Davercin

Leaflet attached to the packaging: patient information

Davercin, 250 mg, film-coated tablets

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.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. 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:

What is Davercin and what is it 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 is Davercin and what is it used for

Davercin contains the active substance erythromycin cyclocarbonate. It is a macrolide antibiotic that inhibits the growth of bacteria that cause infections.

Indications for use

Davercin is used to treat the following infections caused by susceptible bacteria.

• Upper respiratory tract infections: pharyngitis, sinusitis.
• Lower respiratory tract infections: acute bronchitis or exacerbation of chronic bronchitis, pneumonia.
• Skin and soft tissue infections: abscesses and furuncles, erysipelas.
• Gastrointestinal tract infections caused by Campylobacter spp.
• In dentistry: gingivitis, Vincent's angina.
• Other infections: scarlet fever.

2. Important information before taking Davercin

When not to take Davercin

• If you are allergic (hypersensitive) to erythromycin cyclocarbonate or other macrolide antibiotics (such as azithromycin, clarithromycin) or to any of the other ingredients of this medicine (listed in section 6);
• If you have severe liver failure;
• If you are taking any of the following medicines:
• lovastatin or simvastatin (medicines used to lower cholesterol levels in the blood and to treat atherosclerosis of the coronary arteries), astemizole or terfenadine (medicines commonly used to treat hay fever and allergies), cisapride (a medicine used to treat gastrointestinal disorders), pimozide (a medicine used to treat psychiatric disorders), ergotamine or dihydroergotamine (medicines used, among other things, to treat migraines). You should ask your doctor about alternative medicines that you can take instead of these (see section 2 "Davercin and other medicines").

you can take instead of the above-mentioned ones (see section 2 "Davercin and other medicines").

• lomitapide (used to reduce elevated levels of lipids, such as cholesterol and triglycerides, in the blood). Taking this medicine with erythromycin may lead to increased activity of liver enzymes (aminotransferases), which means that the liver is overloaded and liver function disorders may occur.
• If you have abnormally low levels of potassium or magnesium in your blood (hypomagnesemia or hypokalemia);
• If you or a family member have a history of heart rhythm disorders (ventricular tachycardia or torsades de pointes rhythm disorder) or an abnormality in the electrocardiogram (a record of the heart's electrical activity) called "long QT syndrome".

Warnings and precautions

If you are in any of the following situations, you should inform your doctor before taking the medicine:

• you are allergic to macrolide antibiotics (e.g. azithromycin, lincomycin or clindamycin);
• you have liver function disorders or are taking medicines that may have a negative effect on liver function;
• you have myasthenia gravis, a rare disease that causes muscle weakness;
• you are taking other medicines known to cause serious heart rhythm disorders;
• you have heart problems.

If you experience any of the following symptoms while taking the medicine, you should contact your doctor immediately:

• severe allergic reactions, such as a rash, hives, bruising, swelling of the throat, bronchospasm. In such cases, you should contact your doctor immediately, who will provide appropriate treatment;
• severe, prolonged diarrhea;
• symptoms of a new bacterial infection or fungal infection (superinfection), especially during long-term use of the antibiotic;
• loss of appetite, jaundice, dark urine, itching or abdominal pain. These symptoms may indicate liver function disorders.

During long-term treatment with Davercin, your doctor will usually order liver function tests.

Davercin and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take, including those available without a prescription.
You must inform your doctor if you are taking any of the following medicines, as their use with Davercin is contraindicated:
astemizole or terfenadine (medicines used to treat allergies);
lovastatin, simvastatin (statins - medicines that lower cholesterol levels in the blood);
cisapride (a medicine used to treat gastrointestinal disorders);
pimozide (medicines used to treat psychiatric disorders);
ergotamine or dihydroergotamine (medicines used, among other things, to treat migraines).
You should inform your doctor if you are taking any of the following medicines, as special caution is requiredwhen using them with Davercin:
theophylline (a medicine used to treat asthma);
digoxin (a medicine used to treat heart rhythm disorders);
cyclosporin (a medicine used after transplants);
phenytoin (an antiepileptic medicine);
oral anticoagulants, e.g. warfarin, acenocoumarol, and rivaroxaban (used to thin the blood);
corticosteroids, given orally, by injection, or inhaled (used to suppress the immune system - this is useful in the treatment of 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;
oral contraceptives: Davercin used with oral contraceptives may reduce their effectiveness. Your doctor will recommend using additional non-hormonal methods of contraception.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice 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 have been 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 clearly necessary.

Driving and using machines

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

Davercin contains sodium.

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Davercin

Always take Davercin exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Adults

The initial dose is usually 750 mg. Then 500 mg is given every 12 hours.
In severe infections, the dose can be increased to 2 g per day (1 g 2 times a day, 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.
Davercin in tablets can be given to children who are able to swallow the tablet (usually from the age of 6). For younger children, Davercin is available in the form of granules for oral suspension.

Elderly patients

No dose adjustment is necessary in elderly patients. However, due to the frequent occurrence of liver function disorders or biliary tract disorders in this group of patients, caution is recommended.

Duration of treatment

The duration of treatment depends on the severity and type of infection. After the symptoms have subsided, the medicine should be taken for another 2 to 3 days.
Your doctor will determine the appropriate duration of treatment, which should be followed.

Method of administration

Davercin tablets should be swallowed whole, with a large amount of water.
The medicine is given on an empty stomach or 1 hour before a meal or 2 hours after eating.

Taking a higher dose of Davercin than recommended

Taking a higher dose of Davercin than recommended by your doctor may cause gastrointestinal symptoms (vomiting, abdominal pain) or hearing disorders.
If you have taken more than the recommended dose of Davercin, contact your doctor or go to the nearest emergency department in a hospital immediately. Take the medicine in its original packaging so that the staff can check exactly which medicine was taken.

Missing a dose of Davercin

If you miss a dose of Davercin, take it as soon as possible, and then take the next dose at the scheduled time.
Do not take a double dose to make up for the missed dose.

Stopping treatment with Davercin

It is important to take the medicine as recommended for the entire treatment cycle. Do not stop treatment just because you feel better. If the treatment cycle is interrupted too early, the infection may return.
If you feel worse during treatment or do not feel well after completing the recommended treatment cycle, you should consult your doctor.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Davercin can cause side effects, although not everybody gets them.

Serious side effects

• allergic reactions
• severe skin rashes, which can occur with blistering of the limbs, eyes, mouth, throat, and genitals - occur rarely (in less than 1 in 1000 people)
• sudden breathing difficulties, speaking, and swallowing, swelling of the lips, face, and neck, very severe dizziness or fainting - occur with unknown frequency (cannot be estimated from the available data)
• severe, prolonged diarrhea, which may contain blood, accompanied by abdominal pain or fever, may be a sign of severe colitis - occurs very rarely (in less than 1 in 10,000 people)
• abnormal heart rhythm (including palpitations, faster heartbeat, life-threatening heart rhythm disorders called torsades de pointesor abnormal heart function in the ECG) or cardiac arrest - occur with unknown frequency (frequency cannot be estimated from the available data)
• yellowing of the skin and eyes, feeling of tiredness or fever, dark urine (symptoms of jaundice, hepatitis) - occur rarely (in less than 1 in 1000 people)
• severe skin reaction: red, scaly rash with nodules under the skin and blisters (pustular psoriasis) - occurs with unknown frequency (cannot be estimated from the available data).

If you experience any of the above side effects, you should stop taking the medicine and immediatelyinform your doctor or go to the emergency department of the nearest hospital.

Other side effects that may occur when taking Davercin

The following side effects occur rarely(occur in less than 1 in 1000 people)

• lack of certain types of white blood cells;
• transient increase in the level of certain liver enzymes. The following side effects occur very rarely(occur in less than 1 in 10,000 people)
• abdominal pain and back pain - may be a sign of pancreatitis;
• subfebrile state, dull pain in the lumbar region, skin rash of various localization, frequent urination or decreased urine output, hematuria (the presence of red blood cells in the urine gives it a reddish color) may be a sign of interstitial nephritis;
• dizziness, disorientation, hallucinations, nightmares. The following side effects occur with unknown frequency(frequency cannot be estimated from the available data):
• infections with bacteria or fungi that are not susceptible to the medicine;
• hearing disorders (tinnitus, deafness; may occur especially after administration of high doses of the medicine and/or in patients with liver and kidney failure - these disorders usually disappear after withdrawal of the medicine);
• rapid or irregular heart rhythm.
• abdominal pain, nausea, vomiting, diarrhea - most often occur after administration of high doses of the medicine.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Davercin

Keep out of the sight and reach of children.
Store in a temperature below 25°C. Store in the original packaging to protect from moisture.
Do not use the medicine after the expiry date (EXP) 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. Ask your 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

The active substance of Davercin is erythromycin cyclocarbonate.
One film-coated tablet contains 250 mg of erythromycin.
The other ingredients are:
carbomer (type A), talc, magnesium stearate, microcrystalline cellulose.
The coating contains: cellulose acetate phthalate, macrogol 6000, titanium dioxide (E 171), talc

What Davercin looks like and contents of the pack

White or almost white film-coated tablets, round, biconvex.
The pack contains 16 film-coated tablets.

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 about this medicine, please contact the marketing authorization holder.

Date of last revision of the leaflet: