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ISOTREX 0.05% W/W GEL

Active substance(s): ISOTRETINOIN

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(leaflet continued)
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:
x Protect your skin from the sun. You can do
this by using sunscreen and wearing
clothes to stop you getting sunburnt
x Avoid using sun beds (sun lamps) or
spending a long time in the sun.
Î 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 obtained without a
prescription.
In particular, tell your doctor or pharmacist:
x 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).
x 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.
Î Check with your doctor or pharmacist if
you think any of these may apply to you.
Pregnancy and breast-feeding and fertility
Don’t use Isotrex Gel if you are pregnant.
x Tell your doctor if you are pregnant or
planning to become pregnant.
x Use a reliable method of contraception
properly to prevent pregnancy, while you
are using Isotrex Gel.

x

If you do become pregnant during
treatment with Isotrex Gel, tell your doctor.

x
x

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
Always use Isotrex Gel exactly as your
doctor has told you to.
Check with your doctor or pharmacist if you are
not sure.
x Use Isotrex Gel once or twice each day.
Your doctor will tell you how to use this
medicine.
x It can take 6 to 8 weeks before you see the
benefits of Isotrex Gel.
x You should keep using the medicine until
your doctor tells you otherwise.
x This product is flammable. Keep the gel
away from open fire anf flames and all
sources of ignition during and immediately
after you’ve used it.
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 to 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
x Do not apply a double dose to make up for
a missed dose.
Apply the next dose at the usual time.

5.
x
x
x

x

4. Possible side effects
Like all medicines, Isotrex Gel can cause side
effects, although not everybody gets them.

x

x

Serious skin reactions:
x Severe burning, peeling, redness or itching
of your skin.
Î 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:
x 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
x
x
x
x
x

Other side effects
Other side effects have occurred in a very
small number of people but their exact
frequency is unknown:
x Darkening or lightening of skin
x Sensitivity to sunlight

How to store Isotrex Gel
KEEP OUT OF THE SIGHT AND
REACH OF CHILDREN
Do not store above 25°C.
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 the month.
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. Further information
What Isotrex Gel contains
x The active substance is isotretinoin 0.05%
w/w. It also contains
hydroxypropylcellulose, butylated
hydroxytoluene and ethanol.
Isotrex 0.05% w/w Gel is supplied in tubes
each containing 30g Gel.
This medicine is manufactured by Stiefel
Laboratories Ltd, Sligo, Ireland.
It is procured from within the EU and
repackaged on behalf of the Product Licence
Holder: Quadrant Pharmaceuticals Ltd.,
Lynstock House, Lynstock Way, Lostock,
Bolton, BL6 4SA.
Isotrex 0.05% w/w Gel
PL 20774/0587

POM

Leaflet revised 12th September 2014
Isotrex is a registered trademark of
Stiefel Laboratories, Inc.
PP4/0587/V2

Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. 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.

(leaflet continued overleaf)
Read all of this leaflet carefully before you
start using this medicine because it
contains important information for you.
x Keep this leaflet. You may need to read it
again.
x If you have any further questions, ask your
doctor or pharmacist.
x This medicine has been prescribed for you.
Do not pass it on to others. It may harm
them, even if their signs of illness are the
same as yours.
x If you get any side effects not listed in this
leaflet, please tell your doctor or
pharmacist. This includes any possible
side effects not listed in this leaflet. See
section 4.
The name of your medicine is called Isotrex
0.05% w/w Gel but will be referred to as Isotrex
gel throughout the remainder of this leaflet.

2. Before you use Isotrex gel
Do not use Isotrex Gel
x If you are allergic to isotretinoin or any of
the other ingredients of Isotrex (listed in
Section 6)
x If you are pregnant, if you think you could
be pregnant, or if you are planning to
become pregnant.
x If you are breast-feeding
Î Tell your doctor if any of these apply to
you. Don’t use Isotrex.

What is 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. Contents of the pack and other information

x

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.
x Isotretinoin is similar to Vitamin A. It works
by helping the skin so that blocked pores
are less likely.
This helps prevent spots.

x

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:
x Loosen blackheads and whiteheads so that
they come out more easily
x Stop new blackheads, whiteheads and
spots from forming
x Lower the number of red, swollen acne
spots.

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

Don’t use too much Isotrex on sensitive
areas of skin such as the neck.
Don’t use Isotrex on any irritated areas of
skin. For example if you have cuts or grazes,
or sunburn.
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.
Î Check with your doctor if you think any of
these may apply to you.
x
x

If you or any of your close family have has
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:
x Eczema
x Redness of the skin, broken blood
vessels and tiny pimples usually in the
centre of the face (rosacea)
x Redness and soreness around your
mouth (perioral dermatitis)
Isotrex may further irritate these conditions
If you have skin reactions in the sunlight

Warning and precautions
Talk to your doctor before using Isotrex Gel:

ISOTREX® 0.05% w/w GEL
Isotretinoin
PACKAGE LEAFLET: INFORMATION FOR THE USER

PP4/0587/V2

(leaflet continued)

x

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.

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.

