Belakne combi

Package leaflet: Information for the user

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Belakne Combi, 1 mg/g + 25 mg/g, gel
Adapalene + Benzoyl peroxide
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm someone else, even if their symptoms are similar.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor or pharmacist. See section 4.

Table of contents:

1. What Belakne Combi is and what it is used for
2. What you need to know 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 Belakne Combi is and what it is used for

Belakne Combi is used in 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 specifically affects skin processes that cause acne. The second active substance, benzoyl peroxide, has antibacterial effects and softens and exfoliates the outer layer of the skin.

2. Information before using Belakne Combi

When not to use Belakne Combi:

• if the patient is allergic to the active substances or to 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 treatment with Belakne Combi, consult your doctor or pharmacist.
Do not apply Belakne Combi to areas of skin with cuts, abrasions, sunburns, or eruptions.
Care should be taken to avoid contact of Belakne Combi with eyes, mouth, nose, or other sensitive areas of the body. If such contact occurs, the affected area should be rinsed thoroughly with a large amount of lukewarm water.
Avoid excessive exposure to sunlight and UV lamps.
Avoid contact of Belakne Combi with hair and dyed fabrics, as it may cause bleaching. Hands should be washed carefully after applying the medicine.
Belakne Combi contains 40 mg of propylene glycol per 1 g of gel.

Belakne Combi and other medicines
Inform your doctor or pharmacist about all medicines currently or recently used, as well as any medicines planned for use.
Do not use other anti-acne medications (containing benzoyl peroxide and/or retinoids) simultaneously with Belakne Combi.
Avoid using Belakne Combi together with cosmetics that cause skin irritation, drying, or exfoliation.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Do not use Belakne Combi if the patient is pregnant or plans to become pregnant. Further information is available from the doctor.
If pregnancy occurs during treatment with Belakne Combi, therapy must be discontinued immediately and the doctor should be informed as soon as possible for further monitoring.
Belakne Combi may be used during breastfeeding. To avoid exposing the infant to the medicine, do not apply it to the chest area.
Belakne Combi contains 40 mg of propylene glycol (E 1520) in each gram, corresponding to 4% (w/w).

3. How to use Belakne Combi

This medicine should always be used as directed by a physician. If in doubt, consult a
doctor or pharmacist.
Belakne Combi is indicated for use only in adults and adolescents and children aged 9 years and older. The medicine is intended for external use only.
Apply a thin, even layer of the medicine once daily, before bedtime, to the skin area affected by acne, avoiding contact with eyes, mouth, and nostrils. The skin should be clean and dry before application. After applying Belakne Combi, hands should be thoroughly washed.
Bottle: one press of the dispenser delivers on average approximately 0.5 g of gel.
The doctor will inform the patient how long Belakne Combi should be used.
If the effect of Belakne Combi seems too strong or too weak, consult a doctor or pharmacist.
If persistent irritation occurs during treatment with Belakne Combi, contact a doctor.
The doctor may recommend using a moisturizing product, applying the gel less frequently, temporarily interrupting treatment, or completely discontinuing therapy.
Use of more than the recommended dose of Belakne Combi
Using more Belakne Combi than recommended will not lead to faster improvement of acne and may cause skin irritation and redness.
Contact a doctor or hospital:

• if more than the recommended dose of Belakne Combi has been used
• if the medicine has been accidentally used by a child
• if the medicine has been accidentally swallowed. A doctor will advise on the necessary steps.

Missed dose of Belakne Combi
Do not use a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
Treatment should be discontinued and immediate medical help must be sought if the patient develops
tightness in the throat or swelling of the eyes, face, lips or tongue, weakness or difficulty breathing.
Treatment should be discontinued if the patient develops hives or itching of the face or body.
The frequency of these adverse reactions is unknown.
Adverse reactions that are common (may occur in up to 1 in 10 people):
dry skin, localised skin rash (irritant contact dermatitis), burning sensation, skin irritation, redness, peeling.
Adverse reactions that are uncommon (may occur in up to 1 in 100 people):
skin itching (pruritus), sunburn.
Adverse reactions with unknown frequency (frequency cannot be determined from available data):
facial swelling, allergic contact reactions, eyelid swelling, tightness in the throat, skin pain (burning pain), blisters, breathing difficulties, skin discoloration (changes in skin color), burning at the application site.
Skin irritation following the use of Belakne Combi is usually mild or moderate in severity, with local symptoms such as redness, dryness, peeling or burning of the skin and skin pain (burning pain), most pronounced during the first week and resolving without additional treatment.
Cases of burning at the application site have been reported, mostly superficial, but in more severe cases accompanied by blister formation.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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 adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Belakne Combi

Keep this medicine out of 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 stated month.
Store below 30°C.
Shelf life after first opening the 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 in use. This will help protect the environment.

6. Contents of the pack and other information

What Belakne Combi contains
The active substances in this medicinal product are adapalene and benzoyl peroxide.
One gram of gel contains 1 mg of adapalene and 25 mg of benzoyl peroxide (in the form of benzoyl peroxide monohydrate).
The other components (excipients) are disodium edetate, sodium docecyl sulfate, poloxamer 124, glycerol, propylene glycol (E 1520), sorbitan monooleate, Sepineo P 600 (copolymer of acrylamide and sodium acryloyldimethyl taurate, 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 pack:
White PP bottle with a PP/LDPE/EVA pump dispenser and PP cap containing 30 g of gel, packed in a cardboard box.

For further information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in the Czech Republic, 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
Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation Number in the Czech Republic, country of export: 46/537/20-C
Parallel Import Authorisation Number: 78/25

This medicinal product is authorised 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