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

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

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

Differin® 0.1% w/w Gel

(adapalene)

The name of your medicine is Differin 0.1% Gel, but will be referred to as Differin throughout the remainder of the 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 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 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 pregnant.

  • ■ If you are planning a pregnancy.

  • ■ 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, breast-feeding and fertility

  • ■ DO NOT use Differin if you are pregnant or thinking of becoming pregnant. Your doctor can give you more information.

  • ■ 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.

Differin contains:

  • ■ 40 mg of propylene glycol (E1520) in each gram which

is equivalent to 4% w/w, it 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.

Contact a doctor right away if you notice any of the following symptoms-you may need urgent medical treatment: Swelling of the face, lips or throat which makes it difficult to swallow or breathe, rash, itching, hives and dizziness. This could be a sign of angioedema or a severe allergic reaction (frequency not known, cannot be estimated from the available data).

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

  • ■ darkening of fair skin

  • ■ lightening of darker skin

  • ■ application site burn

Application site burns (mostly superficial burns but also second degree or severe burns) have been reported.

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 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.

  • ■ Do not store above 25°C.

  • ■ Do not freeze.

  • ■ Replace cap tightly after each use.

  • ■ If your medicine shows any signs of discolouration or deterioration contact your pharmacist for advice.

  • ■ Return all unused medicine to your pharmacist.

  • ■ 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 information

What Differin contains

The active substance is adapalene. lg of gel contains lmg adapalene.

Also contains: carbomer 980, propylene glycol (E1520), poloxamer 182, sodium edetate, methyl parahydroxybenzoate (E218), phenoxyethanol, sodium hydroxide or hydrochloric acid and purified water.

What Differin looks like and contents of the pack

Differin is a smooth, white, topical gel.

It is available in pack size 30g or 2 × 30g.

Manufacturer

Manufactured by:

LABORATOIRES GALDERMA, ZI DU MONTDESIR, 74540 ALBY-SUR-CHERAN, FRANCE.

Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.

Product Licence holder:

Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.

PL: 21828/0828 POM

Trademark Owner: Nestle Skin Health S.A.

Leaflet issue and revision date: 21.01.22

Blind or partially sighted?

Is this leaflet hard to see or read?

Call +44 (0) 1302 365000 (Regulatory)

Please be ready to give the following information:

Product name:

Differin 0.1% w/w Gel

Reference No: 21828/0828

PACKAGE LEAFLET: INFORMATION FOR THE USER

Adapalene 0.1% w/w Gel

The name of your medicine is Adapalene 0.1% Gel, but will be referred to as Adapalene throughout the remainder of the 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 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 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 adapalene

Do not use Adapalene:

  • ■ If you are pregnant.

  • ■ If you are planning a pregnancy.

  • ■ 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 Adapalene.

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, breast-feeding and fertility

  • ■ DO NOT use Adapalene if you are pregnant or thinking of becoming pregnant. Your doctor can give you more information.

  • ■ 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.

Adapalene contains:

  • ■ 40 mg of propylene glycol (E1520) in each gram which

is equivalent to 4% w/w, it 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.

Contact a doctor right away if you notice any of the following symptoms-you may need urgent medical treatment: Swelling of the face, lips or throat which makes it difficult to swallow or breathe, rash, itching, hives and dizziness. This could be a sign of angioedema or a severe allergic reaction (frequency not known, cannot be estimated from the available data).

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

  • ■ darkening of fair skin

  • ■ lightening of darker skin

  • ■ application site burn

Application site burns (mostly superficial burns but also second degree or severe burns) have been reported.

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 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 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.

  • ■ Do not store above 25°C.

  • ■ Do not freeze.

  • ■ Replace cap tightly after each use.

  • ■ If your medicine shows any signs of discolouration or deterioration contact your pharmacist for advice.

  • ■ Return all unused medicine to your pharmacist.

  • ■ 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 information

What Adapalene contains

The active substance is adapalene. lg of gel contains lmg adapalene.

Also contains: carbomer 980, propylene glycol (E1520), poloxamer 182, sodium edetate, methyl parahydroxybenzoate (E218), phenoxyethanol, sodium hydroxide or hydrochloric acid and purified water.

What Adapalene looks like and contents of the pack

Adapalene is a smooth, white, topical gel.

It is available in pack size 30g or 2 × 30g.

Manufacturer

Manufactured by:

LABORATOIRES GALDERMA, ZI DU MONTDESIR, 74540 ALBY-SUR-CHERAN, FRANCE.

Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.

Product Licence holder:

Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.

PL: 21828/0828 POM

Leaflet issue and revision date: 21.01.22

Blind or partially sighted?

Is this leaflet hard to see or read?

Call +44 (0) 1302 365000 (Regulatory)

Please be ready to give the following information:

Product name:

Adapalene 0.1% w/w Gel

Reference No: 21828/0828

Page 2 of 2

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

Frequently Asked Questions

What is Adapalene 0.1% W/W Gel used for?

Adapalene 0.1% W/W Gel, commonly known as Differin, is primarily used to treat acne by preventing the formation of new acne lesions.

How does Differin Gel work for acne treatment?

Differin Gel works by promoting cell turnover and preventing clogged pores, which helps reduce the formation of acne.

Can I use Differin Gel with other acne treatments?

It's important to consult with your healthcare provider before combining Differin with other acne medications to avoid irritation.

What should I expect when starting Adapalene Gel?

When starting Adapalene Gel, you may experience initial dryness or irritation as your skin adjusts, which usually improves after a few weeks.

Is Differin safe for sensitive skin?

Differin can be safe for sensitive skin; however, it's best to start with a lower frequency of application and monitor your skin's response.

How often should I apply Adapalene 0.1% Gel?

Typically, you should apply Adapalene 0.1% Gel once daily in the evening after cleansing your face.

Can I use moisturizers with Differin Gel?

Yes, using a gentle moisturizer can help counteract dryness while using Differin Gel.

How long does it take to see results from Differin?

Many users begin to see improvements in their acne within 4 to 8 weeks of consistent use.

What happens if I miss an application of Adapalene?

If you miss an application, simply apply it as soon as you remember. Do not double up to make up for the missed dose.

Are there any side effects of using Adapalene Gel?

Common side effects include dryness, redness, and peeling. These usually lessen with continued use.

Can I use Differin during pregnancy or breastfeeding?

You should consult your healthcare provider before using Differin if you are pregnant or breastfeeding.

Is it safe to use sunscreen while on Adapalene treatment?

Yes, using sunscreen is recommended since Adapalene can make your skin more sensitive to sunlight.

Can Differin Gel be used on other body parts besides the face?

Differin is primarily recommended for facial acne but may be used on other areas under the guidance of a healthcare professional.

Should I wash my face before applying Differin?

Yes, you should wash your face with a gentle cleanser and pat it dry before applying the gel.

What type of cleanser should I use with Differin?

Use a mild, non-comedogenic cleanser that will not irritate your skin further.

Can children use Adapalene 0.1% W/W Gel?

Adapalene can be used by adolescents over the age of 12; consult a pediatrician for younger children.

What are some tips for minimizing irritation while using Differin?

Start with a small amount and apply every other night initially; also ensure proper moisturization and avoid harsh products.

Is it normal for my acne to worsen when starting Differin?

Some individuals may experience an initial breakout; this is common and often resolves as treatment continues.

Where can I purchase Adapalene 0.1% W/W Gel or Differin Gel?

Adapalene 0.1% W/W Gel is available at most pharmacies and online retailers; a prescription is not required in many regions.