Belakne combi

Package leaflet: Information for the user

Belakne Combi, 1 mg/g + 25 mg/g, gel
Adapalene + Benzoyl peroxide
Please read all of this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

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 package 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 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 this with your doctor or pharmacist. Do not use Belakne Combi on areas of skin with cuts, abrasions, sunburn or rash. Care should be taken to avoid getting Belakne Combi into the eyes, mouth, nose or other highly sensitive areas of the body. If this occurs, rinse the affected area thoroughly with plenty of warm water. Avoid excessive exposure to sunlight and UV lamps. Avoid contact of Belakne Combi with hair and coloured 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

Tell your doctor or pharmacist about all medicines you are currently using, have recently used, 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 cosmetic products that may irritate, dry out or exfoliate the skin while using Belakne Combi.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think 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, treatment must be discontinued immediately and your doctor must be informed without delay for further monitoring.
Belakne Combi may be used during breastfeeding. To avoid exposing the infant to the medicine, do not apply Belakne Combi 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 exactly as prescribed 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 medicine is intended for external use only.
Apply a thin, even layer of the medicine to the skin area affected by acne once daily, before bedtime, 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.
Tube: the amount of gel that fits on one fingertip covers approximately 2.5 cm and corresponds to an average mass of about 0.5 g of gel.
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 use of Belakne Combi, contact a doctor.
The doctor may recommend using a moisturizing product, less frequent application of the gel, a temporary interruption of gel use, or complete discontinuation of 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. 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.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Treatment should be discontinued and immediate medical help should 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 effects is unknown.
Common adverse effects (may occur in up to 1 in 10 people):
dry skin, local skin rash (irritant contact dermatitis), burning sensation,
skin irritation, redness, peeling.
Uncommon adverse effects (may occur in up to 1 in 100 people):
itching of the skin (pruritus), sunburn.
Adverse 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, breathing difficulties, skin discoloration (changes in skin colour), burning at the site of application.
Skin irritation following the use of Belakne Combi is usually mild or moderate in nature, 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 site of application have been reported, mostly superficial, but in more severe cases with blister formation.
Reporting of adverse 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 of 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

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 carton after "EXP".
The expiry date refers to the last day of the stated month.
Store below 30 °C.
Period of use after first opening of the tube or bottle: 6 months, if the medicine is stored
below 25 °C.
Medicines must not be disposed of via the sewage system or household waste. Ask
your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Belakne Combi contains
The active substances are adapalene and benzoyl peroxide.
One gram of gel contains 0.001 g (1 mg) of adapalene and 0.025 g (25 mg) of benzoyl peroxide (in the form of benzoyl peroxide with water).
The other ingredients (excipients) are disodium edetate, sodium docoglycolate, poloxamer 124, glycerol, propylene glycol (E1520), sorbitan oleate, 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.
It is available in the following pack sizes:
Aluminium laminate tube with an aluminium protective membrane and a polypropylene screw cap containing 15 g or 30 g of gel, in a cardboard box.
White polypropylene airless bottle with an airless snap-on pump equipped with a head and nozzle containing 30 g, 45 g or 60 g of gel, in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
BELUPO lijekovi i kozmetika, d.d.
Ulica Danica 5
48 000 Koprivnica
Croatia

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 v 1 g gel