Belakne Combi

Package Leaflet: Information for the User

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.

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

Adapalene + Benzoyl peroxide

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. 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 to treat mild to moderate acne.
The 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 works specifically on the processes in the skin that cause acne. The second active substance, benzoyl peroxide, has antibacterial properties and also helps to dry and peel the outer layer of the skin.

2. Important information before using Belakne Combi

When not to use Belakne Combi:

• if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6),
• if the patient is pregnant,
• if the patient plans to become pregnant.

Warnings and precautions

Before starting to use Belakne Combi, the patient should discuss it with their doctor or pharmacist.
Belakne Combi should not be used on areas of the skin where there are cuts, scrapes, sunburn, or eczema.
Caution should be exercised to avoid getting Belakne Combi in the eyes, mouth, nose, or other sensitive areas of the body. If this happens, the area should be rinsed with a large amount 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 hands carefully after using the medicine.
Belakne Combi contains 40 mg of propylene glycol in 1 g of gel.
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Belakne Combi and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Do not use other 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 at the same time.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before using this medicine.
Belakne Combi should not be used if the patient is pregnant or plans to become pregnant.
More information can be obtained from the doctor.
If the patient becomes pregnant while using Belakne Combi, treatment should be stopped and the 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

This medicine should always be used exactly as prescribed by your doctor. If you are unsure, consult 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 carefully.
Bottle: one press of the dispenser delivers approximately 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, consult your doctor or pharmacist.
If you experience persistent irritation while using Belakne Combi, contact your doctor.
They 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 Belakne Combi than recommended

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

• if you have used more Belakne Combi than recommended
• if a child has accidentally used the medicine
• if the medicine has been accidentally swallowed.

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Your doctor will advise what to do next.

Missing a dose of Belakne Combi

Do not use a double dose to make up for a missed dose.

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

4. Possible side effects

Like all medicines, Belakne Combi can cause side effects, although not everybody gets them.
Stop using the medicine and seek medical help immediately if you experience swelling of the throat or face, lips, tongue, 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 unknown.
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 reactions, eyelid swelling, throat tightness, skin pain (stinging pain), blisters, breathing difficulties, skin discoloration (changes in skin color), irritation at the application site.
Skin irritation that may occur when using Belakne Combi is usually mild or moderate, with local symptoms such as redness, dryness, peeling, or burning of the skin, and stinging pain, most pronounced in the first week and resolving without additional treatment.
There have been reports of irritation at the application site, mostly superficial, but in more severe cases with blistering.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Pharmacovigilance 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
Website: https://smz.ezdrowie.gov.pl
Reporting side effects will help to gather more information on the safety of this medicine.
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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 packaging.
The expiry date refers to the last day of the month stated.
Store below 30°C.
Shelf life after first opening the bottle: 6 months.
Storage conditions after first opening the bottle: store 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 of the medicine are adapalene and benzoyl peroxide.
One gram of gel contains 1 mg of adapalene and 25 mg of benzoyl peroxide (as benzoyl peroxide hydrate).
The other ingredients (excipients) are disodium edetate, sodium docusate, poloxamer 124, glycerol, propylene glycol (E1520), sorbitan oleate, Sepineo P 600 (acrylamide/sodium acryloyldimethyltaurine copolymer, iso-hexadecane, 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:
White polypropylene (PP) bottle with a PP pump and a PP cap, containing 30 g of gel, in a cardboard box.
For more detailed information, consult the marketing authorization holder or the parallel importer.

Marketing authorization holder in the Czech Republic, the country of export:

BELUPO lijekovi i kozmetika, d.d.
Ulica Danica 5
48000 Koprivnica
Croatia

Manufacturer:

BELUPO lijekovi i kozmetika, d.d.
Ulica Danica 5
48000 Koprivnica
Croatia

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

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Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in the Czech Republic, the country of export: 46/537/20-C

Parallel import authorization number: 216/25

This medicine has been authorized for use in the EEA countries 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 revision of the leaflet: 23.06.2025

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