Differin

Package Leaflet: Information for the Patient

Differin, 1 mg/g, Gel

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, please tell your doctor or nurse. See section 4.

Table of Contents of the Leaflet:

• 1. What is Differin gel and what is it used for
• 2. Important information before using Differin gel
• 3. How to use Differin gel
• 4. Possible side effects
• 5. How to store Differin gel
• 6. Contents of the pack and other information

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

Differin gel 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 changes (papules and pustules).
Adapalene has a stronger anti-inflammatory effect than retinoids.

2. Important information before using Differin gel

When not to use Differin gel:

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
• if you have severe common acne or acne covering a large area of skin;
• in case of skin damage, when it is sunburned or has a non-acne rash;
• in pregnant women;
• in women planning to become pregnant.

Warnings and precautions

Before starting to use Differin gel, consult your doctor or pharmacist.
Differin gel is intended for use on the skin only.
Protect your mouth, eyes, and mucous membranes from contact with the medicine. In case of accidental contact of the medicine with the mouth, eyes, or mucous membranes, rinse them with a large amount of water.
A short time after starting treatment, redness, irritation, and dryness of the face may occur. In such cases, discontinue 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 the effects of ultraviolet radiation and locally applied drugs or cosmetics.
Therefore, during treatment with Differin gel, 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 gel 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.

Pregnancy, breastfeeding, and fertility

Pregnancy
Before using any medicine, consult your doctor.
DO NOT USE Differin gel during pregnancy or when planning to become pregnant. For more information, consult your doctor.
In case of pregnancy during treatment with Differin gel, discontinue treatment and inform your doctor as soon as possible for further observation.
Breastfeeding
Before using any medicine, consult your doctor.
If your doctor recommends using the medicine during breastfeeding, to avoid exposing the child to contact with the medicine, do not apply Differin gel to the breast.

Driving and using machines

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

Differin gel contains propylene glycol and methylparaben. The medicine may cause allergic reactions (possible late reactions).

3. How to use Differin gel

Always use this medicine exactly as your doctor has told you. If you are not sure, check with your doctor.
Apply Differin gel once a day, preferably in the evening. Treatment starts with applying a small amount of the medicine to the areas of the skin affected by acne, except for the areas around the eyes and mouth and the nasolabial folds, 10-15 minutes after washing and drying the skin with a towel. After applying the gel, wash your hands thoroughly.
If after three months there is no improvement, consult your doctor. Your doctor will decide on further use of the medicine.

Use in children

Differin gel is intended for use in adults and adolescents over 12 years of age.

Using more than the recommended dose of Differin gel

Using more medicine than recommended does not speed up or improve treatment results and may cause significant redness, peeling, or other skin irritation symptoms.
In case of accidental ingestion of the medicine, contact your doctor immediately.

Missing a dose of Differin gel

Use the medicine as soon as possible. If it is almost time for the next dose, do not use a double dose to make up for the missed dose.

Stopping treatment with Differin gel

If you have any further questions about using this medicine, ask your doctor.

4. Possible side effects

Like all medicines, Differin gel 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 makes swallowing or breathing difficult, 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 rash,
• skin discomfort,
• sunburn,
• itching of the skin (pruritus),
• peeling of the skin,
• acne (exacerbation of acne).

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

• allergic contact dermatitis,
• skin pain,
• skin swelling,
• itching,
• irritation,
• redness of the eyelids,
• swelling of the eyelids,
• darkening of light skin,
• lightening of darker skin,
• burning at the application site.

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

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
e-mail: [email protected]
Side effects can also be reported 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 gel

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton.
The expiry date refers to the last day of that month.
There are no special precautions for storage of the medicinal product regarding temperature.
Medicines should 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 pack and other information

What Differin gel contains

• The active substance is adapalene
• The other ingredients are: propylene glycol, methylparaben, phenoxyethanol, carbomer 940, disodium edetate, poloxamer 182, sodium hydroxide, purified water.

What Differin gel looks like and contents of the pack

The medicine is a gel.
The pack consists of LDPE tubes containing 15 g or 30 g of gel, 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 leaflet:04/2020