Package leaflet: Information for the patient

DAVERCIN, 25 mg/ml, cutaneous solution
Erythromycini cyclocarbonas
Please read all of this leaflet carefully before using the medicine, because it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any questions, 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 other people, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. 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 adverse reactions
How to store Davercin
Contents of the pack and other information

1. What Davercin is and what it is used for

Davercin cutaneous solution contains as the active substance erythromycin cyclic
11,12-carbonate, which belongs to the macrolide antibiotics.
Indications
Topical treatment of acne vulgaris.

2. Information before using Davercin

When not to use Davercin

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

Warnings and precautions
Before starting treatment with Davercin, discuss this with your doctor or pharmacist.

Davercin solution is intended for topical use only.
Davercin must not be applied to mucous membranes or damaged skin. In case of accidental contact with eyes or mucous membranes, rinse thoroughly with lukewarm water.
If signs of skin irritation occur at the application site, inform your doctor. The doctor will decide whether the medicine should be discontinued.
Do not apply Davercin to damaged skin (abrasions, open, oozing wounds).
If new infections occur, inform your doctor. During treatment, overgrowth of bacteria resistant to erythromycin may occur. The doctor will decide on appropriate antibacterial therapy.
Cross-resistance with other macrolide antibiotics may occur.

Davercin and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to use.
Concomitant topical use of other medicinal products, especially keratolytic and abrasive agents, is not recommended. When other topical medicines are used simultaneously, skin irritation and dryness may occur more frequently.
If combination topical therapy is necessary, another topical medicine should be applied several hours apart from Davercin.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine.
If the patient is pregnant or suspects she may be pregnant
Avoid using Davercin during pregnancy unless the doctor considers its use necessary.
If the patient is breastfeeding
The decision on using Davercin solution in breastfeeding women should be made by the doctor.

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

Davercin contains ethanol
This medicine contains 593.1 mg of alcohol (ethanol) per 1 ml of solution.
The medicine may cause stinging on damaged skin.

3. How to use Davercin
This medicine should always be used as directed by the doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine is for topical use only.
Affected skin areas are usually treated twice daily (morning and evening) with a cotton swab soaked in Davercin solution.
Apply the medicine to clean, dry skin.
After application, wash hands thoroughly.
The average duration of treatment is approximately 4 weeks.
If the effect of the medicine seems too strong or too weak, consult your doctor.

Use in children
There are no data on use in children.

Use of a higher than recommended dose of Davercin
Overuse of the medicine may cause skin irritation, which usually resolves after discontinuation of treatment.
Contact your doctor immediately in case of accidental ingestion.
Davercin is intended for topical use only, not for oral administration. In case of accidental ingestion, the doctor may recommend appropriate gastric evacuation. Bring the medicine in its original packaging so that medical personnel can identify exactly which medicine was taken.

Missed dose of Davercin
If a dose is missed at the usual scheduled time, apply the medicine as soon as possible, then continue regular dosing.
Do not use a double dose to make up for a missed dose.

Stopping Davercin treatment
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Davercin can cause adverse effects, although not everyone will experience them.
With prolonged or repeated treatment with erythromycin, resistant bacteria may develop.
Eye irritation has been reported during application of the medicine to facial skin.
At the site of application, burning, drying of the stratum corneum, itching, peeling, redness, and increased oiliness of the skin may occur.
If the patient develops a severe skin reaction: red, peeling rash with subcutaneous nodules and blisters (bullous eruption), medical advice should be sought immediately. The frequency of these adverse effects is unknown (cannot be estimated from available data).
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse effects 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
Adverse effects can also be reported to the responsible entity.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Davercin

Keep the medicine out of sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date (EXP) 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 in use. This will help protect the environment.

6. Contents of the pack and other information

What Davercin contains
The active substance is erythromycin A cyclic 11,12-carbonate.
1 ml of solution contains 25 mg of erythromycin A cyclic 11,12-carbonate.
Other ingredients of the medicine are: ethanol 96%, isopropyl myristate.

What Davercin looks like and contents of the pack
Colourless or slightly straw-coloured solution.
Pack size: 30 ml solution.

Marketing Authorisation Holder and Manufacturer
Tarchomin Pharmaceutical Works "Polfa" Joint Stock Company
A. Fleminga 2
03-176 Warsaw
Telephone number: 22 811-18-14

For further information, please contact the Marketing Authorisation Holder.