AZITHROMYCIN KRKA 250 mg FILM-COATED TABLETS

2. What you need to know before taking Azithromycin Krka

Do not take Azithromycin:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Azithromycin.

• 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 medicines that induce an alteration of the electrical function of your heart, such as cisapride (used to increase intestinal movement) or hydroxychloroquine or chloroquine (used in the treatment of malaria);
• if you have an irregular or slow heartbeat;
• if you have altered electrolyte levels in your blood, especially low potassium and magnesium levels;
• if you are taking other medicines that produce abnormal changes in the ECG (see section "Other medicines and Azithromycin Krka");
• if you are undergoing treatment with ergotamine derivatives (see section "Other medicines and Azithromycin Krka"), as these medicines should not be taken with azithromycin;
• if you have severe kidney problems;
• if you have myasthenia gravis (localized muscle weakness);
• if you have neurological or mental problems.

During treatment, inform your doctor immediately:

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

Children and adolescents

Azithromycin film-coated tablets are notsuitable for infants and young children (under 2 years of age) and adolescents and children (up to 17 years of age) with a body weight less than45 kg.

Information on the administration of azithromycin in children and adolescents over 45 kg can be found in section 3 "How to take Azithromycin Krka".

Other medicines and Azithromycin Krka

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

• Medicines known as ergotamine derivatives, e.g., ergotamine or dihydroergotamine (medicines used for migraine or to reduce blood flow), as these medicines should not be taken simultaneously with azithromycin,
• Ciclosporin (a medicine used for skin conditions, rheumatoid arthritis, or after organ transplants),
• Atorvastatin (for the treatment of high blood cholesterol levels),
• Cisapride (used for stomach problems),
• Theophylline (for respiratory problems),
• Warfarin or other medicines to thin your blood,
• Digoxin (for heart problems),
• Colchicine (used for gout and familial Mediterranean fever),
• Zidovudine, efavirenz, indinavir, nelfinavir, didanosine (for HIV infections),
• Rifabutin (for HIV infections or tuberculosis treatment),
• Terfenadine (a medicine for allergy treatment),
• Fluconazole (to treat fungal infections),
• Medicines known as antacids (medicines that neutralize stomach acid). Your azithromycin tablets should be taken at least one hour before or two hours after you take your antacids.
• Astemizole (a medicine for allergy treatment), alfentanil (a pain reliever),
• Hydroxychloroquine and chloroquine (for malaria treatment).

Using Azithromycin with food and alcohol

The tablets should be taken with water.

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

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.

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

Driving and using machines

This medicine may make you feel dizzy. If you feel dizzy, do not drive or use any tools or machines.

Azithromycin Krka contains sodium

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

3. How to take Azithromycin Krka

Follow the administration instructions of this medicine 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 under 45 kg in weight:

The tablets are not recommended. Children and adolescents under 45 kg in weight should use other pharmaceutical forms of medicines containing azithromycin.

Patient with kidney or liver problems:

You should inform your doctor if you have kidney or liver problems, as your doctor may need to modify the normal dose.

Dose for elderly patients:

For elderly patients, the same dose applies as for adults.

Administration:

Swallow the film-coated tablets whole with a little water.

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

If you take more Azithromycin than you should

It is essential that you adhere to the dose prescribed by your doctor. If you or someone else has taken several tablets at once, or if you think a child has taken some of the tablets, contact your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount used. Always carry some tablets with you and also the packaging, as this will allow for simpler identification of the tablets. The symptoms of an overdose may include severe nausea, vomiting, and diarrhea, and reversible hearing loss.

If you forget to take Azithromycin

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, you should take it as soon as you remember. However, if it is almost time for the next dose, leave the forgotten dose and continue with the rest of the medicine as usual.

If you stop taking Azithromycin

Do not stop treatment prematurely.

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. These are usually mild to moderate and disappear when treatment is stopped.

If you have any of the following symptoms of a severe allergic reaction, stop taking your tablets and inform your doctor immediately or go to the nearest emergency department:

• 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 rashes that can include blisters or peeling (toxic epidermal necrolysis),

If you experience any of the following side effects, contact your doctor as soon as possible:

• diarrhea that is severe, prolonged, especially if it contains blood or mucus (this can be pseudomembranous colitis, an inflammation of the intestine);
• dark urine, intense loss of appetite, and your skin or the whites of your eyes turn yellow, which are signs of liver problems (liver failure that can rarely result in death, liver necrosis), inflammation of the liver (hepatitis).

These are all serious side effects. You may need urgent medical attention. Serious side effects are rare (may affect up to 1 in 100 people), or the frequency cannot be estimated from the 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
• being sick (vomiting), abdominal pain, feeling sick (nausea)
• changes in white blood cell count
• changes in other blood parameters (decrease in blood bicarbonate)

Uncommon (may affect up to 1 in 100 people)

• thrush (candidiasis) – a fungal infection of the mouth and vagina
• pneumonia, bacterial infection of the throat, inflammation of the gastrointestinal tract, respiratory disorder, inflammation of the mucous membrane inside the nose
• changes in white blood cells (leucopenia, neutropenia, eosinophilia)
• allergic reactions
• loss of appetite (anorexia)
• nervousness, difficulty sleeping (insomnia)
• feeling dizzy, feeling sleepy, change in taste (dysgeusia), feeling of tingling or numbness (paresthesia)
• vision disturbances
• hearing loss, vertigo
• feeling your heartbeat (palpitations)
• hot flushes
• wheezing, nosebleeds
• constipation, gas, indigestion (dyspepsia), inflammation of the stomach lining (gastritis), difficulty swallowing (dysphagia), abdominal distension, dry mouth, belching, mouth ulceration, excessive salivation
• rash, itching, urticaria, dermatitis, dry skin, abnormal sweating (hyperhidrosis)
• degenerative joint disease (osteoarthritis), muscle pain, back pain, neck pain
• difficulty urinating (dysuria), kidney pain
• uterine bleeding at irregular intervals (metrorrhagia), testicular disorder
• edema, weakness, general feeling of being unwell, facial edema, chest pain, fever, pain, peripheral edema
• abnormal laboratory test results (e.g., blood or liver tests)

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

• feeling irritated
• abnormal liver function, yellowing of the skin or eyes
• allergic skin reactions such as increased sensitivity to sunlight
• skin rash characterized by the rapid appearance of areas of red skin sprinkled with small blisters (small fluid-filled bumps)

• skin rash with eosinophilia (an increase in a type of white blood cell) and systemic symptoms such as fever or lymph node inflammation (DRESS syndrome)

Not known (cannot be estimated from the available data)

• reduction in the number of red blood cells due to increased cell breakdown (hemolytic anemia), reduction in platelet count
• feeling angry, aggressive, feeling anxious or worried, acute confusional state (delirium), hallucinations
• fainting (syncope)
• seizures (convulsions)
• reduced sense of touch (hypoesthesia)
• feeling overactive
• 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 heart tracing on an ECG (prolongation of the QT interval)
• hearing problems, including deafness or ringing in the ears
• low blood pressure
• inflammation of the pancreas (pancreatitis)
• change in tongue color
• joint pain (arthralgia)
• inflammation of the kidney (interstitial nephritis) and kidney failure

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

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

• diarrhea
• abdominal pain
• feeling sick (nausea)
• flatulence
• abdominal distension
• loose stools

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• reduced sense of touch (hypoesthesia)
• hearing disturbance, ringing in the ears
• feeling your heartbeat (palpitations)
• inflammation of the liver (hepatitis)
• severe allergic skin reactions (Stevens-Johnson syndrome)
• skin more sensitive than usual to sunlight
• weakness
• general feeling of being unwell

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Azitromicina Krka

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging after CAD. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions .

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Azitromicina

• The active substance is azithromycin.

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

• The other ingredients (excipients) are microcrystalline cellulose (E460), pregelatinized potato starch, sodium lauryl sulfate, hypromellose (E464), sodium croscarmellose (E468), colloidal anhydrous 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 "Azitromicina Krka contains sodium".

Appearance and Package Contents of the Product

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

Blister packs of 4 and 6 film-coated tablets are available.

Only some pack sizes may be marketed.

Marketing Authorization Holder

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

Manufacturer

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

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

You can request more information about this medicine by contacting 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 under the following names:

Date of the last revision of this leaflet: August 2022

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/