Patient Information Leaflet

Keep this leaflet, information on the immediate packaging in a foreign language!
Differin (Différine)
1 mg/g (0.1%) cream
Adapalene
Differin and Différine are different brand names for the same medicinal product.
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.

Keep this leaflet for future reference.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are similar.
If you experience any adverse effects, including those not listed in this leaflet, inform your doctor or nurse. See section 4.

Table of contents:

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

1. What Differin is and what it is used for

Differin 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 stronger anti-inflammatory action than other retinoids.
Differin is used in the treatment of mild to moderate acne vulgaris (acne vulgaris), including comedonal acne (acne comedonica) and papulopustular acne (acne papulo–pustulosa).

2. Important information before using Differin

When not to use Differin:

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 the skin;
in case of skin damage, when the skin is sunburned or has a rash other than acne;
in pregnant women;
in women planning to become pregnant.

Warnings and precautions
Before starting treatment with Differin, consult a doctor or pharmacist.
Differin is intended for topical use only.
Avoid contact of the medicine 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 interrupted for several days until these symptoms subside.
During treatment, due to the reduction in thickness of the stratum corneum of the epidermis, the skin becomes more sensitive to ultraviolet radiation and to topical medicines or cosmetics.
Because of this, during treatment with Differin, 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 skin care or with astringent properties should not be used.

Children
Do not use in children under 12 years of age.

Differin and other medicines
Inform your doctor about all medicines you are currently using or have recently used, as well as any medicines you plan to use.

Do not use Differin simultaneously with medicines having a similar mechanism of action or with other topical medicines containing retinoids.
Do not apply other preparations to the skin that may be irritating (e.g. exfoliating, astringent, abrasive-cleansing agents, alcohol).
If other anti-acne medicines are used concurrently (e.g. erythromycin 4%, clindamycin phosphate 1%, benzoyl peroxide 10%), apply them in the morning and Differin in the evening.

Pregnancy, breastfeeding, and fertility
If a woman is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.

Pregnancy
DO NOT USE Differin during pregnancy or if the patient is planning to become pregnant. More information is available from the treating physician.
If pregnancy occurs during treatment with Differin, treatment must be discontinued immediately and the doctor should be informed as soon as possible for further monitoring.

Breastfeeding
If a doctor prescribes the use of this medicine during breastfeeding, Differin should not be applied to the chest area in order to avoid exposing the infant to the medicine.

Driving and operating machinery
Differin has no known effect on the ability to drive or operate machinery or on psycho-physical performance.

Differin contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216).
These ingredients may cause allergic reactions (delayed-type reactions possible).

3. How to use Differin

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

4. Possible adverse reactions

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

Common adverse reactions (less than 1 in 10 patients)

Dry skin
Skin irritation
Burning sensation on the skin
Redness of the skin (erythema)

Uncommon adverse reactions (less than 1 in 100 patients)

Contact dermatitis, irritant rash
Skin discomfort
Sunburn
Itching (pruritus)
Skin peeling
Acne (worsening of acne)

Frequency not known (cannot be estimated from 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
Application site burn. Cases of application site burns have been reported (mainly superficial burns, but also second-degree burns or serious burns).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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 adverse reactions helps provide more information on the safety of the medicine.

5. How to store Differin

Keep this medicine out of the 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 specified month.
Store below 25°C. Do not freeze.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Differin contains

The active substance is adapalene. 1 g of cream contains 1 mg of adapalene.
The other ingredients are: carbomer 934 P, macrogol 20 sorbitan monostearate, glycerol, natural squalane, methylparaben (E 218), propylparaben (E 216), disodium edetate, sorbitan monostearate, phenoxyethanol, cyclomethicone, sodium hydroxide 10% solution, purified water.

What Differin looks like and contents of the pack
Differin is a cream.
The pack consists of lacquered aluminium tubes with a screw cap containing 30 g of cream, placed in a cardboard carton.
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-Chéran
France
Parallel importer:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Poland
Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Poland
Marketing authorisation number in France, the country of export: 34009 343 763 1 3
343 763-1
Parallel import licence number: 166/19