ERYTHROMYCINUM 200 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Erythromycinum TZF, 200 mg, Film-Coated Tablets
   1. Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.
   2. Table of Contents of the Leaflet
3. What is Erythromycinum TZF and what is it used for
   1. Indications for Use
4. Important Information Before Taking Erythromycinum TZF
   1. When Not to Take Erythromycinum TZF
   2. Warnings and Precautions
   3. Erythromycinum TZF and Other Medicines
   4. In Particular, the Patient Should Inform Their Doctor If They Are Taking Any of the Following Medicines.
   5. Medicines That Should Not Be Taken with Erythromycin
   6. It is Also Important to Know If the Patient is Taking Medicines Such As:
   7. Pregnancy and Breastfeeding
   8. Driving and Using Machines
   9. Erythromycinum TZF Contains Sodium
5. How to Take Erythromycinum TZF
   1. Adults and Children Over 8 Years Old
   2. Children Under 8 Years Old
   3. Elderly Patients
   4. Duration of Treatment
   5. Method of Administration
   6. Taking More Than the Recommended Dose of Erythromycinum TZF
   7. Missing a Dose of Erythromycinum TZF
   8. Stopping Erythromycinum TZF Treatment
6. Possible Side Effects
   1. Severe Side Effects
   2. Other Side Effects That May Occur When Taking Erythromycinum TZF
   3. Reporting Side Effects
7. How to Store Erythromycinum TZF
8. Contents of the Pack and Other Information
   1. What Erythromycinum TZF Looks Like and What the Pack Contains
   2. Marketing Authorization Holder and Manufacturer
   3. Date of Last Revision of the Leaflet:

Package Leaflet: Information for the Patient

Erythromycinum TZF, 200 mg, Film-Coated Tablets

Erythromycinum

Read the Package Leaflet Carefully Before Taking the Medication, 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 inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Erythromycinum TZF and what is it used for

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

Indications for Use

Erythromycinum TZF is indicated for the treatment of infections caused by erythromycin-sensitive microorganisms.

• Infections of the upper respiratory tract - tonsillitis, peritonsillar abscess, pharyngitis, laryngitis, sinusitis, secondary bacterial infections in the course of influenza or colds.
• Infections of the lower respiratory tract - tracheitis, acute bronchitis or exacerbation of chronic bronchitis, pneumonia (lobar, bronchopneumonic, primary atypical pneumonia), bronchiectasis, Legionnaires' disease.
• Middle ear and external ear infections.
• Gingivitis, Vincent's angina.
• Blepharitis.
• Skin and soft tissue infections: furuncles, multiple furuncles, cellulitis, erysipelas.
• Gastrointestinal tract infections - cholecystitis, staphylococcal enteritis and colitis.
• Prevention of postoperative infections, secondary infections in the course of burns, endocarditis in patients undergoing dental procedures.
• Other infections: osteomyelitis, urethritis, gonorrhea, primary syphilis, venereal granuloma, diphtheria, scarlet fever.

2. Important Information Before Taking Erythromycinum TZF

When Not to Take Erythromycinum TZF

• If the patient is allergic (hypersensitive) to erythromycin or other macrolide antibiotics, such as azithromycin, clarithromycin, or any of the other ingredients of this medicine (listed in section 6).
• If the patient is taking any of the following medicines:
• lovastatin or simvastatin (medicines used in hypercholesterolemia and coronary artery disease), astemizole or terfenadine (medicines commonly used in the treatment of hay fever and allergies), cisapride (a medicine used in the treatment of gastrointestinal disorders), pimozide (a medicine used in the treatment of psychiatric disorders), ergotamine or dihydroergotamine during erythromycin treatment, as concomitant use of these medicines may sometimes cause serious heart rhythm disturbances. You should ask your doctor about alternative medicines that you can take instead of those listed above (see section 2 "Erythromycinum TZF and other medicines").
• lomitapide (used to reduce elevated blood lipid levels, such as cholesterol and triglycerides). Taking this medicine with erythromycin may lead to increased activity of liver enzymes (aminotransferases), which means that the liver is overloaded and may cause liver dysfunction.
• If the patient has a low potassium or magnesium level 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 pointes) or an abnormality in the electrocardiogram (a record of the heart's electrical activity) called "long QT syndrome".

Warnings and Precautions

If the patient has any of the following conditions, they should inform their doctor before taking the medicine:

• the patient is allergic to any substances, especially macrolide antibiotics (e.g. azithromycin, lincomycin or clindamycin);
• the patient has liver dysfunction or is taking medicines that may have a negative effect on the liver;
• the patient is taking other medicines known to cause serious heart rhythm disturbances;
• the patient has heart problems;
• the patient suffers from myasthenia, a rare disease that causes muscle weakness.

If the patient experiences any of the following symptoms while taking Erythromycinum TZF, they should inform their doctor:

• severe allergic reactions such as rash, urticaria, purpura, laryngeal edema, bronchospasm; the patient should immediately consult a doctor who will provide appropriate treatment;
• prolonged, severe diarrhea; this may be a sign of pseudomembranous colitis - a complication associated with antibiotic use; the doctor will advise discontinuation of the medicine and provide appropriate treatment;
• symptoms of a new bacterial or fungal infection, especially during prolonged antibiotic use;
• loss of appetite, jaundice, dark urine, itching or abdominal pain - these symptoms may indicate liver dysfunction.

During long-term erythromycin treatment, the doctor usually orders liver function tests.
For pregnant women, erythromycin does not penetrate the fetus in therapeutic concentrations. If a pregnant patient with syphilis receives oral erythromycin, the newborn will receive penicillin.

Erythromycinum TZF and Other Medicines

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

In Particular, the Patient Should Inform Their Doctor If They Are Taking Any of the Following Medicines.

Medicines That Should Not Be Taken with Erythromycin

lovastatin, simvastatin (medicines used in hypercholesterolemia and coronary artery disease),

• astemizole, terfenadine (used in the treatment of allergies),
• lomitapide (used to reduce elevated blood lipid levels, such as cholesterol and triglycerides).
• cisapride (used in gastrointestinal disorders),
• pimozide (used in psychiatric disorders),
• ergotamine or dihydroergotamine (used, among other things, in the treatment of migraines).

It is Also Important to Know If the Patient is Taking Medicines Such As:

rifabutin (an antibiotic used in the treatment of tuberculosis),
digoxin, quinidine, disopyramide, procainamide (medicines used in the treatment of heart rhythm disturbances),
alfentanil, triazolam, midazolam (medicines used in anxiety or insomnia),
anticoagulant medicines, e.g. warfarin, acenocoumarol, and rivaroxaban (used to thin the blood),
carbamazepine, valproic acid, phenytoin (antiepileptic medicines),
methylprednisolone (an anti-inflammatory medicine),
cyclosporine, tacrolimus (medicines used, among other things, after transplants),
theophylline (a medicine used in the treatment of asthma),
benzodiazepines (medicines used, for example, in insomnia, epilepsy),
oral contraceptives,
colchicine (a medicine used in the treatment of gout),
mizolastine (a medicine used mainly in skin allergic reactions),
bromocriptine (a medicine used, for example, in Parkinson's disease),
hexobarbital (a medicine used as an anesthetic for short operations),
zopiclone (a medicine used in the treatment of insomnia),
corticosteroids, administered orally, by injection, or inhaled (used to weaken the body's immune system - which is useful in the treatment of many diseases),
hydroxychloroquine or chloroquine (used in the treatment of diseases such as rheumatoid arthritis or in the treatment or prevention of malaria). Taking these medicines with erythromycin may increase the risk of abnormal heart rhythm and other serious heart-related side effects.
Effect on Laboratory Test Results
Erythromycin may change the results of urinary catecholamine tests performed using the fluorometric method.

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 taking this medicine.
The active substance of Erythromycinum TZF 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 Erythromycinum TZF in early pregnancy.
Erythromycin can be given to pregnant or breastfeeding women only if, in the doctor's opinion, it is absolutely necessary.

Driving and Using Machines

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

Erythromycinum TZF Contains Sodium

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

3. How to Take Erythromycinum TZF

Erythromycinum TZF should always be taken as directed by the doctor. In case of doubts, the patient should contact their doctor or pharmacist.

Adults and Children Over 8 Years Old

Usually, 1 g to 2 g per day is administered, in divided doses. In severe infections, the doctor may increase the dose to 4 g per day, administered in divided doses.

