Davercin

Package Leaflet: Information for the Patient

DAVERCIN, 25 mg/g, Gel

Erythromycin cyclocarbonate

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your 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 pack 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 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 topical 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 application site, you should tell your 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 the medicine in children have not been established.

Davercin and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Concomitant topical use of other medicines, especially exfoliating and abrasive ones, is not recommended. When using other topical medicines, skin irritation and dryness may occur more frequently.
If concomitant topical treatment is necessary, the other skin medicine should be applied at an interval of several hours.

Pregnancy and breastfeeding

Before taking any medicine, consult your doctor or pharmacist.
If you are pregnant or think you may be pregnant
Davercin should be avoided during pregnancy unless your doctor considers it necessary.
If you are breastfeeding
Your doctor should decide whether to use Davercin gel while breastfeeding.

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 burning of damaged skin.

3. How to use Davercin

The medicine is intended for topical 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, wash your hands thoroughly.
The average treatment period is 6 to 8 weeks.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor.

Using more than the recommended dose of Davercin

Too frequent use of the medicine may cause skin irritation, which usually disappears after discontinuation of the medicine.
In case of accidental ingestion of the medicine, contact your doctor immediately.
Davercin is intended for use on the skin only, not for oral use. In case of accidental ingestion of the medicine, your doctor may recommend gastric lavage. Take the medicine in its original packaging so that the medical staff can check exactly which medicine was used.

If you miss a dose of Davercin

If you miss a dose of the medicine at the fixed, specified time, use it as soon as possible, and then continue the regular use of the medicine.
Do 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 you experience a severe skin reaction: red, flaky rash with lumps under the skin and blisters (pustular rash), contact your doctor immediately. The frequency of these side effects is unknown (cannot be estimated from the available data).
The following side effects of Davercin gel occur rarely (less than 1 in 1,000 patients).
During prolonged or repeated treatment with erythromycin, resistant bacteria may develop.
Eye irritation has been reported during use of the medicine on the facial skin.
Burning, dryness, itching, flaking, redness, or oiliness of the skin may occur at the application site.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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 to 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 stated on the packaging .
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Davercin contains

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

What Davercin looks like and contents of the pack

Colorless or straw-colored, clear gel.
Packaging:30 g of gel

Marketing authorization holder and manufacturer

Tarchomińskie Zakłady Farmaceutyczne „Polfa” Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warsaw
Phone number: 22 811-18-14

Date of last revision of the leaflet: