Patient Information Leaflet

Davercin, 150 mg/5 ml, granules for oral suspension
Erythromycini cyclocarbonas
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others. It may harm other people, even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, tell your doctor. See section 4.

Leaflet contents:

What Davercin is and what it is used for
Important information before taking Davercin
How to take Davercin
Possible side effects
How to store Davercin
Contents of the pack and other information

1. What Davercin is and what it is used for

Davercin contains as its active substance erythromycin cyclocarbonate, which belongs to the group of macrolide antibiotics. It inhibits the growth of many bacteria (bacteriostatic action).
Davercin is used in the treatment of the following infections:

respiratory tract infections, e.g. pneumonia caused by Mycoplasma pneumoniae, Chlamydia pneumoniae;
pertussis (whooping cough) caused by Bordetella pertussis in infants and young children, and also for prophylaxis of Bordetella pertussis infection (in individuals in direct contact with infected persons);
urethritis caused by Chlamydia trachomatis, Ureaplasma urealyticum;
gastrointestinal infections caused by Campylobacter jejuni, Campylobacter coli;
erythrasma (caused by Corynebacterium minutissimum);
chancroid (caused by Haemophilus ducreyi);
skin and soft tissue infections caused by Staphylococcus aureus strains resistant to penicillins, and in patients allergic to penicillin antibiotics;
erythromycin cyclocarbonate is considered an alternative antibiotic in cases of penicillin hypersensitivity for streptococcal pharyngitis, erysipelas (Streptococcus pyogenes), infections caused by Streptococcus pneumoniae, diphtheria (Corynebacterium diphtheriae), erysipeloid (Erysipelothrix rhusiopathiae), gonorrhoea (Neisseria gonorrhoeae), early syphilis (Treponema pallidum), and for prophylaxis of bacterial endocarditis in patients undergoing dental procedures.

2. Important information before taking Davercin

When not to take Davercin

if you are allergic (hypersensitive) to erythromycin cyclocarbonate or to other macrolide antibiotics, or to any of the other ingredients of this medicine (listed in section 6);
if you have severe liver impairment;
if you are currently taking any of the following medicines:
- lovastatin or simvastatin (cholesterol-lowering agents), terfenadine or astemizole (commonly used for hay fever and allergies), cisapride (used for gastrointestinal disorders), pimozide (used to treat psychiatric conditions), carbamazepine or ketoconazole during erythromycin therapy, as concomitant use of these medicines may sometimes cause serious cardiac arrhythmias. Ask your doctor about alternative medicines you may take instead of those listed above (see section 2 "Other medicines and Davercin");
- lomitapide (used to reduce elevated blood lipid levels such as cholesterol and triglycerides). Taking this medicine together with erythromycin may lead to increased activity of liver enzymes (aminotransferases), indicating liver stress and possible liver dysfunction;
if you have abnormally low blood levels of potassium or magnesium (hypomagnesemia or hypokalemia);
if you or a family member have a history of cardiac arrhythmias (ventricular tachycardia or torsades de pointes type arrhythmias) or an electrocardiogram (ECG) abnormality known as "long QT syndrome".

If any of the above conditions apply to you, you must not take Davercin.
If in doubt, consult your doctor or pharmacist before starting treatment with Davercin.

Warnings and precautions

Before starting treatment with this medicine, inform your doctor if you have:

liver and/or kidney disease;
are taking other medicines known to cause serious cardiac arrhythmias;
have heart problems.

During treatment with Davercin, inform your doctor if you develop acute, persistent diarrhoea.

Davercin and other medicines

Tell your doctor about all medicines you are currently taking, have recently taken, or plan to take, including medicines available without a prescription.

Concomitant use of Davercin with any of the following medicines is contraindicated:

lovastatin, simvastatin (cholesterol-lowering agents);
astemizole, terfenadine (antihistamines used in allergic conditions);
cisapride (used for gastrointestinal disorders);
carbamazepine, phenytoin (antiepileptic drugs);
ketoconazole (antifungal agent);
lomitapide (used to reduce elevated blood lipid levels such as cholesterol and triglycerides).

It is also important to inform your doctor if you are taking any of the following medicines:

phenytoin (antiepileptic drug);
theophylline (used in the treatment of bronchial asthma and other lung diseases);
digoxin (used in heart failure);
cyclosporine (used to suppress the immune system to prevent or treat organ or bone marrow transplant rejection);
alfentanil (a painkiller and sedative);
sleeping or sedative medicines;
ergotamine, dihydroergotamine (used to treat migraine);
oral anticoagulants such as warfarin, acenocoumarol, and rivaroxaban (used to thin the blood);
oral contraceptives;
corticosteroids taken orally, by injection, or inhaled (used to suppress the immune system – useful in treating many conditions);
hydroxychloroquine or chloroquine (used in treating diseases such as rheumatoid arthritis or for treatment or prevention of malaria). Taking these medicines together with erythromycin may increase the risk of abnormal heart rhythm and other serious cardiac adverse effects.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
The active ingredient in Davercin may cross the placenta in pregnant women and is excreted in breast milk. Data from studies on the risk of congenital malformations are inconsistent; however, some studies have reported cardiac defects after use of Davercin in early pregnancy.
Erythromycin may be administered to pregnant or breastfeeding women only if, in the opinion of the doctor, it is clearly necessary.

Davercin contains sucrose

This medicine contains 2,146 mg of sucrose in 5 ml of suspension. If you have been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.

Davercin contains sodium

This medicine contains 46 mg of sodium in 5 ml of suspension (per dose unit), which is equivalent to 2.3% of the maximum daily recommended sodium intake for adults.

3. How to use Davercin

Davercin should always be used as directed by the physician. In case of doubt, consult the
attending physician or pharmacist again.
Adults
The initial dose is usually 750 mg (5 scoops). Then, 525 mg (3.5 scoops) is administered every
12 hours.
In severe infections, the dose may be increased up to 2 g per day, given in two divided doses,
i.e. 1 g (7 scoops) every 12 hours.
Children
The initial dose is usually 30 mg/kg body weight. Then, 15 mg/kg body weight is administered
every 12 hours.
Duration of treatment
The exact duration of treatment will be determined by the physician.
Administration method
The medicine should be taken on an empty stomach, 1 hour before or 2 hours after a meal.
Preparation of the suspension
Add boiled, cooled water to the mark (60 ml) in the bottle containing the granules. Shake
vigorously until a suspension is obtained. After settling, if necessary, add water up to the mark.
Before each dose, the bottle with suspension must always be shaken vigorously.
If the effect of the medicine seems too strong or too weak, consult the physician.
Use of a higher than recommended dose of Davercin
If a patient has taken a higher dose of Davercin than recommended, symptoms may include
irritation of the stomach and intestines (nausea, vomiting or diarrhea, abdominal pain) and hearing
disturbances.
In case of overdose, inform the attending physician or go immediately to the nearest hospital
emergency department. Bring the medicine in its original packaging so that medical staff can
accurately identify which medicine was taken.
Missed dose of Davercin
If a dose is missed, it should be taken as soon as possible, and subsequent doses should be taken
according to the recommended dosing schedule. However, if the time for the next dose is
approaching, the missed dose should be skipped and the next dose taken as prescribed.
Do not take a double dose to make up for a missed dose.
Discontinuation of Davercin treatment
It is important that the medicine is used according to the recommended treatment course. Do not
stop treatment just because the patient feels better. Premature discontinuation of treatment may
lead to recurrence of the infection.
If the patient feels worse during treatment or does not feel well after completing the recommended
treatment course, they should consult the physician.
If there are any further doubts regarding the use of this medicine, consult the physician or
pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Below is a list of adverse reactions that may occur with this medicine.
Serious adverse reactions
If any of the following reactions occur, stop taking the medicine immediately and
contact your doctor or go to the emergency room of the nearest hospital.

Allergic reactions
- Swelling of the lips, face, or neck leading to severe breathing difficulties, skin rash, or urticaria;
- Blisters or bleeding around the mouth, eyes, nose, oral cavity, and genital organs, which may be caused by severe conditions such as Stevens-Johnson syndrome or toxic epidermal necrolysis;
Irregular heartbeats (including palpitations, rapid heartbeat, life-threatening arrhythmias known as torsades de pointes, or abnormal heart function on ECG) or cardiac arrest;
Persistent diarrhoea containing blood or mucus in the stool.

If a 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).
Other adverse reactions that may occur during treatment:

Infections caused by drug-resistant bacteria or fungi;
Very rarely, a decrease in the number of certain types of white blood cells has been observed;
Occasionally, some patients may experience hearing disturbances (tinnitus, deafness), especially after high doses of the medicine and/or in patients with liver or kidney impairment – these disturbances usually resolve after discontinuation of the medicine;
Occasional heart rhythm disturbances, palpitations;
Abdominal pain, nausea, vomiting, diarrhoea – most commonly occurring after high doses of the medicine;
Transient increases in the activity of certain substances (enzymes) produced in the liver (visible in blood test results);
Rarely, disturbances in liver function, hepatitis with jaundice caused by elevated bilirubin levels (a substance produced in the liver) in the blood, which may lead to yellowing of the skin and whites of the eyes;
Urinary disturbances that may be caused by kidney diseases;
Dizziness, confusion, hallucinations, nightmares, pancreatitis – observed very rarely.

Reporting adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to gather more information on the safety of using this medicine.

5. How to store Davercin

Keep out of the sight and reach of children.
Granules for oral suspension: store below 25°C.
Keep in the original packaging to protect from moisture.
Aqueous suspension: store in the refrigerator (2°C to 8°C); the suspension is stable for 14 days.
Do not use Davercin 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 will help protect the environment.

6. Contents of the package and other information

What Davercin contains
The active substance is erythromycin cyclic carbonate.
1 ml of the prepared suspension contains 30 mg of erythromycin 11,12-cyclic carbonate.
Excipients: sodium carmellose, disodium hydrogen phosphate anhydrous, cherry flavouring, caramel flavouring, soy lecithin, quinoline yellow (E 104), sucrose.

What Davercin looks like and contents of the pack
Yellow granules
Packaging: 30 g granules in a bottle, in a cardboard box.

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

For further information on this medicinal product, please contact the Marketing Authorisation Holder.