Children Under 8 Years Old

Usually, 30 to 50 mg/kg body weight per day is administered, in divided doses every 12 or 6 hours. In severe infections, the doctor may recommend a dose twice as high, administered every 6 hours.
Erythromycinum TZF in tablets can be given to children of any age, provided they are able to swallow the tablet.

Elderly Patients

In elderly patients, dose adjustment is not necessary. However, due to frequent disorders related to liver or biliary tract dysfunction, caution is recommended in this group of patients.

Duration of Treatment

The duration of treatment depends on the severity and type of infection.
The doctor will determine the appropriate duration of treatment, which should be followed.

Method of Administration

Tablets can be taken before or with a meal, with a small amount of boiled, cooled water.
In the treatment of severe and life-threatening infections, the doctor will administer erythromycin intravenously.

Taking More Than the Recommended Dose of Erythromycinum TZF

Taking a higher dose of Erythromycinum TZF than recommended by the doctor may cause gastrointestinal symptoms (nausea, vomiting, diarrhea) or hearing disturbances.
In case of taking a higher dose of Erythromycinum TZF than recommended, the patient should immediately contact their doctor or go to the nearest emergency department in a hospital. The patient should bring the medicine in its original packaging so that the medical staff can accurately check which medicine was used.

Missing a Dose of Erythromycinum TZF

In case of missing a dose of Erythromycinum TZF, the patient should take it as soon as possible, and then take the next dose at the scheduled time.
The patient should not take a double dose to make up for the missed dose.

Stopping Erythromycinum TZF Treatment

It is important to take the medicine as directed for the recommended treatment cycle. The patient should not stop treatment because they feel better. If the treatment cycle is stopped too early, the infection may return.
If the patient feels worse during treatment or does not feel well after completing the recommended treatment cycle, they should consult their doctor.

4. Possible Side Effects

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

Severe Side Effects

• allergic reactions
• severe skin rashes that may include blistering of the skin, eyes, mouth, throat, and genitals - occur with an unknown frequency (cannot be estimated from the available data)
• sudden difficulty breathing, speaking, or swallowing, swelling of the lips, face, and throat, severe dizziness or fainting - occur rarely (may occur in less than 1 in 1000 people)
• yellowing of the skin and eyes, feeling tired or fever, dark urine (symptoms of jaundice, hepatitis) - occur rarely (may occur in less than 1 in 1000 people)
• severe, prolonged diarrhea that may contain blood, accompanied by stomach pain or fever, and may be a sign of severe colitis - occur very rarely (may occur in less than 1 in 10,000 people)
• 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 - occur with an unknown frequency (cannot be estimated from the available data).
• severe skin reaction: red, scaly rash with nodules under the skin and blisters (pustular psoriasis) - occur with an unknown frequency (cannot be estimated from the available data).

➢ If any of the above symptoms occur, the patient should immediately stop taking the medicine and contact their doctor or go to the emergency department of the nearest hospital.
The patient should not take a double dose to make up for the missed dose.

Other Side Effects That May Occur When Taking Erythromycinum TZF

Very Rare(may occur in less than 1 in 10,000 people)
decrease in the number of certain types of white blood cells (agranulocytosis)

• interstitial nephritis

Unknown Frequency(cannot be estimated from the available data)
infections with bacteria or fungi that are not sensitive to the medicine
hearing disturbances - occur especially in patients receiving erythromycin in high doses and (or) in patients with liver and kidney failure; usually disappear after discontinuation of the medicine
abdominal pain, nausea, vomiting, diarrhea
transient increase in liver enzyme activity

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 Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje 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 Erythromycinum TZF

Keep out of the sight and reach of children.
Store in a temperature below 25°C. Protect from light and moisture.
Do not use the medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the 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

The active substance of the medicine is erythromycin.
One film-coated tablet contains 200 mg of erythromycin.
The excipients are:
tablet core: rice starch, sodium carboxymethyl starch (type A), gelatin, polysorbate 80, talc, magnesium stearate, potato starch
coating: polyacrylic resin (Eudragit L30-D55), triethyl citrate, talc.

What Erythromycinum TZF Looks Like and What the Pack Contains

White to cream-colored, round, biconvex tablets.
Packaging: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
In order to obtain more detailed information about this medicine, the patient should contact the marketing authorization holder.

Date of Last Revision of the Leaflet: