Belakne combi

Package leaflet: Information for the patient

Warning! Keep the 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 this leaflet carefully before using the medicine, as it contains important information for the patient.
Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, 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 another person, even if their symptoms are the same.
If the patient experiences any adverse effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Contents of the leaflet:
What Belakne Combi is and what it is used for
Important information before using Belakne Combi
How to use Belakne Combi
Possible side effects
How to store Belakne Combi
Contents of the pack and other information

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.

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, sunburn or rash.
Take care to avoid getting Belakne Combi into the eyes, mouth, nose or other sensitive areas of the body. If this happens, rinse the area thoroughly with plenty 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. Wash hands thoroughly after applying the medicine.
Belakne Combi contains 40 mg of propylene glycol per 1 g of gel.

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

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 planning to become pregnant.
More information can be obtained from the doctor.
If pregnancy occurs during treatment with Belakne Combi, treatment must be stopped 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 Belakne Combi, 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).

How to use Belakne Combi
This medicine should always be used exactly as prescribed by the doctor. If in doubt, 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 intended for external use only.
Apply a thin layer of the medicine evenly to the affected area of skin 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, wash hands thoroughly.
Bottle: one press of the dispenser delivers on average approximately 0.5 g of gel.
Your doctor will inform you how long you should use Belakne Combi.
If you feel the effect of Belakne Combi is too strong or too weak, consult your doctor or pharmacist.
If persistent irritation occurs during treatment with Belakne Combi, contact your doctor.
He or she may recommend using a moisturizing product, less frequent application of the gel, a temporary break in treatment, or complete discontinuation of therapy.

Use of more than the recommended dose of Belakne Combi
Using more Belakne Combi than recommended will not speed up the resolution of acne and may cause skin irritation and redness.
Contact your 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.
  The doctor 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 questions about the use of this medicine, consult your doctor or pharmacist.

Possible side effects
Like all medicines, this medicine may cause side effects, although not everyone 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.
Stop using the medicine if the patient develops hives or itching of the face or body. The frequency of these adverse reactions is unknown.

Frequently occurring side effects (may affect up to 1 in 10 people):
dry skin, local skin rash (contact dermatitis due to irritation), 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 estimated from 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), burn at the site of application.

Skin irritation that may occur after using Belakne Combi is usually mild or moderate, with local symptoms such as redness, dryness, peeling, burning or stinging sensation, and skin pain (burning pain), most pronounced during the first week and resolving without additional treatment.
Cases of burns at the application site have been reported, mostly superficial, but in more severe cases with blister formation.

Reporting of side effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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 helps provide more information on the safety of the medicine.

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. The expiry date refers to the last day of the stated month.
Store below 30°C. Shelf life after first opening of the bottle: 6 months, if stored below 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This helps protect the environment.

Contents of the pack and other information

What Belakne Combi contains
The active substances in this medicine 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).
Other ingredients (excipients) are edetate disodium, sodium docosanate, poloxamer 124, glycerol, propylene glycol (E 1520), sorbitan oleate, Sepineo P 600 (copolymer of acrylamide and sodium acryloyldimethyltaurate, 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:
White PP bottle with PP pump dispenser with PP/LDPE/EVA actuator and PP cap, in a cardboard box containing 30 g of gel.

For more detailed information, contact the responsible entity or 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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

This medicine has been authorised 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 v 1 g gel

Marketing Authorisation number in the Czech Republic, country of export: 46/537/20-C
Parallel import authorisation number: 259/25