Bactrazol

Leaflet attached to the packaging: patient information

BACTRAZOL, 500 mg, coated tablets

Azithromycin

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

• 1. What is Bactrazol and what is it used for
• 2. Important information before taking Bactrazol
• 3. How to take Bactrazol
• 4. Possible side effects
• 5. How to store Bactrazol
• 6. Contents of the pack and other information

1. What is Bactrazol and what is it used for

Bactrazol contains the active substance azithromycin, which is a macrolide antibiotic with a broad spectrum of action. It has a bactericidal effect on susceptible microorganisms.
Bactrazol, 500 mg, coated tablets, is indicated for the treatment of the following infections caused by microorganisms susceptible to azithromycin.

• Upper respiratory tract infections: bacterial pharyngitis, tonsillitis, sinusitis (see also section 2).
• Acute otitis media.
• Lower respiratory tract infections: acute bronchitis, exacerbation of chronic bronchitis, mild to moderate community-acquired pneumonia, including interstitial pneumonia.
• Skin and soft tissue infections: erythema, impetigo, and secondary bacterial infection of the skin; Lyme disease - the first sign of erythema migrans.
• Sexually transmitted diseases: uncomplicated infections caused by Chlamydia trachomatis.

2. Important information before taking Bactrazol

When not to take Bactrazol

• If you are allergic to azithromycin, erythromycin, other macrolide or ketolide antibiotics, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking Bactrazol, discuss with your doctor or pharmacist if:

• you have conditions that may lead to arrhythmias (especially in women and elderly patients):
• congenital or existing arrhythmias (visible in the ECG - a test of heart electrical activity),
• severe heart failure,
• very slow heart rate (called bradycardia),
• electrolyte disturbances in the blood, especially low potassium and magnesium levels,
• taking other medicines that may cause prolongation of the QT interval in the ECG (see "Bactrazol and other medicines");
• you have severe kidney problems;
• you have severe liver problems: your doctor may monitor liver function or discontinue treatment;
• you have a new infection (this may indicate an overgrowth of resistant microorganisms or a fungal infection);
• you have neurological or psychiatric disorders;
• you have a sexually transmitted disease: your doctor should ensure that you do not have a co-existing syphilis infection;
• you have signs of superinfection (e.g., fungal infections);
• you are taking ergotamine derivatives (ergot preparations);
• you have infected burn wounds.

Infections caused by streptococci
In the treatment of pharyngitis and tonsillitis caused by streptococci, penicillin is usually the drug of choice.
Pseudomembranous colitis
If diarrhea occurs, it should be reported to the doctor immediately, as it may be a sign of pseudomembranous colitis - a complication that can occur with the use of macrolide antibiotics. Such a diagnosis should be considered in patients who develop diarrhea after starting azithromycin treatment. In the case of pseudomembranous colitis caused by azithromycin, it may be necessary to discontinue Bactrazol and use appropriate treatment. It is contraindicated to administer anti-peristaltic agents.
Long-term use
There is no data on the safety and efficacy of azithromycin used long-term in the above indications. In the case of rapidly recurring infections, the doctor will consider treatment with another antibacterial agent.
Myasthenia
During azithromycin treatment, exacerbation of myasthenia symptoms or the occurrence of myasthenic syndrome (see "Possible side effects") has been observed.

Children and adolescents

Bactrazol in the form of 500 mg coated tablets is recommended for use in children only with a body weight over 45 kg. For the rest of the pediatric population, azithromycin is recommended in the form of an oral suspension or 125 mg tablets.

Bactrazol and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
If you are taking any of the following medicines, it is especially important to tell your doctor or pharmacist:

• medicines that affect the QT interval, such as
• quinidine, procainamide, dofetilide, amiodarone, sotalol (used to treat arrhythmias),
• hydroxychloroquine (used to treat rheumatologic diseases or malaria),
• cisapride (used to treat stomach disorders),
• terfenadine (used to treat allergies),
• antipsychotic medicines, e.g., pimozide,
• antidepressant medicines, e.g., citalopram,
• fluoroquinolones (used to treat infections), e.g., moxifloxacin, levofloxacin,
• antacids (Bactrazol should be administered at least 1 hour before or 2 hours after taking antacids);
• oral anticoagulants, e.g., warfarin;
• ergot alkaloids (used to treat migraine or reduce blood flow), e.g., ergotamine, which can cause ergotism (symptoms - spasm of peripheral blood vessels and ischemia) when used with azithromycin;
• digoxin (used to treat heart rhythm disorders) and colchicine (used to treat gout or familial Mediterranean fever);
• cyclosporin (used to treat skin diseases, rheumatoid arthritis, or after organ transplantation);
• atorvastatin (a medicine used to lower cholesterol levels);
• rifabutin (used to treat HIV or tuberculosis).

Bactrazol with food and drink

Bactrazol in the form of 500 mg coated tablets can be taken independently of meals.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
The medicine should be used during pregnancy only if the benefit to the mother outweighs the risk to the fetus.
Breastfeeding
Azithromycin passes into breast milk. Breastfeeding should be avoided during azithromycin treatment, unless the doctor recommends otherwise.
Fertility
In fertility studies conducted in rodents, a decrease in the conception rate was observed after administration of azithromycin. The significance of these study results for humans is unknown.

Driving and using machines

There is no data on the effect of Bactrazol on the ability to drive and use machines. However, when performing such activities, the possibility of side effects such as dizziness and seizures should be taken into account.
Bactrazol contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Bactrazol

This medicine should always be taken exactly as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
Dosage for adults, including the elderly, and children and adolescents with a body weight over 45 kg

Upper and lower respiratory tract infections, otitis media, skin and soft tissue infections (except for erythema migrans)
The total dose of azithromycin is 1.5 g over 3 days (500 mg in a single daily dose).
Erythema migrans
The total dose is 3 g and should be taken in the following scheme: 1 g (2 coated tablets of 500 mg) on the first day, and then 500 mg (1 coated tablet) from the second to the fifth day, in single daily doses.
Uncomplicated infections caused by Chlamydia trachomatis
1 g (2 coated tablets of 500 mg) in a single dose.
Patients with kidney or liver disorders
If you have kidney or liver problems, tell your doctor, as they may need to reduce the usual dose of the medicine. The medicine should not be used in patients with severe liver failure.
Method of administration
Oral administration.
Azithromycin should be taken orally, once a day.
Bactrazol in the form of 500 mg coated tablets can be taken independently of meals.
Tablets should be swallowed whole.

Overdose of Bactrazol

Side effects that occurred after taking the medicine in doses higher than recommended were similar to those reported after taking the correct doses. Characteristic symptoms after overdose of macrolide antibiotics include: transient hearing loss, severe nausea, vomiting, and diarrhea.
In case of overdose, seek medical attention immediately. In case of overdose, activated charcoal and symptomatic treatment, as well as supportive treatment of vital functions if necessary, are recommended.

Missed dose of Bactrazol

A missed dose should be taken as soon as possible, and subsequent doses should be taken according to the recommended dosing schedule. Do not take a double dose to make up for a missed dose.

4. Possible side effects

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

In case of the following side effects, stop taking Bactrazol and contact your doctor or go to the emergency department of the nearest hospital immediately:

• Severe allergic reaction (sudden difficulty breathing and swallowing, swelling of the lips, tongue, face, and throat, itching rash, especially on the whole body).
• Severe skin reactions: exanthema characterized by rapid onset of areas of redness on the skin covered with small blisters (vesicles filled with white or yellow fluid); severe skin rash causing redness and peeling; severe blistering and bleeding from the lips, eyes, mouth, nose, and genitals, associated with high fever and joint pain. This may be acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), or drug reaction with eosinophilia and systemic symptoms (DRESS).

• Severe allergic reaction that may include fever, skin rash, organ swelling, increased number of a certain type of white blood cell (eosinophilia), and inflammation of internal organs (drug reaction with eosinophilia and systemic symptoms (DRESS)).

Also, stop taking Bactrazol and contact your doctor immediately if you notice:

• Severe or persistent diarrhea with blood or mucus. This symptom may occur during or after treatment and may indicate serious colitis.
• Weakness, yellowing of the skin or whites of the eyes, and dark urine.
• Unusual tendency to bruise or bleed.
• Rapid (ventricular tachycardia) or irregular heartbeat or changes in heart rhythm in the electrocardiogram (prolongation of the QT interval and torsade de pointes).

The following side effects have been reported:
Very common(may affect more than 1 in 10 people):

• diarrhea.

Common(may affect up to 1 in 10 people):

• headache;
• vomiting, abdominal pain, nausea;
• change in white blood cell count;
• decrease in blood bicarbonate levels.

