Differin

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. 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.

It is necessary to carefully read the contents of the leaflet before using the drug, as it contains important information for the patient.

• The leaflet should be kept so that it can be read again if necessary.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This drug has been prescribed to a specific person. It should not be given to others. The drug may harm another person, even if the symptoms of their disease 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 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 moderately severe: 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, you should consult a doctor or pharmacist.
Differin cream is intended for use on the skin only.
The mouth, eyes, and mucous membranes should be protected from contact with the drug. In case of accidental contact of the drug with the mouth, eyes, or mucous membranes, they should be rinsed with a large amount of water.
Soon after starting treatment, redness, irritation, and dryness of the face may appear. In such cases, treatment should be discontinued for a few days until these symptoms subside.
During the use of the drug, due to the reduction of the thickness of the stratum corneum of the epidermis, the skin becomes more sensitive to the effects of ultraviolet radiation and locally applied drugs or cosmetics.
Therefore, during treatment with Differin cream, excessive exposure to UV radiation and sunlight (using, for example, head covering and protective filters) should be avoided, and cosmetics recommended for acne skin care or with a drying effect should not be used.

Children

Differin cream should not be used in children under 12 years of age.

Differin cream and other drugs

The doctor should be informed about all drugs currently being taken or used by the patient, as well as about the drugs that the patient plans to take or use.
Differin cream should not be used at the same time as drugs with a similar mechanism of action and other drugs used on the skin containing retinoids.
Other preparations that may have an irritating effect (e.g., peeling, drying, scrubbing, and cleaning preparations, alcohols) should not be applied to the skin.
In case of concurrent use of other anti-acne drugs (erythromycin 4%, clindamycin phosphate 1%, benzoyl peroxide 10%), they should be used in the morning, and Differin cream in the evening.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects that she may be pregnant, or plans to have a child, she should consult a doctor before using this drug.
Pregnancy
Differin should not be used during pregnancy or when planning to become pregnant. More information can be obtained from the attending doctor.
In case of pregnancy during the use of Differin, treatment should be discontinued and the doctor informed as soon as possible for further observation.
Breastfeeding
If the doctor recommends the use of the drug during breastfeeding, to avoid exposing the child to contact with the drug, Differin cream should not be applied to the breast.

Driving and using machines

No effect of Differin cream on the ability to drive vehicles, operate machines, and psychophysical fitness has been found.

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

The drug may cause allergic reactions (possible late reactions).

3. How to use Differin cream

This drug should always be used in accordance with the doctor's recommendations. In case of doubts, you should consult a doctor.
Differin is intended for use in adults and adolescents over 12 years of age.
Differin cream should be used once a day, preferably in the evening. Treatment starts with the application of a small amount of the drug to the areas of the skin affected by acne, except for the areas around the eyes and mouth, as well as the nasolabial folds, 10-15 minutes after washing and drying the skin with a towel. After applying the cream, the hands should be washed thoroughly.
If no improvement occurs after three months, the doctor should be consulted. The doctor will decide on further use of the drug.

Children

Differin cream should not be used in children under 12 years of age.

Using more than the recommended dose of Differin cream

Using the drug in excess does not accelerate or improve the treatment result and may cause significant redness, peeling, or other skin irritation symptoms.
In case of accidental ingestion of the drug, the doctor should be consulted immediately.

Missing a dose of Differin cream

The drug should be used as soon as possible. If it is almost time for the next dose, the missed dose should not be used, and the next dose should be used at the usual time.

Stopping the use of Differin cream

In case of any further doubts about the use of this drug, you should consult a doctor.

4. Possible side effects

Like all drugs, this drug may cause side effects, although not everybody gets them.
In case of any of the following symptoms, the doctor should be consulted immediately, as immediate medical attention may be necessary: 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 edema,
• itching of the eyelids,
• irritation of the eyelids,
• redness of the eyelids,
• edema of the eyelids,
• darkening of light skin,
• lightening of darker skin,
• burning at the application site.

There have been reports of burns at the application site (mainly superficial burns, but also second-degree burns or severe burns).

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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
Reporting side effects can help gather more information on the safety of the drug.

5. How to store Differin cream

The drug should be stored out of sight and reach of children.
Store at a temperature below 25°C. Do not freeze.
The drug should not be used after the expiration date stated on the packaging.
The expiration date is the last day of the specified month.
Drugs should not be disposed of in the sewage system or household waste containers. The pharmacist should be asked how to dispose of unused drugs. This will help protect the environment.

6. Package contents and other information

What Differin cream contains

• The active substance of the drug is adapalene. 1 gram of cream contains 1 mg (0.1%) of adapalene.
• The other ingredients of the drug 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 packaging contains

The drug is a cream.
The packaging consists of an aluminum-coated tube with a polypropylene screw cap containing 30 g of cream, placed in a cardboard box.
For more detailed information, the marketing authorization holder or parallel importer should be consulted.

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:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Authorization number in France, the country of export:
343 763-1
34009 343 763 1 3

Parallel import authorization number: 8/09

Date of leaflet approval: 02.02.2024

[Information about the trademark]