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
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 pass it on to others. The medicine may harm other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents:

1. What Belakne Combi is and what it is 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 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 action and softens and exfoliates 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 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, discuss it with your doctor or pharmacist.
Do not use Belakne Combi on areas of skin with cuts, abrasions, sunburns, or rashes.
Take care to avoid getting Belakne Combi into the eyes, mouth, nose, or other highly sensitive areas of the body. If this occurs, rinse the area thoroughly with a large amount of warm 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.
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Belakne Combi and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to use.
Do not use other anti-acne medications (containing benzoyl peroxide and/or retinoids) at the same time as Belakne Combi.
Avoid using cosmetics that irritate, dry out, or exfoliate the skin simultaneously with Belakne Combi.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Do not use Belakne Combi if you are pregnant or planning to become pregnant.
For further information, consult your doctor.
If pregnancy occurs during treatment with Belakne Combi, therapy must be discontinued immediately and your doctor should be informed without delay for further monitoring.
Belakne Combi may be used during breastfeeding. To avoid exposing the infant to Belakne Combi, do not apply it to the chest area.
Belakne Combi contains 40 mg of propylene glycol (E1520) in each gram, equivalent to 4% (w/w).

3. How to use Belakne Combi

This medicine should always be used as directed by the physician. If in doubt, consult a
doctor or pharmacist.
Belakne Combi is indicated for use only in adults and in adolescents and children aged 9 years and older.
Belakne Combi is intended for topical use only.
Apply a thin layer of the medicine evenly to the skin area affected by acne once daily, before bedtime, avoiding contact with the 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 physician 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 physician.
The physician may recommend using a moisturizing product, applying the gel less frequently, temporarily discontinuing the gel, or completely stopping treatment.
Use of a higher than recommended dose of Belakne Combi
Using more Belakne Combi than recommended does 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.

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The physician will advise what further steps should be taken.
Missed dose of Belakne Combi
Do not use a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult 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 immediate medical help if the patient experiences
tightness in the throat or swelling of the eyes, face, lips or tongue, weakness or difficulty breathing.
Discontinue use of the medicine if the patient develops hives or itching of 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, localised skin rash (irritant contact dermatitis), burning sensation, skin irritation, redness, peeling.
Uncommon side effects (may affect up to 1 in 100 people):
itching of the skin (pruritus), sunburn.
Side effects 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 discolouration (changes in skin colour), burning at the site of application.
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 sensation and skin pain (burning pain), most pronounced during the first week and subsiding without additional treatment.
Cases of burning at the site of application have been reported, mostly superficial, but in more severe cases associated with blister formation.
Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform a doctor, pharmacist or nurse. Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 helps to provide more information on the safe use of this medicine.
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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.
Storage conditions after first opening the bottle: store below 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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 with water).
The other ingredients (excipients) are: disodium edetate, sodium docucyl sulfate, poloxamer 124, glycerol, propylene glycol (E 1520), sorbitan oleate, Sepineo P 600 (acrylamide/sodium acryloyldimethyltaurate copolymer, 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:
A 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.

Responsible party in the Czech Republic, 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 in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Authorisation number in the Czech Republic, country of export: 46/537/20-C
Authorisation number for parallel import: 216/25

This medicinal product has been authorised 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 v 1 g gel

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