Bactrazol

Package leaflet: information for the patient

BACTRAZOL, 500 mg, film-coated tablets
Azithromycinum
Please read this leaflet carefully before using the medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, 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 the same.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Bactrazol is and what it is 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 Bactrazol is and what it is used for

Bactrazol contains azithromycin as the active substance, which is an azalide antibiotic from the macrolide group with broad-spectrum activity. It acts bactericidally against sensitive microorganisms.
Bactrazol 500 mg film-coated tablets are indicated for the treatment of the following infections caused by microorganisms sensitive 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 pneumonia, including interstitial pneumonia.
• Skin and soft tissue infections: erysipelas, cellulitis, and secondary bacterial skin infections; erythema migrans – the first sign of Lyme disease.
• Sexually transmitted diseases: uncomplicated infections caused by Chlamydia trachomatis.

2. Important information before using Bactrazol

When not to use Bactrazol

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

Warnings and precautions
Before starting treatment with Bactrazol, consult a doctor or pharmacist if:

• The patient has conditions that may predispose to cardiac arrhythmias (particularly relevant in women and elderly patients):
• Congenital or previously occurring heart rhythm disorders (visible on ECG – electrocardiogram),
• Severe heart failure,
• Very slow heart rate (called bradycardia),
• Electrolyte imbalances in the blood, especially low levels of potassium and magnesium,
• Taking other medicines that may prolong the QT interval on ECG (see section "Bactrazol with other medicines");
  • The patient has severe renal impairment;
  • The patient has severe hepatic impairment: the doctor may monitor liver function or discontinue treatment;
  • The patient develops a new infection (this may indicate overgrowth of resistant microorganisms or fungal infection);
  • The patient has neurological or psychiatric disorders;
  • The patient has a sexually transmitted disease: the doctor should ensure that syphilis is not present;
  • The patient shows signs of superinfection (e.g. fungal infections);
  • The patient is taking ergot derivatives (ergot alkaloids);
  • The patient has infected burn wounds.

Streptococcal infections
For treatment of streptococcal pharyngitis and tonsillitis, penicillin is usually the drug of choice.
Pseudomembranous colitis
If diarrhoea occurs, it should be reported immediately to a doctor, as it may be a sign of pseudomembranous colitis – a complication that may sometimes occur during treatment with macrolide antibiotics. This diagnosis should be considered in patients who develop diarrhoea after starting azithromycin therapy. In cases of pseudomembranous colitis due to azithromycin use, discontinuation of Bactrazol and initiation of appropriate treatment may be necessary. Antiperistaltic agents are contraindicated.
Long-term use
There is lack of data on the safety and efficacy of long-term use of azithromycin for the indications listed above. In cases of rapidly recurring infections, the doctor may consider treatment with another antibacterial agent.
Myasthenia
Exacerbation of myasthenia symptoms or development of a myasthenic syndrome has been observed during azithromycin treatment (see section "Possible side effects").

Children and adolescents
Bactrazol 500 mg film-coated tablets are recommended for use in children only if body weight is above 45 kg. For other paediatric groups, azithromycin in oral suspension or 125 mg tablets is recommended.

Bactrazol with other medicines
Inform the doctor or pharmacist about all medicines currently used, recently used, or planned for use.
It is especially important to inform the doctor or pharmacist if the patient is taking any of the following medicines:

• Medicines affecting the QT interval, such as
• Quinidine, procainamide, dofetilide, amiodarone, sotalol (used to treat heart rhythm disorders),
• Hydroxychloroquine (used to treat rheumatological diseases or malaria),
• Cisapride (used for stomach disorders),
• Terfenadine (used to treat allergies),
• Antipsychotic medicines, e.g. pimozide,
• Antidepressants, e.g. citalopram,
• Fluoroquinolones (used for infections), e.g. moxifloxacin, levofloxacin,
  • Antacids (Bactrazol should therefore be administered at least 1 hour before or 2 hours after antacids);
  • Oral anticoagulants, e.g. warfarin;
  • Ergot alkaloids (used for migraine or reducing blood flow), e.g. ergotamine – co-administration with azithromycin may lead to ergotism (symptoms: peripheral vasoconstriction and ischemia);
  • Digoxin (used for heart disorders) and colchicine (used for gout and familial Mediterranean fever);
  • Cyclosporine (used for skin diseases, rheumatoid arthritis, or after organ transplantation);
  • Atorvastatin (a medicine used to lower cholesterol levels);
  • Rifabutin (used in HIV or tuberculosis treatment).

Bactrazol with food and drink
Bactrazol 500 mg film-coated tablets can be taken regardless of meals.

