ADAPALENE 0.1% GEL,DIFFERIN 0.1% GEL - Patient leaflet, side effects, dosage

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Patient leaflet - ADAPALENE 0.1% GEL,DIFFERIN 0.1% GEL

PACKAGE LEAFLET: INFORMATION FOR THE USER

Differin® 0.1% gel

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 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 name of your medicine is Differin 0.1% gel but will be referred to as Differin throughout this leaflet.

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 has 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 if you have a skin condition called eczema.
Avoid contact with the eyes, mouth or nostrils, and avoid other very sensitive areas of the body. If accidental contact does occur, immediately wash with warm water.
If you experience sensitivity or irritation when applying this medicine, stop using it and tell your doctor. You may be asked to use the gel less often, or to stop using it until symptoms subside.
You should avoid exposure to sunlight and artificial UV light whilst using Differin.

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:

– propylene glycol (E1520) which may cause skin irritation
– methyl parahydroxybenzoate (E218) 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 on a thin film of the gel with your fingertips to the affected areas and rub in gently.
Don’t 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 three 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 the gel

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)
– 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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. how to store differin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the tube and carton. The expiry date refers to the last day of that month.
Keep the medicine in its original container. Replace cap tightly after each use. Do not store above 25°C. Do not freeze.

If this medicine becomes discoloured or shows any other signs of deterioration, please contact your pharmacist who will advise you on what to do.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other informationwhat differin containsthe active substance is adapalene. each 1 g of gel contains 1 mg adapalene. the other ingredients are disodium edetate, purified water, phenoxyethanol, propylene glycol (e1520), sodium hydroxide, poloxamer, carbomer 940 and methylparahydroxybenzoate (e218).

What Differin looks like and contents of the pack

Differin is a smooth white gel. It is available in tubes of 60 g on prescription from your doctor.

Product Licence Holder and Manufacturer

Procured from within the EU by the Product Licence holder Orifarm A/S, Energivej 15, 5260 Odense S, Denmark

Repacked by Orifarm Supply s.r.o., Palouky 1366, 253 01 Hostivice, Czech Republic

Manufactured by Laboratoires Galderma, ZI Montdesir, 74540 Alby-sur-Cheran, France

I POM I

Differin 0.1% gel

PL 46927/0065

Leaflet revision date: 09/03/2018

Blind or partially sighted?

Is this leaflet hard to see or read?

Call +45 63 95 27 00

to obtain the leaflet in a format suitable for you.

PACKAGE LEAFLET: INFORMATION FOR THE USER Adapalene 0.1% gel

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 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 name of your medicine is Adapalene 0.1% gel but will be referred to as Adapalene throughout this leaflet.

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 has 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 adapalenedo 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 if you have a skin condition called eczema.
Avoid contact with the eyes, mouth or nostrils, and avoid other very sensitive areas of the body. If accidental contact does occur, immediately wash with warm water.
If you experience sensitivity or irritation when applying this medicine, stop using it and tell your doctor. You may be asked to use the gel less often, or to stop using it until symptoms subside.
You should avoid exposure to sunlight and artificial UV light whilst using Differin.

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:

– propylene glycol (E1520) which may cause skin irritation
– methyl parahydroxybenzoate (E218) 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 on a thin film of the gel with your fingertips to the affected areas and rub in gently.
Don’t 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 three 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 the gel

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)
– 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

5. how to store adapalene

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the tube and carton. The expiry date refers to the last day of that month.
Keep the medicine in its original container. Replace cap tightly after each use. Do not store above 25°C. Do not freeze.

6. contents of the pack and other informationwhat adapalene containsthe active substance is adapalene. each 1 g of gel contains 1 mg adapalene. the other ingredients are disodium edetate, purified water, phenoxyethanol, propylene glycol (e1520), sodium hydroxide, poloxamer, carbomer 940 and methylparahydroxybenzoate (e218).

What Adapalene looks like and contents of the pack

Adapalene is a smooth white gel. It is available in tubes of 60 g on prescription from your doctor.

Product Licence Holder and Manufacturer

Procured from within the EU by the Product Licence holder Orifarm A/S, Energivej 15, 5260 Odense S, Denmark Repacked by Orifarm Supply s.r.o., Palouky 1366, 253 01 Hostivice, Czech Republic

Manufactured by Laboratoires Galderma, ZI Montdesir, 74540 Alby-sur-Cheran, France

I POM I

Adapalene 0.1% gel

PL 46927/0065

Leaflet revision date: 09/03/2018

Blind or partially sighted?

Is this leaflet hard to see or read?

Call +45 63 95 27 00

to obtain the leaflet in a format suitable for you.

Sources: Original (products.mhra.gov.uk)

Frequently Asked Questions

What is Adapalene 0.1% gel used for?

Adapalene 0.1% gel, also known as Differin, is primarily used to treat acne by preventing the formation of new pimples and promoting cell turnover.

How do I apply Adapalene gel correctly?

To apply Adapalene 0.1% gel, wash your face with a mild cleanser, gently pat it dry, and then apply a thin layer of the gel to the affected areas once daily in the evening.

Can I use makeup while using Adapalene gel?

Yes, you can use makeup after applying Adapalene gel, but it’s best to wait at least 30 minutes for the product to absorb into your skin.

How long does it take to see results from Adapalene gel?

Most patients start to notice improvements in their acne within 8 to 12 weeks of consistent use of Adapalene 0.1% gel.

Is it safe to use Adapalene gel during pregnancy?

It is generally advised to avoid using Adapalene during pregnancy. Consult your doctor for alternatives if you are pregnant or planning to become pregnant.

Can I use other acne treatments with Adapalene?

You should consult your healthcare provider before combining Adapalene with other acne treatments, as some may increase skin irritation.

What should I do if I miss an application of Adapalene gel?

If you miss an application of Adapalene gel, apply it as soon as you remember unless it’s almost time for your next dose. Do not double up on applications.

Is there any food or drink I need to avoid while using Adapalene?

There are no specific foods or drinks that need to be avoided while using Adapalene gel. However, maintaining a healthy diet can benefit your skin.

Can I use Adapalene on sensitive skin?

Adapalene can be used on sensitive skin, but start with a lower frequency of application to assess tolerance and minimize irritation.

What side effects can occur from using Differin gel?

Common side effects include dryness, redness, and peeling of the skin. These often improve over time as your skin adjusts.

Should I use sunscreen while using Adapalene gel?

Yes, using sunscreen is crucial when using Adapalene gel since it can make your skin more sensitive to sunlight.

How should I store Adapalene 0.1% gel?

Store the gel at room temperature, away from direct sunlight and moisture. Keep it out of reach of children.

Can I use Adapalene if I have eczema or rosacea?

If you have eczema or rosacea, consult your dermatologist before using Adapalene, as it may exacerbate these conditions in some cases.

Is it normal for my acne to get worse initially when starting Adapalene treatment?

Yes, some individuals may experience an initial worsening of acne before improvement occurs; this is known as purging and is typically temporary.

How long can I use Differin gel safely?

You can typically use Differin gel for several months or longer under the guidance of a healthcare professional; check with them for personalized advice.

Can adolescents use Adapalene 0.1% gel?

Yes, adolescents aged 12 and older can use Adapalene 0.1% gel for treating acne; however, parental guidance is recommended.

What should I do if my skin becomes irritated from using Differin?

If you experience irritation, reduce the frequency of application or consult your doctor for advice on how to manage symptoms.

Is it safe to combine Differin with retinol products?

Combining Differin with other retinol products is not recommended due to increased risk of irritation. Discuss with a dermatologist before combining treatments.

Will using Adapalene help with acne scars or dark spots?

While Adapalene primarily targets active acne, consistent use may also help improve the appearance of mild acne scars and dark spots over time.

Where can I purchase Differin 0.1% Gel?

Differin 0.1% Gel is available over-the-counter at pharmacies and online retailers; check local regulations regarding its purchase.