Summary of Product Characteristics:information for the patient

Azitromicina Krka 250mg film-coated tablets

Read this leaflet carefully before you start taking this medicine,because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask yourdoctoror pharmacist.
• This medicine has been prescribed for you only, do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Azitromicina, the active ingredient of Azitromicina Krka, belongs to a group of medicines called macrolide antibiotics.

Antibiotics are used to treat bacterial infections and do not work for viral infections, such as the flu or a cold.

It is essential to follow the instructions regarding the dose, administration interval, and treatment duration indicated by your doctor.

Do not store or reuse this medication. If you have leftover antibiotics after treatment, return them to the pharmacy for proper disposal. Do not dispose of the medication through the drain or in the trash.

It is used for the treatment of numerous infections including:

• acute bacterial sinusitis
• acute bacterial otitis media
• pharyngitis, tonsillitis
• acute exacerbation of chronic bronchitis,
• mild to moderately severe pneumonia
• mild to moderately severe skin and soft tissue infections, e.g. folliculitis, cellulitis, erysipelas,
• urinary tract infections caused by a bacteria called Chlamydia trachomatis.

Do not take Azitromicina:

• if you are allergic to azitromicina or to other macrolide antibiotics (such as eritromicina or claritromicina) or ketolides or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Azitromicina.

• if you have severe liver problems: your doctor may need to monitor your liver function or interrupt treatment;
• if you have certain heart conditions (e.g. severe heart problems, "prolongation of the QT interval") or if you are taking medications that induce an alteration of the heart's electrical function such as cisaprida (used to increase intestinal movement) or hydroxychloroquine or chloroquine (used in malaria treatment);
• if you have an irregular or slow pulse;
• if you have altered levels of electrolytes in your blood, especially low levels of potassium and magnesium;
• if you are taking other medications that produce abnormal changes in the ECG (see section "Other medications and Azitromicina Krka");
• if you are being treated with ergotamine derivatives (see section "Other medications and Azitromicina Krka") as these medications should not be taken with azitromicina;
• if you have severe kidney problems;
• if you have myasthenia gravis (localized muscle weakness);
• if you have neurological or psychiatric problems.

Inform your doctor immediately during treatment:

• if you experience severe hypersensitivity reactions with difficulty breathing, dizziness, facial or throat swelling, skin rash, redness, or burning (sometimes fatal). If these symptoms appearstop taking azitromicina and contact your doctor immediately.
• if you see signs of liver problems during treatment (such as dark urine, intense loss of appetite oryour skin or the white of your eyes turns yellow):Stop taking this medication and seek urgent medical advice.
• if you develop diarrhea, which may be a sign of severe intestinal inflammation. If you have watery or bloody diarrhea,call your doctor.Do not use any medication to stop diarrhea unless your doctor advises you to.
• if you feel your heart beating in your chest or an abnormal heartbeat, feel dizzy or about to faint, or experience muscle weakness when taking azitromicina.
• if you have a new infection (which may be a sign of excessive growth of resistant microorganisms);

Children and adolescents

Azitromicina coated tabletsare notsuitable for babies and young children (under 2 years of age) and adolescents and children (up to 17 years of age) with a body weightbelow45 kg.

You can find information on the administration of azitromicina in children and adolescents over 45 kg in section 3 "How to take Azitromicina Krka".

Other medications and Azitromicina Krka

Inform your doctor or pharmacist if you aretaking, haverecentlytakenor may need to take any other medication.

It is especially important to inform your doctor or pharmacist if you are taking:

• Medications known as ergotamine derivatives, e.g. ergotamine or dihydroergotamine (medications used for migraine or to reduce blood flow), as these medications should not be taken simultaneously with azitromicina,
• Ciclosporina (a medication used for skin conditions, rheumatoid arthritis, or after organ transplants),
• Atorvastatina (for the treatment of high cholesterol levels in the blood),
• Cisaprida (used for stomach problems),
• Teofilina (for respiratory problems),
• Warfarina or other medications to thin your blood,
• Digoxina (for heart problems),
• Colchicina (used for gout and familial Mediterranean fever),
• Zidovudina, efavirenz, indinavir, nelfinavir, didanosina (for HIV infections),
• Rifabutina (for HIV infections or for tuberculosis treatment),
• Terfenadina (a medication for allergy treatment),
• Fluconazol (to treat fungal infections),
• Medications known as antacids (medications that neutralize stomach acid). Your azitromicina tablets should be taken at least one hour before or two hours after taking your antacids.
• Astemizol (a medication for allergy treatment), alfentanilo (analgesic),
• Hydroxychloroquine and chloroquine (for malaria treatment).

