Davercin

Leaflet accompanying the packaging: patient information

Davercin, 150 mg/5 ml, granules for oral suspension

Erythromycin cyclocarbonate

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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. See section 4.

Table of contents of the leaflet:

• 1. What is Davercin and what is it used for
• 2. Important information before taking Davercin
• 3. How to take 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 contains the active substance erythromycin cyclocarbonate, which belongs to the group of macrolide antibiotics. It inhibits the growth of many bacteria (bacteriostatic effect). Davercin is used to treat the following infections:

• respiratory tract infections, such as pneumonia caused by Mycoplasma pneumoniaeor Chlamydia pneumoniae;
• whooping cough (caused by Bordetella pertussis) in infants and young children, as well as prevention of whooping cough infection (in people with direct contact with the patient);
• urethritis caused by Chlamydia trachomatisor Ureaplasma urealyticum;
• gastrointestinal infections caused by Campylobacter jejunior Campylobacter coli;
• erythrasma (caused by Corynebacterium minutissimum);
• chancroid (caused by Haemophilus ducreyi);
• skin and soft tissue infections caused by Staphylococcus aureusstrains resistant to penicillins, as well as in patients allergic to penicillin antibiotics;
• erythromycin cyclocarbonate is considered an alternative antibiotic in case of penicillin allergy in streptococcal pharyngitis, scarlet fever (Streptococcus pyogenes), infections caused by Streptococcus pneumoniae, diphtheria (Corynebacterium diphtheriae), erysipeloid (Erysipelothrix rhusiopathiae), gonorrhea (Neisseria gonorrhoeae), early syphilis (Treponema pallidum), and in the prevention of bacterial endocarditis in patients undergoing dental procedures.

2. Important information before taking Davercin

When not to take Davercin

• if the patient is allergic (hypersensitive) to erythromycin cyclocarbonate or other macrolide antibiotics or any of the other ingredients of this medicine (listed in section 6);
• if the patient has severe liver failure;
• if the patient is taking a medicine called:
• lovastatin or simvastatin (cholesterol-lowering medicines), terfenadine or astemizole (commonly used to treat hay fever and allergies), cisapride (used to treat stomach disorders), pimozide (used to treat psychiatric disorders), carbamazepine or ketoconazole while taking erythromycin, as the combined use of these medicines may sometimes cause serious heart rhythm disturbances. The patient should ask their doctor about alternative medicines that can be taken instead of the above-mentioned ones (see section 2 "Other medicines and Davercin").
• lomitapide (used to reduce elevated blood lipid levels, such as cholesterol and triglycerides). Taking this medicine with erythromycin may lead to increased liver enzyme activity (aminotransferase), which means that the liver is overloaded and may cause liver dysfunction.
• if the patient has abnormally low potassium or magnesium levels in the blood (hypomagnesemia or hypokalemia);
• if the patient or a family member has a history of heart rhythm disturbances (ventricular tachycardia or torsades de pointestype arrhythmia) or an abnormality in the electrocardiogram (a record of the heart's electrical activity) called "long QT syndrome".

If any of the above conditions apply to the patient, they should not take Davercin.

In case of doubts before starting Davercin, the patient should consult their doctor or pharmacist.

Warnings and precautions

Before starting this medicine, the patient should inform their doctor if they have:

• liver and/or kidney disease;
• the patient is taking other medicines known to cause serious heart rhythm disturbances;
• the patient has heart problems.

During treatment with Davercin, the patient should tell their doctor if they experience severe, prolonged diarrhea.

Davercin and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription.

If the patient is taking any of the following medicines, their concurrent use with Davercin is contraindicated:

Davercin is contraindicated:

• lovastatin, simvastatin (cholesterol-lowering medicines);
• astemizole, terfenadine (antihistamine medicines used to treat allergic reactions);
• cisapride (used to treat stomach disorders);
• carbamazepine, phenytoin (medicines used to treat epilepsy);
• ketoconazole (an antifungal medicine);
• lomitapide (used to reduce elevated blood lipid levels, such as cholesterol and triglycerides).

It is also important to note if the patient is taking medicines such as:

• •phenytoin (medicines used to treat epilepsy);
• theophylline (used to treat asthma and other lung diseases);
• digoxin (used to treat heart failure);
• cyclosporin (used to suppress the immune system in preventing and treating organ or bone marrow transplant rejection);
• alfentanil (a pain-relieving and sedating medicine);
• sleeping pills/sedatives;
• ergotamine, dihydroergotamine (used to treat migraines);
• oral anticoagulants, such as warfarin, acenocoumarol, and rivaroxaban (used to thin the blood);
• oral contraceptives;
• corticosteroids, given orally, by injection, or inhaled (used to suppress the immune system - useful in treating many diseases);
• hydroxychloroquine or chloroquine (used to treat diseases such as rheumatoid arthritis or to treat or prevent malaria). Taking these medicines with erythromycin may increase the risk of abnormal heart rhythm and other serious heart-related side effects.

Pregnancy and breastfeeding

In pregnancy and during breastfeeding, or if the patient is planning to become pregnant, they should consult their doctor or pharmacist before taking this medicine. The active substance of Davercin may pass through the placenta in pregnant women and is excreted in breast milk. Information from studies on the risk of congenital malformations is inconsistent, but in some studies, heart defects were found after taking Davercin in early pregnancy. Erythromycin can be given to pregnant or breastfeeding women only if, in the doctor's opinion, it is absolutely necessary.

