Azitrox 500

Leaflet attached to the packaging: patient information

Azitrox 500

500 mg, film-coated tablets

Azithromycin

Read the contents of the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Azitrox 500 and what is it used for
• 2. Important information before taking Azitrox 500
• 3. How to take Azitrox 500
• 4. Possible side effects
• 5. How to store Azitrox 500
• 6. Contents of the packaging and other information

1. What is Azitrox 500 and what is it used for

Azitrox 500 contains the active substance azithromycin, which is a broad-spectrum antibiotic (bactericidal effect on susceptible microorganisms). It works by inhibiting protein synthesis in bacterial cells, preventing the growth and reproduction of bacteria.
Azitrox 500 is indicated for the treatment of the following infections caused by microorganisms susceptible to azithromycin:

• upper respiratory tract infections: bacterial pharyngitis, tonsillitis, sinusitis,
• acute otitis media,
• lower respiratory tract infections: bacterial bronchitis, exacerbation of chronic bronchitis, mild to moderate interstitial and alveolar pneumonia,
• skin and soft tissue infections: erythema migrans (first sign of Lyme disease); rosacea, impetigo, secondarily infected purulent skin infection; moderate acne, exclusively in adults,
• sexually transmitted diseases, such as: uncomplicated urethritis and cervicitis caused by Chlamydia trachomatis.

When deciding to use Azitrox 500, the doctor will take into account the official recommendations for the use of antibacterial drugs.

2. Important information before taking Azitrox 500

When not to take Azitrox 500

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

Warnings and precautions

The patient should inform their doctor about all concomitant health problems, especially if:

• the patient has conditions that predispose to cardiac arrhythmias (especially important in women and elderly patients):
• congenital or existing cardiac 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 "Azitrox 500 and other medicines");
• the patient has severe kidney problems;
• the patient has severe liver problems: the doctor may monitor liver function or discontinue treatment;
• the patient has a new infection (may indicate excessive growth of resistant microorganisms or fungal infection);
• the patient has neurological (neurological) or mental (psychiatric) disorders;
• the patient has a sexually transmitted disease: the doctor should ensure that the patient does not have a co-existing syphilis infection;
• the patient is taking ergotamine derivatives (ergot preparations);
• the patient has infected burn wounds.

Infections caused by streptococci
In the treatment of pharyngitis and tonsillitis caused by streptococci, the drug of choice is usually penicillin.
Pseudomembranous colitis
In case of diarrhea, the patient should immediately inform their doctor, as it may be a sign of pseudomembranous colitis - a complication that sometimes occurs during the use of macrolide antibiotics. Such a diagnosis should be considered in patients who develop diarrhea after starting azithromycin treatment. In case of pseudomembranous colitis caused by azithromycin, it may be necessary to discontinue Azitrox 500 and use appropriate treatment. It is contraindicated to administer agents that inhibit peristalsis.
Long-term use
There is no data on the safety and efficacy of long-term use of azithromycin in the above indications. In case of rapidly recurring infections, the doctor will consider treatment with another antibacterial drug.
Myasthenia
During azithromycin treatment, exacerbation of myasthenia symptoms or development of myasthenic syndrome has been observed (see "Possible side effects").

Children and adolescents

Azitrox 500 in the form of 500 mg film-coated tablets is recommended for use in children only with a body weight of 45 kg or more. For the remaining group of children, it is recommended to use azithromycin in another pharmaceutical form, e.g., oral suspension.

Azitrox 500 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.
This medicine should not be taken at the same time as ergotamine derivatives (ergot preparations): ergotamine, dihydroergotamine (used to treat migraine), as ergotism may occur (symptoms - itching in the limbs, muscle cramps, and tissue necrosis of the hands and feet caused by poor blood circulation).

If the patient is taking any of the following medicines, they should inform their doctor, as special caution may be necessary:

• medicines that affect the QT interval, such as:
• quinidine, procainamide, dofetilide, amiodarone, and sotalol (used to treat arrhythmias),
• cisapride (used to treat gastrointestinal disorders),
• terfenadine (used to treat hay fever),
• antipsychotic medicines (used to treat mental disorders), e.g., pimozide,
• antidepressant medicines (used to treat depression), e.g., citalopram,
• fluoroquinolones (antibacterial medicines used to treat infections), e.g., moxifloxacin and levofloxacin,
• hydroxychloroquine (used to treat rheumatoid arthritis, lupus, malaria), there is an increased risk of arrhythmias.
• medicines that neutralize stomach acid (used to treat hyperacidity or indigestion) - Azitrox 500 should be taken 1 hour before or 2 hours after taking the acid-neutralizing medicine,
• warfarin (used to prevent blood clot formation),
• ergotamine derivatives (used to treat migraine or reduce blood flow), e.g., ergotamine, which can cause ergotism when taken with azithromycin (symptoms - constriction of peripheral blood vessels and tissue ischemia);
• digoxin (used to treat heart rhythm disorders),
• colchicine (used to treat gout and familial Mediterranean fever)
• cyclosporin (used to suppress the immune system to prevent and treat organ and bone marrow transplant rejection),
• statins (used to lower high cholesterol levels in the blood), e.g., atorvastatin.
• rifabutin (used to treat tuberculosis),
• nelfinavir, zidovudine (used to treat HIV infections),
• other antibiotics (such as erythromycin, lincomycin, and clindamycin).

Taking Azitrox 500 with food and drink

The medicine should be taken orally once a day, on an empty stomach, at least 1 hour before a meal or 2 hours after a meal. The tablet should be swallowed whole and washed down with water.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or are planning to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Azithromycin can be used in pregnant women only when the benefit to the mother outweighs the risk to the fetus
Breastfeeding
Azithromycin passes into breast milk, and therefore, it should not be used in breastfeeding women, unless the doctor recommends otherwise.
Fertility
In fertility studies conducted in rodents, a decrease in fertility was observed after administration of azithromycin. The significance of these findings for humans is unknown.

Driving and using machines

There is no data on the effect of azithromycin on the ability to drive and use machines. When performing such activities, the patient should take into account the possibility of side effects such as dizziness and seizures.

3. How to take Azitrox 500

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
Adults, adolescents, and children with a body weight over 45 kg
Respiratory tract infections, otitis media, skin and soft tissue infections (except for erythema migrans and moderate acne):the total dose is 1.5 g over 3 days (500 mg once a day).
Erythema migrans:the total dose is 3 g and should be administered according to the following scheme: on the first day of treatment, 1 g (2 tablets of 500 mg), and then 500 mg (1 tablet) from the second to the fifth day of treatment.
Moderate acne: exclusively in adults:the total dose is 6 g and is recommended to be administered according to the following scheme: 1 tablet of 500 mg once a day for 3 days, then 1 tablet of 500 mg once a week for the next 9 weeks. In the second week of treatment, the medicine should be taken 7 days after the first dose, and the next eight doses should be taken at 7-day intervals.
Before starting and during the above treatment in patients with moderate acne, it is necessary to monitor liver enzyme activity due to the high dose of azithromycin.
Due to the lack of data from controlled clinical trials on the repetition of the above treatment scheme for moderate acne, this scheme (3 days + 9 weeks) can be used in a given patient only once.
Uncomplicated Chlamydia trachomatis infections:1 g (2 film-coated tablets of 500 mg) in a single dose.
Taking Azitrox 500 in elderly patients
The dosage of Azitrox 500 in elderly patients is the same as in other adult patients. Due to the risk of heart disease, caution is recommended when using this medicine in these patients
Children with a body weight below 45 kg
Azitrox 500 is used only in children with a body weight over 45 kg - according to the dosage for adults.
In children with a body weight below 45 kg, azithromycin should be used in another pharmaceutical form, e.g., oral suspension.
Taking Azitrox 500 in patients with kidney and/or liver problems
If the patient has kidney or liver problems, they should inform their doctor, as it may be necessary to change the usual recommended dose of the medicine.
Since azithromycin is metabolized in the liver and excreted in the bile, the medicine should not be used in patients with severe liver failure. No studies have been conducted on the use of azithromycin in these patients.
Method of administration
Oral administration.
Azithromycin should be administered once a day. Azitrox 500 film-coated tablets should be taken whole, at least 1 hour before a meal or 2 hours after eating.

Taking a higher dose of Azitrox 500 than recommended

Side effects observed after taking higher doses than recommended were similar to those that occurred after taking the correct doses. Typical symptoms of macrolide antibiotic overdose are: transient hearing loss, severe nausea, vomiting, and diarrhea.
In case of taking a higher dose of the medicine than recommended, the patient should immediately consult a doctor, who will provide appropriate treatment.

Missing a dose of Azitrox 500

In case of missing a dose, the patient should take it as soon as possible. However, if the time for the next dose is approaching, the missed dose should be skipped, and the recommended dosing schedule should be continued.
The patient should not take a double dose to make up for the missed dose. The patient should not take more than one dose of the medicine per day.

Stopping Azitrox 500 treatment

The medicine should be taken for as long as the doctor recommends. It is important not to stoptreatment even if the symptoms of the disease have disappeared after a few days of taking the medicine. If the patient stops treatment too early, the infection may recur.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Azitrox 500 can cause side effects, although not everybody gets them.

The patient should stop taking Azitrox 500 and immediately contact their doctor or go to the nearest hospital emergency department if they experience any of the following side effects:

• Swelling of the hands, feet, ankles, face, lips, or throat, which may cause difficulty swallowing or breathing, low blood pressure, itching, and hives. These may be symptoms of a severe allergic reaction (angioedema or anaphylaxis).
• Severe skin reactions, such as blistering of the skin, peeling of the skin in the mouth, around the eyes, and genitals, rash, redness of the skin, swelling of the skin and mucous membranes, acute generalized exanthematous pustulosis (a skin rash characterized by rapid onset of areas of redness of the skin studded with small pustules [blisters filled with white or yellow fluid]), "toxic epidermal necrolysis", or "Stevens-Johnson syndrome".
• Severe or prolonged diarrhea (with blood or mucus) occurring during or after treatment with Azitrox 500. These may be symptoms of severe colitis (pseudomembranous colitis).
• Rapid or irregular heartbeat - frequency of occurrence is unknown (may occur more frequently in women and elderly patients).

The following side effects may occur during treatment with Azitrox 500, listed by frequency of occurrence.

Very common side effects (occurring in at least 1 in 10 patients):

• Diarrhea

Common side effects (occurring in 1 to 10 in 100 patients):

• Headache
• Abdominal pain, nausea, vomiting
• Changes in blood counts of different types of white blood cells (decrease in lymphocytes, increase in eosinophils, basophils, monocytes, neutrophils)
• Decrease in blood bicarbonate levels

Uncommon side effects (occurring in 1 to 10 in 1,000 patients):

• Fungal infections, including those in the mouth or vagina, pneumonia, fungal infection, bacterial infection, sore throat (pharyngitis), gastroenteritis, common cold, respiratory disorders
• Changes in blood counts of different types of white blood cells (decrease in leukocytes, neutrophils, increase in eosinophils)
• Allergic reactions of varying severity, including angioedema
• Anorexia (loss of appetite)
• Nervousness, insomnia
• Dizziness, headache, paresthesia (sensory disturbance - tingling, pricking, or numbness of the skin), taste disturbances
• Visual disturbances
• Hearing disturbances, vertigo
• Palpitations
• Flushes
• Dyspnea, epistaxis
• Gastritis, constipation, bloating, indigestion, swallowing disorders, abdominal distension, dryness of the mucous membranes of the mouth, belching, oral mucosal ulceration, excessive salivation
• Rash, itching, urticaria, skin inflammation, dry skin, excessive sweating
• Arthrosis, muscle pain, back pain, neck pain
• Painful urination, kidney pain
• Irregular menstruation, testicular disorders
• Chest pain, feeling of general physical weakness, edema (e.g., of the face or limbs), general malaise, fatigue, fever, pain
• Abnormal laboratory test results (e.g., related to blood parameters or liver function)
• Post-procedure complications

Rare side effects (occurring in 1 to 10 in 10,000 patients):

• Agitation
• Photosensitivity reaction
• Liver function disorders, cholestatic jaundice
• Severe skin reactions: acute generalized exanthematous pustulosis

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

• Pseudomembranous colitis
• Anaphylactic reaction
• Aggression, anxiety, delirium, hallucinations
• Fainting, seizures, numbness, excessive psychomotor activity, muscle weakness
• Anosmia (loss of smell) or ageusia (loss of taste)
• Hearing disturbances, including deafness and/or tinnitus
• Arrhythmias, including significant acceleration and irregularity of the heart rate
• Low blood pressure
• Pancreatitis, tongue discoloration
• Severe skin reaction that can occur with blisters, peeling, or detachment of the skin, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS);
• Arthralgia (joint pain)
• Liver failure, rarely fatal, fulminant hepatitis, liver necrosis
• Kidney failure, kidney inflammation
• Abdominal pain with diarrhea and fever
• Decreased platelet count causing a tendency to bruising or bleeding
• Fatigue associated with dark urine, caused by hemolytic anemia.

The following side effects are probably related to the use of azithromycin in the treatment of infections caused by the Mycobacterium aviumcomplex, other than those reported in other indications.

Very common (occurring in at least 1 in 10 patients):

• -Diarrhea, abdominal pain, nausea, bloating, feeling of discomfort in the abdominal cavity, loose stools

Common (occurring in 1 to 10 in 100 patients):

• Anorexia (loss of appetite)
• Dizziness, headache, paresthesia (sensory disturbance - tingling, pricking, or numbness of the skin), taste disturbances
• Visual disturbances
• Deafness
• Rash, itching
• Arthralgia (joint pain)
• Fatigue

Uncommon (occurring in 1 to 10 in 1,000 patients):

• Numbness
• Hearing disturbances, tinnitus
• Palpitations
• Hepatitis
• Severe skin reactions (Stevens-Johnson syndrome), photosensitivity reaction
• Feeling of general physical weakness, malaise

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 Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw,
Phone: 22 49-21-301
Fax: 22 49-21-309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative in Poland.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Azitrox 500

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C.
Do not use this medicine after the expiry date stated on the packaging. 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 packaging and other information

What Azitrox 500 contains

The active substance of the medicine is azithromycin.
Each film-coated tablet contains 500 mg of azithromycin in the form of azithromycin dihydrate.
The other ingredients are: maize starch pre-gelatinized, croscarmellose sodium, calcium hydrogen phosphate, magnesium stearate, sodium lauryl sulfate; coating:hypromellose 2910/5, titanium dioxide, macrogol 6000, talc, simethicone emulsion SE 4, polysorbate 80.

What Azitrox 500 looks like and contents of the pack

White or almost white, oblong film-coated tablet.
Pack sizes: 2, 3, or 6 film-coated tablets.

Marketing authorization holder and manufacturer

Zentiva k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic

For more information about this medicine, please contact the representative of the marketing authorization holder:

Zentiva Polska Sp. z o.o., ul. Bonifraterska 17, 00-203 Warsaw.
Phone: (22) 375 92 00

Date of last revision of the leaflet: