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ISOTREX GEL 0.05%

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Isotrex Gel 0.05%/Isotretinoin Gel 0.05%
(Isotretinoin)
Your medicine is available as the above names but will be referred to as
Isotrex Gel throughout this:
Patient Information Leaflet
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 gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1) What Isotrex Gel is and what it is used for
2) Before you use Isotrex Gel
3) How to use Isotrex Gel
4) Possible side effects
5) How to store Isotrex Gel
6) Further information

1) What Isotrex Gel is and what it is used for
The name of your medicine is Isotrex Gel. Isotrex Gel contains an
active ingredient called isotretinoin.
 Isotretinoin is similar to Vitamin A. It works by helping the skin so that
blocked pores are less likely.
This helps prevent spots.
Isotrex Gel is used to treat acne (spots) in young people who are going
through or have gone through puberty, and in adults. It is not for use by
children who have not started puberty. Isotrex helps to:
 loosen blackheads and whiteheads so that they come out more easily
 stop new blackheads, whiteheads and spots from forming
 lower the number of red, swollen acne spots.

2) Before you use Isotrex Gel
Do not use Isotrex Gel:
 if you are allergic (hypersensitive) to isotretinoin or any of the other
ingredients in Isotrex (listed in Section 6)
➔ Tell your doctor if any of these apply to you. Don’t use Isotrex Gel.
Take special care with Isotrex Gel
Before you use Isotrex Gel, your doctor needs to know:
 if you or any of your close family have had skin cancer
 if you have had problems tolerating this or similar medicines in the past
(you have found them too irritating for your skin)
 if 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).
Isotrex may further irritate these conditions.
 if you have skin reactions in the sunlight
➔ Check with your doctor if you think any of these may apply to you.

Take care not to use too much gel 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.
Only use Isotrex Gel on your skin. Keep it away from areas such as your
mouth, lips, and eyes.
Don’t use Isotrex Gel on any irritated areas of skin. For example if you
have cuts or grazes, or sunburn.
Don’t use too much Isotrex Gel on sensitive areas of skin such as the
neck.
Isotrex Gel can cause skin irritation when used with other medicines
used to treat acne. If your skin becomes irritated, reduce the amount of
times you use Isotrex Gel, or stop using it until the irritation goes away.
Stop using Isotrex Gel all together if the irritation does not go away.
Sunlight
Using Isotrex Gel can make your skin more sensitive to sunlight.
When you are using Isotrex Gel you need to:
 protect your skin from the sun. You can do this by using sunscreen 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 Isotrex Gel until your skin is better.
Important information about some of the ingredients of Isotrex Gel
Isotrex Gel contains butylated hydroxytoluene (E321). This can cause local
skin reactions e.g. contact dermatitis, reddening or flaking of skin. It can
also cause irritation to your eyes and mucous membranes such as the
lining of your nose.
Other medicines and Isotrex Gel
Tell your doctor or pharmacist if you are taking any other medicines,
if you’ve taken any recently, or if you start taking new ones. This includes
medicines obtained without a prescription.
In particular, tell your doctor or pharmacist:
 if you are using benzoyl peroxide (another acne treatment). If used at the
same time, it may make Isotrex Gel 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).
 if 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 Isotrex Gel 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.
➔ Check with your doctor or pharmacist if you think any of these may
apply to you.
Pregnancy and breast-feeding
Isotrex Gel is not recommended for use during pregnancy:
 Tell your doctor if you are pregnant or planning to become pregnant
 Use a reliable method of contraception properly to prevent pregnancy,
while you are using Isotrex Gel
 If you do become pregnant during treatment with Isotrex Gel, tell your
doctor.

Breast-feeding is not recommended during treatment with Isotrex Gel.
Discuss with your doctor whether you choose to breast-feed or to use
Isotrex Gel. Ask your doctor or pharmacist for advice before taking any
medicine, while you are pregnant or breast-feeding.

3) How to use Isotrex Gel
Always use Isotrex Gel exactly as your doctor has told you to. Check with
your doctor or pharmacist if you are not sure.
 Use Isotrex Gel once or twice each day. Your doctor will tell you how to
use the medicine.
 It can take 6 to 8 weeks before you see the benefits of Isotrex Gel.
 You should keep using the medicine until your doctor tells you otherwise.
How to apply Isotrex Gel
1. Wash your hands.
2. Completely remove any make-up.
3. Wash the area with a mild soap and warm water, and dry gently.
4. Put a thin layer of gel on the affected skin, using your fingertips, and
smooth in.
5. Apply to all of the area of your skin which has acne, not just each
spot.
6. Wash your hands after using the gel.
If you use more Isotrex than you should
If you use too much Isotrex, or use it more frequently than you should, it
may cause redness, peeling or irritation of your skin. If this happens, use
the gel less often or stop using it for a few days and then start again. Using
more gel than you should will not help your spots clear up more quickly.
If you accidentally swallow Isotrex Gel
The ingredients of Isotrex should not be harmful if swallowed in small
amounts.
 If you accidentally get Isotrex in your mouth, rinse at once with plenty of
water
 Talk to a doctor if you swallow a lot of Isotrex.
If you forget to use Isotrex Gel
 Do not apply a double dose to make up for a missed dose.
 Apply the next dose at the usual time.

4) Possible side effects
Like all medicines, Isotrex Gel can cause side effects, although not
everybody gets them.
Serious skin reactions:
 severe burning, peeling, redness or itching of your skin.
➔ Stop using Isotrex 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 (at least 1 in 10 people are affected):
These effects can occur on the area of skin where you use the gel. If they
cause you a problem, try using Isotrex less often, or stop using it for a few
days until the irritation goes away, then start again. Stop using Isotrex if
the irritation does not go away:
 redness or peeling of your skin, especially during the first few weeks of
use
 slight stinging or skin pain
 skin irritation or tenderness

 skin burning sensation
 dry skin
 itching
Other side effects
Other side effects have occurred in a very small number of people but their
exact frequency is unknown:
 darkening or lightening of skin
 sensitivity to sunlight
➔ Tell your doctor or pharmacist if any of the side effects listed become
severe or troublesome, or if you notice any side effects not listed in this
leaflet.

5) How to store Isotrex Gel





Keep out of the sight and reach of children.
Do not use after the expiry date printed on the carton, label or tube.
Do not store above 25°C. Discard 2 months after first opening the tube.
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.
 If your doctor tells you to stop using the gel, please take it back to the
pharmacist for safe disposal. Only keep them if your doctor tells you to.
 If the gel becomes discoloured or shows any other signs of deterioration,
you should seek the advice of your pharmacist who will tell you what to
do.

6) Further information
What Isotrex Gel contains
It contains 0.05% w/w of the active ingredient isotretinoin.
Isotrex Gel 0.05%/Isotretinoin Gel 0.05% also contains butylated
hydroxytoluene (E321), hydroxypropyl cellulose (E463) and ethanol.
What Isotrex Gel looks like and contents of the pack
It is a pale yellow transparent gel.
Isotrex Gel 0.05%/Isotretinoin Gel 0.05% is available in tubes of 30g.
PL10383/1246

POM

Your medicine is manufactured by Stiefel Laboratories Ireland, Finisklin
Industrial Estate, Sligo, Ireland Procured from within the EU and
repackaged by the Product Licence holder: Primecrown Ltd, 4/5 Northolt
Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet Date: 13.06.2013

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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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