Document: document 4 change

• document 0
• document 1
• document 2
• document 3
• document 4
• document 5

---

S431 LEAFLET Isotrex 20140822

PACKAGE LEAFLET: INFORMATION FOR THE USER ISOTREX GEL (isotretinoin)

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.

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

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.

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.

^ 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 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.

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 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

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. HOW TO STORE ISOTREX GEL

•    KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

•    Isotrex 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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Isotrex Gel contains

•    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.

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.

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)

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

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 Isotretinoin Gel is and what it is used for

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

3.    How to use Isotretinoin Gel

4.    Possible side effects

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

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

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

^ Tell your doctor if any of these apply to you. Don't use Isotretinoin.

Warnings and precautions

Talk to your doctor before using Isotretinoin 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)

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.

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.

Don’t use Isotretinoin on any irritated areas of skin. For

example if you have cuts or grazes, or sunburn.

Don’t use too much Isotretinoin 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 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.

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

Other medicines and Isotretinoin

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 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.

^ 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.

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.

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.

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

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 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.

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 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

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. HOW TO STORE ISOTRETINOIN 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.

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.

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.

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

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