AZITHROMYCIN VIATRIS 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Azitromicina Viatris 500 mg film-coated tablets EFG

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

• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Azitromicina Viatris is and what it is used for
2. What you need to know before you take Azitromicina Viatris
3. How to take Azitromicina Viatris
4. Possible side effects
5. Storage of Azitromicina Viatris
6. Contents of the pack and other information

1. What Azitromicina Viatris is and what it is used for

Azitromicina belongs to a group of antibiotics called macrolide antibiotics.

It is used to treat bacterial infections caused by microorganisms such as bacteria in adults and children weighing over 45 kg.

It is used to treat the following infections:

• Throat, tonsil, ear, or sinus infections.
• Bronchitis and pneumonia (mild to moderate severity).
• Skin and soft tissue infections (mild to moderate severity).
• Urethra (urethritis) or cervix (cervicitis) infections, see section 3.
• Sexually transmitted infections (chancroid), see section 3.

2. What you need to know before you take Azitromicina Viatris

Do not take Azitromicina Viatris:

• If you are allergic to azithromycin, erythromycin, any other macrolide or ketolide antibiotic, 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 this medicine:

• During treatment with azithromycin, allergic reactions (itching, redness, skin rash, swelling, or difficulty breathing or an allergic reaction to the medicine characterized by an increase in white blood cells in the blood and generalized symptoms) may occur, which could be severe. Inform your doctor, who may decide to discontinue treatment and initiate appropriate treatment.
• If you have liver problems or during treatment, your skin and/or the whites of your eyes turn yellow, consult your doctor to confirm whether you should discontinue treatment or undergo liver function tests.
• If you are being treated with ergotamine derivatives (used to treat migraines), inform your doctor, as concomitant treatment with azithromycin may cause a potentially serious adverse reaction called ergotism.
• During treatment with this medicine, there is a possibility of developing a superinfection with resistant germs, including fungi. In this case, inform your doctor.
• During or after treatment with azithromycin, symptoms suggesting antibiotic-associated colitis (diarrhea) may appear. If so, treatment should be discontinued, and your doctor will provide the most appropriate treatment.
• If you have any kidney function impairment, inform your doctor.
• If you have heart rhythm disturbances (arrhythmias) or factors that predispose you to them (certain heart diseases, electrolyte level alterations in the blood, or certain medications), inform your doctor, as this medicine may contribute to worsening or triggering these disturbances.
• If you have a disease called myasthenia gravis or if muscle weakness and fatigue appear during treatment, inform your doctor, as azithromycin may trigger or worsen the symptoms of this disease.

Children and adolescents

Children and adolescents weighing less than 45 kg.

The tablets are not indicated for this patient group. Other pharmaceutical forms of azithromycin may be used. It should not be administered to children under 6 months.

Children and adolescents weighing over 45 kg.

This medicine is not suitable for children who are unable to swallow the tablets whole. Other pharmaceutical forms of azithromycin may be used.

Other medicines and Azitromicina Viatris

Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Inform your doctor or pharmacist if you are being treated with any of the following medicines:

• Antacids (medicines used for digestive problems). It is recommended to avoid concomitant administration of both drugs at the same time of day.
• Ergotamine derivatives (such as ergotamine, used to treat migraines), as concomitant administration with azithromycin may cause ergotism (a potentially serious adverse reaction with numbness or tingling in the limbs, muscle cramps, headaches, seizures, or abdominal or chest pain).
• Digoxin (a medicine used to treat heart arrhythmias), as azithromycin may increase digoxin levels in the blood, and their levels should be monitored.
• Colchicine (used for gout and familial Mediterranean fever).
• Cyclosporin (a medicine used in transplant patients), as azithromycin may increase cyclosporin levels in the blood, and their levels should be monitored.
• Oral anticoagulants (medicines used to prevent blood clots), as azithromycin may potentiate the effect of these anticoagulants. Your doctor should monitor coagulation parameters (prothrombin time).
• Nelfinavir, zidovudine (medicines for the treatment of HIV infections), as they may increase azithromycin levels in the blood.
• Fluconazole (medicines for treating fungal infections), as they may increase azithromycin levels in the blood.
• Terfenadine (a medicine used to treat allergies), as the combination of both may cause heart problems.
• Rifabutin (a medicine for the treatment of pulmonary and non-pulmonary tuberculosis and mycobacterial infections), as it may cause a decrease in the number of white blood cells in the blood.
• Medicines with active substances that prolong the QT interval, such as antiarrhythmics of class IA (quinidine and procainamide) and class III (dofetilide, amiodarone, and sotalol), cisapride, terfenadine, antipsychotic agents (such as pimozide), antidepressants (such as citalopram), and antiinfectives (fluoroquinolones such as moxifloxacin or levofloxacin and chloroquine), as it may cause serious heart rhythm disturbances and even cardiac arrest.

No interactions have been observed between azithromycin and cetirizine (for treating allergic reactions); didanosine, efavirenz, indinavir (for treating HIV infection); atorvastatin (for treating high cholesterol and heart problems); carbamazepine (for treating epilepsy), cimetidine (for treating excess stomach acid); methylprednisolone (for suppressing the immune system); theophylline (for respiratory problems); midazolam, triazolam (for sedation); sildenafil (for treating impotence), and trimethoprim/sulfamethoxazole (for treating infections).

Taking Azitromicina Viatris with food and drink

The tablets should be taken whole with water and 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 baby, ask your doctor or pharmacist for advice before taking this medicine.

Your doctor will assess whether you should take this medicine during pregnancy, if the benefit of treatment outweighs the potential risks. Azithromycin is excreted in breast milk. Due to potential adverse reactions in the infant, the use of azithromycin is not recommended during breastfeeding, although you may continue breastfeeding two days after completing treatment with azithromycin.

Driving and using machines

The influence of this medicine on the ability to drive or use machines is negligible or non-existent.

Azitromicina Viatris contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

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

3. How to take Azitromicina Viatris

Follow the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

Your doctor will determine the most suitable dose and treatment duration for you, according to your condition and response to treatment. As a general rule, the recommended dose of the medicine and the frequency of administration are as follows:

Adults (including elderly patients) and children weighing over 45 kg:

The usual dose is 1,500 mg divided over 3 or 5 days as follows:

• When taken over 3 days, 500 mg per day.
• When taken over 5 days, 500 mg on the first day and 250 mg from the 2nd to the 5th day.

In elderly patients, the same dose as for adults can be administered. However, in the case of patients with heart rhythm disturbances, your doctor will closely monitor you.

Urethra or cervix infection (cervicitis):

The usual dose is 1,000 mg taken as a single dose, in one day.

In case the infection is caused by N. gonorrhoeae, your doctor will administer the same dose in combination with another antibiotic (ceftriaxone, 250 mg).

Chancroid:

The usual dose is 1,000 mg taken as a single dose, in one day.

Sinusitis:

Treatment is indicated in adults and adolescents over 16 years.

Children and adolescents weighing less than 45 kg:

The tablets are not recommended for these patients. Other pharmaceutical forms containing azithromycin (e.g., suspensions) may be used.

Use in patients with hepatic impairment

Inform your doctor if you have severe liver problems, as it may be necessary to modify the normal dose.

Use in patients with renal impairment

Inform your doctor if you have kidney problems, as it may be necessary to modify the normal dose.

Method of administration

Oral use.

This medicine should be administered as a single daily dose. The tablets should be taken whole with water and can be taken with or without food.

If you take more Azitromicina Viatris than you should

In case of overdose, you may experience reversible hearing loss, severe nausea, vomiting, and diarrhea.

Information for the prescriber

In case of overdose, activated charcoal administration is indicated, and general symptomatic and supportive measures for vital functions should be applied.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested. Bring this leaflet, some of the remaining tablets, and the packaging to the hospital or your doctor, so they know which tablets you have taken.

If you forget to take Azitromicina Viatris

In case of a missed dose, use the medicine as soon as possible, continuing with the treatment as prescribed. However, if the next dose is near, it is better not to take the missed dose and wait for the next one. Do not take a double dose to make up for the missed dose. Continue using azithromycin as your doctor has indicated.

If you stop taking Azitromicina Viatris

If you stop treatment with azithromycin before your doctor recommends, symptoms may worsen or reappear.