Uncommon(may affect up to 1 in 100 people):

• fungal infections (candidiasis), vaginal infection, pneumonia, fungal infection, bacterial infection, pharyngitis, gastrointestinal inflammation, respiratory disorders, rhinitis, oral thrush;
• change in white blood cell count (leukopenia, neutropenia, eosinophilia);
• angioedema (swelling in the face and throat, which can cause difficulty breathing), hypersensitivity;
• loss of appetite (anorexia);
• nervousness, insomnia, dizziness, drowsiness, taste disorders, abnormal skin sensations, e.g., tingling and numbness of limbs (paresthesia);
• vision disorders;
• hearing disorders, balance disorders;
• palpitations;
• flushing;
• dyspnea, epistaxis;
• constipation, bloating with gas, indigestion, gastritis, dysphagia, bloated abdomen, dry mouth, belching, oral ulcers, excessive salivation;
• rash, itching, urticaria, skin inflammation, dry skin, excessive sweating;
• degenerative joint disease, muscle pain, back pain, neck pain;
• urinary disorders (dysuria), kidney pain;
• menstrual bleeding, testicular disorders;
• edema, weakness (asthenia), malaise (apathy), fatigue, facial edema, chest pain, fever, pain, peripheral edema;
• abnormal laboratory test results (e.g., blood, liver function, glucose, electrolytes);
• post-procedural complications.

Rare(may affect up to 1 in 1,000 people):

• agitation;
• liver function disorders, jaundice with bile stasis (cholestatic jaundice);
• hypersensitivity to light, severe skin reactions, exanthema characterized by rapid onset of areas of redness on the skin covered with small blisters (vesicles filled with white or yellow fluid).

Frequency not known(cannot be estimated from the available data):

• pseudomembranous colitis;
• thrombocytopenia (decreased platelet count), decreased red blood cell count (hemolytic anemia);
• anaphylactic reaction (generalized allergic reaction, which can rarely be fatal; may occur with symptoms such as: swelling of the lips, face, or throat, leading to severe breathing difficulties, rash on the skin or urticaria);
• aggressive behavior, anxiety, hallucinations, delusions;
• loss of consciousness (syncope), seizures, sensory disturbances (hypoesthesia), excessive psychomotor activity, loss of smell, loss of taste, smell disorders, rapid muscle fatigue (myasthenia);
• hearing disorders, including deafness and (or) tinnitus;
• heart rhythm disorders (including torsade de pointesand ventricular tachycardia), prolongation of the QT interval in the electrocardiogram;
• decreased blood pressure;
• pancreatitis, tongue discoloration;
• liver failure (rarely leading to death), fulminant hepatitis, liver necrosis;
• severe skin reactions: Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), drug reaction with eosinophilia and systemic symptoms (DRESS);
• arthritis;
• acute kidney failure, interstitial nephritis.

Side effects probably or possibly related to the use of azithromycin in the treatment of Mycobacterium aviumcomplex infections or prevention of them, based on clinical trials and post-marketing surveillance

Very common(may affect more than 1 in 10 people):

• diarrhea;
• abdominal pain;
• nausea;
• bloating;
• abdominal discomfort;
• loose stools.

Common(may affect up to 1 in 10 people):

• loss of appetite;
• dizziness;
• headache;
• abnormal skin sensations, e.g., tingling and numbness of limbs (paresthesia);
• taste disorders;
• vision disorders;
• hearing loss;
• rash, itching;
• joint pain;
• fatigue.

Uncommon(may affect up to 1 in 100 people):

• sensory disturbances (hypoesthesia);
• hearing disorders, tinnitus;
• palpitations;
• hepatitis;
• Stevens-Johnson syndrome, hypersensitivity to light;
• sudden weakness (asthenia), malaise.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa
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, you can help provide more information on the safety of this medicine.

5. How to store Bactrazol

• The medicine should be stored out of sight and reach of children.
• There are no special precautions for storage.
• Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the 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

What Bactrazol contains

• The active substance of the medicine is azithromycin in the form of azithromycin dihydrate. Each coated tablet contains 500 mg of azithromycin.
• The other ingredients are: tablet core: anhydrous calcium phosphate, hypromellose, maize starch, maize starch paste, microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate. coating: hypromellose, colorant - indigo carmine (E132), titanium dioxide (E171), polysorbate 80, talc.

What Bactrazol looks like and contents of the pack

Coated tablets, light blue, biconvex, with a score line on one side.
The score line on the tablet is only to facilitate breaking and not to divide the tablet into equal doses.
The pack contains 2, 3, or 6 coated tablets in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder
Teva B.V.
Swensweg 5
2031 GA Haarlem
Netherlands
tel.: (22) 345 93 00
Manufacturer
Teva Operations Poland Sp. z o.o.
Mogilska 80, 31-546 Kraków
Pliva Hrvatska d.o.o. (Pliva Croatia Ltd.)
Prilaz Baruna Filipovića 25, 10000 Zagreb
Croatia

Date of last revision of the leaflet: