Differin

Package leaflet: Information for the user

DIFFERIN 0.1% GEL, 0.1% CREAM

adapalene
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Differin is and what it is used for
2. What you need to know before using 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

Adapalene, the active ingredient in Differin, belongs to the class of retinoids, which are chemical compounds related to Vitamin A. It is indicated for topical treatment (application on the skin) of comedonal acne (small, pinpoint skin elevations), papules (small raised skin lesions without pus), and pustules (small skin lesions containing pus).
It is suitable for the treatment of acne on the face, chest, and back.

2. What you need to know before using Differin

Do not use Differin:

• if you are allergic to adapalene or to any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant
• if you are planning a pregnancy

Warnings and precautions
Talk to your doctor or pharmacist before using Differin.
Avoid contact with eyes, mouth, corners of the nose, or mucous membranes.
If the medicine comes into contact with your eyes, rinse them immediately with plenty of warm water.
Avoid applying the medicine to damaged skin (cuts or abrasions), sunburned skin, or eczematous skin (a skin inflammation), and in case of severe acne affecting large areas of the body.
Avoid excessive exposure to sunlight or UV radiation (sunlamps, tanning beds). When exposure cannot be avoided, use sunscreen products and wear protective clothing over treated areas.
Stop using the medicine immediately if a sensitization reaction or severe irritation occurs.

Children and adolescents
The safety and efficacy of adapalene have not been established in children under 12 years of age.

Other medicines and Differin
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

• No interactions are known with other medicines used locally in combination with Differin; however, do not use the medicine together with other retinoids or medicines with the same mechanism of action.
• Absorption of adapalene through the skin is low, and therefore interaction with non-topical medicines is unlikely. There is no evidence that topical use of adapalene affects the effectiveness of oral medicines such as contraceptives (used to prevent pregnancy) or antibiotics (used to treat infections).
• Differin may cause local irritation. If used together with exfoliating agents (which remove dead skin cells), abrasive cleansers, strong drying agents, astringents, or irritating products (containing fragrances or alcohol), the irritating effect may be increased. However, anti-acne skin treatments such as erythromycin solutions (up to 4%), clindamycin phosphate (1% base), or aqueous gels of benzoyl peroxide up to 10% may be used in the morning if Differin is applied in the evening.

Pregnancy and breastfeeding
DO NOT USE Differin if you are pregnant or planning to become pregnant. Your doctor can provide further information.
If you become pregnant unexpectedly, stop treatment immediately.
Differin may be used during breastfeeding. To avoid exposing the infant by contact, avoid applying Differin to the breast area.

Driving and using machines
Differin does not affect the ability to drive or operate machinery.

Differin Gel contains:

• Methyl parahydroxybenzoate (E218), which may cause allergic reactions (including delayed reactions)
• Propylene glycol, which may cause skin irritation.

Differin Cream contains:

• Methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (including delayed reactions).

3. How to use Differin

Use this medicinal product exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
You should apply Differin to acne-affected areas once daily, after thoroughly washing and drying the skin. Apply only a thin layer of gel or cream, avoiding contact with the eyes, lips, mucous membranes, and corners of the nose.
The recommended daily dose is approximately 3 finger-tip units (2 g total weight of product), corresponding to the amount needed to treat all potentially affected areas (the entire face, shoulders, upper chest, and upper back).
One finger-tip unit is the amount of product squeezed from the tube onto the surface of the distal phalanx of the index finger.

Do not use astringent cosmetics or those that promote comedone formation (punctate skin elevations).
Your doctor will reassess the treatment after 12 weeks.
If you use more Differin than you should
If you apply an excessive amount of Differin, you will not achieve better or faster results, and you may experience marked redness, peeling, or skin irritation.
Do not take Differin orally.
If you accidentally ingest a considerable amount of Differin, contact your doctor immediately or go to the nearest hospital.
If you have any questions about the use of this medicinal product, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Differin can cause side effects, although not everybody gets them.
Contact a doctor immediately if you experience any of the following symptoms, as you may require urgent medical treatment: swelling of the face, lips or throat, making swallowing or breathing difficult, urticaria, itching, skin rashes and dizziness. These could be symptoms of angioedema or a severe allergic reaction (frequency not known, cannot be estimated based on available data).

The following side effects are listed according to frequency:
Common (may affect up to 1 in 10 people)

• Dry skin
• Skin irritation
• Burning sensation
• Erythema (skin irritation)

Uncommon (may affect up to 1 in 100 people)

• Contact dermatitis (inflammatory skin reaction)
• Skin discomfort
• Sunburn
• Itching
• Peeling
• Acne

Side effects with frequency not known* (cannot be estimated based on available data)

• Allergic dermatitis (allergic contact dermatitis)
• Skin pain
• Swelling
• Eyelid irritation
• Eyelid erythema
• Eyelid itching
• Eyelid swelling
• Darkening of light skin
• Lightening of dark skin
• Application site burn

* Post-marketing pharmacovigilance data
Burns at the application site have been observed (mostly superficial burns, but also second-degree or severe burns).
Skin irritation is reversible by reducing the frequency of treatment or discontinuing it.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
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 stated on the packaging. The expiry date refers to the last day of that month.
The expiry date applies to the medicine stored in its original, unopened packaging and kept under proper storage conditions.
Differin 0.1% Cream: this medicine requires no special storage conditions.
Differin 0.1% Gel: do not freeze.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Differin 0.1% Gel contains

• The active substance is adapalene. 100 g of gel contain 0.1 g of adapalene.
• The other ingredients are carbomer, propylene glycol, poloxamer 182, disodium edetate, methyl parahydroxybenzoate, phenoxyethanol, sodium hydroxide to adjust pH to 5, purified water.

What Differin 0.1% Cream contains

• The active substance is adapalene. 100 g of cream contain 0.1 g of adapalene.
• The other ingredients are carbomer 934P, PEG-20 methyl glucose sesquistearate, glycerol, natural squalane, methyl parahydroxybenzoate, propyl parahydroxybenzoate, disodium edetate, methyl glucose sesquistearate, phenoxyethanol, cyclomethicone, sodium hydroxide to adjust pH to 6.5 ± 0.2, purified water.

Description of the appearance of Differin and contents of the pack
Topical gel, 30 g tube
Topical cream, 30 g tube
Marketing Authorization Holder
Galderma Italia S.p.A. - Via dell'Annunciata, 21 - Milan
Manufacturer
Laboratoires Galderma, Z. I. Montdésir, 74540 Alby-sur-Chéran (France)