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ISOTREX CREAM

Active substance(s): ISOTRETINOIN

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Reason for Update: Type IB QRD V09 update D2014-6445
Agency Approval Date: TBC
Text Date: 15/10/2014
Text Issue and Draft No.: Issue 4, Draft 1
SPC Issue and Draft No.: Issue 4, Draft 1
CO Number: NA

PACKAGE LEAFLET: INFORMATION FOR THE USER
Isotrex 0.05% Cream
Isotretinoin
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 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

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

1.

What Isotrex is and what it is used for

The name of your medicine is Isotrex 0.05% Cream (called Isotrex in this leaflet). Isotrex contains an active
ingredient called isotretinoin.
Isotrex 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.
It is especially suitable if you have dry skin.

2.

Before you use Isotrex

Don’t use Isotrex
 if you are allergic (hypersensitive) to isotretinoin or any of the other ingredients in Isotrex (listed in
Section 6).
 if you are pregnant, if you think you could be pregnant, or if you are planning to become pregnant.
 if you are breast-feeding.
Tell your doctor if any of these apply to you. Don’t use Isotrex.
Take special care with Isotrex
Before you use Isotrex your doctor needs to know:
 if you or any of your close family have had skin cancer
1






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)
- if you have 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 cream 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 on your skin. Keep it away from areas such as your mouth, lips, and eyes.
Don’t use Isotrex on any irritated areas of skin. For example if you have cuts or grazes, or sunburn.
Don’t use too much Isotrex on sensitive areas of skin such as the neck.
Sunlight
Using Isotrex can make your skin more sensitive to sunlight. When you are using Isotrex 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 until your skin is better.
Other medicines and Isotrex
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 bought 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 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 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
Don’t use Isotrex if you are pregnant.
 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
 If you do become pregnant during treatment with Isotrex, tell your doctor.
Don't breast-feed while you are using Isotrex. Discuss with your doctor whether you choose to breast-feed
or to use Isotrex.
Ask your doctor or pharmacist for advice before taking any medicine, while you are pregnant or breastfeeding.

Important information about some of the ingredients of Isotrex
 Isotrex contains butylated hydroxytoluene (BHT). This may cause local skin reactions. It can also cause
irritation to your eyes and mucous membranes such as the lining of your nose
 Isotrex contains cetostearyl alcohol. This may cause local skin reactions (e.g contact dermatitis)
 Isotrex contains chlorocresol. This may cause allergic reactions
 Isotrex contains propylene glycol. This may cause skin irritation.

3.

How to use Isotrex

Always use Isotrex exactly as your doctor has told you to. Check with your doctor or pharmacist if you’re
not sure.
 Use Isotrex 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
 You should keep using the medicine until your doctor tells you otherwise.
How to apply Isotrex
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 Isotrex cream 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 cream.
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 cream less often or stop using it for a few days and then start
again. Using more cream than you should will not help your spots clear up more quickly.
If you accidentally swallow Isotrex
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
Don’t use extra cream to make up for a missed dose. Just apply your next dose at the usual time.

4.

Possible side effects

Like all medicines, Isotrex 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 cream. 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

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 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 Isotrex

Keep Isotrex out of the reach and sight of children.
Don’t store Isotrex above 25C.
Don’t use Isotrex after the expiry date shown on the tube and carton.
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.

Further information

What Isotrex contains



The active ingredient is isotretinoin 0.05% w/w
The other ingredients are light liquid paraffin, di-n-butyl adipate, macrogol stearyl ether, propylene
glycol, cetostearyl alcohol, benzyl alcohol, PEG-5 glyceryl stearate, carbomer, chlorocresol, sodium
hydroxide, butylated hydroxytoluene, and purified water

What Isotrex looks like and contents of the pack




Isotrex is a pale yellow cream
Isotrex comes in tubes each containing 15g, 25 g, 30 g, 40 g or 50 grams of cream
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
GlaxoSmithKline UK Limited
Stockley Park West,
Uxbridge, Middlesex UB11 1BT, UK
Manufacturer:
Stiefel Laboratories (Ireland) Ltd. Finisklin Business Park, Sligo, Ireland
or
Glaxo Operations UK Ltd. Harmire Road, Barnard Castle, Durham, DL12 8DT, UK

This leaflet was last revised in October 2014.
PL 19494/0069

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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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