If you do become pregnant during
treatment with Isotrex Gel, tell your doctor.

x
x

Sunlight
Using Isotrex can make your skin more
sensitive to sunlight.
When you are using Isotrex you need to:
x Protect your skin from the sun. You can do
this by using sunscreen and wearing
clothes to stop you getting sunburnt
x Avoid using sun beds (sun lamps) or
spending a long time in the sun.
Î 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 obtained without a
prescription.
In particular, tell your doctor or pharmacist:
x 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).
x 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.

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
Always use Isotrex Gel exactly as your
doctor has told you to.
Check with your doctor or pharmacist if you are
not sure.
x Use Isotrex Gel once or twice each day.
Your doctor will tell you how to use this
medicine.
x It can take 6 to 8 weeks before you see the
benefits of Isotrex Gel.
x You should keep using the medicine until
your doctor tells you otherwise.
x This product is flammable. Keep the gel
away from open fire anf flames and all
sources of ignition during and immediately
after you’ve used it.
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 to clear up more quickly.

Î Check with your doctor or pharmacist if
you think any of these may apply to you.
Pregnancy and breast-feeding and fertility
Don’t use Isotrex Gel if you are pregnant.
x Tell your doctor if you are pregnant or
planning to become pregnant.
x Use a reliable method of contraception
properly to prevent pregnancy, while you
are using Isotrex Gel.

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
x Do not apply a double dose to make up for
a missed dose.
x 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:
x Severe burning, peeling, redness or itching
of your skin.
Î 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:
x Redness or peeling of your skin, especially
during the first few weeks of use
x Slight stinging or skin pain
x Skin irritation or tenderness
x Skin burning sensation
x Dry skin
x Itching
Other side effects
Other side effects have occurred in a very
small number of people but their exact
frequency is unknown:
x Darkening or lightening of skin
x Sensitivity to sunlight
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. 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.

If you accidentally swallow Isotrex Gel
The ingredients of Isotrex should not be
harmful if swallowed in small amounts.

5. How to store Isotrex Gel
x KEEP OUT OF THE SIGHT AND
REACH OF CHILDREN
x Do not store above 25°C.
x 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 the month.
x This product should be used within two
months of first opening. After two months,
discard any unused portion.
x 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 Gel contains
x The active substance is isotretinoin 0.05%
w/w. It also contains
hydroxypropylcellulose, butylated
hydroxytoluene and ethanol.
Isotrex 0.05% w/w Gel is supplied in tubes
each containing 30g Gel.
This medicine is manufactured by Stiefel
Laboratories Ltd, Sligo, Ireland.
It is procured from within the EU and
repackaged on behalf of the Product Licence
Holder: Quadrant Pharmaceuticals Ltd.,
Lynstock House, Lynstock Way, Lostock,
Bolton, BL6 4SA.
Isotrex 0.05% w/w Gel
PL 20774/0587

POM

Leaflet revised 12th September 2014
Isotrex is a registered trademark of
Stiefel Laboratories, Inc.
PP4/0587/V2

(leaflet continued overleaf)
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:
x Loosen blackheads and whiteheads so that
they come out more easily
x Stop new blackheads, whiteheads and
spots from forming
Lower the number of red, swollen acne
spots.
x

Don’t use too much Isotrex on sensitive
areas of skin such as the neck.
Don’t use Isotrex on any irritated areas of
skin. For example if you have cuts or grazes,
or sunburn.
Only use Isotrex on your skin. Keep it away
from areas such as your mouth, lips and eyes.
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.
x

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.
x Isotretinoin is similar to Vitamin A. It works
by helping the skin so that blocked pores
are less likely.
This helps prevent spots.

x

What is 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. Contents of the pack and other information
Read all of this leaflet carefully before you
start using this medicine because it
contains important information for you.
x Keep this leaflet. You may need to read it
again.
x If you have any further questions, ask your
doctor or pharmacist.
x This medicine has been prescribed for you.
Do not pass it on to others. It may harm
them, even if their signs of illness are the
same as yours.
x If you get any side effects not listed in this
leaflet, please tell your doctor or
pharmacist. This includes any possible
side effects not listed in this leaflet. See
section 4.
The name of your medicine is called Isotrex
0.05% w/w Gel but will be referred to as Isotrex
gel throughout the remainder of this leaflet.

Î Check with your doctor if you think any of
these may apply to you.
x
x

If you or any of your close family have has
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:
x Eczema
x Redness of the skin, broken blood
vessels and tiny pimples usually in the
centre of the face (rosacea)
x Redness and soreness around your
mouth (perioral dermatitis)
Isotrex may further irritate these conditions
If you have skin reactions in the sunlight

Warning and precautions
Talk to your doctor before using Isotrex Gel:
2. Before you use Isotrex gel
Do not use Isotrex Gel
x If you are allergic to isotretinoin or any of
the other ingredients of Isotrex (listed in
Section 6)
x If you are pregnant, if you think you could
be pregnant, or if you are planning to
become pregnant.
x If you are breast-feeding
Î Tell your doctor if any of these apply to
you. Don’t use Isotrex.

ISOTREX® 0.05% w/w GEL
Isotretinoin
PACKAGE LEAFLET: INFORMATION FOR THE USER

PP4/0587/V2

Expand view ⇕

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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