Davercin

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

DAVERCIN

25 mg/g, gel

Erythromycin cyclocarbonate

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

• Please 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. Do not pass it on 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 inform their doctor or nurse. 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 cyclocarbonate of erythromycin A, which belongs to the macrolide antibiotics. Cyclocarbonate 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 intact 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 lukewarm water.
• If skin irritation symptoms occur at the site of application, the patient should inform 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 inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. It is not recommended to use other local medicines, especially those that dry and irritate the skin, at the same time. If other local medicines are used at the same time, skin irritation and dryness may occur more frequently. If concomitant local treatment is necessary, the other skin medicine should be applied 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 doctor should decide whether to use Davercin.

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

This medicine contains 640 mg of alcohol (ethanol) in each gram of gel. Due to the ethanol content, the medicine may cause a burning sensation on 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 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 discontinuing 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 using an appropriate method to empty the stomach. 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 the usual, fixed time, the medicine should be used as soon as possible, and then the regular use of the medicine should be continued. The patient should not use a double dose to make up for the 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: red, flaky 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 estimated from the available data). The following side effects may occur rarely (less than 1 in 1,000 patients) after using Davercin. During long-term or repeated treatment with erythromycin, resistant bacteria may develop. Eye irritation has been reported during use of the medicine on the facial skin. At the site of application, the product may cause burning, dryness of the skin, itching, flaking, redness, or skin oiliness.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform 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, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, more information can be gathered 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 refers to 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 cyclocarbonate of erythromycin A. 1 gram of gel contains 25 mg of cyclocarbonate 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 contents of the packaging

Colorless or straw-colored, transparent gel. Packaging: aluminum tube with a membrane, a latex ring, and a polyethylene cap with a puncture device, in a cardboard box containing 30 grams of gel. For 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, Poland

Manufacturer:

Tarchomińskie Zakłady Farmaceutyczne "Polfa" S.A., ul. A. Fleminga 2, 03-176 Warsaw, Poland

Parallel importer:

Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź

Repackaged by:

Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź, SHIRAZ PRODUCTIONS Sp. z o.o., ul. Tymiankowa 24/28, 95-054 Ksawerów. Marketing authorization number in Bulgaria, the country of export: 20050504

Parallel import authorization number: 256/23

Date of leaflet approval: 09.11.2023
[Information about the trademark]