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Isotrexin® Gel


(isotretinoin 0.05%/erythromycin 2%)
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 signs of illness are the same as
- 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.
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
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.
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
➔ 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.

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 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
Ask your doctor or pharmacist for advice before using any 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.
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. You 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.

Manufacturer and Product Licence Holder
Manufactured by Stiefel Laboratories Ltd., Finisklin Business Park, Sligo,
Ireland and Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex HA1 1XD.
Repackaged by Servipharm Ltd.

PL No: 20636/2571

Leaflet revision and issue date (Ref) 19.02.14[3]
Isotrexin is a trademark of Stiefel Laboratories, Inc.

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 develop 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 or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly via Yellow Card Scheme at
By reporting side effects you can help provide more information on the
safety of this medicine.
Keep out of the sight and reach of children.
Do not store above 25 C.
Do not use Isotrexin after the expiry date printed on the tube and the carton.
The expiry date refers to the last day of that month.
If your doctor tells you to stop using your medicine, take any that are left
back to your pharmacist.
If your gel becomes discoloured or shows any other signs of deterioration
please contact your doctor or pharmacist before taking this medicine
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.
What Isotrexin contains
Each 1 g of gel contains 0.5 mg isotretinoin and 20 mg erythromycin.
Isotrexin Gel also contains hydroxypropylcellulose, butylhydroxytoluene
(BHT) and anhydrous ethanol.
What Isotrexin looks like and the contents of the pack
Isotrexin is available in aluminium tubes, each containing 30 g of a pale
yellow soft gel.

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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.