Nobaxin

Leaflet attached to the packaging: patient information

NOBAXIN, 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, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Nobaxin and what is it 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 is Nobaxin and what is it used for

Nobaxin contains the active substance azithromycin, which is an azalide antibiotic from the macrolide group with a broad spectrum of action. It has a bactericidal effect on susceptible microorganisms.
Nobaxin, 500 mg, film-coated tablets, is indicated for the treatment of the following infections, caused by microorganisms susceptible 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 community-acquired pneumonia, including interstitial pneumonia.
• Skin and soft tissue infections: erythrasma, impetigo and secondary infected dermatitis; erythema migrans - the first sign of Lyme disease; moderate acne, exclusively in adults.
• Sexually transmitted diseases: uncomplicated infections caused by Chlamydia trachomatis.

2. Important information before taking Nobaxin

When not to take Nobaxin

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

Warnings and precautions

Before starting treatment with Nobaxin, you should discuss it with your doctor or pharmacist if:

• you have conditions that may lead to arrhythmias (especially in women and elderly patients):
• congenital or documented arrhythmias (visible in the ECG - a test of the heart's 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 "Nobaxin and other medicines”);
• you have severe kidney problems;
• you have severe liver problems: your doctor may monitor liver function or discontinue treatment;
• you have a new infection (this may indicate excessive growth of resistant microorganisms or a fungal infection);
• you have neurological (neurological) or mental (psychiatric) disorders;
• you have a sexually transmitted disease: your doctor should ensure that you do not have a co-existing syphilis infection;
• you are taking ergotamine derivatives (ergot preparations);
• you have infected burn wounds.

You should also read the warnings in section 4.
If, despite treatment, the symptoms of the infection do not disappear or new symptoms of another infection appear, e.g. fungal, you should consult your doctor again.

Infections caused by streptococci

In the treatment of pharyngitis and tonsillitis caused by streptococci, the drug of choice is usually penicillin.

Pseudomembranous colitis

If you experience diarrhea, you should report it to your doctor immediately, as it may be a sign of pseudomembranous colitis - a complication that can occur during the use of macrolide antibiotics. Such a diagnosis should be considered in patients who develop diarrhea after starting azithromycin treatment. In the case of pseudomembranous colitis caused by azithromycin, it may be necessary to discontinue Nobaxin and use appropriate treatment. It is contraindicated to administer anti-peristaltic agents.

Long-term use

There is no data on the safety and efficacy of azithromycin used long-term in the above indications. In the case of frequently recurring infections, the doctor will consider treatment with another antibacterial agent.

Myasthenia

During azithromycin treatment, exacerbation of myasthenia symptoms or the occurrence of myasthenic syndrome (see "Possible side effects") has been observed.

Children and adolescents

Nobaxin in the form of 500 mg film-coated tablets is recommended for use only in children with a body weight of not less than 45 kg.

Nobaxin and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
If you are taking any of the following medicines, it is especially important to tell your doctor or pharmacist:

• medicines that affect the QT interval, such as
• quinidine, procainamide, dofetilide, amiodarone, sotalol (used to treat arrhythmias),
• hydroxychloroquine (used to treat rheumatologic diseases or malaria),
• cisapride (used to treat stomach disorders),
• terfenadine (used to treat allergies),
• antipsychotic drugs, e.g. pimozide,
• antidepressant drugs, e.g. citalopram,
• fluoroquinolones (used in infections), e.g. moxifloxacin, levofloxacin;
• antacids (Nobaxin should be administered at least 1 hour before or 2 hours after taking antacids);
• oral anticoagulants, e.g. warfarin;
• ergot alkaloids (used in migraine or reducing blood flow), e.g. ergotamine, which when used with azithromycin can cause ergotism (symptoms - spasm of peripheral blood vessels and ischemia);
• digoxin (used to treat heart rhythm disorders);
• colchicine (used to treat gout and familial Mediterranean fever)
• cyclosporin (used in skin diseases, rheumatoid arthritis or after organ transplantation);
• atorvastatin (a drug used to lower cholesterol levels);
• rifabutin (used to treat HIV or tuberculosis).

