
➔ Stop using Isotrexin and see a doctor straight away, if you
notice any of the side effects above you may need urgent
medical treatment.

Very common side effects
These may affect more than 1 in 10 people:
skin pain
rash
dry skin
itchy skin
skin burning sensation
redness of the skin
skin irritation
skin peeling or scaling
Common side effects
These may affect up to 1 in 10 people:
itchy skin rash (dermatitis, eczema)
These effects are normal. If they cause you a problem, try using
Isotrexin less often, or stop using it for a few days and then start
again.
Other side effects
These side effects have occurred in a very small number of
people but their exact frequency is unknown:
allergic reaction
swelling of the face
itchy, bumpy rash (hives)
abdominal pain
diarrhoea
increased sensitivity of the skin to sunlight
discolouration of the skin
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 Isotrexin

Keep out of the sight and reach of children.
Do not store above 25°C
A ‘use by date (Exp.) is printed on the tube and the carton.
Do not use the gel after this date.
If your medicine becomes discoloured or shows any signs of
deterioration, you should seek the advice of your pharmacist.
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.

Contents of the pack and other information

What Isotrexin contains
It contains 0.05% w/w of isotretinoin and 2.0%w/w erythromycin
as the active ingredients.
The other ingredients are hydroxypropylcellulose, butylated
hydroxytoluene and anhydrous ethanol.
What Isotrexin looks like and the contents of the pack
Isotrexin is a pale yellow soft gel which is supplied in tubes each
containing 30g.
Manufactured by: Stiefel Laboratories (Ireland) Ltd, Finisklin
Business Park, Sligo, Ireland.
Procured from within the EU and repackaged by Product
Licence holder: B&S Healthcare, Unit 4, Bradfield Road,
Ruislip, Middlesex, HA4 0NU, UK
POM
ISOTREXIN GEL, PL No: 18799/1693
Leaflet date: 22.08.2014
Isotrexin is a registered trademark of Stiefel Laboratories (UK)
Ltd.

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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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