ACNELEC 1 mg /G Gel

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Acnelec, 1 mg/g, Gel
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet:
3. What is Acnelec gel and what is it used for
4. Important information before using Acnelec gel
   1. When not to use Acnelec gel:
   2. Warnings and precautions
   3. Children and adolescents
   4. Acnelec gel and other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Acnelec gel contains propylene glycol and methyl parahydroxybenzoate
5. How to use Acnelec gel
   1. Use in children
   2. Using more than the recommended dose of Acnelec gel
   3. Missing a dose of Acnelec gel
   4. Stopping treatment with Acnelec gel
6. Possible side effects
   1. If you experience any of the following symptoms, consult a doctor immediately, as you may need urgent medical attention: swelling of the face, lips, or throat, which makes swallowing or breathing difficult, rash, itching,
7. How to store Acnelec gel
8. Contents of the pack and other information
   1. What Acnelec gel contains
   2. What Acnelec gel looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. Date of last revision of the leaflet:

Package Leaflet: Information for the Patient

Acnelec, 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.
In case of any doubts, consult a doctor or pharmacist.
This medicine has been prescribed to you by a doctor. 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 those not listed in this leaflet, tell your doctor or pharmacist.
See section 4.

Table of Contents of the Leaflet:

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

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

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

2. Important information before using Acnelec gel

When not to use Acnelec gel:

• 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 gel, consult a doctor or pharmacist.
Acnelec 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 immediately 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 reduction of the thickness of the stratum corneum of the epidermis, the skin becomes more sensitive to the effects of ultraviolet radiation and topical medications or cosmetics.
Therefore, during treatment with Acnelec 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 and adolescents

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

Acnelec gel 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 gel 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 gel to the breast.

Driving and using machines

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

Acnelec gel contains propylene glycol and methyl parahydroxybenzoate

The medicine contains 40 mg of propylene glycol in 1 g of gel.
Propylene glycol may cause skin irritation.
Due to the presence of methyl parahydroxybenzoate, the medicine may cause allergic reactions (possible late reactions).

3. How to use Acnelec gel

Always use this medicine exactly as your doctor has told you.
In case of doubts, consult a doctor.
Acnelec gel 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 and the nasolabial folds, 10-15 minutes after washing and drying the skin with a towel. After applying the medicine, wash your hands thoroughly.
If after three months there is no improvement, consult a doctor. The doctor will decide on further use of the medicine.

Use in children

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

Using more than the recommended dose of Acnelec gel

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

Missing a dose of Acnelec 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 Acnelec gel

In case of any further doubts about using this medicine, consult a doctor.

4. Possible side effects

If you experience any of the following symptoms, consult a 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).
As with any medicine, Acnelec gel 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 those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Medicines Monitoring of 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

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 gel

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C. Do not freeze.
Shelf life after first opening the tube – 6 months.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
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 Acnelec gel contains

• The active substance is adapalene. 1 g of gel contains 1 mg of adapalene.
• The other ingredients are: methyl parahydroxybenzoate (E 218), disodium edetate, carbomer 980, propylene glycol, poloxamer 182, phenoxyethanol, sodium hydroxide, purified water.

What Acnelec gel looks like and contents of the pack

Acnelec gel is a white or almost white, semi-transparent gel with a characteristic odor.
An aluminum tube with an inner lacquered membrane, with a neck and a cap made of HDPE, containing 30 g of gel, in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

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

Manufacturer

Przedsiębiorstwo Farmaceutyczne Jelfa SA
ul. Wincentego Pola 21
58-500 Jelenia Góra
Poland

Date of last revision of the leaflet: