Erythromycin tzf

Package leaflet: Information for the patient

Erythromycinum TZF, 200 mg, coated tablets
Erythromycinum
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are identical.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet
What Erythromycinum TZF is and what it is 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 Erythromycinum TZF is and what it is used for

Erythromycinum TZF contains the active substance – erythromycin. It is a macrolide antibiotic which inhibits the growth of bacteria causing infections.
Indications
Erythromycinum TZF is indicated for the treatment of infections caused by microorganisms sensitive to erythromycin.

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

2. Important information before using Erythromycinum TZF

When not to use Erythromycinum TZF

• If the patient is allergic (hypersensitive) to erythromycin or other macrolide antibiotics, such as azithromycin, clarithromycin, or to any of the other ingredients of this medicine (listed in section 6).
• If the patient is currently taking any of the following medicines:
• lovastatin or simvastatin (medicines used in hypercholesterolemia and coronary artery atherosclerosis), 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 during erythromycin treatment, because concomitant use of these medicines may sometimes cause serious disturbances in heart rhythm. Please consult your doctor about alternative medicines that the patient may take instead of those listed above (see section 2 "Erythromycinum TZF and other medicines").
• lomitapide (used to reduce elevated blood levels of lipids 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 function disorders.
• If the patient has abnormally low levels of potassium or magnesium in the blood (hypomagnesemia or hypokalemia).
• If the patient or a family member has a history of heart rhythm disorders (ventricular tachycardia or torsades de pointes arrhythmias) or an abnormality in the electrocardiogram (ECG) called "long QT syndrome".

Warnings and precautions
If any of the following situations apply to the patient, inform the 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 function disorders or is taking medicines that may adversely affect 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 gravis, a rare disease causing muscle weakness.

If any of the following symptoms occur during treatment with Erythromycinum TZF, inform the doctor immediately:

• Severe hypersensitivity reactions such as maculopapular rash, urticaria, petechiae, laryngeal edema, or bronchospasm; immediate medical attention is required;
• Severe, persistent diarrhea; this may be a sign of pseudomembranous colitis—a complication associated with antibiotic use; the doctor will recommend discontinuation of the medicine and appropriate treatment;
• Signs of a new infection with bacteria resistant to clarithromycin or fungal superinfection, especially during prolonged antibiotic therapy;
• Loss of appetite, jaundice, dark urine, itching, or abdominal pain—these symptoms may indicate liver function disorders.

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

Erythromycinum TZF and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, including over-the-counter medicines and those planned for future use.
In particular, inform the doctor if the patient is taking any of the following medicines:
Medicines whose concomitant use with erythromycin is contraindicated:

• lovastatin, simvastatin (medicines used in hypercholesterolemia and coronary artery atherosclerosis),
• astemizole, terfenadine (used in the treatment of allergies),
• lomitapide (used to reduce elevated blood levels of lipids such as cholesterol and triglycerides),
• cisapride (used in gastrointestinal motility disorders),
• pimozide (used in psychiatric disorders),
• ergotamine or dihydroergotamine (used, among others, in migraine treatment).

It is also important whether the patient is taking medicines named:

• rifabutin (an antibiotic used in tuberculosis treatment),
• digoxin, quinidine, disopyramide, procainamide (medicines used in the treatment of cardiac arrhythmias),
• alfentanil, triazolam, midazolam (medicines used in anxiety or insomnia),
• anticoagulants such as 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 others, after organ transplantation),
• theophylline (a medicine used in the treatment of bronchial asthma),
• benzodiazepines (medicines used, e.g., in insomnia or epilepsy),
• oral contraceptives,
• colchicine (a medicine used in the treatment of gout),
• mizolastine (a medicine mainly used in allergic skin reactions),
• bromocriptine (a medicine used, e.g., in Parkinson's disease),
• hexobarbital (a medicine used as an anesthetic for short procedures),
• zopiclone (a medicine used in the treatment of insomnia),
• corticosteroids administered orally, by injection or by inhalation (used to suppress the immune system—this is useful in treating many conditions),
• hydroxychloroquine or chloroquine (used in the treatment of diseases such as rheumatoid arthritis or in the treatment or prevention of malaria).

Taking these medicines together with erythromycin may increase the risk of developing abnormal heart rhythms and other serious cardiac adverse effects.

Effect on laboratory test results
Erythromycin may alter the results of urinary catecholamine measurements performed by fluorometric methods.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.
The active substance of Erythromycinum TZF 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 heart defects after use of Erythromycinum TZF in early pregnancy.
Erythromycin may be administered to pregnant or breastfeeding women only if, in the opinion of the doctor, it is clearly necessary.

Driving and operating machinery
There is no data available on the effect of the medicine on the ability to drive vehicles or operate machinery.

