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ADAPALENE 0.1%W/W CREAM

Active substance(s): ADAPALENE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Differin 0.1%w/w Cream
(adapalene)
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.
The name of your medicine is Differin 0.1%w/w Cream but it will be referred to as Differin throughout this leaflet.
What is in this leaflet:
1. What Differin is and what it is used for
2. What you need to know before you use Differin
3. How to use Differin
4. Possible side effects
5. How to store Differin
6. Contents of the pack and other information

1. What Differin is and what it is used for
The active substance in Differin is adapalene which has an anti-inflammatory effect reducing soreness and irritation.
It is used on the face, chest or back for acne, where the skin may have lots of blackheads, spots and pimples.
Differin is only absorbed into the body in very small amounts, and has little effect, except on the surface of the skin.

2. What you need to know before you use Differin
Do not use Differin:
If you are allergic to adapalene or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Do not use this medicine on areas where you have cuts or scrapes or on sunburnt skin or if you have a skin condition called
eczema.
Avoid contact with the eyes, mouth or angles of the nose, and avoid other very sensitive areas of your body. If accidental
contact does occur, immediately wash with warm water.
Avoid exposure to strong sunlight and artificial UV light. Use of sunscreen products and protective clothing over the treated
area is recommended.
If you experience sensitivity or irritation when applying this medicine, stop using it and tell your doctor. You may be asked to
use the cream less often, or to stop using it for a short time.

Talk to your doctor or pharmacist if you are not sure.
Other medicines and Differin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Other acne products (containing benzoyl peroxide, erythromycin or clindamycin) may be used with Differin, but they MUST
be applied in the morning and Differin at night.
Cosmetics may be used but they must not cause blackheads or dry the skin.

Pregnancy and breast-feeding
Differin should not be used during pregnancy. If you fall pregnant while using Differin, the treatment must be discontinued
and you should inform your doctor as soon as possible for a further follow-up.
Differin can be used during breast-feeding. To avoid contact exposure of the infant, application of Differin to the chest should
be avoided.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before using this medicine.
Differin contains:
Methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly
delayed).

3. How to use Differin
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Differin is only intended for use in adults and adolescents aged 12 years and over.
This medicine is for EXTERNAL USE ONLY.
Differin is applied at night before going to bed, unless your doctor has told you otherwise.
Thoroughly wash the areas to be treated with water. Make sure the skin is clean and dry before using this medicine.
Put a thin film of the cream with your fingertips on to the affected areas and rub in gently.
Do not forget to wash your hands afterwards.
How long you will have to use this medicine will depend on how quickly your acne improves. After you have used this
medicine for 3 months, it is important that you see your doctor. He or she can then check the improvement of your acne.

If you use more Differin than you should or accidentally swallow any of the cream
If you put too much Differin on your skin, you will not get rid of your acne any quicker, but your skin may become irritated
and red. Some peeling or discomfort could also occur.
In the rare event that you accidentally swallow any of this medicine, seek medical advice.
If you forget to use Differin
Don’t worry if you forget to apply your Differin at the right time. When you remember, start using this medicine again, in the
same way as before.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Differin may cause the following side effects at the site of application.
Common: may affect up to 1 in 10 people
dry skin
irritation of the skin
burning sensation of the skin
redness of the skin (erythema)
Uncommon: may affect up to 1 in 100 people
local skin reaction (contact dermatitis)
skin discomfort
sunburn
itching of the skin (pruritus)
peeling skin (exfoliation)
flare up of acne
Not known: frequency cannot be estimated from the available data
allergic contact reaction
pain or swelling of the skin
irritation, redness, itching or swelling of the eyelids
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 Differin
Keep out of the sight and reach of children.
Do not use Differin after the expiry date which is stated on the carton and tube label after ‘Éxp’. The expiry date refers to the
last day of that month.
Keep the medicine in its original container. Replace cap tightly after use.
Do not store above 25°C. Do not freeze.
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 Differin contains
The active ingredient in Differin is adapalene.
Differin contains 0.1%w/w adapalene.
The other ingredients are carbomer 934P, PEG-20 methyl glucose sesquistearate, glycerol, natural squalane, methyl
parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), disodium edetate, methyl glucose sesquistearate,
phenoxyethanol, cyclomethicone, sodium hydroxide (to adjust pH) and purified water.
What Differin looks like and contents of the pack
Differin is a white, shiny cream. It is available in tubes of 60g on prescription from your doctor.
Manufacturer: Laboratoires Galderma, ZI Montdesir, 74540 Alby-sur-Cheran, France.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road,
Ruislip, Middlesex, HA4 0NU, UK.
POM
Differin 0.1%w/w Cream; PL 18799/2906
Leaflet date: 10.03.2016

PACKAGE LEAFLET: INFORMATION FOR THE USER

Adapalene 0.1%w/w Cream
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.
The name of your medicine is Adapalene 0.1%w/w Cream but it will be referred to as Adapalene throughout this leaflet.
What is in this leaflet:
1. What Adapalene is and what it is used for
2. What you need to know before you use Adapalene
3. How to use Adapalene
4. Possible side effects
5. How to store Adapalene
6. Contents of the pack and other information

1. What Adapalene is and what it is used for
The active substance in Adapalene is adapalene which has an anti-inflammatory effect reducing soreness and irritation.
It is used on the face, chest or back for acne, where the skin may have lots of blackheads, spots and pimples.
Adapalene is only absorbed into the body in very small amounts, and has little effect, except on the surface of the skin.

2. What you need to know before you use Adapalene
Do not use Adapalene:
If you are allergic to adapalene or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Do not use this medicine on areas where you have cuts or scrapes or on sunburnt skin or if you have a skin condition called
eczema.
Avoid contact with the eyes, mouth or angles of the nose, and avoid other very sensitive areas of your body. If accidental
contact does occur, immediately wash with warm water.
Avoid exposure to strong sunlight and artificial UV light. Use of sunscreen products and protective clothing over the treated
area is recommended.
If you experience sensitivity or irritation when applying this medicine, stop using it and tell your doctor. You may be asked to
use the cream less often, or to stop using it for a short time.

Talk to your doctor or pharmacist if you are not sure.
Other medicines and Adapalene
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Other acne products (containing benzoyl peroxide, erythromycin or clindamycin) may be used with Adapalene, but they
MUST be applied in the morning and Adapalene at night.
Cosmetics may be used but they must not cause blackheads or dry the skin.

Pregnancy and breast-feeding
Adapalene should not be used during pregnancy. If you fall pregnant while using Adapalene, the treatment must be
discontinued and you should inform your doctor as soon as possible for a further follow-up.
Adapalene can be used during breast-feeding. To avoid contact exposure of the infant, application of Adapalene to the chest
should be avoided.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before using this medicine.
Adapalene contains:
Methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly
delayed).

3. How to use Adapalene
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Adapalene is only intended for use in adults and adolescents aged 12 years and over.
This medicine is for EXTERNAL USE ONLY.
Adapalene is applied at night before going to bed, unless your doctor has told you otherwise.
Thoroughly wash the areas to be treated with water. Make sure the skin is clean and dry before using this medicine.
Put a thin film of the cream with your fingertips on to the affected areas and rub in gently.
Do not forget to wash your hands afterwards.
How long you will have to use this medicine will depend on how quickly your acne improves. After you have used this
medicine for 3 months, it is important that you see your doctor. He or she can then check the improvement of your acne.

If you use more Adapalene than you should or accidentally swallow any of the cream
If you put too much Adapalene on your skin, you will not get rid of your acne any quicker, but your skin may become irritated
and red. Some peeling or discomfort could also occur.
In the rare event that you accidentally swallow any of this medicine, seek medical advice.
If you forget to use Adapalene
Don’t worry if you forget to apply your Adapalene at the right time. When you remember, start using this medicine again, in the
same way as before.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Adapalene may cause the following side effects at the site of application.
Common: may affect up to 1 in 10 people
dry skin
irritation of the skin
burning sensation of the skin
redness of the skin (erythema)
Uncommon: may affect up to 1 in 100 people
local skin reaction (contact dermatitis)
skin discomfort
sunburn
itching of the skin (pruritus)
peeling skin (exfoliation)
flare up of acne
Not known: frequency cannot be estimated from the available data
allergic contact reaction
pain or swelling of the skin
irritation, redness, itching or swelling of the eyelids
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 Adapalene
Keep out of the sight and reach of children.
Do not use Adapalene after the expiry date which is stated on the carton and tube label after ‘Éxp’. The expiry date refers to
the last day of that month.
Keep the medicine in its original container. Replace cap tightly after use.
Do not store above 25°C. Do not freeze.
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 Adapalene contains
The active ingredient in Adapalene is adapalene.
Adapalene contains 0.1%w/w adapalene.
The other ingredients are carbomer 934P, PEG-20 methyl glucose sesquistearate, glycerol, natural squalane, methyl
parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), disodium edetate, methyl glucose sesquistearate,
phenoxyethanol, cyclomethicone, sodium hydroxide (to adjust pH) and purified water.
What Adapalene looks like and contents of the pack
Adapalene is a white, shiny cream. It is available in tubes of 60g on prescription from your doctor.
Manufacturer: Laboratoires Galderma, ZI Montdesir, 74540 Alby-sur-Cheran, France.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road,
Ruislip, Middlesex, HA4 0NU, UK.
POM
Adapalene 0.1%w/w Cream; PL 18799/2906
Leaflet date: 10.03.2016

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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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