Differin

Package Leaflet: Information for the Patient

Differin, 1 mg/g, Cream

Adapalene

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of the Package Leaflet:

• 1. What Differin cream is and what it is used for
• 2. Important information before using Differin cream
• 3. How to use Differin cream
• 4. Possible side effects
• 5. How to store Differin cream
• 6. 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 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 lesions (papules and pustules).
Adapalene has a stronger anti-inflammatory effect than retinoids.
Differin is used to treat mild or moderate common acne (acne vulgaris) – comedonal acne (acne comedonica), papulopustular acne (acne papulo-pustulosa).

2. Important information before using Differin cream

When not to use Differin cream:

Warnings and precautions

Before starting to use Differin cream, consult your doctor or pharmacist.
Differin cream is for use on the skin only.
Keep your mouth, eyes, and mucous membranes away from the medicine. If the medicine accidentally comes into contact with your mouth, eyes, or mucous membranes, rinse them with plenty of water.
In the short term after starting treatment, redness, irritation, and dryness of the face may occur. In such cases, stop the treatment for a few days until these symptoms subside.
During treatment, due to the thinning of the stratum corneum of the epidermis, the skin becomes more sensitive to ultraviolet radiation and locally applied drugs or cosmetics.
Therefore, during treatment with Differin cream, avoid excessive exposure to UV radiation and sunlight (using, for example, headgear and protective filters) and do 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 cream and other medicines

Tell your doctor about all medicines you are taking or using now or recently, and about medicines you plan to take or use.

• Do not use Differin cream at the same time as medicines with a similar mechanism of action and other medicines used on the skin containing retinoids.
• Do not apply other products that may irritate the skin (e.g., exfoliating, drying, scrubbing, or alcohol-containing products).
• If you are using other anti-acne medicines (erythromycin 4%, clindamycin phosphate 1%, benzoyl peroxide 10%) at the same time, use them in the morning and Differin cream in the evening.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
Pregnancy
Do not use Differin during pregnancy or if you are planning to become pregnant. For more information, consult your doctor.
If you become pregnant while using Differin, stop the treatment and inform your doctor as soon as possible for further monitoring.
Breastfeeding
If your doctor advises you to use the medicine while breastfeeding, to avoid exposing your baby to the medicine, do not apply Differin cream to the breast area.

Driving and using machines

No effects on the ability to drive and use machines have been observed.

Differin cream contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216)

This medicine may cause allergic reactions (possible late reactions).

3. How to use Differin cream

Always use this medicine exactly as your doctor has told you. If you are not sure, check with your doctor.
Differin cream is for use in adults and adolescents over 12 years of age.
Apply Differin cream once a day, preferably in the evening. Start with a small amount of the medicine on the areas of the skin affected by acne, avoiding the eye and mouth areas and the nasolabial folds, 10-15 minutes after washing and drying the skin with a towel. After applying the cream, wash your hands thoroughly.
If there is no improvement after three months, consult your doctor. Your doctor will decide whether to continue the treatment.

Children

Do not use Differin cream in children under 12 years of age.

Using more Differin cream than recommended

Using more medicine than recommended will not improve the results and may cause significant redness, peeling, or other skin irritation symptoms.
If you accidentally swallow the medicine, contact your doctor immediately.

Missing a dose of Differin cream

Apply the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose. Do not apply a double dose to make up for a forgotten dose.

Stopping Differin cream treatment

If you have any further questions on the use of this product, ask your doctor.

4. Possible side effects

Like all medicines, Differin cream can cause side effects, although not everybody gets them.

If you experience any of the following symptoms, contact your doctor immediately, as you may need urgent medical attention:

swelling of the face, lips, or throat, which may cause difficulty swallowing or breathing, 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 dermatitis,
• skin discomfort,
• sunburn,
• itching (pruritus),
• peeling skin,
• acne (exacerbation of acne).

Frequency not known(cannot be estimated from the available data)

• allergic contact dermatitis,
• skin pain,
• skin swelling,
• eyelid itching,
• eyelid irritation,
• eyelid redness,
• eyelid swelling,
• skin hyperpigmentation,
• skin hypopigmentation,
• burning sensation at the application site. There have been reports of burning sensations at the application site (mainly superficial, but also second-degree or severe burns).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Poland, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Differin cream

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and tube after EXP. The expiry date refers to the last day of that month.
There are no special precautions for storage of the medicinal product.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will 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, polyethylene glycol methyl glucose sesquistearate, glycerol, natural squalane, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), disodium edetate, methyl glucose sesquistearate, phenoxyethanol, cyclomethicone, sodium hydroxide, purified water.

What Differin cream looks like and contents of the pack

The medicine is a cream.
The pack consists of aluminum tubes containing 15 g or 30 g of cream, placed in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Galderma Polska Sp. z o.o.
ul. Puławska 145
02-715 Warsaw
Poland
phone: +48 22 331 21 80

Manufacturer

Laboratoires Galderma
Z.I. Montdésir
74 540 Alby-sur-Chéran
France

Date of last revision of the package leaflet: