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%), 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 you need to.
• If you have any doubts, you should consult a 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 you experience any side effects, including those not listed in this leaflet, you should tell your doctor 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 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.

2. Important information before using Differin gel

When not to use Differin gel:

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
• if you have 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.
A short time after starting treatment, redness, irritation, and dryness of the face may appear. In such cases, you should stop the treatment for a few days until these symptoms disappear.
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

Do not use 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 during pregnancy or if you are planning to become pregnant. More information can be obtained from your doctor.
In case of pregnancy during the use of Differin, you should stop 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, do 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 found.

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. If you are unsure, 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 there is no improvement after three months, 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 outcome and may cause significant redness, peeling, or other skin irritation symptoms.
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

If you have any further doubts about using 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 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,
• irritation,
• redness of the eyelids,
• swelling of the eyelids,
• darkening of light skin,
• lightening of darker skin,
• burns 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 those not listed in this leaflet, you should tell your doctor 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

Store in a temperature below 25°C. Do not freeze.
The medicine should be stored out of 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.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. 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 of adapalene.
• The other ingredients of the medicine are: carbomer 980, propylene glycol, poloxamer 182, disodium edetate, methyl parahydroxybenzoate (E 218), phenoxyethanol, 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 polyethylene 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
ZI DU Montdésir
74540 Alby Sur Cheran
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 337 887 4 2
337 887-4
Parallel import authorization number: 167/19

Date of approval of the leaflet: 03.04.2024

[Information about the trademark]