Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

azithromycin dihydrate

Read all of 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Leaflet contents

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

2. What you need to know before taking Azithromycin Viatris

3. How to take Azithromycin Viatris

4. Possible side effects

5. How to store Azithromycin Viatris

6. Contents of the pack and other information

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

Azitromicina Viatris contains the active substance azithromycin. Azithromycin is an antibiotic that belongs to a group of antibiotics known as macrolides, which inhibit the growth of susceptible bacteria.

Azithromycin is indicated for the treatment of the following infections:

Children aged 6 months or older weighing less than 45 kg

• Infection of the tonsils (tonsillitis) or throat (pharyngitis) caused by streptococcal bacteria.
• Bacterial infection of the sinuses (sinusitis).
• Bacterial infection of the middle ear (otitis media).
• Pneumonia (community-acquired pneumonia, not contracted in a hospital).
• Bacterial infection of the skin and underlying tissues.

Adults and adolescents weighing at least 45 kg who have difficulty swallowing

In addition to the infections listed above, azithromycin may also be administered for the treatment of the following infections:

• Infection of the urethra and cervix caused by bacteria of the species Chlamydia trachomatis.
• Infection of the urethra and cervix caused by bacteria of the species Neisseria gonorrhoeae. Azithromycin should be used in combination with another antibacterial agent selected by your doctor or pharmacist.
• Bacterial infection of the genitals with painful ulcers (chancroid).
• Adults with prolonged lung inflammation (chronic bronchitis).

2. What you need to know before starting Azithromycin Viatris

Do not take Azithromycin Viatris:

• If you are allergic to azithromycin, erythromycin, or any other macrolide or ketolide antibiotic, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting this medicine if you have or have had any of the following conditions:

• Heart disorders (e.g., problems with heart rhythm or heart failure) or low levels of potassium or magnesium in the blood: these conditions may contribute to serious cardiac adverse effects of azithromycin;
• Liver disorders: your doctor may need to monitor your liver function or discontinue treatment;
• Severe diarrhea following administration of any other antibacterial agent;
• Localized muscle weakness (myasthenia gravis), as symptoms of this disease may worsen during treatment; or if you are being treated with any ergot derivatives such as ergotamine (used to treat migraines), since these medicines should not be taken with azithromycin.

Stop taking this medicine and contact your doctor immediately (see also “Serious adverse reactions” in section 4):

• If you think you are having an allergic reaction (e.g., difficulty breathing, swelling of the face or throat, skin rash or blistering);
• If you notice any of the symptoms described in section 4 related to serious skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), or acute generalized exanthematous pustulosis (AGEP);
• If you feel your heartbeat is irregular or you experience palpitations, dizziness, or fainting during treatment with azithromycin;
• If you show signs of liver disorders (e.g., dark urine, loss of appetite, or yellowing of the skin or whites of the eyes);
• If you develop severe diarrhea during or after treatment. Do not take any medication for diarrhea without first speaking to your doctor. If your diarrhea persists or recurs within the first few weeks after treatment, inform your doctor as well.

Superinfection

Your doctor may monitor you for signs of additional bacterial or fungal infections that cannot be treated with azithromycin (superinfection).

Sexually transmitted infections

Your doctor may perform tests to rule out possible syphilis, a sexually transmitted disease that may otherwise progress undetected and be diagnosed late. Additionally, in cases of sexually transmitted bacterial infections, your doctor will carry out follow-up laboratory tests to monitor treatment effectiveness.

Children and adolescents

Ask your doctor or pharmacist if your child is under 6 months of age, as the efficacy and safety of this medicine have not been established in these children.

Infantile hypertrophic pyloric stenosis (IHPS)

If your child is under 6 months of age and your doctor has prescribed azithromycin treatment, stop giving this medicine and contact your doctor immediately if your child experiences projectile vomiting or irritability during or shortly after feeding.

Other medicines and Azithromycin Viatris

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

Using azithromycin with other medicines may lead to adverse effects. Therefore, it is especially important that you inform your doctor if you are taking any of the following medicines:

• Atorvastatin and other statins (to lower blood cholesterol levels and prevent heart diseases, including myocardial infarction and stroke).

• Cyclosporine (to prevent organ transplant rejection)

• Colchicine (for the treatment of gout and familial Mediterranean fever)

• Dabigatran (to prevent and treat blood clot formation [anticoagulant])

• Digoxin (for the treatment of heart conditions)

• Warfarin or similar medicines (to thin the blood [anticoagulants])

• Medicines that may prolong the time it takes for the heart muscle to contract and relax (QT interval prolongation), such as:

• Quinidine, procainamide, dofetilide, amiodarone, and sotalol (for treating heart rhythm disorders such as abnormally fast or slow heartbeats: cardiac arrhythmia)

• Pimozide (for treating mental illnesses)

• Citalopram (for treating depression)

• Moxifloxacin and levofloxacin (antibacterial agents)

• Cisapride (for treating gastrointestinal disorders)

• Hydroxychloroquine or chloroquine (for treating certain autoimmune diseases such as rheumatoid arthritis, or for treating or preventing malaria)

Pregnancy and breastfeeding

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.

Pregnancy

Your doctor will assess whether you should take this medicine during pregnancy, only after confirming that the benefits of treatment outweigh the potential risks.

Breastfeeding

Azithromycin is excreted in breast milk. Therefore, your doctor will decide together with you whether you should discontinue breastfeeding or avoid treatment with Azithromycin Viatris, taking into account both the benefit of breastfeeding for your child and the benefit of treatment for you.

Driving and using machines

The effect of azithromycin on the ability to drive and operate machinery is moderate. Dizziness, drowsiness, and seizures, as well as vision and hearing disturbances, have been reported with azithromycin in some individuals. These possible adverse effects may affect your ability to drive and operate machinery.

Azithromycin Viatris contains sucrose and sodium:

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

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

3. How to take Azithromycin Viatris

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended doses and duration of treatment are as follows:

Children from 6 months of age and older weighing less than 45 kg

It is important to ensure that you use the amount of azithromycin indicated in the table below, based on the patient's body weight, the infection being treated, and the specific treatment cycle (1 day, 3 days, 5 days, 10 days) prescribed by your doctor or pharmacist.

^ After reconstitution, the oral suspension concentration is 40 mg/mL and the total volume of suspension in the bottle is 15 mL (600 mg azithromycin) or 30 mL (1200 mg azithromycin), depending on the presentation.

+Doses have been rounded to obtain the appropriate dose to be administered.

++ Doses have been rounded to obtain the appropriate dose to be administered.

*Azithromycin 20 mg/mL (100 mg/5 mL) powder for oral suspension is more suitable for treating these patients.

do not exceed the adult daily dose of 500 mg

Adult and adolescent patients weighing at least 45 kg who have difficulty swallowing

• For adult patients only.

For adult patients, an initial intravenous treatment may be followed by oral therapy.

Use in children and adolescents

The safety and efficacy of azithromycin in children under 6 months of age have not been established for any of the indications listed in section 1.

Method of administration

For oral use after reconstitution.

Azithromycin should be administered orally as a single daily dose. The oral suspension may be taken with or without food. Taking this medicine just before a meal may improve gastrointestinal tolerability.

Preparation of the suspension

1. Invert the bottle and gently shake until all the powder moves freely (Figure 1).
2. Open the bottle and add the following amount of water according to the bottle size, using the provided dosing syringe (Figure 2):
   1. 15 ml bottle: add 10 ml of water
   2. 30 ml bottle: add 15 ml of water
3. Insert the perforated plastic cap and press it down until it fits securely into the mouth of the bottle (Figure 3).
4. Close the bottle with the metal lid (Figure 4).
5. Shake vigorously until a homogeneous suspension is obtained (Figure 5).

If the bottle of azithromycin you receive from your doctor or pharmacist contains powder only and no liquid, then it is necessary to add a specific volume of water to the bottle before the medicine is ready for use. If your doctor or pharmacist has already reconstituted the powder, then proceed directly to the next section, “Instructions for administering daily doses of azithromycin viatris oral suspension”.

Each 5 mL of reconstituted suspension will contain 200 mg of azithromycin.

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Instructions for administering daily doses of azithromycin viatris oral suspension

Do not forget to shake the suspension before each dose.

1. Remove the metal safety cap. Insert the syringe into the pierced plastic cap (Figure 6).
2. While keeping the syringe inserted, turn the bottle upside down so that it remains in a vertical position (Figure 7).
3. Draw up the syringe to the mark corresponding to the dose prescribed by your doctor (Figure 8).
4. Turn the bottle back upright, remove the syringe, and proceed with administration (Figure 9).
5. Wash the syringe after each administration.

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

Once the syringe has been prepared, administer immediately.

Administer the medication slowly to the child and ensure it is swallowed properly. This will help avoid the risk of choking.

Figure 6

Figure 7

Figure 8

Figure 9

If you take more Azithromycin Viatris than you should

If you take more azithromycin than you should, you may feel unwell. Typical signs of overdose include vomiting, diarrhea, abdominal pain, and nausea. Inform your doctor or contact immediately the nearest hospital emergency department.

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 medication and the amount ingested.

If you forget to take Azithromycin Viatris

If you forget to take azithromycin, take it as soon as possible, provided that at least 12 hours remain before the next dose. If less than 12 hours remain before the next dose, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for missed doses.

If you stop treatment with Azithromycin Viatris

If you stop treatment with azithromycin too early, the infection may recur. Take azithromycin for the full duration of treatment, even if you start to feel better.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Serious adverse effects

Stop taking azithromycin and seek immediate medical attention if you notice any of the following symptoms:

• Sudden chest pain, difficulty breathing, swelling of the eyelids, face or lips, skin rash or itching affecting especially the entire body (anaphylactic reaction, frequency not known).
• Fast or irregular heartbeat (cardiac arrhythmia or torsade de pointes, tachycardia, frequency not known).
• Dark urine, loss of appetite, or yellowing of the skin or whites of the eyes, which are signs of liver disease (hepatic failure or hepatic necrosis [frequency not known]).
• Severe diarrhoea with abdominal cramps, bloody stools or fever, which may indicate an infection in the large intestine (antibiotic-associated colitis, frequency not known). Do not take anti-diarrhoeal medicines that inhibit peristaltic movements (antiperistaltics).
• Raised red spots, target-shaped or circular rashes on the trunk, often with central blisters, skin peeling, and sores in the mouth, throat, nose, genitals and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome or toxic epidermal necrolysis, frequency not known).
• Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome, rare [may affect up to 1 in 1,000 people]).
• Widespread red, scaly rash with swellings under the skin and blisters accompanied by fever. Symptoms usually occur at the beginning of treatment (acute generalized exanthematous pustulosis, rare [may affect up to 1 in 1,000 people]).

Other adverse effects

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

• Diarrhoea.

Common (may affect up to 1 in 10 people)

• Headache.
• Vomiting, stomach pain, nausea.
• Changes in blood test results (decreased lymphocyte count, increased eosinophil count, increased basophil count, increased monocyte count, increased neutrophil count, decreased blood bicarbonate).

Uncommon (may affect up to 1 in 100 people)

• Candidiasis: fungal infection of the mouth and vagina, other fungal infections.
• Pneumonia, bacterial throat infection, inflammation of the digestive tract, respiratory disorder, inflammation of the nasal mucosa, vaginal infection.
• Changes in the number of white blood cells (leukopenia, neutropenia, eosinophilia).
• Increased platelet count.
• Reduction in the proportion of all blood cells in the total blood volume (decreased hematocrit).
• Allergic reactions, swelling of the hands, feet and face (angioedema).
• Loss of appetite.
• Nervousness, difficulty sleeping (insomnia).
• Dizziness, sensation of numbness (somnolence), changes in taste sensation (dysgeusia), tingling or numbness sensation (paraesthesia).
• Loss of vision.
• Ear disorder.
• Sensation of spinning (vertigo).
• Sensation of rapid or forceful heartbeat (palpitations).
• Hot flushes.
• Sudden chest pain, nosebleeds.
• Constipation, flatulence, indigestion (dyspepsia), inflammation of the stomach lining (gastritis), difficulty swallowing (dysphagia), bloated abdomen, dry mouth, burping, mouth ulceration, increased salivation.
• Skin rash, itching, hives (urticaria), dermatitis, dry skin, abnormally increased sweating (hyperhidrosis).
• Swelling and pain in the joints (osteoarthritis), muscle pain, back pain, neck pain.
• Pain when urinating (dysuria), kidney pain.
• Irregular menstrual bleeding (metrorrhagia), testicular disorder.
• Swelling due to fluid accumulation, especially in the face, ankles and feet (edema, facial edema, peripheral edema).
• Weakness, fatigue, general malaise, fever.
• Chest pain, pain.
• Abnormal laboratory test results (e.g., blood tests or liver function tests).
• Post-procedural complications.

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

• Irritation sensation.
• Liver problems, yellowing of the skin or eyes.
• Increased sensitivity to sunlight.

Frequency not known (cannot be estimated from available data)

• Reduction in red blood cell count due to increased destruction of red blood cells, which may cause fatigue and paleness of the skin (haemolytic anaemia).
• Reduction in the number of platelets in the blood, which may lead to bleeding and bruising (thrombocytopenia).
• Feeling irritable, aggression, feeling of fear or worry (anxiety), acute state of confusion (delirium).
• Hallucinations.
• Fainting (syncope).
• Seizures (convulsions).
• Reduced sensitivity to touch, pain and temperature (hypoesthesia).
• Feeling of hyperactivity.
• Changes in the sense of smell (anosmia, parosmia).
• Complete loss of taste sensation (ageusia).
• Muscle weakness (myasthenia gravis).
• Abnormal electrocardiogram (ECG) trace (prolongation of QT interval).
• Deafness, hearing loss or ringing in the ears (tinnitus).
• Low blood pressure.
• Inflammation of the pancreas causing severe abdominal and back pain (pancreatitis).
• Change in tongue colour.
• Joint pain (arthralgia).
• Kidney inflammation (interstitial nephritis) and kidney failure.

Reporting of adverse effects

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

5. Storage of Azithromycin Viatris

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

Reconstituted solution: 10 days, do not store above 25°C. Write the day and month of suspension reconstitution in the box provided for this purpose, both on the carton and on the bottle label. Do not use the medicine after 10 days from reconstitution; discard any remaining solution.

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 or EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Azithromycin Viatris:

The active substance 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 flavour, vanilla flavour and banana flavour; see section 2 Azithromycin Viatris contains sucrose and sodium.

Appearance of the medicine and content of the pack

It is presented in a 15 ml or 30 ml amber glass bottle, closed with an aluminium cap. The perforated cap and the syringe supplied with the bottle are made of plastic.

The pack contains one 15 ml or 30 ml bottle.

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Viatis Pharmaceuticals, S.L.

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 most recent review of this leaflet: September 2025

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