Acnelec

Package leaflet: Information for the user

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

Contents of the leaflet:

1. What Acnelec cream is and what it is 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 Acnelec cream is and what it is used for
Acnelec cream contains the active substance adapalene, which acts similarly to retinoids (a group of potent medications used in skin disorders).
Topically applied adapalene helps normalize keratinization and epidermal differentiation, prevents the formation of comedones, and reduces inflammatory lesions (papules and pustules). Adapalene has stronger anti-inflammatory activity than retinoids.
Acnelec cream is indicated for the treatment of mild to moderate acne vulgaris (Acne vulgaris), including comedonal and papulopustular acne.

2. Important information before using Acnelec cream

When not to use Acnelec cream

• in pregnant women
• in women planning pregnancy
• if the patient is allergic (hypersensitive) to adapalene or 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 damaged skin, sunburned skin, or skin with a rash not caused by acne

Warnings and precautions
Before starting treatment with Acnelec cream, consult your doctor or pharmacist. Acnelec cream is for topical use only. Avoid contact with lips, eyes, and mucous membranes. In case of accidental contact with the eyes, mouth, 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, discontinue treatment for several days until symptoms subside.

During treatment, due to thinning of the stratum corneum, the skin becomes more sensitive to ultraviolet radiation and to topical medications or cosmetics.
Therefore, during treatment with Acnelec 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 and adolescents
Acnelec cream should not be used in children under 12 years of age.

Acnelec cream and other medicines
Tell your doctor or pharmacist about all medicines you are currently using, have recently used, or plan to use.

Pregnancy, breastfeeding, and fertility
Acnelec cream MUST NOT be used during pregnancy or if the patient is planning to become pregnant.
Further information should be obtained from your doctor.

Breastfeeding
Consult your doctor before using any medicine during breastfeeding.
If your doctor advises using this medicine while breastfeeding, avoid applying Acnelec cream to the chest area to prevent the infant from being exposed to the medicine.

Driving and operating machinery
Acnelec cream has no known effect on the ability to drive or operate machinery.

Acnelec cream contains methyl parahydroxybenzoate and propyl parahydroxybenzoate.
These may cause allergic reactions (delayed-type hypersensitivity reactions possible).

3. How to use Acnelec cream

This medicine should always be used as directed by the physician. If in doubt, consult
your doctor.
Acnelec cream should be applied once daily, preferably in the evening.
Treatment begins with applying small amounts of the medicine to the skin, avoiding 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 application, hands should be thoroughly washed.
If there is no improvement after three months, consult your doctor. Your doctor will decide on further treatment.
Use in children
Acnelec cream is intended for use only in adults and adolescents over 12 years of age.
Use of more than the recommended dose of Acnelec cream
Using more than the recommended amount of the 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 immediate medical advice.
Missed dose of Acnelec 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 Acnelec cream
If you have any further questions regarding the use of this medicine, consult your doctor.

4. Possible adverse effects

If any of the following symptoms occur, contact your 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 signs of angioedema or a severe allergic reaction
(frequency unknown, cannot be estimated from available data).

Like all medicines, this medicine can cause adverse effects, although not everybody gets them.

Common adverse effects (less than 1 in 10 patients):

• dry skin,
• skin irritation,
• burning sensation of the skin,
• redness of the skin (erythema).

Uncommon adverse effects (less than 1 in 100 patients):

• contact dermatitis, irritant rash,
• skin discomfort,
• sunburn,
• skin itching (pruritus),
• skin peeling,
• acne (acne aggravation).

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 application site burns have been reported (mainly superficial burns, but also second-degree
burns or severe burns).

Reporting of adverse effects

If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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

Adverse effects can also be reported to the Marketing Authorisation Holder.

By reporting adverse effects, additional information on the safety of this medicine can be collected.

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 specified month.

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