Differin

Package Leaflet: Information for the Patient

Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language.

Differin(Différine)

1 mg/g (0.1%), cream

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

Read the Leaflet Carefully Before Using the Medication, 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 medication has been prescribed to a specific person. Do not give it to others. The medication 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 inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

• 1. What is Differin cream and what is it used for
• 2. Important information before using Differin cream
• 3. How to use Differin cream
• 4. Possible side effects
• 5. How to store Differin cream
• 6. Package contents and other information

1. What is Differin cream and what is it used for

Differin cream contains the active substance adapalene, which works similarly to retinoids (a group of potent drugs used in skin diseases).
Adapalene applied to the skin affects the normalization of keratinization and differentiation processes 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 mild or moderate common acne (acne vulgaris) - comedonal acne (acne comedonica), papulopustular acne (acne papulo-pustulosa).

2. Important information before using Differin cream

When not to use Differin cream:

• in pregnant women;
• in women planning to become pregnant.

Warnings and precautions

Before starting to use Differin cream, consult your doctor or pharmacist.
Differin cream is intended for use on the skin only.
Protect your mouth, eyes, and mucous membranes from contact with the medication. In case of accidental contact of the medication with the 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 occur. 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 medications or cosmetics.
Therefore, during treatment with Differin cream, avoid excessive exposure to UV radiation and sunlight (using, for example, head covering 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 cream and other medications

Tell your doctor about all medications you are taking or using now or recently, as well as medications you plan to take or use.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor before using this medication.
Pregnancy
DO NOT USE Differin during pregnancy or if you plan 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 observation.
Breastfeeding
If your doctor recommends using the medication while breastfeeding, to avoid exposing the baby to the medication, do not apply Differin cream to the breast area.

Driving and using machines

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

Differin cream contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216).

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

3. How to use Differin cream

Always use this medication exactly as your doctor has told you. If you are not sure, consult your doctor.
Differin cream is intended for use in adults and adolescents over 12 years of age.
Use Differin cream once a day, preferably in the evening. Treatment starts with applying a small amount of the medication to the areas of the 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 medication.

Children

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

Using more than the recommended dose of Differin cream

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

Missing a dose of Differin cream

Use the medication 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 cream

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

4. Possible side effects

Like all medications, Differin cream 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 dark skin,
• burning at the application site. There have been reports of burns at the application site (mainly superficial, but also second-degree 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 for Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +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 medication.

5. How to store Differin cream

Keep the medication out of sight and reach of children.
Do not use this medication after the expiry date stated on the packaging.
The expiry date refers to the last day of the month stated.
Do not store above 25°C. Do not freeze.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Differin cream contains

• The active substance of the medication is adapalene. 1 g of cream contains 1 mg of adapalene.
• The other ingredients of the medication are: carbomer 934 P, macrogol 20 methylglucose sesquisterate, glycerol, natural squalane, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), disodium edetate, methylglucose sesquisterate, phenoxyethanol, cyclomethicone, sodium hydroxide, 10% solution, purified water.

What Differin cream looks like and what the package contains

The medication is a cream.
The packaging consists of an aluminum tube with a polypropylene 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-Cheran
France

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in France, the country of export:343 763.1
3400934376313
Parallel import authorization number:163/09

Date of leaflet approval: 19.07.2024

[Information about the trademark]