Differin

Package Leaflet: Information for the Patient

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Differin(Différine)

1 mg/g (0.1%), cream

Adapalene
Differin and Différine are different trade names for the same medicine.

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or nurse. See section 4.

Table of Contents of the Leaflet:

• 1. What is Differin and what is it used for
• 2. Important information 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 is Differin and what is it used for

Differin contains the active substance adapalene, which works similarly to retinoids (a group of strongly acting medicines used in skin diseases).
Adapalene applied to the skin affects the normalization of keratinization and differentiation of the epidermis, prevents the formation of comedones, and reduces inflammatory changes (papules and pustules).
Adapalene has a stronger anti-inflammatory effect than retinoids.
Differin is used to treat common acne (acne vulgaris) – mild or moderate: comedonal acne (acne comedonica), papulopustular acne (acne papulo-pustulosa).

2. Important information before using Differin

When not to use Differin:

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
• if the patient has a severe form of common acne or acne covering a large area of skin;
• in case of skin damage, when it is sunburned or has a rash other than acne;
• in pregnant women;
• in women planning to become pregnant.

Warnings and precautions

Before starting to use Differin, consult your doctor or pharmacist.
Differin is intended for use on the skin only.
Protect your mouth, eyes, and mucous membranes from contact with the medicine. If the medicine accidentally comes into contact with your mouth, eyes, or mucous membranes, rinse them with a large amount of water.
Soon after starting treatment, redness, irritation, and dryness of the face may appear. In such cases, stop the treatment for a few days until these symptoms subside.
During treatment, due to the thinning of the stratum corneum of the epidermis, the skin becomes more sensitive to the effects of ultraviolet radiation and locally applied medicines or cosmetics.
Therefore, during treatment with Differin, avoid excessive exposure to UV radiation and sunlight (using, for example, headgear and protective filters) and do not use cosmetics recommended for acne skin care or with a drying effect.

Children

Do not use in children under 12 years of age.

Differin and other medicines

Tell your doctor about all medicines you are taking or using, or have recently taken or used, as well as any medicines you plan to take or use.

• Do not use Differin at the same time as medicines with a similar mechanism of action and other medicines used on the skin containing retinoids.
• Do not apply other preparations to the skin that may irritate (e.g., exfoliating, drying, scrubbing, or alcohol-containing preparations).
• If you are using other anti-acne medicines (erythromycin 4%, clindamycin phosphate 1%, benzoyl peroxide 10%) at the same time, use them in the morning and Differin in the evening.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
Pregnancy
DO NOT USE Differin during pregnancy or if you are planning to become pregnant. For more information, consult your doctor.
If you become pregnant while using Differin, stop the treatment and inform your doctor as soon as possible for further monitoring.
Breastfeeding
If your doctor advises you to use the medicine while breastfeeding, to avoid exposing the baby to the medicine, do not apply Differin to the breast area.

Driving and using machines

No effects of Differin on the ability to drive and use machines have been found.

Differin contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216).

The medicine may cause allergic reactions (possible late-type reactions).

3. How to use Differin

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor.
Differin is intended for use in adults and adolescents over 12 years of age.
Use Differin once a day, preferably in the evening. Treatment starts with applying a small amount of the medicine to the areas of skin affected by acne, except for the areas around the eyes and mouth and the nasolabial folds, 10-15 minutes after washing and drying the skin with a towel. After applying the cream, wash your hands thoroughly.
If there is no improvement after three months, consult your doctor. The doctor will decide on further use of the medicine.

Children

Do not use Differin in children under 12 years of age.

Using more than the recommended dose of Differin

Using more medicine than recommended does not speed up or improve the treatment result and may cause significant redness, peeling, or other skin irritation symptoms.
If you accidentally swallow the medicine, contact your doctor immediately.

Missing a dose of Differin

Use the medicine as soon as possible. If it is almost time for the next dose, do not use a double dose to make up for the missed dose.

Stopping the use of Differin

If you have any further doubts about using this medicine, consult your doctor.

4. Possible side effects

Like all medicines, Differin can cause side effects, although not everybody gets them.

If you experience any of the following symptoms, contact your doctor immediately, as you may need urgent medical attention:

swelling of the face, lips, or throat, which makes swallowing or breathing difficult, rash, itching, hives, and dizziness. This may be a sign of angioedema or a severe allergic reaction (frequency not known, cannot be estimated from the available data).
Common side effects(less than 1 in 10 patients)

• dry skin,
• skin irritation,
• burning sensation of the skin,
• redness of the skin (erythema).

Uncommon side effects(less than 1 in 100 patients)

• contact dermatitis, irritant rash,
• skin discomfort,
• sunburn,
• itching of the skin (pruritus),
• peeling of the skin,
• acne (exacerbation of acne).

Frequency not known(cannot be estimated from the available data)

• allergic contact dermatitis,
• skin pain,
• skin swelling,
• itching of the eyelids,
• irritation of the eyelids,
• redness of the eyelids,
• swelling of the eyelids,
• darkening of light skin,
• lightening of darker skin,
• burning at the application site. There have been reports of burning at the application site (mainly superficial burns, but also second-degree burns or severe burns).

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Differin

Keep the 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 the month stated.
Store below 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. This will help protect the environment.

6. Contents of the pack and other information

What Differin contains

• The active substance of Differin is adapalene. 1 g of cream contains 1 mg of adapalene.
• The other ingredients are: carbomer 934P, macrogol 20 methylglucose sesquisterate, glycerol, natural squalane, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), disodium edetate, methylglucose sesquisterate, phenoxyethanol, cyclomethicone, sodium hydroxide, 10% solution, purified water.

What Differin looks like and contents of the pack

Differin is a cream.
The pack consists of aluminum tubes with a screw cap containing 30 g of cream, placed in a cardboard box.
For more detailed information, consult the marketing authorization holder or the parallel importer.

Marketing authorization holder in France, the country of export:

Galderma International
Tour Europlaza – La Défense 4
20, Avenue André Prothin
92927 La Défense Cedex
France

Manufacturer:

Laboratoires Galderma
ZI DU Montdésir
74540 Alby-sur-Chéran
France

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in France, the country of export: 34009 343 763 1 3
343 763-1
Parallel import authorization number: 166/19

Date of approval of the leaflet: 25.03.2024

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