DAVERCIN 25 mg /G Gel

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
   1. 25 mg/g, gel
   2. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   3. Table of contents of the leaflet:
3. What is Davercin and what is it used for
   1. Indications for use
4. Important information before using Davercin
   1. When not to use Davercin
   2. Warnings and precautions
   3. Davercin and other medicines
   4. Pregnancy and breastfeeding
   5. Driving and using machines
   6. Davercin contains propylene glycol
   7. Davercin contains dimethyl sulfoxide
   8. Davercin contains ethanol 96%
5. How to use Davercin
   1. Using more than the recommended dose of Davercin
   2. If a dose of Davercin is missed
6. Possible side effects
   1. Reporting side effects
7. How to store Davercin
8. Contents of the packaging and other information
   1. What Davercin contains
   2. What Davercin looks like and what the packaging contains
   3. Marketing authorization holder in Bulgaria, the country of export:
   4. Manufacturer:
   5. Parallel importer:
   6. Repackaged by:
   7. Number of the parallel import authorization: 172/22 Date of approval of the leaflet: 14.04.2022

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Davercin(ДАВЕРЦИН)

25 mg/g, gel

Erythromycini cyclocarbonas
Davercin and ДАВЕРЦИН are the same trade names of the same drug written in Polish and Bulgarian.

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or nurse.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Davercin and what is it used for
• 2. Important information before using Davercin
• 3. How to use Davercin
• 4. Possible side effects
• 5. How to store Davercin
• 6. Contents of the packaging and other information

1. What is Davercin and what is it used for

Davercin gel contains as an active substance cyclic 11,12-carbonate of erythromycin A, which belongs to macrolide antibiotics.
Cyclic 11,12-carbonate of erythromycin A acts on some Gram-negative bacteria and many Gram-positive bacteria, including the anaerobic Gram-positive rod Propionibacterium acnes, which is a pathogenic factor in acne.
Davercin applied to undamaged skin acts locally and is practically not absorbed into the body.

Indications for use

Local treatment of common acne.

2. Important information before using Davercin

When not to use Davercin

Warnings and precautions

• Davercin gel is intended for local use on the skin only.
• In case of accidental contact of the medicine with the eyes or mucous membranes, these areas should be rinsed with warm water.
• If skin irritation symptoms occur at the site of application, the patient should tell their doctor. The doctor will decide whether to discontinue the medicine.
• The medicine should not be used on damaged skin (cuts, open, weeping wounds).
• Cross-resistance with other macrolide antibiotics may occur.
• The safety and efficacy of using the medicine in children have not been established.

Davercin and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Concomitant local use of other medicines, especially those that are peeling and abrasive, is not recommended. If other medicines are used locally at the same time, skin irritation and dryness may occur more frequently.
If concomitant local treatment is necessary, the other medicine should be applied to the skin at an interval of several hours.

Pregnancy and breastfeeding

Before using any medicine, the patient should consult their doctor or pharmacist.
If the patient is pregnant or thinks she may be pregnant
Davercin should be avoided during pregnancy, unless the doctor considers the use of the medicine necessary.
If the patient is breastfeeding
The use of Davercin gel in breastfeeding women should be decided by the doctor.

Driving and using machines

There are no data on the effect of the medicine on the ability to drive and use machines.

Davercin contains propylene glycol

The medicine contains 20 mg of propylene glycol in each gram of gel.
Propylene glycol may cause skin irritation.

Davercin contains dimethyl sulfoxide

The medicine may cause skin irritation.

Davercin contains ethanol 96%

This medicine contains 640 mg of alcohol (ethanol) in each gram of gel.
Due to the ethanol content, the medicine may cause burning of damaged skin.

3. How to use Davercin

The medicine is intended for local use.
Davercin gel should be applied in a thin layer to the affected areas twice a day - in the morning and in the evening.
The gel should be applied to clean, dry skin.
After each application of the gel, the hands should be washed thoroughly.
The average treatment period is 6 to 8 weeks.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.

Using more than the recommended dose of Davercin

Using the medicine too frequently may cause skin irritation, which usually disappears after discontinuation of the medicine.
In case of accidental ingestion of the medicine, the patient should immediately consult their doctor.
Davercin is intended for use on the skin only, not for oral use. In case of accidental ingestion of the medicine, the doctor may recommend the use of an appropriate method of stomach emptying. The patient should take the medicine in its original packaging so that the medical staff can check exactly which medicine was used.

If a dose of Davercin is missed

If a dose of the medicine is missed at a fixed, specified time, the medicine should be used as soon as possible, and then the regular use of the medicine should be continued.
A double dose should not be used to make up for a missed dose.

4. Possible side effects

Like all medicines, Davercin can cause side effects, although not everybody gets them.
If the patient experiences a severe skin reaction: a red, peeling rash with bumps under the skin and blisters (pustular rash), they should immediately consult their doctor. The frequency of these side effects is unknown (cannot be determined from available data).
The following side effects may occur rarely (less than 1 in 1,000 patients) after using Davercin gel.
Prolonged or repeated treatment with erythromycin may lead to the development of bacteria that are resistant to the medicine.
Eye irritation has been reported during use of the medicine on the skin of the face.
Burning, dryness of the skin, itching, peeling, redness, skin oiliness may occur at the site of application of the product.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should tell their 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:
Aleje 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 will help to gather more information on the safety of the medicine.

5. How to store Davercin

The medicine should be stored out of sight and reach of children.
Store at a temperature below 25°C.
Do not use this medicine after the expiry date stated on the packaging .
The expiry date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Davercin contains

The active substance of the medicine is cyclic 11,12-carbonate of erythromycin A.
1 g of gel contains 25 mg of cyclic 11,12-carbonate of erythromycin A.
The other ingredients of the medicine are: dimethyl sulfoxide, propylene glycol, isopropyl alcohol, ethanol 96%, hydroxypropyl cellulose.

What Davercin looks like and what the packaging contains

Colorless or straw-colored, transparent gel.
Packaging:30 g of gel
To obtain more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Bulgaria, the country of export:

Tarchomińskie Zakłady Farmaceutyczne „Polfa” S.A.
ul. A. Fleminga 2
03-176 Warsaw

Manufacturer:

Tarchomińskie Zakłady Farmaceutyczne „Polfa” S.A.
ul. A. Fleminga 2
03-176 Warsaw

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
Number of the marketing authorization in Bulgaria, the country of export:20050504

Number of the parallel import authorization: 172/22 Date of approval of the leaflet: 14.04.2022

[Information about the trademark]