Azibiot

Patient Information Leaflet

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

• Keep this leaflet, so that you can read it again if necessary.
• 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 the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

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

1. What Azibiot is and what it is used for

Azibiot contains azithromycin, which is an antibiotic belonging to the macrolide group.
Azibiot is indicated for the treatment of the following bacterial infections caused by organisms sensitive to azithromycin:

• upper respiratory tract infections: sinusitis, pharyngitis and tonsillitis;
• acute otitis media;
• lower respiratory tract infections: bacterial bronchitis and exacerbation of chronic bronchitis, community-acquired pneumonia;
• skin and soft tissue infections: erythema migrans (the first sign of Lyme disease), erysipelas, impetigo, secondary bacterial skin infections;
• sexually transmitted diseases: uncomplicated urethritis, cervicitis, caused by Chlamydia trachomatis or Neisseriae gonorrhoeae.

2. Important information before using Azibiot

Inform your doctor about any chronic diseases, metabolic disorders,
hypersensitivity (allergy) to other medicines, and about any other medications you are currently taking.

When not to use Azibiot

• If the patient is allergic to azithromycin or 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 Azibiot, discuss with your doctor if:

• The patient has liver or kidney disorders,
• The patient is taking medications containing ergot alkaloids,
• The patient suffers from myasthenia gravis,
• The patient has neurological or psychiatric disorders,
• The patient is elderly. Elderly patients may be more susceptible to QT interval prolongation associated with the use of this medicine.
• If vomiting or irritability occurs in an infant (up to 6 weeks of age) during feeding while taking azithromycin, contact your doctor immediately.

Discontinue taking Azibiot and seek medical advice immediately if the patient experiences any of the following severe adverse reactions during treatment:

• Swelling of the face, lips, tongue or throat, difficulty breathing or swallowing, rash, itching, large blisters on the skin or skin peeling, or ulcers on the lips, around the eyes, nose, mouth, and genital organs accompanied by fever, joint pain, increased number of eosinophils, and internal organ involvement (most commonly: liver, kidneys, lungs); these may be signs of a severe allergic reaction, angioedema, or anaphylactic reaction;
• Persistent diarrhoea containing blood or mucus in the stool; this may indicate a serious complication related to antibiotic use.
• Severe skin reactions with the following symptoms: fever, red skin patches, blisters or skin peeling, joint pain, swelling around the eyes; these may be due to serious skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis (Lyell's syndrome) (frequency unknown); rarely, skin eruptions characterized by rapid appearance of red skin areas with small vesicles (small blisters filled with white or yellow fluid), rash characterized by rapid appearance of red skin areas with small vesicles (small blisters filled with whitish-yellow fluid).
• Liver function disorders, hepatitis, cholestatic jaundice, liver necrosis, and liver failure (rarely leading to death).

Additionally, if the patient experiences any of the following symptoms during treatment, consult your doctor again:

• Symptoms of liver dysfunction, such as rapidly progressing weakness with jaundice, dark urine, loss of appetite, tendency to bleed;
• Symptoms of a new infection, e.g., fungal infection.

Special caution is required when using Azibiot in patients at increased risk of developing
cardiac arrhythmias, particularly:

• Patients with congenital or confirmed QT interval prolongation on ECG;
• Patients receiving concomitant medications that prolong the QT interval, such as class IA (quinidine, procainamide) and class III (dofetilide, amiodarone, sotalol) antiarrhythmics, cisapride and terfenadine, antipsychotic drugs such as pimozide, antidepressants such as citalopram, fluoroquinolones such as moxifloxacin and levofloxacin; or hydroxychloroquine used in the treatment of malaria;
• Patients with electrolyte imbalances, especially low potassium and magnesium levels;
• Patients with clinically significant bradycardia (slow heart rate), cardiac arrhythmias, or severe heart failure.
• In the treatment of streptococcal pharyngitis and tonsillitis, penicillin is usually the drug of choice.
• In treating sexually transmitted diseases, the doctor should ensure the patient is not simultaneously infected with syphilis.
• There is a lack of data on the safety and efficacy of long-term azithromycin use for the above-mentioned indications. If infection recurs rapidly, the doctor may consider treatment with another antibacterial agent.
• Azithromycin should not be used in the treatment of infected burn wounds.

Children and adolescents
The safety and efficacy of azithromycin in the prevention or treatment of Mycobacterium avium complex (MAC) infection in children have not been established.

Azibiot and other medicines
Tell your doctor about all medicines currently used or recently used, as well as any medicines the patient plans to take.
If the patient is taking any of the following medicines, inform the doctor or pharmacist before starting Azibiot:

• Medicines known as ergot derivatives, e.g., ergotamine or dihydroergotamine (used in migraine or to reduce blood flow); these should not be used concomitantly with Azibiot,
• Cyclosporine (used in skin diseases, rheumatoid arthritis, or after organ transplantation),
• Atorvastatin (used to treat high blood cholesterol),
• Theophylline (used to treat respiratory disorders),
• Warfarin or other anticoagulants,
• Digoxin (used to treat heart function disorders),
• Colchicine (used to treat gout and familial Mediterranean fever),
• Zidovudine, efavirenz, indinavir, nelfinavir, didanosine (used in the treatment of HIV infections),
• Rifabutin (used in the treatment of HIV infections or tuberculosis),
• Sildenafil (used to treat erectile dysfunction),
• Carbamazepine, midazolam (used in the treatment of epilepsy),
• Triazolam (used as a sedative in the treatment of severe insomnia),
• Terfenadine (used to treat allergies),
• Fluconazole (used to treat fungal infections),
• Trimethoprim with sulfamethoxazole (used to treat various bacterial infections),
• Cetirizine (used to treat allergies),
• Cimetidine (used to reduce gastric acid secretion),
• Antacids (medications that neutralize gastric acid); Azibiot should be taken at least 1 hour before or 2 hours after antacids,
• Methylprednisolone (used in the treatment of rheumatoid arthritis and other inflammatory joint conditions, asthma, and hypersensitivity),
• Medications that may prolong the QT interval on ECG, e.g., hydroxychloroquine used in the treatment of malaria (see above "Warnings and precautions").

Taking Azibiot with food and drink
Azibiot can be taken independently of meals.

Pregnancy, breastfeeding, and fertility

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

Pregnancy
The safety of using this medicine during pregnancy has not been established. The doctor will prescribe it to pregnant women only if absolutely necessary, when, in the doctor's opinion, the benefit to the mother outweighs the risk to the fetus.

Breastfeeding
Azithromycin passes into breast milk. No severe adverse effects have been observed in breastfed infants related to azithromycin use. The decision on whether to use this product during breastfeeding should be made by the doctor.

Fertility
In fertility studies conducted in rats, a reduced pregnancy rate was observed after administration of azithromycin. The significance of this observation for humans is unknown.

Driving and operating machinery
There is no evidence that azithromycin affects the ability to drive or operate mechanical equipment. However, the possibility of adverse effects such as dizziness and seizures should be considered.

Azibiot contains lactose monohydrate and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to use Azibiot

This medicine should always be used exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Azithromycin is administered once daily; the dosage regimen is determined by the doctor.

Dosage in adults and children with body weight above 45 kg

• Respiratory tract, skin and soft tissue infections: A total dose of 1.5 g (3 tablets of 500 mg) should be given as three daily doses of 500 mg each for three consecutive days.
• Uncomplicated urinary tract or cervical infections caused by Chlamydia trachomatis or Neisseria gonorrhoeae:
  For uncomplicated genital infections caused by Chlamydia trachomatis – a single dose of 1 g (2 tablets of 500 mg).
  For genital infections caused by Neisseria gonorrhoeae – a single oral dose of 2 g (4 tablets of 500 mg) together with a single intramuscular dose of ceftriaxone 500 mg.

Dosage in elderly patients
Dosage adjustment is not required in elderly patients. However, particular caution should be exercised in elderly patients who have an increased risk of cardiac arrhythmias.

Patients with renal or hepatic impairment
If the patient has impaired kidney or liver function, this should be reported to the doctor. The doctor may decide to adjust the dosage of the medicine.

Use of a higher than recommended dose of Azibiot
If a higher than recommended dose is taken, contact your doctor immediately.
Excessive doses may cause nausea, vomiting, diarrhoea and hearing disturbances.

Missed dose of Azibiot
Do not take a double dose to make up for a missed dose.
If a dose is missed, take it as soon as possible. Take the next dose at the usual scheduled time.

