PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet. Information on the immediate packaging is in a foreign language!
DAVERCIN
25 mg/g, gel
Erythromycini cyclocarbonas
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

Keep this leaflet so that you may read it again if necessary.
If you have any doubts, please consult your doctor or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or nurse. See section 4.

Table of contents of the leaflet:

What Davercin is and what it is used for
Important information before using Davercin
How to use Davercin
Possible side effects
How to store Davercin
Contents of the packaging and other information

1. What Davercin is and what it is used for

Davercin is a gel containing as its active substance erythromycin A cyclic 11,12-carbonate,
which belongs to the macrolide antibiotics.
Erythromycin A cyclic 11,12-carbonate acts against certain Gram-negative bacteria and many Gram-positive bacteria, including the anaerobic Gram-positive bacillus Propionibacterium acnes, which is a pathogenic factor in acne.
Davercin, when applied to intact skin, acts locally and is practically not absorbed into the body.
Indications
Topical treatment of acne vulgaris.

2. Important information before using Davercin

When not to use Davercin

if the patient is allergic to erythromycin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Davercin gel is intended for topical use on the skin only.
In case of accidental contact with eyes or mucous membranes, flush thoroughly with lukewarm water.
If skin irritation occurs at the application site, inform your doctor. The doctor will decide whether the medicine should be discontinued.
Do not apply the medicine to damaged skin (abrasions, open, oozing wounds).
Cross-resistance with other macrolide antibiotics may occur.
Safety and efficacy of the medicine in children have not been established.

Davercin and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
Concomitant topical use of other medicines, especially keratolytic and abrasive agents, is not recommended. When other topical medicines are used simultaneously, skin irritation and dryness may occur more frequently.
If combined topical treatment is necessary, another topical medicine should be applied several hours apart.

Pregnancy and breastfeeding
Consult your doctor or pharmacist before using any medicine.
If the patient is pregnant or suspects she might be pregnant
Avoid using Davercin during pregnancy unless the doctor considers its use necessary.
If the patient is breastfeeding
The decision on using Davercin in breastfeeding women should be made by a doctor.

Driving and operating machinery
There are no data available regarding the effect of this medicine on the ability to drive or operate machinery.

Davercin contains propylene glycol
The medicine contains 20 mg of propylene glycol in each g 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 g of gel.
Due to its ethanol content, the medicine may cause stinging on damaged skin.

3. How to use Davercin

Davercin is intended for topical use.
Apply the Davercin gel thinly to affected areas twice daily – in the morning and evening.
Apply the gel to clean, dry skin.
After each application, hands should be thoroughly washed.
The average duration of treatment is 6 to 8 weeks.
If you feel the medicine's effect is too strong or too weak, consult your doctor.
Use of a higher than recommended dose of Davercin
Excessive use of the medicine may cause skin irritation, which usually resolves after discontinuation of the medicine.
Seek immediate medical advice if the medicine is accidentally ingested.
Davercin is intended for cutaneous use only, not for oral administration.
In case of accidental ingestion, the doctor may recommend appropriate gastric evacuation measures.
Bring the medicine in its original packaging so that medical personnel can clearly identify which medicine was taken.
If a dose of Davercin is missed
If a dose is missed at the usual scheduled time, apply the medicine as soon as possible, then continue with the regular dosing schedule.
Do not apply a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, Davercin may cause adverse reactions, although not everyone experiences them.
If the patient develops a severe skin reaction: red, peeling rash with subcutaneous nodules and blisters (erythema multiforme), contact a doctor immediately. The frequency of these adverse reactions is unknown (cannot be estimated from available data).

The following adverse reactions have been reported rarely (less frequently than in 1 out of 1,000 patients) during treatment with Davercin.
With prolonged or repeated use of erythromycin, resistant bacteria may develop.
Eye irritation has been reported during application of the product to facial skin.
At the site of application, burning sensation, drying of the stratum corneum, itching, scaling, erythema, and increased skin oiliness may occur.

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

5. How to store Davercin

Keep this medicine out of sight and reach of children.
Store 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 stated month.
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 packaging and other information

What Davercin contains
The active substance is cyclic 11,12-carbonate of erythromycin A.
Each 1 g of gel contains 25 mg of cyclic 11,12-carbonate of erythromycin A.
Other ingredients are: dimethyl sulfoxide, propylene glycol, isopropyl alcohol, ethanol 96%, hydroxypropylcellulose.

What Davercin looks like and contents of the pack
Colourless or straw-coloured, transparent gel.
Pack: aluminium tube with a membrane, latex ring and polyethylene cap with a piercing device, in a cardboard box containing 30 g of gel.
For more detailed information, please contact the responsible party or parallel importer.

Marketing Authorisation Holder in Bulgaria, country of export:
Tarchomin Pharmaceutical Works "Polfa" S.A.
A. Fleminga 2 Street
03-176 Warsaw
Poland

Manufacturer:
Tarchomin Pharmaceutical Works "Polfa" S.A.
A. Fleminga 2 Street
03-176 Warsaw
Poland

Parallel importer:
Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
Poland
SHIRAZ PRODUCTIONS Sp. z o.o.
Tymiankowa 24/28 Street
95-054 Ksawerów
Poland

Bulgaria, country of export, Marketing Authorisation Number: 20050504
Parallel Import Licence Number: 256/23