Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging is 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 so that you can read it again if necessary.
If you have any questions, please 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 another person, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents:

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

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

Differin cream 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 keratinization and differentiation processes in the epidermis, prevents the formation of comedones, and reduces inflammatory lesions (papules and pustules).
Adapalene has stronger anti-inflammatory activity 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 cream

When not to use Differin cream:

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 sunburnt or has a non-acne rash;
in women who are pregnant;
in women planning to become pregnant.

Warnings and precautions
Before starting treatment with Differin cream, consult a doctor or pharmacist.
Differin cream is intended for topical use only.
Avoid contact with the lips, eyes, and mucous membranes. In case of accidental contact with the lips, 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 a reduction in the thickness of the stratum corneum, the skin becomes more sensitive to ultraviolet radiation and to topical medications or cosmetics.
Therefore, during treatment with Differin cream, 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 cream and other medicines
Inform your doctor about all medicines currently or recently taken or applied, as well as any medicines you plan to take or apply.

Do not use Differin cream simultaneously with medicines having a similar mechanism of action or with other topical medicines containing retinoids.
Do not apply other skin preparations that may be irritating (e.g. exfoliating, astringent, abrasive-cleansing products, alcohol-based products).
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 cream in the evening.

Pregnancy, breastfeeding, and fertility
If the patient 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 cream during pregnancy or if the patient plans to become pregnant. Further information is available 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
If a doctor prescribes the use of this medicine during breastfeeding, avoid applying Differin cream to the chest area in order to prevent the infant's exposure to the medicine.

Driving and operating machinery
No effects of Differin cream on the ability to drive or operate machinery or on psycho-physical performance have been observed.

Differin cream contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216).
This medicine may cause allergic reactions (delayed-type reactions are possible).

3. How to use Differin cream

This medicine should always be used as directed by the physician. If in doubt, consult your doctor.
Differin cream is intended only for use in adults and adolescents over the age of 12.
Differin cream should be applied once daily, preferably in the evening. Treatment should begin by applying small amounts of the medicine to the skin areas affected by acne, avoiding the eye area, lips, and nasolabial folds, 10–15 minutes after washing and drying the skin with a towel. After application, hands should be thoroughly washed.
If there is no improvement after three months, consult your doctor. The physician will decide whether treatment should continue.
Children
Differin cream should not be used in children under 12 years of age.
Use of more than the recommended dose of Differin cream
Using more than the recommended amount of this medicine 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 medical advice immediately.
Missed dose of Differin cream
Apply the medicine 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 dose.
Stopping treatment with Differin cream
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, contact a doctor immediately,
as immediate medical assistance may be required:
swelling of the face, lips or throat causing difficulty in swallowing or breathing, 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,
itching of the skin (pruritus),
skin peeling,
acne (worsening of acne).

Frequency not known (cannot be estimated from available data)

allergic contact dermatitis,
skin pain,
skin swelling,
eyelid itching,
eyelid irritation,
eyelid redness,
eyelid swelling,
darkening of light skin,
lightening of dark skin,
application site burn. 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 the leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department for 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 enables further collection of information on the safety of the medicine.

5. How to store Differin cream

Keep the 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 stated month.
Do not store above 25°C. Do not freeze.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Differin cream contains

The active substance is adapalene. 1 g of cream contains 1 mg of adapalene.
The other ingredients are: carbomer 934 P, polyglyceryl-4 methylglucoside monostearate, glycerol, natural squalane, methylparahydroxybenzoate (E 218), propylparahydroxybenzoate (E 216), disodium edetate, methylglucoside monostearate, phenoxyethanol, cyclomethicone, sodium hydroxide 10% solution, purified water.

What Differin cream looks like and contents of the pack
The medicine is in the form of a cream.
The pack consists of an aluminium tube with a polypropylene cap, containing 30 g of cream,
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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Authorisation Number in France, the country of export: 343 763.1
Parallel Import Authorisation Number: 163/09