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
This medicine may be used during pregnancy only if, in the opinion of the doctor, the benefit to the mother outweighs the risk to the foetus.

Breastfeeding
Azithromycin passes into human milk. Breastfeeding is not recommended during treatment with azithromycin unless otherwise advised by a doctor.

Fertility
In fertility studies conducted in rodents, a reduced pregnancy rate was observed after administration of azithromycin. The relevance of these findings to humans is unknown.

Driving and using machines
There are no data on the effect of Bactrazol on the ability to drive or operate machinery. However, when performing such activities, consider the possibility of side effects such as dizziness and convulsions.

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

3. How to use Bactrazol

This medicine should always be used as directed by a physician. In case of doubt, consult a
physician or pharmacist.
Dosage in adults, including elderly patients, and in children and adolescents with body weight
above 45 kg
Upper and lower respiratory tract infections, otitis media, skin and soft tissue infections (except
erythema migrans)
The total dose of azithromycin is 1.5 g over 3 days (500 mg as a single daily dose).
Erythema migrans
The total dose is 3 g, administered according to the following regimen: 1 g on the first day (2 film-coated tablets of 500 mg), followed by 500 mg (1 film-coated tablet) once daily from the second to the fifth day.
Uncomplicated infections caused by Chlamydia trachomatis
1 g (2 film-coated tablets of 500 mg) as a single dose.
Patients with renal or hepatic impairment
If a patient has impaired kidney or liver function, this should be reported to the physician, as the
usual dose may need to be reduced. This medicine should not be used in patients with severe hepatic
impairment.
Method of administration
Oral administration.
Azithromycin should be taken orally once daily.
Bactrazol 500 mg film-coated tablets can be taken with or without food.
Tablets should be swallowed whole.
Use of a higher than recommended dose of Bactrazol
Adverse effects observed after administration of higher than recommended doses were similar to
those reported after correct dosing. Characteristic symptoms of overdose with macrolide antibiotics
include transient hearing loss, severe nausea, vomiting, and diarrhea.
In case of ingestion of a higher than recommended dose, seek immediate medical advice from a
physician or pharmacist. In the event of overdose, administration of activated charcoal is recommended, along with symptomatic treatment and, if necessary, supportive measures to maintain vital functions.
Missed dose of Bactrazol
If a dose is missed, it should be taken as soon as possible. Subsequent doses should be taken according to the recommended dosing schedule. A double dose should not be taken to make up for a missed dose.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
If any of the following adverse reactions occur, stop using the medicine
Bactrazol and immediately contact a doctor or go to the emergency department of the
nearest hospital:

• Severe allergic reaction (sudden breathing and swallowing difficulties, swelling of lips, tongue, face and neck, itchy rash, especially if widespread throughout the body).

• Severe skin reactions: skin eruption characterized by sudden appearance of red skin areas covered with small blisters (vesicles filled with white or yellow fluid); severe skin rash causing redness and peeling; severe blistering and bleeding of lips, eyes, mouth, nose and genital organs, associated with high fever and joint pain. This may be acute generalized pustular eruption (AGEP),
  erythema multiforme, bullous erythema multiforme (Stevens-Johnson syndrome), or
  toxic epidermal necrolysis (Lyell's syndrome).

• Severe hypersensitivity reaction possibly including fever, skin rash, organ swelling, increased levels of certain white blood cells (eosinophilia), and inflammation of internal organs (drug reaction with eosinophilia and systemic symptoms (DRESS)).

You should also stop using Bactrazol and immediately contact your doctor if you notice:

• Severe or prolonged diarrhoea with blood or mucus. This symptom may occur during or after treatment and may indicate a serious intestinal inflammation.
• Weakness, yellowing of the skin or whites of the eyes, and dark-coloured urine.
• Unusual tendency to bruise or bleed.
• Rapid (ventricular tachycardia) or irregular heartbeat, or changes in heart rhythm on electrocardiogram (prolongation of QT interval and torsade de pointes-type arrhythmias).

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

• Diarrhoea.

Common (may affect less than 1 in 10 people):

• Headache;
• Vomiting, abdominal pain, nausea;
• Changes in white blood cell count;
• Decreased bicarbonate levels in blood.