Interrupting treatment with Azibiot
Continue taking the medicine for as long as directed by your doctor. Premature discontinuation of treatment may result in ineffective therapy or recurrence of the disease.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

Method of administration
Azibiot should be taken orally.
Azibiot may be taken independently of meals.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Azibiot treatment must be discontinued and a doctor should be contacted immediately if the patient experiences any of the following serious adverse reactions:

• swelling of the face, lips, tongue or throat, difficulty breathing or swallowing, rash, itching of the skin progressing to large blisters or skin peeling, or ulcers on the lips, eyes, nose, mouth or genital organs; these may be symptoms of a severe allergic reaction, angioedema or anaphylactic reaction (occur less frequently than in 1 out of 100 patients);
• severe, prolonged diarrhoea containing blood or mucus in the stool; this may be a sign of a serious intestinal disorder called "pseudomembranous colitis" (frequency unknown);
• severe skin reactions with the following symptoms: fever, red skin patches, blisters or skin peeling, joint pain, swelling around the eyes; these may be due to serious skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis (Lyell's syndrome) (frequency unknown); rarely, exanthema characterized by rapid appearance of red skin areas with small vesicles (small blisters filled with white or yellow fluid), rash characterized by rapid appearance of red skin areas with small vesicles (small blisters filled with whitish-yellow fluid).
• liver function disorders, hepatitis, cholestatic jaundice, hepatic necrosis and liver failure (rarely leading to death) (frequency unknown),

Other adverse reactions that may occur during azithromycin treatment:
Very common (may occur in more than 1 out of 10 patients):

• diarrhoea

Common (may occur in less than 1 out of 10 patients):

• headache
• vomiting, abdominal pain, nausea
• changes in the count of certain types of white blood cells (lymphocytes, eosinophils, basophils, monocytes and neutrophils), low bicarbonate levels in blood

Uncommon (may occur in less than 1 out of 100 patients):

• fungal and bacterial infections, especially of the mouth, throat, nose, lungs, intestines and vagina
• changes in the count of certain types of white blood cells (leukopenia, neutropenia, eosinophilia)
• loss of appetite
• nervousness, insomnia
• dizziness, drowsiness, taste disturbances, tingling or numbness of hands or feet
• visual disturbances
• ear disorder, dizziness with sensation of spinning
• palpitations
• hot flushes
• shortness of breath, nosebleeds
• constipation, flatulence, indigestion, gastritis, difficulty swallowing, bloating, dry mouth, belching, oral ulceration, excessive salivation
• itchy rash, dermatitis, dry skin, sweating
• bone and joint inflammation, muscle, back and neck pain
• pain during urination, kidney pain
• genital tract bleeding, testicular disorders
• oedema, weakness, malaise, fatigue, facial swelling, chest pain, fever, pain
• abnormal laboratory test results (e.g. blood, liver and kidney function tests)
• complications following treatment

Rare (may occur in less than 1 out of 1,000 patients):

• agitation
• abnormal liver function, jaundice
• photosensitivity reactions
• drug reaction with eosinophilia and systemic symptoms (DRESS)

Adverse reactions with unknown frequency (frequency cannot be estimated from available data):

• decreased platelet count, increasing the risk of bleeding or bruising
• decreased red blood cell count, causing pale-yellow skin discoloration, weakness or shortness of breath
• aggression, anxiety, delirium, hallucinations
• seizures, fainting, reduced skin sensitivity to touch, psychomotor hyperactivity, disturbances in smell, loss of smell or taste, muscle weakness (myasthenia)
• hearing disturbances, deafness or tinnitus
• abnormal ECG findings
• low blood pressure
• pancreatitis
• tongue discoloration
• joint pain
• acute renal failure or interstitial nephritis
• liver failure (rarely leading to death), fulminant hepatitis, hepatic necrosis

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, the patient should inform their 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 the medicine.

5. How to store Azibiot

Keep this medicine out of the sight and reach of children.
No special storage instructions are required for this medicine.
Do not use this medicine after the expiry date stated on the packaging following: 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 you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Azibiot contains

• The active substance is azithromycin. One coated tablet contains 500 mg of azithromycin in the form of azithromycin dihydrate.
• The other ingredients are: pregelatinized starch, crospovidone, calcium hydrogen phosphate, sodium lauryl sulfate, magnesium stearate; film-coating ingredients: hypromellose, titanium dioxide (E 171), monohydrate lactose, triacetin. See section 2 "Azibiot contains monohydrate lactose and sodium".

What Azibiot looks like and contents of the pack
White, oval tablets with a score line on both sides allowing the tablet to be divided into equal doses.
The pack contains 3 coated tablets in PVC/Aluminium blisters packed in a cardboard box.

Marketing Authorisation Holder
KRKA, d.d., Novo Mesto,
Šmarješka cesta 6,
8501 Novo mesto,
Slovenia

Manufacturer
KRKA - Polska Sp. z o.o.,
Równoległa 5,
02-235 Warszawa,
Poland
KRKA, d.d., Novo Mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
KRKA - Polska Sp. z o.o.,
Równoległa 5,
02-235 Warszawa,
Poland
Tel: (22) 57 37 500