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 brand names for the same medicine.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or nurse. See section 4.

Contents of the leaflet:

What Differin gel is and what it is used for
Important information before using Differin gel
How to use Differin gel
Possible side effects
How to store Differin gel
Contents of the pack and other information

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

Differin gel contains the active substance adapalene, which acts similarly to retinoids (a group of potent medicines used in skin disorders).
When applied to the skin, adapalene helps normalize the processes of keratinization and differentiation of the epidermis, prevents the formation of comedones, and reduces inflammatory lesions (papules and pustules).
Adapalene has a stronger anti-inflammatory effect than other retinoids.

2. Important information before using Differin gel

When not to use Differin gel:

if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
if the patient has severe acne vulgaris or acne affecting a large area of skin;
in case of skin damage, when the skin is sunburned or affected by a non-acne rash;
in pregnant women;
in women planning to become pregnant.

Warnings and precautions
Before starting treatment with Differin gel, consult a doctor or pharmacist.
Differin gel is intended for topical use only.
Avoid contact with the mouth, eyes, and mucous membranes. In case of accidental contact with the mouth, eyes, or mucous membranes, rinse thoroughly with plenty of water.
Shortly after starting treatment, redness, irritation, and dryness of the face may occur. In such cases, treatment should be discontinued for several days until these symptoms subside.
During treatment, due to a reduction in the thickness of the stratum corneum, the skin becomes more sensitive to ultraviolet radiation and to topical medications or cosmetics.
Because of this, during treatment with Differin gel, excessive exposure to UV radiation and sunlight should be avoided (e.g. by wearing a hat and using sun protection filters), and cosmetics recommended for acne-prone skin or with astringent properties should not be used.
Children
Do not use in children under 12 years of age.
Differin gel and other medicines
Inform your doctor about all medicines you are currently taking or using, have recently taken or used, as well as any medicines you plan to take or use.
Pregnancy, breastfeeding, and fertility
Pregnancy
Consult your doctor before using any medicine.
DO NOT use Differin gel during pregnancy or if the patient plans to become pregnant. More information can be obtained from the attending physician.
If pregnancy occurs during treatment with Differin, discontinue treatment immediately and inform your doctor as soon as possible for further monitoring.
Breastfeeding
Consult your doctor before using any medicine.
If your doctor advises using the medicine during breastfeeding, avoid applying Differin gel to the chest area in order to prevent the infant's exposure to the medicine.
Driving and operating machinery
Differin gel has no known effect on the ability to drive motor vehicles or operate machinery or on psycho-motor performance.
Differin gel contains propylene glycol and methyl parahydroxybenzoate. It may cause allergic reactions (delayed-type reactions possible).

3. How to use Differin gel

This medicine should always be used as directed by a physician. If in doubt, consult your doctor.
Differin gel should be applied once daily, preferably in the evening. Treatment should begin by applying small amounts of the medicine to skin areas affected by acne, avoiding the eye area, lips, and nasolabial folds, 10–15 minutes after washing and gently drying the skin with a towel. Hands should be thoroughly washed after applying the gel.
If no improvement is observed after three months, consult your doctor. Your doctor will decide whether to continue treatment.
Use in children
Differin gel is intended for use only in adults and adolescents over 12 years of age.
Use of more than the recommended dose of Differin gel
Using more than the recommended amount of medicine does not speed up or improve treatment outcomes and may cause significant redness, peeling, or other signs of skin irritation.
In case of accidental ingestion, seek immediate medical advice.
Missed dose of Differin gel
Apply the missed dose as soon as possible. If it is almost time for the next dose, do not apply a double dose to make up for the missed one.
Stopping Differin gel
If you have any further questions about the use of this medicine, consult your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
If any of the following symptoms occur, you should contact your doctor immediately, as immediate medical attention may be required: swelling of the face, lips or throat, which makes swallowing or breathing difficult, rash, itching, hives and dizziness.
These may be symptoms of angioedema or a severe allergic reaction (frequency unknown, cannot be estimated from available data).

Common adverse reactions (less than 1 case in 10 patients)

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

Uncommon adverse reactions (less than 1 case in 100 patients)

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

Frequency not known (cannot be estimated from available data)

allergic contact dermatitis,
skin pain,
skin swelling,
itching,
irritation,
eyelid redness,
eyelid swelling,
darkening of light skin,
lightening of dark skin,
burns at the site of application.

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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
By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store Differin gel

Store below 25°C. Do not freeze.
Keep the medicine in a place 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 stated month.
Medicines must 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 packaging and other information

What Differin gel contains

The active substance is adapalene. 1 gram of gel contains 1 mg of adapalene.
The other components are: carbomer 980, propylene glycol, poloxamer 182, disodium edetate, methyl 4-hydroxybenzoate (E 218), phenoxyethanol, sodium hydroxide or hydrochloric acid, purified water.

What Differin gel looks like and contents of the pack
The medicine is in the form of a gel.
The packaging consists of a polyethylene tube containing 30 g of gel, placed in a cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation 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.
Zbąszyńska 3 Street
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
Marketing Authorisation Number in France, the country of export: 34009 337 887 4 2
337 887-4
Parallel Import Licence Number: 167/19