Uncommon (may affect less than 1 in 100 people):

• Fungal infections (candidiasis), vaginal infection, pneumonia, fungal infection, bacterial infection, pharyngitis, gastritis and enteritis, respiratory disorders, rhinitis, oral candidiasis;
• Changes in white blood cell count (leukopenia, neutropenia, eosinophilia);
• Angioedema (swelling of face and throat, possibly causing breathing difficulties), hypersensitivity;
• Loss of appetite (anorexia);
• Nervousness, insomnia, dizziness, drowsiness, taste disturbances, unusual skin sensations such as tingling and numbness of limbs (paresthesia);
• Visual disturbances;
• Ear disorders, balance disorders;
• Palpitations;
• Hot flushes;
• Shortness of breath, nosebleeds;
• Constipation, bloating with flatulence, dyspepsia, gastric mucosal inflammation, swallowing difficulties (dysphagia), abdominal distension, dry mouth, regurgitation with vomiting, oral ulcers, excessive salivation;
• Rash, itching, urticaria, dermatitis, dry skin, excessive sweating;
• Osteoarthritis, muscle pain, back pain, neck pain;
• Urinary disorders (dysuria), kidney pain;
• Uterine bleeding, testicular disorders;
• Edema, weakness (asthenia), malaise, fatigue, facial swelling, chest pain, fever, pain, peripheral edema;
• Abnormal laboratory test results (e.g. blood tests, liver function parameters, glucose, electrolytes);
• Post-procedural complications.

Rare (may affect less than 1 in 1,000 people):

• Restlessness;
• Liver function disorders, cholestatic jaundice;
• Photophobia, severe skin reactions, skin eruption characterized by sudden appearance of red skin areas covered with small blisters (vesicles filled with white or yellow fluid).

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

• Pseudomembranous colitis;
• Thrombocytopenia (reduced platelet count), reduced number of red blood cells (hemolytic anemia);
• Anaphylactic reaction (generalized allergic reaction, rarely leading to death; may present with symptoms such as swelling of lips, face or neck leading to severe breathing difficulties, skin rash or urticaria);
• Aggressive behavior, anxiety, delirium, hallucinations;
• Loss of consciousness (fainting), seizures, sensory disturbances (hypoesthesia), excessive psychomotor activity, loss of smell, loss of taste, disturbances of smell, rapid muscle fatigue (myasthenia);
• Hearing disorders including deafness and (or) tinnitus;
• Cardiac rhythm disorders (including torsade de pointes and ventricular tachycardia), QT interval prolongation on electrocardiogram;
• Hypotension;
• Pancreatitis, tongue discoloration;
• Liver failure (rarely leading to death), fulminant hepatitis, hepatic necrosis;
• Severe skin reactions: bullous erythema multiforme (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), erythema multiforme, drug reaction with eosinophilia and systemic symptoms (DRESS);
• Joint pain;
• Acute renal failure, interstitial nephritis.

Adverse reactions probably or possibly related to the use of azithromycin in the treatment or prevention of Mycobacterium avium complex infections, based on clinical trials and post-marketing surveillance
Very common (may affect more than 1 in 10 people):

• Diarrhoea;
• Abdominal pain;
• Nausea;
• Bloating;
• Feeling of abdominal discomfort;
• Loose stools.

Common (may affect less than 1 in 10 people):

• Anorexia;
• Dizziness;
• Headache;
• Unusual skin sensations, such as tingling and numbness of limbs (paresthesia);
• Taste disturbances;
• Visual disturbances;
• Deafness;
• Rash, itching;
• Joint pain;
• Feeling of fatigue.

Uncommon (may affect less than 1 in 100 people):

• Sensory disturbances (hypoesthesia);
• Hearing disorders, tinnitus;
• Palpitations;
• Hepatitis;
• Bullous erythema multiforme (Stevens-Johnson syndrome), photophobia;
• Sudden weakness (asthenia), malaise.

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

5. How to store Bactrazol

• Keep this medicine out of the sight and reach of children.
• No special storage instructions apply to this medicine.
• Do not use this medicine after the expiry date stated on the carton and on the blister after "Expiry date". The expiry date refers to the last day of the stated month.

Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Bactrazol contains

• The active substance is azithromycin in the form of azithromycin dihydrate. Each coated tablet contains 500 mg of azithromycin.
• Other ingredients are: tablet core: anhydrous calcium hydrogen phosphate, hypromellose, corn starch, pregelatinized corn starch, microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate.
  Coating: hypromellose, colourant – indigo carmine (E132), titanium dioxide (E171), polysorbate 80, talc.

What Bactrazol looks like and contents of the packaging
Coated tablets, light blue in colour, biconvex on both sides, with the imprint AI 500 and a score line on one side.
The break line on the tablet is intended only to facilitate breaking for ease of swallowing, and does not ensure equal dose division.
The packaging contains 2, 3 or 6 coated tablets in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands
Tel.: (22) 345 93 00

Manufacturer
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80, 31-546 Kraków
Pliva Hrvatska d.o.o. (Pliva Croatia Ltd.)
Prilaz Baruna Filipovića 25, 10000 Zagreb
Croatia