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ISOTREX GEL

Active substance(s): ISOTRETINOIN

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PACKAGE LEAFLET: INFORMATION FOR THE USER

10000000121303

Isotrex® Gel
isotretinoin 0.05% w/w

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.
What is in this leaflet:
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
6. Contents of the pack and other 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.

• 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
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.

3

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.

10000000121303

Ask your doctor or pharmacist for advice before
taking any medicine, while you are pregnant or
breast-feeding.

GSK-GBR-Barnard Castle-UKBAR

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.

Stiefel; United Kingdom-GBR
Isotrex Gel
1

3. How to use Isotrex Gel
Always use this medicine 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.

K

JMF036

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
➔ 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
➔ 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.

• 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.
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, this medicine can cause side
effects, although not everybody gets them.

Don’t use Isotrex on any irritated areas of
skin. For example if you have cuts or grazes, or
sunburn.

Serious skin reactions:

Don’t use too much Isotrex on sensitive
areas of skin such as the neck.

➔ Stop using Isotrex and see a doctor straight
away, if you notice any of the side effects
above – you may need urgent medical
treatment.

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.
➔ 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:
• 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).

TEXT SIZE CONTAINED IN THIS ARTWORK
Body text size: 8pt
Leading: 9.6pt
Horizontal Scale: 100%
Smallest text size: 8pt
Microtext: Y

-

severe burning, peeling, redness or
itching of your skin.

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.

Pharma code ref. no: 7436

2. What you need to know before you use
Isotrex Gel

Front of Leaflet
Page 1 of 2

Pharma code ref. no: 7436

Pharma code ref. no: 7436
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Malta
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D'Argens
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt
5. How to store Isotrex Gel
Keep this medicine out of the sight and reach of
children.
• Store below 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.
• This product should be used within two
months of first opening. After two months,
discard any unused portion.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines you
no longer use. These measures will help to
protect the environment.

3
10000000121303
GSK-GBR-Barnard Castle-UKBAR

6. Contents of the pack and other
information

Stiefel; United Kingdom-GBR

What Isotrex Gel contains

Isotrex Gel

• The active substance is isotretinoin
0.05% w/w (0.05 g per 100 g gel).
• The other ingredients are
hydroxypropylcellulose, butylated
hydroxytoluene (E321) and ethanol.

1

What Isotrex Gel looks like and contents of
the pack
Isotrex Gel comes in tubes each containing 30 g
of a greenish-yellow gel.

K

JMF036

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
GlaxoSmithKline UK Limited
Stockley Park West, Uxbridge,
Middlesex UB11 1BT, UK
Manufacturer:
Glaxo Operations UK Ltd, Harmire Road,
Barnard Castle, Co. Durham, DL12 8DT,
United Kingdom
Other formats
To listen to or request a copy of this leaflet in
Braille, large print or audio please call, free of
charge:

0800 198 5000 (UK Only)

Please be ready to give the following
information:
Product name: Isotrex gel
Reference number: PL 19494/0063

TEXT SIZE CONTAINED IN THIS ARTWORK
Body text size: 8pt
Leading: 9.6pt
Horizontal Scale: 100%
Smallest text size: 8pt
Microtext: Y

This is a service provided by the
Royal National Institute of Blind People.
This leaflet was last revised in: March 2014
Isotrex is a registered trademark of Stiefel
Laboratories Inc.
© 2014 Stiefel Laboratories, Inc. All rights
reserved.
PL 19494/0063
MA 300/00901

Back of Leaflet
Page 2 of 2

1000000
0121303

PA C K A G E L E A F L E T: I N F O R M AT I O N F O R T H E U S E R

Isotretinoin 0.05% w/w

GEL

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.

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

What is in this leaflet:
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
6. Contents of the pack and other information

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
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. What you need to know before you use Isotrex Gel

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.

➔ 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:
• 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 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

• 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.

➔ Tell your doctor if any of these apply to you. Don’t use
Isotrex.

➔ Check with your doctor or pharmacist if you think
any of these may apply to you.

Warnings and precautions

Pregnancy, breast-feeding and fertility

Talk to your doctor before using Isotrex Gel:

Don’t use Isotrex Gel if you are pregnant.

• 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

• 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.

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

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.

Do not use Isotrex Gel:

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.

Front of Leaflet
Page 1 of 2

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.

TEXT SIZE CONTAINED IN THIS ARTWORK
Body text size: 8pt
Leading: 9.5pt
Horizontal Scale: 95%
Smallest text size: 8pt
Microtext: Y

7156N

1
Isotrex Gel
K

7156N
GSK-IRL-Sligo-IESLI
United Kingdom-GBR; Stiefel

S7LFLT-2D

3

3. How to use Isotrex Gel
Always use this medicine 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.
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, this medicine 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

United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Malta
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D’Argens
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt
5. How to store Isotrex Gel
Keep this medicine out of the sight and reach of children.
• Store below 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.
• This product should be used within two months of first
opening. After two months, discard any unused portion.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help to
protect the environment.
6. Contents of the pack and other information
What Isotrex Gel contains
• The active substance is isotretinoin 0.05% w/w (0.05 g
per 100 g gel).
• The other ingredients are hydroxypropylcellulose,
butylated hydroxytoluene (E321) and ethanol.
What Isotrex Gel looks like and contents of the pack
Isotrex Gel comes in tubes each containing 30 g of a
greenish-yellow gel.
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
Other formats
To listen to or request a copy of this leaflet in Braille, large
print or audio please call, free of charge:

0800 198 5000 (UK Only)

Please be ready to give the following information:
Product name:
Isotrex gel
Reference number: PL 19494/0063
This is a service provided by the Royal National Institute of
Blind People.
This leaflet was last revised in: March 2014
Isotrex is a registered trademark of Stiefel Laboratories Inc.
© 2014 Stiefel Laboratories, Inc. All rights reserved.

Back of Leaflet
Page 2 of 2

PL 19494/0063
MA 300/00901

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.

TEXT SIZE CONTAINED IN THIS ARTWORK
Body text size: 8pt
Leading: 9.5pt
Horizontal Scale: 95%
Smallest text size: 8pt
Microtext: Y

7156N

1
Isotrex Gel
K

7156N
GSK-IRL-Sligo-IESLI
United Kingdom-GBR; Stiefel

S7LFLT-2D

3

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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