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%), gel
Adapalene
Differin and Différine are different trade names for the same drug.

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness 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 gel and what is it used for
• 2. Important information before using Differin gel
• 3. How to use Differin gel
• 4. Possible side effects
• 5. How to store Differin gel
• 6. Contents of the packaging and other information

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

Differin gel contains the active substance adapalene, which works similarly to retinoids (a group of powerful 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.

2. Important information before using Differin gel

When not to use Differin gel:

• 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 severe 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 gel, you should consult a doctor or pharmacist.
Differin gel is intended for use on the skin only.
You should protect your mouth, eyes, and mucous membranes from contact with the medicine. In case of accidental contact of the medicine with the mouth, eyes, or mucous membranes, you should rinse them with a large amount of water.
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In the short term after starting treatment, redness, irritation, and dryness of the face may occur. In such cases, you should interrupt the treatment for a few days until these symptoms subside.
During the use of the medicine, 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 medicines or cosmetics.
Therefore, during treatment with Differin gel, you should avoid excessive exposure to UV radiation and sunlight (using, for example, headgear and protective filters) and not use cosmetics recommended for acne skin care or with a drying effect.

Children

This medicine should not be used in children under 12 years of age.

Differin gel and other medicines

You should tell your doctor about all medicines you are taking or using now or recently, as well as about medicines you plan to take or use.

Pregnancy, breastfeeding, and fertility

Pregnancy
Before using any medicine, you should consult a doctor.
DO NOT USE Differin gel during pregnancy or if you plan to become pregnant. More information can be obtained from your doctor.
In case of pregnancy during the use of Differin gel, you should interrupt the treatment and inform your doctor as soon as possible for further observation.
Breastfeeding
Before using any medicine, you should consult a doctor.
If your doctor recommends using the medicine during breastfeeding, to avoid exposing the child to contact with the medicine, you should not apply Differin gel to the breast.

Driving and using machines

No effect of Differin gel on the ability to drive and use machines has been observed.

Differin gel contains propylene glycol and methyl parahydroxybenzoate. The medicine may cause allergic reactions (possible late-type reactions).

3. How to use Differin gel

This medicine should always be used as directed by your doctor. In case of doubts, you should consult your doctor.
Differin gel should be used once a day, preferably in the evening. The treatment starts with applying a small amount of the medicine 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 gel, you should wash your hands thoroughly.
If after three months there is no improvement, you should contact your doctor. Your doctor will decide on further use of the medicine.

Use in children

Differin gel is intended for use in adults and adolescents over 12 years of age.

Using more than the recommended dose of Differin gel

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

Missing a dose of Differin gel

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

Stopping the use of Differin gel

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In case of any of the following symptoms, you should contact your doctor immediately, as 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 swelling,
• itching,
• irritation,
• 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 burns 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, you should inform your doctor, pharmacist, or nurse. 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
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 gather more information on the safety of the medicine.

5. How to store Differin gel

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C. Do not freeze.
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.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Differin gel contains

• The active substance of the medicine is adapalene. 1 gram of gel contains 1 mg (0.1%) of adapalene.
• The other ingredients of the medicine are: propylene glycol, methyl parahydroxybenzoate, phenoxyethanol, carbomer 980, disodium edetate, poloxamer 182, sodium hydroxide or hydrochloric acid, purified water.

What Differin gel looks like and what the packaging contains

The medicine is a gel.
The packaging is a PE tube containing 30 g of gel, placed in a cardboard box.
For more detailed information, you should contact 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
Z.I. Montdésir
74540 Alby-sur-Chéran, 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.
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ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorization number in France, the country of export:
337 887-4
34009 337 887 4 2

Parallel import authorization number: 13/09

Date of approval of the leaflet: 22.02.2024

[Information about the trademark]
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