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ISOTREXIN GEL

Active substance: ISOTRETINOIN

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Isotrexin® Gel
(erythromycin and isotretinoin)
This medicine will be referred to as Isotrexin throughout this leaflet.

Sunlight
While you are using Isotrexin, you should protect your skin from the sun.
This can be done by using a suitable sunscreen which provides both UVA
and UVB protection. You should also avoid using sun beds (sun lamps). If
you get sunburnt, stop using Isotrexin for a few days.

Read all of this leaflet carefully before you start using this medicine.
- 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. 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 get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.

Important information about some of the ingredients of Isotrexin
Isotrexin contains butylated hydroxytoluene (E321). This can cause local
skin reactions. It can also cause
irritation to your eyes and mucous membranes such as the lining of your
nose.

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

Always use Isotrexin 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.

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 is similar to 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. 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 suffer from acute eczema, rosacea (redness of the skin, broken
blood vessels and tiny pimples usually on the central area of the face)
and perioral dermatitis (red and sometimes bumpy rash around the
mouth and chin area).
Do not use Isotrexin if the above applies to you. If you are not sure, ask
your doctor or pharmacist before using this medicine.
Taking other medicines
Please tell your doctor or pharmacist if you are using or have recently used
any other medicines. This includes medicines obtained without a prescription, including herbal medicines.
In particular, tell your doctor or pharmacist before using your medicine if:
 you are using any other acne treatment such as:
- a product containing a topical antibiotic
- medicated or abrasive soaps or cleansers
- products which have a drying effect on the skin, such as cosmetics
or other products which contain alcohol or which otherwise make
the skin feel tight (known as astringents) and especially
- products containing peeling agents such as benzoyl peroxide.
Following prolonged use of a peeling agent, it is advisable to “rest”
the skin until the peeling effects subside before starting to use
Isotrexin.
These products should be used with caution to avoid a cummulative irritant
effect occurring.
If you are not sure if the above applies to you, check with your doctor or
pharmacist before using Isotrexin.
Pregnancy and breast-feeding
Do not 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.
Ask your doctor or pharmacist for advice before using any medicine, if you
are pregnant or breast-feeding.

3. How to use Isotrexin

How to apply Isotrexin
1. Wash your hands.
2. Completely remove any make-up.
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
 Only use Isotrexin on your skin. Keep it away from areas like your eyes,
lips and mouth.
 Do not use too much Isotrexin on sensitive areas of skin.
 Do not use Isotrexin on any irritated areas of your skin. For example, if
you have cuts, grazes, sunburn or eczema.
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.
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.
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:
 slight stinging and your skin may feel warm, especially when first applied.
 flaking and redness of your skin during the first few weeks of use.
 Increased sensitivity to sunlight
 Long-term use may occasionally trigger infection of hair follicles
(folliculitis).
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.
If any of the side effects get serious, last longer than a few days or if you
notice any side effects not listed in this leaflet, please tell your doctor or
pharmacist.
5. How to store Isotrexin





Keep out of the reach and sight of children
Do not store above 25°C
Do not use after the expiry date shown on the tube and carton label.
If your doctor tells you to stop using this medicine, take any unused
medicine to your pharmacist for safe disposal. Only keep it if told to do
so by your doctor.
 If you notice any signs of the medicine deteriorating, consult your
pharmacist.

6. Further information
What Isotrexin contains
Each 30g tube contains 2% w/w erythromycin and 0.05% w/w isotretinoin.
Isotrexin Gel also contains hydroxypropylcellulose, butylated
hydroxytoluene and ethanol.
What Isotrexin looks like and the contents of the pack
Isotrexin comes in a printed tube containing 30g of a clear, faintly yellow
gel.
Manufacturer:
This product is manufactured by:
Stiefel Laboratories Ireland
Finisklin Industrial Estate
Sligo (IRELAND)
It is procured from within the EU Parallel Import Product Licence holder:
G Pharma Ltd, Dakota Avenue, Salford M50 2PU.
POM
PL No. 16369/0484
ISOTREXIN® Gel

29th February 2012

‘Isotrexin’ is a registered trademark of Stiefel Laboratories

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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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