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ISOTRETINOIN 0.05% W/W GEL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

ISOTREX® 0.05% w/w GEL
(isotretinoin)
Read all of this leaflet carefully before you start using
this medicine.
− 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 any of the side effects get serious or if you notice any side
effects not listed in the leaflet, please tell your doctor or
pharmacist.
The name of your medicine is Isotrex 0.05% w/w Gel but will be
referred to as Isotrex Gel throughout this leaflet.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Isotrex Gel is and what it is used for
Before you use Isotrex Gel
How to use Isotrex Gel
Possible side effects
How to store Isotrex Gel
Further 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 Gel
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. Before you use Isotrex Gel

• 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 Gel 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 Gel on your skin. Keep it away from areas
such as your mouth, lips, and eyes.
Don’t use Isotrex Gel on any irritated areas of skin. For
example if you have cuts or grazes, or sunburn.
Don’t use too much Isotrex Gel 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 Gel can make your skin more sensitive to
sunlight.
When you are using Isotrex Gel 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 Gel until your skin is
better.

Important information about some of the ingredients
of Isotrex Gel
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 if:

Other medicines and Isotrex Gel

• if you are allergic (hypersensitive) to isotretinoin or any of

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.

the other ingredients in Isotrex Gel (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 Gel.

Take special care with Isotrex Gel
Before you use Isotrex Gel, your doctor needs to know:
• 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,

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 Gel 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 Gel 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 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.

Very common side effects (at least 1 in 10 people are
affected):

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.

These effects can occur on the area of skin where you use the
gel. If they cause you a problem, try using Isotrex Gel less often,
or stop using it for a few days until the irritation goes away, then
start again. Stop using Isotrex Gel 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

3. How to use Isotrex Gel

Other side effects

Always use Isotrex Gel exactly as your doctor has told you.
Check with your doctor or pharmacist if you’re not sure.

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

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

• It can take 6 to 8 weeks before you see the full effect of


Isotrex Gel.
You should keep using the medicine until your doctor tells
you otherwise.

➔Tell your doctor or pharmacist if any of the side effects
listed become severe or troublesome, or if you notice any
side effects not listed in this leaflet.

5. How to store Isotrex Gel
How to apply Isotrex Gel



Keep out of the sight and reach of children.

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.



Isotrex Gel should be stored at room temperature. Do not
store above 25°C.



Store in the original package, in a dry place away from direct
sunlight.



A use by date printed on the tube and on the carton. Do not
use the gel after this date.



If your doctor tells you to stop taking this medicine, return
any unused gel to your pharmacist for safe disposal. Only
keep this medicine if your doctor tells you to.

If you use more Isotrex Gel than you should



If you use too much Isotrex Gel, 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 the gel shows any signs of deterioration or discolouration,
seek the advice of your pharmacist.

6. Further information

If you accidentally swallow Isotrex Gel
The ingredients of Isotrex Gel should not be harmful if
swallowed in small amounts.
• If you accidentally get Isotrex Gel in your mouth, rinse at
once with plenty of water
• Talk to a doctor if you swallow a lot of Isotrex Gel.

What Isotrex Gel contains
• Isotrex Gel/Isotretinoin Gel contains Isotretinoin 0.05%.
Isotretinoin is similar to Vitamin A.

• It also contains butylated hydroxytoluene,
hydroxypropylcellulose and ethanol

What Isotrex Gel looks like and the contents of the
pack

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.

Isotrex Gel/Isotretinoin Gel is supplied in tubes each containing
30g. It comes in a white/blue sealed tube fitted with a plastic
screw cap, containing a clear, greenish-yellow gel with an odour
of ethanol.

4. Possible side effects

Manufactured by: SITIEFEL Laboratories Ltd, Finisklin
Industrial Estate, Sligo - Ireland.

