Package leaflet: Information for the user

Differin, 1 mg/g, cream
Adapalene
Please read all of this leaflet carefully before using this medicine because it contains
important information for you.

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 leaflet:

What Differin cream is and what it is used for
Important information 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 works 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 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 forms of acne vulgaris or acne affecting a large area of skin;
in case of skin damage, when the skin is sunburned or affected by a rash other than acne;
in female patients who are pregnant;
in female patients 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 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 facial dryness may occur. In such cases, discontinue treatment 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, avoid excessive exposure to UV radiation and sunlight (e.g. by wearing a hat and using sun protection filters), and do not use cosmetics recommended for acne-prone skin or those with astringent properties.

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 used, as well as any medicines you plan to use.

Do not use Differin cream simultaneously with medicines having a similar mechanism of action or with other topical retinoid-containing products.
Do not apply other skin preparations that may be irritating (e.g. exfoliating, astringent, abrasive-cleansing products, alcohol-based products).
If other anti-acne medications are used concurrently (e.g. 4% erythromycin, 1% clindamycin phosphate, 10% benzoyl peroxide), 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 become pregnant, 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. For further information, consult your 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 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 have been observed.

Differin cream contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216). This medicine may cause allergic reactions (delayed-type reactions possible).

3. How to use Differin cream

This medicine should always be used exactly as directed by your doctor. If in doubt, consult your doctor.
Differin cream is intended for use only 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 cream to the areas of skin 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 washed thoroughly.
If there is no improvement after three months, consult your doctor. Your doctor 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 the medicine will 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.
Missed dose of Differin cream
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 cream
If you have any further questions about the use of this medicine, consult your doctor.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everybody experiences them.
If any of the following symptoms occur, contact your doctor immediately,
as immediate medical assistance may be required:
facial swelling, swelling of the 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 based on 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 dermatitis,
skin discomfort,
sunburn,
skin itching (pruritus),
skin peeling,
acne (acne aggravation).

Frequency not known (cannot be estimated based on 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 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this 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 carton and tube following EXP.
The expiry date refers to the last day of that month.
No special precautions regarding the storage temperature of the medicinal product are required.
Medicines must 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 hexastearate, glycerol, natural squalane, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), disodium edetate, methyl glucose hexastearate, phenoxyethanol, cyclomethicone, sodium hydroxide, purified water.

What Differin cream looks like and contents of the pack
The medicine is a cream.
The packaging consists of aluminium tubes containing 15 g or 30 g of cream, placed in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Galderma Polska Sp. z o.o.
ul. Puławska 145
02-715 Warsaw
Poland
tel.: +48 22 331 21 80

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