Use of Azitromicinawith food and alcoholl

The tablets should be taken with water.

You can take your medication with or without food as it does not affect azitromicina absorption.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consultyour doctor or pharmacist before using this medication.

This medicationshould not be used during pregnancy or breastfeedingunless you have discussed it with your doctor.

Driving and operating machinery

This medication may make you feel dizzy. If you feel dizzy, do not drive or operate any tools or machinery.

Azitromicina Krka contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per dose; this is, essentially "sodium-free".

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again.

For adults and children and adolescents with a body weight of 45 kg or more:

Children and adolescents weighing less than 45 kg::

The tablets are not recommended. Children and adolescents weighing less than 45 kg should use other pharmaceutical forms of medications containing azithromycin.

Patients with renal or hepatic problems::

Inform your doctor if you have kidney or liver problems as this may require modification of the normal dose.

Dose for elderly patients:

The same dose as for adults should be applied for elderly patients.

Administration:

Swallow the film-coated tablets without chewing them with a little water.

You can take your medication with or without food as it does not affect the absorption of azithromycin.

If you take more Azitromicinathan you should

It is essential to follow the dose prescribed by your doctor. If you or another person ingests several tablets together, or if you believe a child has ingested any of the tablets, contact your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount used. Always carry some tablets with you and also the packaging, as this will facilitate easier identification of the tablets. The symptoms of an overdose may include intense nausea, vomiting, and diarrhea and reversible hearing loss.

If you forgot to take Azitromicina

Do not take a double dose to compensate for a missed dose. If you forgot to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, leave the missed dose and continue with the rest of the medication as usual.

If you interrupt the treatment with Azitromicina

Do not interrupt the treatment before time.

It is essential to continue taking your tablets for the indicated period by your doctor, even when you start feeling better.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. These are usually mild to moderate and resolve when treatment is stopped.

If you experience any of the following severe allergic reactions, stop taking your tablets and inform your doctor immediately or visit the nearest emergency service:

• low blood pressure, rapid or irregular heartbeat (anaphylactic reaction);
• swelling of the hands, feet, ankles, face, lips, mouth, or throat (angioedema),
• difficulty swallowing or breathing,
• severe skin reactions including Stevens-Johnson syndrome (a severe skin rash) and other severe skin reactions that may include blisters or peeling (toxic epidermal necrolysis),

If you experience any of the following side effectscontact your doctor as soon as possible:

• severe, prolonged diarrhea, especially if it contains blood or mucus (this may be pseudomembranous colitis, an intestinal inflammation);
• dark urine, significant loss of appetite, and your skin or the whites of your eyes turn yellow, which are signs of liver damage (hepatic failure, which rarely leads to death, liver necrosis), liver inflammation (hepatitis).

These are all the severe side effects. You may need urgent medical attention. Severe side effects are rare (may affect up to 1 in 100 people), or the frequency cannot be estimated from available data.

Other reported side effects are:

Very common (may affect more than 1 in 10 people)

• diarrhea

Common (may affect up to 1 in 10 people)

• headache
• nausea, vomiting, abdominal pain, feeling unwell
• changes in white blood cell count
• change in other blood parameters (decreased bicarbonate in blood)

Rare (may affect up to 1 in 100 people)

