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ISOTRETINOIN 0.05% GEL

Active substance(s): ISOTRETINOIN

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S431 LEAFLET Isotrex 20140822

PACKAGE LEAFLET: INFORMATION FOR THE USER

ISOTREX GEL
(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.

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.
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.

What is in this leaflet:

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

1. What Isotrex Gel is and what it is used for

Other medicines and Isotrex

2. What you need to know before you use Isotrex Gel
4. Possible side effects

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.

5. How to store Isotrex Gel

In particular, tell your doctor or pharmacist:

6. Contents of the pack and other information



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.

3. How to use Isotrex Gel

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.

 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

2. WHAT YOU NEED TO KNOW BEFORE YOU USE ISOTREX
GEL



Use a reliable method of contraception properly to prevent
pregnancy, while you are using Isotrex Gel

Do not use Isotrex Gel:



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



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:

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



eczema,

Always use this medicine exactly as your doctor has told you
to. Check with your doctor or pharmacist if you’re not sure.



redness of the skin, broken blood vessels and tiny pimples
usually in the centre of the face (rosacea)



Use Isotrex Gel once or twice each day. Your doctor will tell you
how to use the medicine.



redness and soreness around your mouth (perioral
dermatitis)



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.

Isotrex may further irritate these conditions.


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.

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.

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.

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.

5. Apply to all of the area of your skin which has acne, not just
each spot.

5. HOW TO STORE ISOTREX GEL


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

6. Wash your hands after using the gel.



Isotrex Gel should not be stored above 25°C. Discard any
unused gel 2 months after first opening.

If you use more Isotrex than you should



Do not use after the expiry date printed on the carton or tube
label.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



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 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.
6. CONTENTS OF THE PACK AND OTHER INFORMATION

If you forget to use Isotrex Gel

What Isotrex Gel contains



Do not apply a double dose to make up for a missed dose.





Apply the next dose at the usual time.

Isotrex Gel contains 0.05%w/w of isotretinoin as an active
ingredient.



Isotrex Gel also contains the following inactive ingredients:
butylated hydroxytoluene, hydroxypropylcellulose and ethanol.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although
not everybody gets them.

What Isotrex Gel looks like and contents of the pack


Isotrex Gel is a white/blue sealed tube fitted with a plastic screw
cap, containing clear, greenish-yellow gel with an odour of
ethanol.



Isotrex Gel is available in tubes containing 30g.

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

Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Stiefel Laboratories Ltd, Sligo,
Ireland.
POM

PL No. 19488/0431

Leaflet revision date: 22 August 2014
Isotrex is a registered trade mark of Stiefel Laboratories Inc, USA.
S431 LEAFLET Isotrex 20140822

S431 LEAFLET Isotretinoin 20140822

PACKAGE LEAFLET: INFORMATION FOR THE USER

ISOTRETINOIN 0.05% GEL
(isotretinoin)

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

Your medicine is known as Isotretinoin 0.05% Gel but will be
referred to as Isotretinoin Gel throughout the following leaflet.

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

Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.

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

-

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.

Isotretinoin 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 Isotretinoin Gel, or stop using it until
the irritation goes away. Stop using Isotretinoin Gel all together if
the irritation does not go away.

-

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 Isotretinoin Gel is and what it is used for

Sunlight
Using Isotretinoin can make your skin more sensitive to
sunlight. When you are using Isotretinoin 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.

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

 If you do get sunburnt, stop using Isotretinoin until your skin is
better.

3. How to use Isotretinoin Gel

Other medicines and Isotretinoin

4. Possible side effects

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.

5. How to store Isotretinoin Gel
6. Contents of the pack and other information
1. WHAT ISOTRETINOIN GEL IS AND WHAT IT IS USED FOR

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 Isotretinoin 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 Isotretinoin 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.

The name of your medicine is Isotretinoin Gel. Isotretinoin 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.

Isotretinoin 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. Isotretinoin
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
ISOTRETINOIN GEL

 Check with your doctor or pharmacist if you think any of
these may apply to you.
Pregnancy, breast-feeding and fertility
Don’t use Isotretinoin 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 Isotretinoin Gel
If you do become pregnant during treatment with Isotretinoin
Gel, tell your doctor.

Do not use Isotretinoin 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 breast-feed while you are using Isotretinoin Gel. Discuss
with your doctor whether you choose to breast-feed or to use
Isotretinoin Gel.

 Tell your doctor if any of these apply to you. Don’t use
Isotretinoin.

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

Warnings and precautions

Isotretinoin Gel contains butylated hydroxytoluene (E321)

Talk to your doctor before using Isotretinoin Gel:

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.



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)

Isotretinoin 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.

3. HOW TO USE ISOTRETINOIN 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 Isotretinoin 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
Isotretinoin 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 Isotretinoin Gel

4. Put a thin layer of gel on the affected skin, using your
fingertips, and smooth in.

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.

5. Apply to all of the area of your skin which has acne, not just
each spot.

5. HOW TO STORE ISOTRETINOIN GEL

6. Wash your hands after using the gel.



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Isotretinoin Gel should not be stored above 25°C. Discard any
unused gel 2 months after first opening.



Do not use after the expiry date printed on the carton or tube
label.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



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.

1. Wash your hands.
2. Completely remove any make-up.
3. Wash the area with a mild soap and warm water, and dry
gently.

If you use more Isotretinoin than you should
If you use too much Isotretinoin, 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 Isotretinoin
The ingredients of Isotretinoin should not be harmful if swallowed in
small amounts.


If you accidentally get Isotretinoin in your mouth, rinse at once
with plenty of water



Talk to a doctor if you swallow a lot of Isotretinoin.

If you forget to use Isotretinoin Gel


Do not apply a double dose to make up for a missed dose.



Apply the next dose at the usual time.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Isotretinoin Gel contains


Isotretinoin Gel contains 0.05%w/w of isotretinoin as an active
ingredient.



Isotretinoin Gel also contains the following inactive ingredients:
butylated hydroxytoluene, hydroxypropylcellulose and ethanol.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although
not everybody gets them.

What Isotretinoin Gel looks like and contents of the pack


Isotretinoin Gel is a white/blue sealed tube fitted with a plastic
screw cap, containing clear, greenish-yellow gel with an odour
of ethanol.



Isotretinoin Gel is available in tubes containing 30g.

Serious skin reactions:


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

 Stop using Isotretinoin 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 Isotretinoin less often, or stop
using it for a few days until the irritation goes away, then start again.
Stop using Isotretinoin 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

Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Stiefel Laboratories Ltd, Sligo,
Ireland.
POM

PL No. 19488/0431

Leaflet revision date: 22 August 2014
S431 LEAFLET Isotretinoin 20140822

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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