BELAKNE 1 mg /G + 25 Mg/G Gel

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language.
3. Belakne Combi, 1 mg/g + 25 mg/g, Gel
   1. Read the Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.
   2. Table of Contents of the Leaflet:
4. What is Belakne Combi and what is it used for
5. Important information before using Belakne Combi
   1. When not to use Belakne Combi:
   2. Warnings and precautions
   3. Belakne Combi and other medications
   4. Pregnancy, breastfeeding, and fertility
6. How to use Belakne Combi
   1. Using a higher dose of Belakne Combi than recommended
   2. Missing a dose of Belakne Combi
   3. If you have any further questions about using this medication, consult a doctor or pharmacist.
7. Possible side effects
   1. Reporting side effects
8. How to store Belakne Combi
9. Contents of the packaging and other information
   1. What Belakne Combi contains
   2. What Belakne Combi looks like and what the packaging contains
   3. Marketing authorization holder in the Czech Republic, the country of export:
   4. Manufacturer:
   5. Parallel importer:
   6. Repackaged by:
   7. Parallel import authorization number: 78/25
   8. This medication has been authorized for marketing in EEA member states under the following names:
   9. Date of revision of the leaflet: 25.02.2025

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 Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, so you can read it again if you need to.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed to a specific person. Do not pass it on to others. The medication 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 inform their 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 packaging and other information

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

Belakne Combi is used to treat acne vulgaris.
The gel contains two active substances, adapalene and benzoyl peroxide, which work together but in different ways.
Adapalene belongs to a group of medications 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 exfoliates 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 medication.
Belakne Combi contains 40 mg of propylene glycol in 1 g of gel.

Belakne Combi and other medications

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

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medication.
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 must be discontinued, and the doctor should be informed as soon as possible for further observation.
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 (E 1520) per gram, which corresponds to 4% (w/w).

3. How to use Belakne Combi

This medication should always be used as directed by the doctor. In case of doubts, consult a doctor or pharmacist.
Belakne Combi is indicated for use only in adults and adolescents and children aged 9 years and older. The medication is for external use only.
Apply a thin layer of the medication evenly to the area of the skin affected by acne once a day, before bedtime, avoiding contact with the eyes, mouth, and nostrils. Before applying the medication, 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.
The doctor will inform the patient how long to use Belakne Combi.
If the patient feels that the effect of Belakne Combi is too strong or too weak, they should consult a doctor or pharmacist.
If the patient experiences persistent irritation while using Belakne Combi, they should contact their doctor.
The doctor 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 a higher dose of Belakne Combi than recommended

Using a higher dose of Belakne Combi than recommended will not cause acne to clear up faster and may cause irritation and redness of the skin.
Consult a doctor or hospital:

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 medication, consult a doctor or pharmacist.

4. Possible side effects

Like all medications, Belakne Combi can cause side effects, although not everybody gets them.
Stop using the medication and seek medical attention immediately if the patient experiences tightness in the throat or swelling of the eyes, face, lips, or tongue, weakness, or difficulty breathing.
Stop using the medication if the patient experiences 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, exfoliation.
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, tightness in the throat, skin pain (burning pain), blisters, difficulty breathing, skin discoloration (changes in skin color), 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, exfoliation, or burning of the skin, as well as skin pain (burning 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 any side effects occur, including any side effects not listed in the leaflet, inform a doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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.
Reporting side effects can help gather more information on the safety of the medication.

5. How to store Belakne Combi

Keep the medication out of sight and reach of children.
Do not use this medication after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
Store in a temperature below 30°C.
Shelf life after first opening the bottle: 6 months, if the medication is stored at a temperature below 25°C.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Belakne Combi contains

The active substances of the medication 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 (E 1520), sorbitan oleate, Sepineo P 600 (copolymer of acrylamide and sodium acryloyldimethyltaurine, isohexadecane, polysorbate 80), purified water.

What Belakne Combi looks like and what the packaging contains

Belakne Combi is a white or very pale yellow, opaque gel available in the following packaging:
A white PP bottle with a PP/LDPE/EVA pump with a dispenser and a PP cap, containing 30 g of gel, in a cardboard box.
For more detailed information, consult the marketing authorization holder or parallel importer.

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

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

Manufacturer:

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

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in the Czech Republic, the country of export:46/537/20-C

Parallel import authorization number: 78/25

This medication has been authorized for marketing in 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 revision of the leaflet: 25.02.2025