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

Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4, Bradfield
Road, Ruislip, Middlesex, HA4 0NU
®
ISOTREX 0.05% w/w GEL - PL No: 18799/1695

POM

Leaflet date: 01.10.2012
ISOTREX is a registered trademark of Stiefel Laboratories (UK)
Ltd.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Isotretinoin 0.05% w/w Gel
Read all of this leaflet carefully before you start using
this medicine.
− 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 any of the side effects get serious or if you notice any side
effects not listed in the leaflet, please tell your doctor or
pharmacist.

• 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 Gel 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.

The name of your medicine is Isotretinoin 0.05% w/w Gel but it
will be referred as Isotretinoin Gel throughout this leaflet.

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

In this leaflet:

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

1.
2.
3.
4.
5.
6.

What Isotretinoin Gel is and what it is used for
Before you use Isotretinoin Gel
How to use Isotretinoin Gel
Possible side effects
How to store Isotretinoin Gel
Further information

1. What Isotretinoin Gel is and what it is used for
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 Gel 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. Before you use Isotretinoin Gel

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

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

Important information about some of the ingredients
of Isotretinoin Gel
Isotretinoin 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 Isotretinoin Gel if:
• if you are allergic (hypersensitive) to isotretinoin or any of
the other ingredients in Isotretinoin Gel (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
Isotretinoin Gel.

Take special care with Isotretinoin Gel
Before you use Isotretinoin Gel, your doctor needs to know:
• 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,

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

3. How to use Isotretinoin Gel
Always use Isotretinoin Gel exactly as your doctor has told
you. 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 many times to use the medicine.
It can take 6 to 8 weeks before you see the full effect of
Isotretinoin Gel.
You should keep using the medicine until your doctor tells
you otherwise.

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
gel. If they cause you a problem, try using Isotretinoin Gel less
often, or stop using it for a few days until the irritation goes
away, then start again. Stop using Isotretinoin Gel 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
➔Tell your doctor or pharmacist if any of the side effects
listed become severe or troublesome, or if you notice any
side effects not listed in this leaflet.

5. How to store Isotretinoin Gel


Keep out of the sight and reach of children.



Isotretinoin Gel should be stored at room temperature. Do
not store above 25°C.



Store in the original package, in a dry place away from direct
sunlight.



A use by date printed on the tube and on the carton. Do not
use the gel after this date.



If your doctor tells you to stop taking this medicine, return
any unused gel to your pharmacist (chemist) for safe
disposal. Only keep this medicine if your doctor tells you to.



If the gel shows any signs of deterioration or discolouration,
you should seek the advice of your pharmacist.

How to apply Isotretinoin 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 Isotretinoin Gel than you should
If you use too much Isotretinoin Gel, 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 Gel

6. Further information
What Isotretinoin Gel contains
• Isotretinoin Gel contains Isotretinoin 0.05%. Isotretinoin is
similar to Vitamin A.

• It also contains butylated hydroxytoluene,
hydroxypropylcellulose and ethanol

The ingredients of Isotretinoin Gel should not be harmful if
swallowed in small amounts.
• If you accidentally get Isotretinoin Gel in your mouth, rinse at
once with plenty of water
• Talk to a doctor if you swallow a lot of Isotretinoin Gel.

What Isotretinoin Gel looks like and the contents of
the pack

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.

Manufactured by: SITIEFEL Laboratories Ltd, Finisklin
Industrial Estate, Sligo - Ireland.

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

Serious skin reactions:
• severe burning, peeling, redness or itching of your skin.
➔ Stop using Isotretinoin Gel and see a doctor straight away, if
you notice any of the side effects above – you may need
urgent medical treatment.

Isotretinoin Gel is supplied in tubes each containing 30g. It
comes in a white/blue sealed tube fitted with a plastic screw cap,
containing a clear, greenish-yellow gel with an odour of ethanol.

Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4, Bradfield
Road, Ruislip, Middlesex, HA4 0NU
Isotretinoin 0.05% w/w Gel Leaflet date: 01.10.2012

PL No: 18799/1695

POM

+ 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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