AZITHROMYCIN VIATRIS 200 mg/5 ml ORAL SUSPENSION POWDER

Introduction

Leaflet: information for the user

Azitromicina Viatris 200 mg/5 ml powder for oral suspension EFG

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

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

Contents of the leaflet

1. What Azitromicina Viatris is and what it is used for
2. What you need to know before taking Azitromicina Viatris
3. How to take Azitromicina Viatris
4. Possible side effects
5. Storage of Azitromicina Viatris

1. Contents of the pack and additional 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 taking Azitromicina Viatris

Do not take Azitromicina Viatris:

• If you are allergic to azitromicina, another macrolide antibiotic, or ketolide, such as erythromycin or telithromycin, or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Azitromicina Viatris if:

• During treatment with azitromicina, 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 can be severe. Inform your doctor, who may decide to interrupt treatment and initiate appropriate treatment.
• If you have liver problems or if your skin and/or the whites of your eyes turn yellow during treatment, discuss this with your doctor to confirm whether you should interrupt 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 azitromicina 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. If this occurs, inform your doctor.
• During or after treatment with azitromicina, symptoms suggesting antibiotic-associated colitis (diarrhea) may appear. If this occurs, treatment should be suspended, and your doctor will provide the most appropriate treatment.
• If you have severe kidney function impairment, inform your doctor.
• If you have heart rhythm disorders (arrhythmias) or factors that predispose you to them (certain heart diseases, electrolyte disturbances in the blood, or certain medications), inform your doctor, as this medicine may contribute to worsening or triggering these disorders.
• If you have a disease called myasthenia gravis or if muscle weakness and fatigue appear during treatment, inform your doctor, as azitromicina may trigger or worsen the symptoms of this disease.

If you experience severe and persistent diarrhea, especially with blood or mucus, during or after treatment, consult your doctor immediately.

If symptoms persist after finishing treatment with azitromicina or if you notice any new and persistent symptoms, inform your doctor.

Children and adolescents

This medicine is not indicated in children under 1 year of age.

Sinusitis: treatment is indicated in adults and adolescents over 16 years of age.

Other medicines and Azitromicina Viatris

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medicine, including those obtained without a prescription.

Azitromicina may interact with other medicines. Inform your doctor or pharmacist if you are taking any of the following medicines:

• Antacids (medicines used for digestive problems). It is recommended to avoid simultaneous administration of both medicines at the same time of day.
• Ergotamine derivatives (such as ergotamine, used to treat migraines), as concomitant administration with azitromicina may cause ergotism (a potentially serious adverse reaction with numbness or tingling in the limbs, muscle cramps, headaches, convulsions, or abdominal or chest pain).
• Digoxin (a medicine used to treat heart arrhythmias), as azitromicina may increase digoxin levels in the blood, and its levels should be monitored.
• Colchicine (used for gout and familial Mediterranean fever).
• Ciclosporin (a medicine used in transplant patients), as azitromicina may increase ciclosporin levels in the blood, and its levels should be monitored.
• Anticoagulant dicumarinics (medicines used to prevent blood clots), as azitromicina 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 azitromicina levels in the blood.
• Fluconazole (medicines for the treatment of fungal infections), as they may increase azitromicina 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 class IA (quinidine and procainamide) and class III (dofetilide, amiodarone, and sotalol), cisapride, terfenadine, antipsychotic agents (such as pimozide), antidepressants (such as citalopram), and anti-infectives (fluoroquinolones such as moxifloxacin or levofloxacino and chloroquine), as they may cause serious heart rhythm disorders and even cardiac arrest.
• • Hydroxychloroquine (used for rheumatoid arthritis, lupus, and malaria prevention).

No interactions have been observed between azitromicina and cetirizine (for the treatment of allergic reactions); didanosine, efavirenz, indinavir (for HIV infection); atorvastatin (for cholesterol and heart problems); carbamazepine (for epilepsy), cimetidine (an antacid); methylprednisolone (to suppress the immune system); theophylline (for respiratory problems); midazolam, triazolam (sedatives); sildenafil (for impotence), and trimethoprim/sulfamethoxazole (for the treatment of infections).

Taking Azitromicina Viatris with food

It can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Your doctor will assess whether you should take this medicine during pregnancy, if the benefit of treatment outweighs the potential risks.

Azitromicina is excreted in breast milk. Due to the potential adverse reactions in the infant, the use of azitromicina is not recommended during breastfeeding. You can continue breastfeeding two days after finishing treatment with azitromicina.

Driving and using machines

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

Azitromicina Viatris contains sucrose and sodium:

This medicine contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine. It contains 3.6 mg of sucrose per 5 ml of reconstituted suspension, which should be taken into account in patients with diabetes mellitus.

This medicine contains 18.17 mg of sodium (the main component of table salt) per 5 ml of reconstituted suspension. This is equivalent to 0.91% of the maximum recommended daily sodium intake for an adult.

3. How to take Azitromicina Viatris

Follow the administration instructions for this medicine exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

This medicine is administered orally. To facilitate administration, each bottle is accompanied by a dosing syringe.

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 medicine and administration frequency is as follows:

This medicine is not indicated in children under 1 year of age, see the Children and adolescentssection.

Dose

The azitromicina suspension should be administered in a single dose once a day, with or without food.

Shake the bottle vigorously before using the suspension.

Other presentations are available for different dosing regimens.

The usual dose is as follows:

Use in children and adolescents over 45 kg in weight, adults, and the elderly

The total dose of azitromicina is 37.5 ml (1,500 mg) administered over 3 days (12.5 ml (500 mg) once a day). Alternatively, the dose can be administered over 5 days (12.5 ml (500 mg) as a single dose on the first day and 6.25 ml (250 mg) once a day).

For the treatment of urethra or cervix infections caused by Chlamydia, the dose is 25 ml (1,000 mg) in a single dose.

Treatment for sinusitis is only indicated for adults and adolescents over 16 years of age.

Other presentations are available that are more suitable for patients weighing over 45 kg.

Use in children and adolescents under 45 kg in weight

Treatment with azitromicina suspension should be carefully measured using the dosing syringe provided, based on the child's weight, according to the following table:

For the treatment of tonsillitis/pharyngitis in children over 2 years of age: the recommended dose of azitromicina is a single dose of 10 mg/kg or 20 mg/kg for 3 days, not exceeding a maximum daily dose of 500 mg.

Sinusitis

For the treatment of sinusitis, data in children under 16 years of age are limited.

Patient with liver or kidney problems:

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

Method of administration

Oral route.

Preparation of the suspension

1. Invert the bottle and shake it gently until all the powder moves freely.
2. Open the bottle and add the following amount of water, depending on the bottle size, using the dosing syringe provided:
   1. 15 ml bottle: add 10 ml of water
   2. 30 ml bottle: add 15 ml of water
3. Place the plastic perforated cap and press it until it is inserted into the bottle mouth.
4. Close the bottle with the metal cap.
5. Shake vigorously until a homogeneous suspension is obtained.
6. Do not forget to shake the suspension before each intake.

Each 5 ml of reconstituted suspension contains 200 mg of azitromicina.

The reconstituted oral suspension can be stored at room temperature for a period of 10 days. After this time, discard any remaining solution.

Administration of the preparation:

1. Open the metal safety cap. Insert the syringe into the plastic perforated cap.
2. Keeping the syringe inserted, invert the bottle so that it remains in a vertical position.
3. Fill the syringe to the measure corresponding to the dose prescribed by your doctor.
4. Invert the bottle again, remove the syringe, and proceed with administration.
5. Wash the syringe after each administration.

The dosing syringe is also graduated to administer the dose according to the child's weight.

Once the syringe is prepared, administer immediately.

WARNING: ADMINISTER THE MEDICINE SLOWLY TO THE CHILD AND ENSURE IT IS SWALLOWED. THIS WILL AVOID THE RISK OF ASPHYXIA.

If you take more Azitromicina Viatris than you should

If you (or someone else) take more azitromicina than you should, inform your doctor or pharmacist immediately. A overdose is likely to cause temporary 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. Telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Azitromicina Viatris

If you forget a 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 missed doses.

If you interrupt treatment with Azitromicina Viatris

Do not stop taking your medicine without consulting your doctor first, even if you feel better. It is very important that you continue taking azitromicina for the time indicated by your doctor, otherwise the infection may recur.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

The adverse 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 of 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)

• Infection with the Candida fungus in the mouth or generalized, vaginal infection, pneumonia, fungal or bacterial infection, pharyngitis, gastroenteritis, alteration of breathing, rhinitis.
• Decrease in the number of some types of white blood cells (leukocytes, neutrophils, and eosinophils).
• Allergic reaction, including an inflammatory process in the deep layer of the skin (angioedema).
• Alteration of eating behavior (anorexia).
• Nervousness, insomnia.
• Somnolence, dizziness, alteration of taste, loss of tactile sensation.
• Alteration of vision.
• Alteration of hearing, vertigo.
• Palpitations.
• Hot flashes.
• Alteration of breathing, nosebleeds.
• Constipation, flatulence, indigestion, gastritis, difficulty swallowing, abdominal distension, dry mouth, belching, mouth ulcers, increased salivation.
• Rash, itching, appearance of reddened raised patches, dermatitis, dry skin, excessive sweating, redness.
• Inflammation of the joints, 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 of liver function tests (increase in liver enzymes got, gpt, and alkaline phosphatase) and increase in bilirubin, urea, creatinine, chloride, glucose, bicarbonate, and platelets in blood, alteration of sodium and potassium levels, decrease in hematocrit.
• Complications after surgical intervention

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

• Agitation.
• Alteration of liver function, yellowish skin discoloration.
• Sensitivity to sun exposure (photosensitivity), drug reaction with increased white blood cell count (eosinophilia) and generalized symptoms (multi-organ involvement) (DRESS syndrome).
• Skin rash characterized by the rapid appearance of red skin areas sprinkled with small pustules (small blisters filled with white/yellow liquid).

Frequency Not Known(cannot be estimated from available data)

• Diarrhea caused by Clostridium difficile.
• Decrease in platelet count in blood, anemia.
• Severe allergic reaction
• Aggressive reactions, anxiety, delirium, hallucinations.
• Loss of consciousness, convulsions, decreased sensitivity, hyperactivity, alteration and/or loss of smell, loss of taste, muscle weakness and fatigue (myasthenia gravis).
• Alteration of hearing, including deafness and ringing.
• Torsades de pointes, cardiac rhythm disorders, prolongation of the QTc interval in the electrocardiogram.
• Decrease in blood pressure.
• Pancreatitis, change in tongue color.
• Severe liver damage and liver failure that can rarely be fatal, liver tissue death, fulminant hepatitis.
• Appearance of reddened raised 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 renal tubules (interstitial nephritis).

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Azitromicina Viatris

Closed bottles: No special storage conditions are required. Store in the original packaging.

Reconstituted solution: 10 days, do not store at a temperature above 25°C. Note on the box and label of the bottle the day and month of reconstitution of the suspension. Do not take the medicine after 10 days of reconstitution; discard the remaining solution.

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

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 the sewers or in the trash. Deposit the packaging and unused medicines in the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. 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 5 ml of reconstituted suspension contains 200 mg of azithromycin (as dihydrate).

The other components (excipients) are: sucrose, hydroxypropylcellulose (E-463), trisodium phosphate, xanthan gum (E-415), cherry flavor, vanilla flavor, and banana flavor, see section 2 Azitromicina Viatris containssucrose and sodium.

Appearance of the Product and Package Contents.

It is packaged in a topaz glass bottle, closed with an aluminum cap. The perforated cap and the syringe that accompany the bottle are made of plastic.

Each package contains a 15 ml or 30 ml bottle.

The dosing syringe has three types of scales: in kg (from 10 to 40 kg) based on body weight; in ml (from 0.25 to 10 ml) based on the volume of suspension; and in mg (from 10 to 400 mg) based on the amount of active ingredient.

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 Prospectus:September 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