If you have any further questions on 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.

Side effects reported during clinical trials and after marketing, classified by frequency, are:

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.
• Alteration in the number of some types of white blood cells (lymphocytes, eosinophils, basophils, monocytes, and neutrophils), decrease in bicarbonate.

Uncommon(may affect up to 1 in 100 people)

• Candida infection in the mouth or generalized, vaginal infection, pneumonia, fungal or bacterial infection, pharyngitis, gastroenteritis, respiratory alteration, rhinitis.
• Decrease in the number of some types of white blood cells (leukocytes, neutrophils, and eosinophils).
• Allergic reaction, including a deep skin inflammation (angioedema).
• Alteration in eating behavior (anorexia).
• Nervousness, insomnia.
• Somnolence, dizziness, alteration in taste, loss of tactile sensation.
• Visual alteration.
• Hearing alteration, vertigo.
• Palpitations.
• Hot flashes.
• Respiratory alteration, nosebleed.
• Constipation, flatulence, indigestion, gastritis, difficulty swallowing, abdominal distension, dry mouth, eructation, mouth ulcers, increased salivation.
• Rash, itching, appearance of red elevated patches, dermatitis, dry skin, excessive sweating, redness.
• Joint inflammation, muscle pain, back pain, neck pain.
• Difficulty urinating, kidney pain.
• Vaginal bleeding, alteration in the testicles.
• Generalized swelling, weakness, discomfort, fatigue, facial edema, chest pain, fever, pain and swelling of the limbs.
• Alteration in liver function tests (increase in liver enzymes got, gpt, and alkaline phosphatase) and increase in bilirubin, urea, creatinine, chloride, glucose, bicarbonate, and platelets in the blood, alteration in sodium and potassium levels, decrease in hematocrit.
• Complications after surgery.

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

• Agitation.
• Liver function alteration, yellowing of the skin.
• Sensitivity to sun exposure (photosensitivity), drug reaction with an increase in a type of white blood cells (eosinophilia) and generalized symptoms (multiorgan involvement) (DRESS syndrome).
• Skin rash characterized by the rapid appearance of red skin areas with small pus-filled bumps (small blisters filled with white/yellow liquid).

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

• Clostridium difficile-associated diarrhea.
• Decrease in platelet count in the blood, anemia.
• Severe allergic reaction.
• Aggressive reactions, anxiety, delirium, hallucinations.
• Loss of consciousness, seizures, decreased sensitivity, hyperactivity, alteration and/or loss of smell, loss of taste, muscle weakness and fatigue (myasthenia gravis).
• Hearing alteration, including deafness and ringing in the ears.
• Torsade de pointes, heart rhythm disturbances, prolongation of the QTc interval in the electrocardiogram.
• Decrease in blood pressure.
• Pancreatitis, change in tongue color.
• Severe liver damage and liver failure, which can rarely be fatal, liver tissue death, fulminant hepatitis.
• Appearance of red elevated patches, generalized rash with blisters and peeling skin, which occurs especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), severe skin reactions such as erythema multiforme, toxic epidermal necrolysis.
• Joint pain.
• Acute kidney failure and inflammation of the tissue between the kidney tubules (interstitial nephritis).

Reporting of side effects

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

5. Storage of Azitromicina Viatris

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

It does not require special storage conditions.

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

Medicines should not be thrown away through wastewater or in the trash. Deposit the packaging and medicines you no longer need at the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Azitromicina Viatris

The active ingredient is azithromycin (as dihydrate). Each tablet contains 500 mg of azithromycin (as dihydrate).

The other components (excipients) are: pregelatinized corn starch, crospovidone, anhydrous calcium hydrogen phosphate, sodium lauryl sulfate, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide (E171), lactose, and glycerol triacetate. See section 2 Azitromicina Viatris contains lactose and sodium.

Appearance of the Product and Package Contents

White, film-coated, capsule-shaped tablets. They are packaged in blisters, in packs of 3 and 150 tablets (clinical packaging).

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Manufacturer:

KERN PHARMA, S.L.

Polígono Ind. Colón II, C/ Venus, 72

08228 - Terrassa (Barcelona)

Spain

Date of the Last Revision of this Leaflet:April 2024

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