BELAKNE (1 mg + 25 mg)/g Gel

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Belakne Combi, 1 mg/g + 25 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 Belakne Combi and what is it used for
4. Important information before using Belakne Combi
   1. When not to use Belakne Combi:
   2. Warnings and precautions
   3. Belakne Combi and other medicines
   4. Pregnancy, breastfeeding, and fertility
5. How to use Belakne Combi
   1. Using more than the recommended dose of Belakne Combi
   2. Missing a dose of Belakne Combi
   3. If you have any further questions about using this medicine, ask your doctor or pharmacist.
6. Possible side effects
   1. Reporting side effects
7. How to store Belakne Combi
8. Contents of the pack and other information
   1. What Belakne Combi contains
   2. What Belakne Combi looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. This medicine has been authorized for marketing in the EEA member states under the following names:

Package Leaflet: Information for the User

Belakne Combi, 1 mg/g + 25 mg/g, Gel

Adapalene + Benzoyl Peroxide

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 inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Belakne Combi and what is it used for

Belakne Combi is used for the treatment of acne vulgaris.
This gel contains two active substances, adapalene and benzoyl peroxide, which work together but in different ways.
Adapalene belongs to a group of medicines called retinoids and acts specifically on the processes in the skin that cause acne. The second active substance - benzoyl peroxide - has antibacterial effects and softens and peels off the outer layer of the skin.

2. Important information before using Belakne Combi

When not to use Belakne Combi:

Warnings and precautions

Before starting to use Belakne Combi, discuss it with your doctor or pharmacist.
Do not use Belakne Combi on areas of the skin where there are cuts, abrasions, sunburn, or eczema.
Be careful not to get Belakne Combi in your eyes, mouth, nose, or other sensitive areas of the body. If this happens, rinse the area with plenty of warm water.
Avoid excessive exposure to sunlight and UV lamps.
Avoid contact between Belakne Combi and hair or dyed fabrics, as it may discolor them. Wash your hands carefully after using the medicine.
Belakne Combi contains 40 mg of propylene glycol in 1 g of gel.

Belakne Combi and other medicines

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.
Do not use other anti-acne medicines (containing benzoyl peroxide and/or retinoids) at the same time as Belakne Combi.
Avoid using Belakne Combi and cosmetics that cause irritation, dryness, or peeling of the skin.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Do not use Belakne Combi if you are pregnant or planning to become pregnant. For more information, consult your doctor.
If you become pregnant while using Belakne Combi, treatment must be discontinued and your doctor informed as soon as possible for further monitoring.
Belakne Combi can be used during breastfeeding. To avoid exposing the baby to Belakne Combi, do not apply it to the breast area.
Belakne Combi contains 40 mg of propylene glycol (E1520) per gram, which corresponds to 4% (w/w).

3. How to use Belakne Combi

Always use this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
Belakne Combi is indicated for use in adults and adolescents and children aged 9 years and older. The medicine is for external use only.
Apply a thin layer of the medicine evenly to the affected area of the skin once a day, before bedtime, avoiding contact with the eyes, mouth, and nostrils. Before applying the medicine, the skin should be clean and dry. After using Belakne Combi, wash your hands thoroughly.
Tube: one fingertip unit (approximately 2.5 cm of gel) contains about 0.5 g of gel.
Bottle: one press of the dispenser delivers about 0.5 g of gel.
Your doctor will tell you how long to use Belakne Combi.
If you feel that the effect of Belakne Combi is too strong or too weak, talk to your doctor or pharmacist.
If you experience persistent irritation while using Belakne Combi, contact your doctor.
He or she may recommend using a moisturizing preparation, applying the gel less frequently, stopping the use of the gel for a short time, or completely stopping treatment.

Using more than the recommended dose of Belakne Combi

Using more than the recommended dose of Belakne Combi will not make acne disappear more quickly, but may cause irritation and redness of the skin.
Contact your doctor or hospital:

Missing a dose of Belakne Combi

Do not take a double dose to make up for a forgotten dose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using the medicine and seek medical help immediately if you experience swelling of the face, lips, tongue, or throat, or difficulty breathing. Stop using the medicine if you experience hives or itching on the face or body.
The frequency of these side effects is not known.
Common side effects(may affect up to 1 in 10 people):
dry skin, local skin rash (irritant contact dermatitis), burning sensation, skin irritation, redness, peeling.
Uncommon side effects(may affect up to 1 in 100 people):
skin itching (pruritus), sunburn.
Side effects with unknown frequency(frequency cannot be estimated from the available data):
facial swelling, allergic contact dermatitis, eyelid swelling, throat tightness, skin pain (stinging pain), blisters, difficulty breathing, skin discoloration (skin color changes), irritation at the application site.
Skin irritation that may occur after using Belakne Combi is usually mild or moderate, with local symptoms such as redness, dryness, peeling, or burning of the skin, and skin pain (stinging pain), most pronounced in the first week and resolving without additional treatment.
Cases of irritation at the application site have been reported, mostly superficial, but in more severe cases with blistering.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +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 Belakne Combi

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP".
The expiry date refers to the last day of the month.
Store below 30°C.
Shelf life after first opening of the tube or bottle: 6 months, if the medicine is stored below 25°C.
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 Belakne Combi contains

The active substances are adapalene and benzoyl peroxide.
One gram of gel contains 1 mg of adapalene and 25 mg of benzoyl peroxide (as benzoyl peroxide with water).
The other ingredients (excipients) are disodium edetate, sodium docusate, poloxamer 124, glycerol, propylene glycol (E1520), sorbitan oleate, Sepineo P 600 (copolymer of acrylamide and sodium acryloyldimethyltaurine, isohexadecane, polysorbate 80), purified water.

What Belakne Combi looks like and contents of the pack

Belakne Combi is a white or very pale yellow, opaque gel
available in the following packs:
Tube with protective aluminum membrane and plastic screw cap made of polypropylene containing 15 g or 30 g of gel, in a cardboard box.
Bottle with a pump dispenser made of white polypropylene with a non-return valve and a protective cap containing 30 g, 45 g, or 60 g of gel, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

BELUPO lijekovi i kozmetika, d.d.
Danica Street 5
48 000 Koprivnica
Croatia

This medicine has been authorized for marketing in the EEA member states under the following names:

Croatia: Sona Duo 1 mg/g + 25 mg/g gel
Slovakia, Czech Republic: Belakne Combi
Slovenia: Belakne Combo 1 mg/25 mg per 1 g gel
Date of last revision of the leaflet:September 2023