Nobaxin with food and drink

Nobaxin in the form of 500 mg film-coated tablets can be taken regardless of meals.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
The medicine should only be used during pregnancy if the doctor considers it necessary.
Breastfeeding
Azithromycin passes into breast milk. Breastfeeding should be avoided during azithromycin treatment 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 not known.

Driving and using machines

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

Nobaxin contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means that it is considered "sodium-free".

Nobaxin contains lactose monohydrate

One film-coated tablet contains 4.788 mg of lactose monohydrate. If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Nobaxin

This medicine should always be taken exactly as prescribed by your doctor. If you are not sure, ask your doctor or pharmacist.
The medicine is taken orally.

Dosage for adults, including the elderly, and children and adolescents with a body weight over 45 kg

Upper and lower respiratory tract infections, otitis media, skin and soft tissue infections (except for erythema migrans and moderate acne)
The total dose of azithromycin is 1.5 g over 3 days (500 mg in a single daily dose).
Alternatively, the same total dose (1500 mg) can also 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 in the following regimen: 1 g (2 film-coated tablets of 500 mg) on the first day, and then 500 mg (1 film-coated tablet) from the second to the fifth day, in single daily doses.
Moderate acne - exclusively in adults
The total dose is 6 g and is recommended to be administered in the following regimen: 1 film-coated tablet of 500 mg once a day for 3 days, then 1 film-coated 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, maintaining 7-day intervals in administration.
Due to the use of a high dose of azithromycin in the above dosage regimen in patients with moderate acne, it is necessary to monitor liver enzyme activity before and during the course of azithromycin treatment.
The above regimen of cyclic treatment of moderate acne (3 days + 9 weeks) can only be used once in a given patient, as there are no controlled clinical trials that have shown the safety and efficacy of repeating this regimen for moderate acne.

Patients with renal or hepatic impairment

If you have kidney or liver problems, you should tell your doctor, as it may be necessary to reduce the usual dose of the medicine. The medicine should not be used in patients with severe liver failure.

Method of administration

Nobaxin should be taken orally, once a day.
Nobaxin in the form of 500 mg film-coated tablets can be taken regardless of meals.
The tablets should be swallowed whole.

Overdose of Nobaxin

Side effects that occurred after taking the medicine in doses higher than recommended were similar to those reported after administration of the correct doses. Characteristic symptoms of overdose of macrolide antibiotics include: transient hearing loss, severe nausea, vomiting, and diarrhea.
If you have taken more than the recommended dose of the medicine, you should immediately consult a doctor or pharmacist. In case of overdose, it is recommended to administer activated charcoal and use symptomatic treatment, and if necessary, life-supporting treatment.

Missed dose of Nobaxin

A missed dose should be taken as soon as possible, and subsequent doses should be taken according to the recommended dosage regimen. Do not take a double dose to make up for a missed dose.

4. Possible side effects

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

In case of the following side effects, stop taking Nobaxin and contact your doctor or go to the emergency department of the nearest hospital immediately:

Nobaxin and

• severe allergic reaction (sudden difficulty breathing or swallowing, swelling of the lips, tongue, face, and throat, itchy rash, especially on the whole body),
• severe skin reactions: a skin rash characterized by rapid onset of areas of redness on the skin covered with small blisters (blisters filled with white or yellow fluid); severe skin rash causing redness and peeling; severe blistering and bleeding from the lips, eyes, mouth, nose, and genitals, associated with high fever and joint pain. This may be "acute generalized exanthematous pustulosis" (AGEP), "Stevens-Johnson syndrome", "toxic epidermal necrolysis", or "drug reaction with eosinophilia and systemic symptoms" (DRESS).
• severe allergic reaction that may include fever, skin rash, organ swelling, increased number of a certain type of white blood cells (eosinophilia), and inflammation of internal organs (drug rash with eosinophilia and systemic symptoms).

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

• severe or persistent diarrhea with blood or mucus in the stool. This symptom may occur during or after treatment and may indicate serious colitis,
• weakness, yellowing of the skin or whites of the eyes, and dark urine,
• unusual tendency to bruise or bleed,
• rapid (ventricular tachycardia) or irregular heartbeat or changes in heart rhythm in the electrocardiogram (prolongation of the QT interval and arrhythmias of the torsade de pointestype).

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

• diarrhea.

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

• headache;
• vomiting, abdominal pain, nausea;
• change in white blood cell count;
• decrease in blood bicarbonate levels.

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

• fungal infections (candidiasis), vaginal infection, pneumonia, fungal infection, bacterial infection, pharyngitis, gastrointestinal upset, respiratory disorders, rhinitis, vaginal fungal infection;
• change in white blood cell count (leukopenia, neutropenia, eosinophilia);
• angioedema (swelling in the face and throat, which can cause difficulty breathing), hypersensitivity;
• loss of appetite (anorexia);
• nervousness, insomnia, dizziness, drowsiness, taste disorders, abnormal skin sensations, e.g. tingling and numbness of limbs (paresthesia);
• vision disorders;
• hearing disorders, balance disorders;
• palpitations;
• hot flashes;
• dyspnea, epistaxis;
• constipation, bloating with gas, indigestion, gastritis, swallowing disorders (dysphagia), bloated stomach, dry mouth, belching, oral ulcers, excessive salivation;
• rash, itching, urticaria, skin inflammation, dry skin, excessive sweating;
• degenerative joint disease, muscle pain, back pain, neck pain;
• urinary disorders (dysuria), kidney pain;
• menstrual bleeding, testicular disorders;
• edema, weakness (asthenia), malaise (apathy), fatigue, facial edema, chest pain, fever, pain, peripheral edema;
• abnormal laboratory test results (e.g. blood, liver function, glucose, electrolytes);
• post-procedural complications.

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

• agitation;
• liver disorders, jaundice with bile stasis (cholestatic jaundice);
• photosensitivity;
• severe skin reactions: a skin rash characterized by rapid onset of areas of redness on the skin covered with small blisters (blisters filled with white or yellow fluid).

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

• pseudomembranous colitis;
• thrombocytopenia (decreased platelet count), decreased red blood cell count (hemolytic anemia);
• anaphylactic reaction (generalized allergic reaction, which can rarely be fatal; may occur with symptoms such as: swelling of the lips, face, or throat, leading to severe breathing difficulties, rash on the skin or urticaria);
• aggressive behavior, anxiety, hallucinations, delusions;
• loss of consciousness (syncope), seizures, sensory disturbances (hypoesthesia), excessive psychomotor activity, loss of smell, loss of taste, taste disorders, hearing disorders;
• hearing disorders, including deafness and (or) tinnitus;
• heart rhythm disorders (including torsade de pointesand ventricular tachycardia), prolongation of the QT interval in the electrocardiogram;
• decreased blood pressure;
• pancreatitis, tongue discoloration;
• liver failure (rarely leading to death), fulminant hepatitis, liver necrosis;
• severe skin reactions: Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, drug reaction with eosinophilia and systemic symptoms (DRESS);
• joint pain;
• acute kidney failure, interstitial nephritis.

Side effects probably or possibly related to the use of azithromycin in the treatment of infections caused by mycobacteria of the Mycobacterium aviumcomplex or prevention of them, observed during clinical trials and after the marketing authorization of the medicine

Clinical trials and post-marketing experience
Very common(may affect more than 1 in 10 people):

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

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

• loss of appetite;
• dizziness;
• headache;
• abnormal skin sensations, e.g. tingling and numbness of limbs (paresthesia)
• taste disorders;
• vision disorders;
• hearing loss;
• rash, itching;
• joint pain;
• fatigue.

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

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

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, you should 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 Nobaxin

• The medicine should be stored out of the sight and reach of children.
• Store in a temperature 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 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 pack and other information

What Nobaxin contains

The active substance of Nobaxin is azithromycin. One film-coated tablet contains 500 mg of azithromycin.
The other ingredients are:
tablet core: corn starch, maize starch, magnesium stearate, povidone, colloidal anhydrous silica, 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 film-coated tablets are white to cream-colored, oblong, biconvex.
The pack contains 2, 3, 6, 9 or 12 film-coated tablets
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

LEK-AM Pharmaceutical Company Ltd.
Ostrzykowizna 14A
05-170 Zakroczym
Phone: +48 22 785 20 69

Date of last revision of the leaflet: