Isotrex 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. 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. 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
Do not use Isotrex Gel if:
• if you are allergic (hypersensitive) to isotretinoin or any of 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,
• 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.
Other medicines and 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 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.
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.
3. How to use Isotrex Gel
Always use Isotrex Gel exactly as your doctor has told you.
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 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.
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 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 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.
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.
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 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
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 Isotrex Gel
• Keep out of the sight and reach of children.
• 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 the gel shows any signs of deterioration or discolouration, seek the advice of your pharmacist.
6. Further information
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
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
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.
Manufactured by: SITIEFEL Laboratories Ltd, Finisklin Industrial Estate, Sligo - Ireland.
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
Leaflet date: 01.10.2012
POM
ISOTREX is a registered trademark of Stiefel Laboratories (UK) Ltd.
PACKAGE LEAFLET: INFOR MATION 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.
The name of your medicine is Isotretinoin 0.05% w/w Gel but it
will be referred as Isotretinoin Gel throughout this leaflet.
In this leaflet:
1. What Isotretinoin Gel is and what it is used for
2. Before you use Isotretinoin Gel
3. How to use Isotretinoin Gel
4. Possible side effects
5. How to store Isotretinoin Gel
6. 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
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,
• 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.
Only use Isotretinoin Gel on your skin. Keep it away from areas such as your mouth, lips, and eyes.
Don't use Isotretinoin Gel on any irritated areas of skin. For
example if you have cuts or grazes, or sunburn.
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.
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.
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
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
• T alk to a doctor if you swallow a lot of Isotretinoin Gel.
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.
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
What Isotretinoin Gel looks like and the contents of the pack
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.
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.
4. Possible side effects
Like all medicines, Isotretinoin Gel can cause side effects, although not everybody gets them.
Manufactured by: SITIEFEL Laboratories Ltd, Finisklin Industrial Estate, Sligo - Ireland.
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 -
POM
PL No: 18799/1695
Serious skin reactions: Leaflet date: 01.10.2012
• 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.