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

3. How to use Erythromycinum TZF

Erythromycinum TZF should always be used as directed by the physician. In case of
doubt, consult your doctor or pharmacist.
Adults and children over 8 years of age
The usual dose is 1 g to 2 g per day, given in divided doses. In severe infections, the doctor may
increase the dose up to 4 g per day, administered in divided doses.
Children under 8 years of age
The usual dose is 30 to 50 mg/kg body weight per day, given in divided doses every 12 or 6 hours. In
severe infections, the doctor may prescribe a dose twice as high, administered every 6 hours.
Erythromycinum TZF tablets may be given to children of any age, provided they are able to
swallow the tablet.
Elderly patients
Dosage adjustment is not usually required in elderly patients. However, due to the higher likelihood
of impaired liver or biliary function in this patient group, caution is recommended.
Duration of treatment
The duration of treatment depends on the severity and type of infection.
Your doctor will determine the appropriate duration of treatment, which must be strictly followed.
Method of administration
Tablets may be taken before or with meals, swallowed with a small amount of boiled,
cooled water.
In the treatment of severe and life-threatening infections, the doctor will administer erythromycin
by intravenous infusion.
Accidental overdose of Erythromycinum TZF
Taking more Erythromycinum TZF than prescribed may cause gastrointestinal symptoms
(nausea, vomiting, diarrhoea) or hearing disturbances.
If an overdose of Erythromycinum TZF has been taken, seek immediate medical advice or go to the
nearest hospital emergency department. Take the medicine in its original packaging with you so
that the medical staff can identify exactly which medicine has been taken.
Missed dose of Erythromycinum TZF
If a dose of Erythromycinum TZF is missed, take it as soon as possible,
then continue with the next dose at the usual time.
Do not take a double dose to make up for a missed dose.
Stopping Erythromycinum TZF treatment
It is important to take the medicine exactly as prescribed for the full duration of treatment. Do not stop
treatment early, even if you start to feel better. Premature discontinuation of treatment may cause the
infection to return.
If you feel worse during treatment or do not feel well after completing the prescribed course of
treatment, consult your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Serious adverse reactions

• Allergic reactions
• Severe skin rashes which may involve blistering affecting limbs, eyes, mouth, throat and genital organs – frequency unknown (cannot be estimated from available data)
• Sudden breathing, speaking or swallowing difficulties, swelling of lips, face and neck, severe dizziness or collapse – occur rarely (may affect fewer than 1 in 1,000 people)
• Yellowing of the skin and eyes, feeling of fatigue or fever, dark urine (symptoms of jaundice, liver inflammation) – occur rarely (may affect fewer than 1 in 1,000 people)
• Severe diarrhoea which is prolonged or contains blood, accompanied by stomach pain or fever and may indicate a serious inflammation of the large intestine – occur very rarely (may affect fewer than 1 in 10,000 people)
• Irregular heart rhythm (including palpitations, rapid heartbeat, life-threatening arrhythmias known as torsades de pointes, or abnormal heart activity on ECG) or cardiac arrest – frequency unknown (cannot be estimated from available data)
• Severe skin reaction: red, peeling rash with subcutaneous nodules and blisters (erythema multiforme) – frequency unknown (cannot be estimated from available data)

➢ If any of the above symptoms occur, stop taking the medicine immediately and contact a doctor or go to the nearest hospital emergency department.
Other adverse reactions that may occur during treatment with Erythromycinum TZF
Very rare (may affect fewer than 1 in 10,000 people)
decrease in the number of certain types of white blood cells (agranulocytosis)

• Interstitial nephritis

Frequency unknown (cannot be estimated from available data)
infections caused by drug-resistant bacteria or fungi
hearing disturbances – occur especially in patients receiving erythromycin at high doses and/or in patients with hepatic or renal impairment; usually reversible upon discontinuation of the drug
abdominal pain, nausea, vomiting, diarrhoea
transient increase in liver enzyme activity

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

5. How to store Erythromycinum TZF

Keep out of the sight and reach of children.
Store below 25 °C. Protect from light and moisture.
Do not use this medicine after the expiry date stated on the packaging after 'EXP'. 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 help protect the environment.

6. Contents of the packaging and other information

The active substance is erythromycin.
One coated tablet contains 200 mg of erythromycin.
Excipients:
tablet core: rice starch, sodium carboxymethylstarch (type A), gelatin, polysorbate 80, talc,
magnesium stearate, potato starch
coating: polyacrylate resin (Eudragit L30-D55), triethyl citrate, talc.
What Erythromycinum TZF looks like and contents of the pack
White to creamy white, round, biconvex coated tablets.
Packaging: 16 coated tablets.
Marketing Authorisation Holder and Manufacturer
Tarchomińskie Zakłady Farmaceutyczne „Polfa” Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warszawa
Telephone number: (22) 811-18-14
For further information on this medicinal product, please contact the Marketing Authorisation Holder.