Azibiot

Leaflet attached to the packaging: patient information

Azibiot, 500 mg, film-coated tablets

Azithromycin

Read 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 your 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 Azibiot and what is it 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 packaging and other information

1. What is Azibiot and what is it 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:

• 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 symptom of Lyme disease), rosacea, impetigo, secondary pyoderma;
• sexually transmitted diseases: uncomplicated urethritis, cervicitis caused by Chlamydia trachomatis or Neisseria gonorrhoeae.

2. Important information before taking Azibiot

Inform your doctor about any chronic diseases, metabolic disorders, allergies to other medicines, and the use of other medicines.

When not to take Azibiot

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

Warnings and precautions

Before startingAzibiot, discuss with your doctor if:

• the patient has liver or kidney disease,
• the patient is taking medicines containing ergot derivatives,
• the patient has myasthenia gravis,
• the patient has neurological or psychiatric disorders
• the patient is elderly. Elderly patients may be more susceptible to changes in the QT interval associated with the use of this medicine.

Stop taking Azibiot and consult your doctor immediately if the following serious side effects occur:

• swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing, rash, from skin itching to large blisters on the skin, or ulcers on the lips, eyes, nose, mouth, and genitals; these may be symptoms of a severe allergic reaction, angioedema, or anaphylaxis;
• prolonged diarrhea with blood or mucus in the stool; this may be a sign of a serious complication associated with antibiotic use.
• severe skin reactions with symptoms such as fever, red spots on the skin, blisters, or peeling of the skin, joint pain, swelling around the eyes; this may be caused by severe skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis (Lyell's syndrome) (frequency unknown); rare skin rash characterized by rapid onset of areas of red skin with small blisters (small blisters filled with white or yellow fluid), rash characterized by rapid onset of areas of red skin with small blisters (small blisters filled with white-yellow fluid).
• liver function disorders, hepatitis, cholestatic jaundice, liver necrosis, and liver failure (rarely leading to death).

In addition, if during treatmentwith Azibiot, the patient experiences the following symptoms, they should consult their doctor again:

• symptoms of liver function disorders, such as rapidly progressing weakness with jaundice, dark urine, loss of appetite, tendency to bleed;
• symptoms of a secondary infection, e.g. fungal infection.

Particular caution should be exercised when using Azibiot in patients who are at increased risk of developing heart rhythm disorders, especially:

• patients with congenital or confirmed QT interval prolongation in the ECG;
• patients taking other medicines that prolong the QT interval, such as antiarrhythmic drugs of class IA (quinidine, procainamide) and class III (dofetilide, amiodarone, sotalol), cisapride, and terfenadine, antipsychotic drugs, such as pimozide, antidepressant drugs, such as citalopram, and fluoroquinolones, such as moxifloxacin and levofloxacin; or hydroxychloroquine, used to treat malaria (see above "Warnings and precautions").
• patients with electrolyte disorders, especially with decreased potassium and magnesium levels;
• patients with significant bradycardia (slow heart rate), heart rhythm disorders, or severe heart failure.
• In the treatment of pharyngitis and tonsillitis caused by streptococci, the drug of choice is usually penicillin.
• In the treatment of sexually transmitted diseases, the doctor should ensure that the patient is not simultaneously infected with syphilis.
• There is no data on the safety and efficacy of long-term use of azithromycin in the above indications. If the infection recurs quickly, the doctor will consider treatment with another antibacterial drug.
• Azithromycin is not used to treat 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 you are currently taking or have recently taken, as well as any medicines you plan to take.
If you are taking any of the following medicines, tell your doctor or pharmacist before starting Azibiot:

• medicines known as ergot derivatives, such as ergotamine or dihydroergotamine (used to treat migraine or reduce blood flow); these medicines should not be taken at the same time as Azibiot,
• cyclosporin (used to treat skin diseases, rheumatoid arthritis, or after organ transplantation),
• atorvastatin (used to treat high cholesterol),
• theophylline (used to treat respiratory disorders),
• warfarin or other anticoagulant medicines,
• digoxin (used to treat heart rhythm disorders),
• colchicine (used to treat gout and familial Mediterranean fever),
• zidovudine, efavirenz, indinavir, nelfinavir, didanosine (used to treat HIV infections),
• rifabutin (used to treat HIV infections or tuberculosis),
• sildenafil (used to treat erectile dysfunction),
• carbamazepine, midazolam (used to treat 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 stomach acid production),
• antacids (medicines that neutralize stomach acid); Azibiot should be taken at least 1 hour before or 2 hours after taking antacids,
• methylprednisolone (used to treat rheumatoid arthritis and other joint inflammatory conditions, as well as asthma and hypersensitivity),
• medicines that may prolong the QT interval in the ECG, such as hydroxychloroquine, used to treat malaria (see above "Warnings and precautions").

Taking Azibiot with food and drink

Azibiot can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a child, consult your doctor or pharmacist before taking this medicine.
Pregnancy
The safety of this medicine during pregnancy has not been established. Your doctor will prescribe it to pregnant women only if necessary, when the benefit to the mother outweighs the risk to the fetus.
Breastfeeding
Azithromycin passes into breast milk. No serious side effects have been observed in breastfed infants in connection with the use of azithromycin. The decision to use the product during breastfeeding is made by the doctor.
Fertility
In rat studies, a reduced fertility index was observed after administration of azithromycin. The significance of this observation for humans is unknown.

Driving and using machines

There is no evidence that azithromycin affects the ability to drive vehicles or operate machinery. However, consider the possibility of side effects such as dizziness and seizures.

Azibiot contains lactose and sodium

If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".

3. How to take Azibiot

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
Azithromycin is given once a day, and the dosing schedule is determined by your doctor.

Dosage for adults and children over 45 kg

• Respiratory tract, skin, and soft tissue infections The total dose of 1.5 g (3 tablets of 500 mg) is given in three daily doses of 500 mg for three consecutive days.
• Uncomplicated urethritis or cervicitis caused by Chlamydia trachomatis or Neisseria gonorrhoeae In the case of uncomplicated genital infections caused by Chlamydia trachomatis - 1 g (2 tablets of 500 mg) as a single dose. In the case of genital infections caused by Neisseria gonorrhoeae - 2 g (4 tablets of 500 mg) as a single oral dose, along with ceftriaxone 500 mg intramuscularly as a single dose.

Dosage for elderly patients

No dose adjustment is necessary for elderly patients. However, in elderly patients with an increased risk of heart rhythm disorders, particular caution should be exercised.

Patients with liver or kidney disorders

If you have liver or kidney disorders, inform your doctor. Your doctor may decide to adjust the dose of the medicine.

Taking more than the recommended dose of Azibiot

If you have taken more than the recommended dose, contact your doctor immediately.
Too high a dose may cause nausea, vomiting, diarrhea, and hearing disorders.

Missing a dose of Azibiot

Do not take a double dose to make up for a missed dose.
If you miss a dose, take it as soon as possible. Take the next dose at the usual time.

Stopping Azibiot treatment

Take the medicine for as long as your doctor has prescribed. If you stop treatment too early, it may not be effective or the disease may recur.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

Method of administration

Azibiot should be taken orally.
Azibiot can be taken with or without food.

4. Possible side effects

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

Stop taking Azibiot and consult your doctor immediately if you experience any of the following serious side effects:

• swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing, rash, from skin itching to large blisters on the skin, or ulcers on the lips, eyes, nose, mouth, and genitals; these may be symptoms of a severe allergic reaction, angioedema, or anaphylaxis (rare, less than 1 in 100 patients);
• severe, prolonged diarrhea with blood or mucus in the stool; this may be a sign of a serious complication associated with antibiotic use (frequency unknown);
• severe skin reactions with symptoms such as fever, red spots on the skin, blisters, or peeling of the skin, joint pain, swelling around the eyes; this may be caused by severe skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis (Lyell's syndrome) (frequency unknown); rare skin rash characterized by rapid onset of areas of red skin with small blisters (small blisters filled with white or yellow fluid), rash characterized by rapid onset of areas of red skin with small blisters (small blisters filled with white-yellow fluid).
• liver function disorders, hepatitis, cholestatic jaundice, liver necrosis, and liver failure (rarely leading to death) (frequency unknown),

Other side effects that may occur during azithromycin treatment:

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

• diarrhea

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

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

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

• fungal or bacterial infections, especially of the mouth, throat, nose, lungs, intestines, and vagina
• changes in the number of certain types of white blood cells (leukopenia, neutropenia, eosinophilia)
• loss of appetite
• anxiety, insomnia
• dizziness, drowsiness, taste disorders, numbness or tingling of the hands or feet
• vision disorders
• hearing disorders, ringing in the ears
• heart palpitations
• hot flashes
• shortness of breath, nosebleeds
• constipation, gas, indigestion, gastritis, swallowing disorders, bloating, dry mouth, belching, oral ulcers, increased salivation
• itching rash, skin inflammation, dry skin, sweating
• bone and joint inflammation, muscle pain, back and neck pain
• pain when urinating, kidney pain
• genital bleeding, testicular disorders
• edema, weakness, general malaise, fatigue, facial swelling, chest pain, fever, pain
• abnormal laboratory test results (e.g., blood, liver, and kidney function)
• post-treatment complications

Rare (may affect up to 1 in 1000 patients):

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

Side effects with unknown frequency (frequency cannot be estimated from the available data):

• decreased platelet count, which increases the risk of bleeding or bruising
• decreased red blood cell count, which causes pale yellow skin and weakness or shortness of breath
• aggression, anxiety, hallucinations, delusions
• seizures, fainting, decreased skin sensitivity to touch, excessive psychomotor activity, smell disorders, loss of smell or taste, muscle weakness (myasthenia)
• hearing disorders, deafness, or ringing in the ears
• abnormal ECG
• low blood pressure
• pancreatitis
• tongue discoloration
• joint pain
• acute kidney failure or interstitial nephritis
• liver failure (rarely leading to death), fulminant hepatitis, liver necrosis

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. 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: +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 Azibiot

Keep the medicine out of the sight and reach of children.
There are no special precautions for storing the medicine.
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 month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Azibiot contains

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

What Azibiot looks like and contents of the pack

The tablets are white, oval, and have a dividing line on both sides. The tablet can be divided into equal doses.
The packaging contains 3 film-coated tablets in PVC/Aluminum blisters in a cardboard box.

Marketing authorization holder

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

Manufacturer

KRKA - Polska Sp. z o.o.,
ul. Równoległa 5,
02-235 Warszawa,
Poland
KRKA, d.d., Novo Mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia
To obtain more detailed information about this medicine, contact the local representative of the marketing authorization holder:
KRKA - Polska Sp. z o.o.,
ul. Równoległa 5,
02-235 Warszawa,
Poland
phone: (22) 57 37 500

Date of last revision of the leaflet: