Nobaxin

Package leaflet: Information for the patient

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

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, 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 Nobaxin is and what it is used for
2. Important information before taking Nobaxin
3. How to take Nobaxin
4. Possible side effects
5. How to store Nobaxin
6. Contents of the pack and other information

1. What Nobaxin is and what it is used for

Nobaxin contains azithromycin as the active substance, which is an azalide antibiotic belonging to the macrolide group with a broad spectrum of activity. It acts bactericidally against susceptible microorganisms.
Nobaxin 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; moderate acne vulgaris, in adults only.
• Sexually transmitted infections: uncomplicated infections caused by Chlamydia trachomatis.

2. Important information before using Nobaxin

When not to use Nobaxin

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

Warnings and precautions
Before starting treatment with Nobaxin, discuss with your doctor or pharmacist if:

• the patient has conditions predisposing to cardiac arrhythmias (particularly relevant in women and elderly patients):
• congenital or previous history of cardiac arrhythmias (visible on ECG – test measuring electrical activity of the heart),
• severe heart failure,
• very slow heart rate (called bradycardia),
• electrolyte imbalances in the blood, especially low potassium or magnesium levels,
• taking other medicines that may prolong the QT interval on ECG (see section "Nobaxin with other medicines");
  • the patient has severe kidney function impairment;
  • the patient has severe liver function 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 co-existing;
  • the patient is taking ergotamine derivatives (ergot preparations);
  • the patient has infected burn wounds.

Also refer to the warnings contained in section 4.
If, despite treatment, symptoms of infection do not improve or symptoms of a new infection appear,
e.g. fungal infection, consult your doctor again.
Streptococcal infections
In the treatment of streptococcal pharyngitis and tonsillitis, penicillin is usually the drug of choice.
Pseudomembranous colitis
If diarrhea occurs, it should be reported immediately to the doctor, as it may be a sign of
pseudomembranous colitis—a complication that may occasionally occur during treatment with
macrolide antibiotics. Doctors should consider this diagnosis in patients who develop diarrhea
after starting azithromycin therapy. In case of pseudomembranous colitis due to azithromycin use,
discontinuation of Nobaxin and initiation of appropriate treatment may be necessary.
Medicines that inhibit peristalsis should not be used.
Long-term use
There are no data on the safety and efficacy of long-term use of azithromycin in the indications
listed above. In cases of rapidly recurring infections, the doctor may consider treatment with another
antibacterial agent.
Myasthenia
Worsening of myasthenia symptoms or development of a myasthenic syndrome has been observed
during azithromycin treatment (see section "Possible side effects").
Children and adolescents
Nobaxin 500 mg film-coated tablets are recommended for use only in children with body weight of at least 45 kg.

Nobaxin with other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any
medicines planned for use.
If the patient is taking any of the following medicines, it is especially important to inform the doctor or pharmacist:

• medicines affecting the QT interval, such as
  • quinidine, procainamide, dofetilide, amiodarone, sotalol (used to treat cardiac arrhythmias),
  • hydroxychloroquine (used to treat rheumatological diseases or malaria),
  • cisapride (used for gastrointestinal disorders),
  • terfenadine (used to treat allergies),
  • antipsychotic medicines, e.g. pimozide,
  • antidepressants, e.g. citalopram,
  • fluoroquinolones (used for infections), e.g. moxifloxacin, levofloxacin;
• antacids (Nobaxin should be taken at least 1 hour before or 2 hours after antacids);
• oral anticoagulants, e.g. warfarin;
• ergot alkaloids (used in migraine or reducing blood flow), e.g. ergotamine used with azithromycin may cause ergotism (symptoms: peripheral vasoconstriction and ischemia);
• digoxin (used in cardiac disorders);
• colchicine (used in the treatment of gout and familial Mediterranean fever);
• cyclosporine (used in skin diseases, rheumatoid arthritis, or after organ transplantation);
• atorvastatin (a medicine used to lower cholesterol levels);
• rifabutin (used in the treatment of HIV or tuberculosis).

Nobaxin with food and drink
Nobaxin 500 mg film-coated tablets can be taken with or without food.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child,
she should consult her doctor or pharmacist before using this medicine.
Pregnancy
The medicine may be used during pregnancy only if, in the opinion of the doctor, the benefit to the mother outweighs the risk to the fetus.
Breastfeeding
Azithromycin passes into human milk. It is recommended not to breastfeed during azithromycin treatment unless otherwise advised by a doctor.
Fertility
In fertility studies conducted in rodents, a decreased pregnancy rate was observed after administration of azithromycin. The relevance of these findings to humans is unknown.
Driving and operating machinery
There are no data on the effect of Nobaxin on the ability to drive or operate machinery. However, when performing such activities, consider the possibility of adverse effects such as dizziness and convulsions.
Nobaxin contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".
Nobaxin contains lactose monohydrate
One film-coated tablet contains 4.788 mg of lactose monohydrate. If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Nobaxin

This medicine should always be used as directed by the physician. If in doubt, consult your
doctor or pharmacist.
The medicine is taken orally.
Dosage in adults, including elderly, and in children and adolescents with body weight
over 45 kg
Upper and lower respiratory tract infections, otitis media, skin and soft tissue infections
(except erythema migrans and acne vulgaris)
The total dose of azithromycin is 1.5 g over 3 days (500 mg as a single daily dose).
Alternatively, the same total dose (1500 mg) may be administered over 5 days: 500 mg on the first
day of treatment and 250 mg from the second to the fifth day of treatment.
Erythema migrans
The total dose is 3 g and should be taken according to the following regimen: 1 g on the first day
(2 coated tablets of 500 mg), followed by 500 mg (1 coated tablet) from the second to the fifth day,
as single daily doses.
Moderate acne vulgaris – in adults only
The total dose is 6 g and is recommended to be administered according to the following regimen:
1 coated tablet of 500 mg once daily for 3 days, followed by 1 coated tablet of 500 mg once weekly
for the next 9 weeks. In the second week of treatment, the medicine should be taken 7 days after the
first dose, and the subsequent eight doses should be taken with 7-day intervals between doses.
Due to the administration of a high dose of azithromycin in the above regimen in patients with
moderate acne vulgaris, monitoring of liver enzyme activity is required before starting and during
the course of azithromycin treatment.
The above cyclic regimen for moderate acne vulgaris (3 days + 9 weeks) may be applied only once
in a given patient, as there are no controlled clinical trials demonstrating the safety and efficacy of
repeating this acne treatment regimen.
Uncomplicated infections caused by Chlamydia trachomatis
1 g (2 coated tablets of 500 mg) as a single dose.
Patients with renal or hepatic impairment
If the patient has renal or hepatic impairment, inform the physician, as the usual dose of the
medicine may need to be reduced. The medicine should not be used in patients with severe hepatic
insufficiency.
Method of administration
Nobaxin should be taken orally, once daily.
Nobaxin 500 mg coated tablets may be taken with or without food.
Tablets should be swallowed whole.
Taking more Nobaxin than recommended
Adverse effects observed after taking higher than recommended doses of the medicine were
similar to those reported with the recommended doses. Characteristic symptoms following
overdose of macrolide antibiotics include transient hearing loss, severe nausea, vomiting, and
diarrhea.
In case of overdose, seek immediate medical advice from a doctor or pharmacist. In the event of
overdose, activated charcoal is recommended, along with symptomatic treatment and, if
necessary, supportive measures to maintain vital functions.
Missed dose of Nobaxin
If a dose is missed, take it as soon as possible, and then continue with the next doses according to
the recommended dosing schedule. Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur, stop taking the medicine
Nobaxin and immediately contact a doctor or go to the emergency department of the
nearest hospital:

• severe allergic reaction (sudden difficulty breathing or swallowing, swelling of the lips, tongue, face and neck, itchy rash especially affecting the whole body),
• severe skin reactions: skin eruption characterized by rapid 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 from 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",
• severe hypersensitivity reaction which may include fever, skin rash, organ swelling, increase in number of certain type of white blood cells (eosinophilia), and inflammation of internal organs (drug rash with eosinophilia and systemic symptoms (DRESS)).