Davercin contains sucrose

The medicine contains 2,146 mg of sucrose in 5 ml of suspension. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Davercin contains sodium

The medicine contains 46 mg of sodium in 5 ml of suspension (in each unit dose) (main component of common salt). This corresponds to 2.3% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take Davercin

Davercin should always be taken according to the doctor's recommendations. In case of doubts, the patient should contact their doctor or pharmacist again.

Adults

The initial dose is usually 750 mg (5 measuring spoons). Then, 525 mg (3.5 measuring spoons) is given every 12 hours. In severe infections, the dose can be increased to 2 g per day, divided into two doses, i.e., 1 g (7 measuring spoons) every 12 hours.

Children

The initial dose is usually 30 mg/kg body weight. Then, 15 mg/kg body weight is given every 12 hours.

Treatment duration

The exact treatment duration is determined by the doctor.

Method of administration

The medicine is given on an empty stomach, 1 hour before or 2 hours after a meal.

Method of preparing the suspension

Pour boiled, cooled water up to the mark (60 ml) into the bottle with the granules. Shake until a suspension is obtained. After standing, if necessary, fill with water up to the mark.

Before administering each dose, the bottle with the suspension should always be shaken vigorously.

If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.

Taking a higher dose of Davercin than recommended

If the patient has taken a higher dose of Davercin than recommended, symptoms may include stomach and intestinal irritation (nausea, vomiting, or diarrhea, abdominal pain) and hearing disturbances. In case of taking a higher dose than recommended, the patient should inform their doctor or go to the nearest hospital emergency department. The patient should take the medicine in its original packaging so that the medical staff can accurately check which medicine was taken.

Missing a dose of Davercin

A missed dose should be taken as soon as possible, and subsequent doses should be given according to the recommended dosing schedule. However, if it is almost time for the next dose, the missed dose should be skipped, and the next dose should be taken as recommended.

Do not take a double dose to make up for a missed dose.

Stopping treatment with Davercin

It is essential to take the medicine according to the recommended treatment cycle. The patient should not stop treatment just because they feel better. If the treatment cycle is interrupted too early, the infection may recur. If the patient feels worse during treatment or does not feel well after completing the recommended treatment cycle, they should consult their doctor. In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Davercin can cause side effects, although not everybody gets them. The following side effects may occur:

Severe side effects

If any of the following side effects occur, the patient should stop taking the medicine and immediately inform their doctor or go to the hospital emergency department.

• allergic reactions
• swelling of the lips, face, or throat, leading to severe breathing difficulties, skin rash, or hives;
• blisters or bleeding in the mouth, eyes, nose, mouth, and genital areas, which may be caused by severe diseases such as Stevens-Johnson syndrome or toxic epidermal necrolysis;
• abnormal heart rhythm (including palpitations, faster heart rate, life-threatening arrhythmias called torsades de pointes, or abnormal heart function in the EKG) or cardiac arrest;
• prolonged diarrhea, with blood or mucus in the stool.

If the patient experiences a severe skin reaction: a red, scaly rash with bumps under the skin and blisters (pustular psoriasis), they should immediately contact their doctor. The frequency of these side effects is unknown (cannot be estimated from the available data).

Other side effects that may occur during treatment with Davercin:

• infections with bacteria or fungi that are not susceptible to the medicine;
• very rarely, a decrease in the number of certain types of white blood cells has been observed;
• sporadically, some patients may experience hearing disturbances (tinnitus, deafness), especially after taking high doses of the medicine and (or) in patients with liver and kidney failure - these disturbances usually disappear after stopping the medicine;
• sporadically, heart rhythm disturbances, palpitations may occur;
• abdominal pain, nausea, vomiting, diarrhea - most often occur after taking high doses of the medicine;
• transient increase in the activity of certain substances (enzymes) produced in the liver (visible in blood test results);
• rarely, liver function disorders, hepatitis with jaundice, caused by an increase in bilirubin levels (a substance produced in the liver) in the blood, which can cause yellowing of the skin and eyes;
• urination disorders, which may be caused by kidney disease;
• dizziness, confusion, hallucinations, nightmares, pancreatitis have been observed very rarely.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Davercin

Keep out of sight and reach of children. Granules for oral suspension: store in a temperature below 25°C. Store in the original packaging to protect from moisture. Water suspension: store in the refrigerator (2°C to 8°C); shelf life of the suspension: 14 days. Do not use Davercin after the expiry date stated on the packaging. The expiry date refers to the last day of the given month. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Davercin contains

The active substance of Davercin is erythromycin cyclocarbonate. 1 ml of the prepared suspension contains 30 mg of erythromycin cyclocarbonate. The other ingredients are: sodium carmellose, anhydrous disodium phosphate, cherry flavor, caramel flavor, soybean 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 authorization holder and manufacturer

Tarchomińskie Zakłady Farmaceutyczne "Polfa" S.A., ul. A. Fleminga 2, 03-176 Warsaw, Phone: 22 811-18-14. For more detailed information on this medicine, the patient should contact the marketing authorization holder.

Date of the last revision of the leaflet: