Acnelec

Package Leaflet: Information for the Patient

Acnelec, 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, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

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

Acnelec cream contains the active substance adapalene, which works similarly to retinoids (a group of potent drugs used in skin diseases).
Adapalene, when applied topically 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.
Acnelec cream is indicated for the treatment of mild or moderate common acne (Acne vulgaris): comedonal and papulopustular acne.

2. Important information before using Acnelec cream

When not to use Acnelec cream

• in pregnant women
• in women planning to become pregnant
• if the patient is hypersensitive (allergic) to adapalene or any of the other ingredients of this medicine (listed in section 6)
• if the patient has severe common acne or acne covering a large skin area
• in case of skin damage, when it is sunburned or has a rash other than acne

Warnings and precautions

Before starting to use Acnelec cream, consult your doctor or pharmacist.
Acnelec cream 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.
Soon after starting treatment, redness, irritation, and dryness of the face may appear. In such a case, 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 Acnelec 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 and adolescents

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

Acnelec cream and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Pregnancy, breastfeeding, and fertility

DO NOT USE Acnelec cream during pregnancy or when planning to become pregnant.
For more information, consult your doctor.
Breastfeeding
Before using any medicine, consult your doctor.
If your doctor recommends using the medicine during breastfeeding, to avoid exposing the child to the medicine, do not apply Acnelec cream to the breast area.

Driving and using machines

No effects of Acnelec cream on the ability to drive and use machines have been observed.
Acnelec cream contains methyl parahydroxybenzoate and propyl parahydroxybenzoate. The medicine may cause allergic reactions (possible late reactions).

3. How to use Acnelec cream

This medicine should always be used as directed by your doctor. If you are unsure, consult your doctor.
Acnelec cream should be used once a day, preferably in the evening.
Treatment starts with applying a small amount of the medicine to the skin, except for the areas around the eyes and mouth, as well as the nasolabial folds, 10-15 minutes after washing and drying the skin with a towel. After applying the medicine, wash your hands thoroughly.
If there is no improvement after three months, consult your doctor. The doctor will decide on further use of the medicine.

Use in children

Acnelec cream is intended for use in adults and adolescents over 12 years of age.

Using more than the recommended dose of Acnelec cream

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 Acnelec cream

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 Acnelec cream

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

4. Possible side effects

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).
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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 of the eyelids,
• irritation of the eyelids,
• 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 of 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 Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
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 Acnelec cream

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Date of last revision of the leaflet: