DAVERCIN 25 mg /Ml Solution

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. DAVERCIN, 25 mg/ml, solution for the skin
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. 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 ethanol
5. How to use Davercin
   1. Use in children
   2. Using more than the recommended dose of Davercin
   3. Missing a dose of Davercin
   4. Stopping the use of Davercin
6. Possible side effects
   1. Reporting side effects
7. How to store Davercin
8. Package contents and other information
   1. What Davercin contains
   2. What Davercin looks like and contents of the package
   3. Marketing authorization holder and manufacturer
   4. Date of the last update of the leaflet:

Package Leaflet: Information for the Patient

DAVERCIN, 25 mg/ml, solution for the skin

Erythromycin cyclocarbonate

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• This leaflet should be kept, so that it can be re-read if necessary.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for one person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform 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. Package contents and other information

1. What is Davercin and what is it used for

Davercin solution for the skin contains the active substance cyclic 11,12-carbonate erythromycin, which belongs to the macrolide antibiotics.

Indications for use

Local treatment of common acne.

2. Important information before using Davercin

When not to use Davercin

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

Warnings and precautions

Before starting to use Davercin, discuss it with your doctor or pharmacist.

• Davercin solution is intended for use on the skin only.
• Davercin should not be used on mucous membranes and damaged skin. In case of accidental contact with eyes or mucous membranes, rinse the area with lukewarm water.
• If skin irritation symptoms occur at the application site, inform your doctor. The doctor will decide whether to discontinue the medicine.
• The medicine should not be used on damaged skin (cuts, open, weeping wounds).
• If new infections occur, inform your doctor. During treatment, excessive growth of erythromycin-resistant bacteria may occur. The doctor will decide on the use of appropriate antibacterial treatment.
• Cross-resistance with other macrolide antibiotics may occur.

Davercin and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
It is not recommended to use other medicines, especially exfoliating and abrasive ones, at the same time.
If other medicines are used on the skin at the same time, skin irritation and dryness may occur more frequently.
If combined local treatment is necessary, the other skin medicine should be applied at an interval of several hours.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.
If the patient is pregnant or thinks they may be pregnant
Davercin should be avoided during pregnancy, unless the doctor considers it necessary.
If the patient is breastfeeding
The use of Davercin solution in breastfeeding women should be decided by the doctor.

Driving and using machines

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

Davercin contains ethanol

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

3. How to use Davercin

This medicine should always be used as directed by the doctor or pharmacist. In case of doubts, consult a doctor or pharmacist.
The medicine is intended for local use.
Areas of the skin affected by the disease are usually rubbed with a swab soaked in Davercin solution 2 times a day (morning and evening).
The medicine should be applied to clean, dry skin.
After applying the medicine, wash your hands thoroughly.
The average treatment period is about 4 weeks.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor.

Use in children

There is no data on the use of Davercin in children.

Using more than the recommended dose of Davercin

Using the medicine too frequently may cause skin irritation, which usually disappears after stopping the use of the medicine.
In case of accidental ingestion of the medicine, contact a doctor immediately.
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.
Take the medicine in its original packaging, so that the medical staff can check exactly which medicine was used.

Missing a dose of Davercin

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

Stopping the use of Davercin

In case of any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Davercin can cause side effects, although not everybody gets them.
During long-term or repeated treatment with erythromycin, the development of medicine-resistant bacteria may occur.
Eye irritation has been reported during the use of the medicine on the skin of the face.
At the application site, burning, dryness of the epidermis, itching, flaking, redness, skin oiliness may occur.
If the patient experiences a severe skin reaction: red, flaking rash with nodules under the skin and blisters (pustular rash), they should contact their doctor immediately. The frequency of these side effects is unknown (cannot be estimated from the available data).

Reporting side effects

If any side effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse.
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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Davercin

Keep the medicine out of the sight and reach of children.
Store in a temperature 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 specified month.
Medicines should not be disposed of via wastewater or household waste containers.
Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Davercin contains

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

What Davercin looks like and contents of the package

Colorless or slightly straw-colored solution.
Package:30 ml solution.

Marketing authorization holder and manufacturer

Tarchomińskie Zakłady Farmaceutyczne „Polfa” Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warsaw
Phone number: 22 811-18-14
To obtain more detailed information, contact the marketing authorization holder.

Date of the last update of the leaflet: