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ISOTREX GEL

Active substance(s): ISOTRETINOIN

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Ref: 0874/200516/1/F

®

Isotrex Gel
(isotretinoin)
Patient Information Leaflet
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. Do not pass it on to others. It
may harm them, even if their symptoms 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.
What is in this leaflet

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.
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 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.

1

What Isotrex Gel is and what it is used for

2

What you need to know before you use Isotrex Gel

3

How to use Isotrex Gel

4

Possible side effects

5

How to store Isotrex Gel

➔ If you do get sunburnt, stop using Isotrex until your skin is better.

6

Contents of the pack and other information

Other medicines and Isotrex

1

What Isotrex Gel is and what it is used for

The name of your medicine is Isotrex Gel. Isotrex Gel contains a medicine
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

What you need to know before you use 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 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, breast-feeding and fertility

Do not use Isotrex Gel:
* if you are allergic to isotretinoin or any of the other ingredients of this
medicine (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

Don’t use Isotrex Gel 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 Gel
* If you do become pregnant during treatment with Isotrex Gel, tell your
doctor.

➔ Tell your doctor if any of these apply to you. Don’t use Isotrex.
Warnings and precautions
Talk to your doctor before using Isotrex Gel:
* 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

Don’t breast-feed while you are using 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.
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.

3

How to use Isotrex Gel

➔ 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 on your skin. Keep it away from areas such as your
mouth, lips, and eyes.

Always use Isotrex Gel exactly as your doctor has told you to. Check
with your doctor or pharmacist if you’re 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.
* This product is flammable. Keep the gel away from open fire and flames
and all sources of ignition during and immediately after you’ve used it

*

Ref: 0874/200516/1/B

Isotrex Gel
®

(isotretinoin)
Patient Information Leaflet (continued)
5
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
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 (may affect more than 1 in 10 people):
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
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 (see details below). By reporting side effects you can help
provide more information on the safety of this medicine.
United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard

How to store Isotrex Gel

* KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
* Do not store above 25°C.
* Keep the tube tightly closed when not in use.
* Contents are flammable. Keep away from all sources of fire, flame and

heat. Do not leave in direct sunlight.
Do not use Isotrex Gel after the expiry date which is stated on the tube
and carton (after exp). The expiry date refers to the last day of that month.
If your doctor tells you to stop taking this medicine, return any unused
medicine to your pharmacist (chemist) for safe disposal. Only
keep this medicine, if your doctor tells you to.
* If your medicine becomes discoloured or show any other signs of
deterioration, consult your pharmacist (chemist) who will tell you what to
do.
* This product should be used within two months of first opening. After two
months, discard any unused portion.
* 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 this medicine contains:
The active substance is isotretinoin. Contains 0.05% w/w (0.05 g per
100 g gel).
The other ingredients are hydroxypropylcellulose, butylated hydroxytoluene
(E321) and ethanol.
What this medicine looks like and contents of the pack
Isotrex comes in a white/blue sealed tube fitted with a plastic screw cap,
containing a clear greenish-yellow gel with an odour of ethanol. Each tube
contains 30g of gel.
Manufacturer and Licence Holder
This medicine is manufactured by Glaxo Operations UK Limited, Barnard
Castle, United Kingdom and is procured from within the EU and repackaged
by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow
Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/0874

Isotrex Gel

Isotrex Gel is a registered trademark of Stiefel Laboratories, Inc.
Revision date: 20/05/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Ref: 0874/200516/2/F

®

Isotrex Gel
(isotretinoin)
Patient Information Leaflet
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. Do not pass it on to others. It
may harm them, even if their symptoms 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.
What is in this leaflet

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.
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 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.

1

What Isotrex Gel is and what it is used for

2

What you need to know before you use Isotrex Gel

3

How to use Isotrex Gel

4

Possible side effects

5

How to store Isotrex Gel

➔ If you do get sunburnt, stop using Isotrex until your skin is better.

6

Contents of the pack and other information

Other medicines and Isotrex

1

What Isotrex Gel is and what it is used for

The name of your medicine is Isotrex Gel. Isotrex Gel contains a medicine
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

What you need to know before you use 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 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, breast-feeding and fertility

Do not use Isotrex Gel:
* if you are allergic to isotretinoin or any of the other ingredients of this
medicine (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

Don’t use Isotrex Gel 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 Gel
* If you do become pregnant during treatment with Isotrex Gel, tell your
doctor.

➔ Tell your doctor if any of these apply to you. Don’t use Isotrex.
Warnings and precautions
Talk to your doctor before using Isotrex Gel:
* 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

Don’t breast-feed while you are using 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.
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.

3

How to use Isotrex Gel

➔ 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 on your skin. Keep it away from areas such as your
mouth, lips, and eyes.

Always use Isotrex Gel exactly as your doctor has told you to. Check
with your doctor or pharmacist if you’re 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.
* This product is flammable. Keep the gel away from open fire and flames
and all sources of ignition during and immediately after you’ve used it

*

Ref: 0874/200516/2/B

Isotrex Gel
®

(isotretinoin)
Patient Information Leaflet (continued)
5
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
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 (may affect more than 1 in 10 people):
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
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 (see details below). By reporting side effects you can help
provide more information on the safety of this medicine.
United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard

How to store Isotrex Gel

* KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
* Do not store above 25°C.
* Keep the tube tightly closed when not in use.
* Contents are flammable. Keep away from all sources of fire, flame and

heat. Do not leave in direct sunlight.
Do not use Isotrex Gel after the expiry date which is stated on the tube
and carton (after exp). The expiry date refers to the last day of that month.
If your doctor tells you to stop taking this medicine, return any unused
medicine to your pharmacist (chemist) for safe disposal. Only
keep this medicine, if your doctor tells you to.
* If your medicine becomes discoloured or show any other signs of
deterioration, consult your pharmacist (chemist) who will tell you what to
do.
* This product should be used within two months of first opening. After two
months, discard any unused portion.
* 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 this medicine contains:
The active substance is isotretinoin. Contains 0.05% w/w (0.05 g per
100 g gel).
The other ingredients are hydroxypropylcellulose, butylated hydroxytoluene
(E321) and ethanol.
What this medicine looks like and contents of the pack
Isotrex comes in a white/blue sealed tube fitted with a plastic screw cap,
containing a clear greenish-yellow gel with an odour of ethanol. Each tube
contains 30g of gel.
Manufacturer and Licence Holder
This medicine is manufactured by Stiefel Laboratories Ltd, Sligo, Ireland and
is procured from within the EU and repackaged by the Product Licence
Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat,
Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/0874

Isotrex Gel

Isotrex Gel is a registered trademark of Stiefel Laboratories, Inc.
Revision date: 20/05/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

+ Expand Transcript

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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