You should also stop taking Nobaxin and immediately contact a doctor if you notice:

• severe or prolonged diarrhoea with blood or mucus in the stool. This symptom may occur during or after treatment and may indicate serious intestinal inflammation,
• weakness, yellowing of the skin or whites of the eyes, and dark urine,
• unusual tendency to bruise or bleed,
• fast (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 up to 1 in 10 people):

• headache;
• vomiting, abdominal pain, nausea;
• change in white blood cell count;
• decreased concentration of bicarbonates in blood.

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

• fungal infections (candidiasis), vaginal infection, pneumonia, fungal infection, bacterial infection, sore throat, gastritis and enteritis, respiratory disorders, rhinitis, oral fungal infection;
• change in white blood cell count (leukopenia, neutropenia, eosinophilia);
• angioedema (swelling of the face and throat, which may cause 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 passing of gas, indigestion, inflammation of gastric mucosa, swallowing difficulties (dysphagia), distended abdomen, dry mouth, regurgitation with belching, oral ulcers, excessive salivation;
• rash, itching, urticaria, dermatitis, dry skin, excessive sweating;
• degenerative joint disease, muscle pain, back pain, neck pain;
• urinary disorders (dysuria), kidney pain;
• uterine bleeding, testicular disorders;
• swelling, 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 fewer than 1 in 1,000 people):

• restlessness;
• liver function disorders, cholestatic jaundice (cholestatic jaundice);
• photosensitivity;
• severe skin reactions: skin eruption characterized by rapid appearance of red skin areas covered with small blisters (vesicles filled with white or yellow fluid).

Frequency not known (frequency 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 arrhythmias (including torsade de pointes-type arrhythmias and ventricular tachycardia), QT interval prolongation on electrocardiogram;
• low blood pressure;
• pancreatitis, tongue discoloration;
• liver failure (rarely leading to death), fulminant hepatitis, liver necrosis;
• severe skin reactions: bullous erythema multiforme (Stevens-Johnson syndrome), toxic epidermal necrolysis, erythema multiforme, drug reaction with eosinophilia and systemic symptoms (DRESS);
• joint pain;
• acute kidney failure, interstitial nephritis.

Adverse reactions probably or possibly related to the use of azithromycin in the treatment of
infections caused by Mycobacterium avium complex organisms or prophylaxis, observed during
clinical trials and after marketing authorization
Very common (may affect more than 1 in 10 people):

• diarrhoea;
• abdominal pain;
• nausea;
• bloating;
• discomfort in the abdominal cavity;
• loose stools.

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

• anorexia;
• dizziness;
• headache;
• unusual skin sensations, e.g. tingling and numbness of limbs (paresthesia);
• taste disturbances;
• visual disturbances;
• deafness;
• rash, itching;
• joint pain;
• fatigue.

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

• sensory disturbances (hypoesthesia);
• hearing disorders, tinnitus;
• palpitations;
• hepatitis;
• bullous erythema multiforme (Stevens-Johnson syndrome (severe skin reaction)), photosensitivity;
• weakness (asthenia), malaise.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 Nobaxin

• Keep this medicine out of sight and reach of children.
• Store below 25°C in a dry place.
• Do not use this medicine after the expiry date stated on the carton. 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 Nobaxin contains
The active substance in Nobaxin is azithromycin. One coated tablet contains 500 mg of azithromycin.
The other ingredients are:
tablet core: pregelatinized starch, maize starch, magnesium stearate, povidone, anhydrous colloidal silicon dioxide, sodium croscarmellose, sodium lauryl sulfate, microcrystalline cellulose;
tablet coating: hypromellose, lactose monohydrate, macrogol 3350, titanium dioxide (E171), triacetin.
What Nobaxin looks like and contents of the pack
Nobaxin 500 mg coated tablets are white to cream-colored, elongated, biconvex tablets.
The pack contains 3, 9 or 12 coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
LEK-AM Sp. z o.o.
Ostrzykowizna 14A
05-170 Zakroczym
Tel.: +48 22 785 20 69
09.01.2026