• thrush (candidiasis) – a fungal infection of the mouth and vagina
• bronchitis, bacterial throat infection, gastrointestinal inflammation, respiratory disorder, nasal mucosa inflammation
• changes in white blood cell count (leucopenia, neutropenia, eosinophilia)
• allergic reactions
• loss of appetite (anorexia)
• nervousness, insomnia
• feeling dizzy, feeling sleepy, change in sense of taste (disgeusia), feeling of numbness or tingling (paresthesia)
• vision changes
• hearing loss, vertigo
• feeling heart palpitations
• angina
• sudden wheezing, nosebleed
• constipation, gas, altered digestion (dyspepsia), stomach lining inflammation (gastritis), difficulty swallowing (dysphagia), abdominal distension, dry mouth, belching, mouth ulcers, excessive salivation
• rash, itching, urticaria, dermatitis, dry skin, excessive sweating (hyperhidrosis)
• degenerative joint disease (osteoarthritis), muscle pain, back pain, neck pain
• difficulty urinating (dysuria), kidney pain
• irregular menstrual bleeding (metrorrhagia), testicular disorder
• swelling, weakness, general feeling of illness, facial edema, chest pain, fever, pain, peripheral edema
• abnormal laboratory findings (e.g., blood or liver tests)

Rare (may affect up to 1 in 1,000 people)

• feeling irritable
• abnormal liver function, yellowing of the skin or eyes
• allergic skin reactions such as sun sensitivity
• skin rash characterized by rapid appearance of red skin areas with small white or yellowish blisters (pustules)

• skin rash with eosinophilia (increased eosinophils) and systemic symptoms such as fever or lymph node inflammation (DRESS syndrome)

Not known (cannot be estimated from available data)

• reduction in red blood cell count due to increased cell degradation (hemolytic anemia), reduction in platelet count
• feeling angry, aggressive, feeling anxious, feeling fearful and worried (anxiety), acute confusional state (delirium), hallucinations
• syncope (fainting)
• seizures (convulsions)
• reduced sense of touch (hypoaesthesia)
• feeling hyperactive
• change in sense of smell (anosmia, parosmia)
• loss of sense of taste (ageusia)
• muscle weakness (myasthenia gravis)
• life-threatening irregular heartbeat (arrhythmia, torsades de pointes), abnormal ECG tracing (prolonged QT interval)
• hearing problems, including hearing loss or tinnitus
• low blood pressure
• pancreatitis
• change in tongue color
• joint pain (arthralgia)
• interstitial nephritis and renal insufficiency

Adverse reactions possibly or probably related to the prophylaxis and treatment ofMycobacterium Avium complex(MAC):

Very common (may affect more than 1 in 10 people)

• diarrhea
• abdominal pain
• nausea
• flatulence
• abdominal distension
• loose stools

Common (may affect up to 1 in 10 people)

• loss of appetite (anorexia)
• feeling dizzy
• headache
• feeling of numbness or tingling (paresthesia)
• change in sense of taste (disgeusia)
• vision changes
• hearing loss
• skin rash, itching
• joint pain (arthralgia)
• fatigue

Rare (may affect up to 1 in 100 people)

• reduced sense of touch (hypoaesthesia)
• hearing problems, tinnitus
• feeling heart palpitations
• liver inflammation (hepatitis)
• severe skin allergic reactions (Stevens-Johnson syndrome)
• skin more sensitive to sunlight than normal
• weakness
• general feeling of illness

Reporting of adverse reactions

If you experience any type of adverse reactions, consult your doctor or pharmacist, even if they do not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:www.notificaram.es.By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Azithromycin

• The active ingredient is azithromycin.

Each film-coated tablet contains 250 mg of azithromycin (as azithromycin dihydrate).

• The other components (excipients) are microcrystalline cellulose (E460), pregelatinized potato starch, sodium lauryl sulfate, hypromellose (E464), croscarmellose sodium (E468), anhydrous colloidal silica (E551), and magnesium stearate (E470b) in the tablet core and hypromellose 5 cP (E464), titanium dioxide (E171), and macrogol 400 in the film coating.See section 2 “Azithromycin Krka contains sodium”.

Appearance of the product and contents of the package

The film-coated tablets are white or almost white, in capsule shape (length: 13.8 – 14.2 mm, width: 6.3 – 6.7 mm), engraved with “S19” on one side and the other side is blank.

They are available in blister packs of 4 and 6 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

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

Responsible for manufacturing

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

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

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

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of thisleaflet: August 2022

More detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/