Azithromycin Vir 500 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Azitromicina Vir 500 mg film-coated tablets EFG

azithromycin dihydrate

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

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

Leaflet contents:

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

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

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

Azithromycin Vir is indicated for the treatment of the following infections:

Adults and adolescents weighing over 45 kg

• Infection of the tonsils (tonsillitis) or throat (pharyngitis) caused by streptococcal bacteria
• Bacterial infection of the sinuses (sinusitis)
• Bacterial middle ear infection (otitis media)
• Pneumonia (community-acquired pneumonia, not contracted in a hospital)
• Bacterial infection of the skin and underlying tissues
• 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 antibiotic selected by your doctor or pharmacist.
• Bacterial genital infection with painful ulcers (chancroid)

Adults

• Bacterial infection in patients with prolonged lung inflammation (chronic bronchitis)

2. What you need to know before taking Azithromycin Vir

Do not take Azithromycin Vir:

• If you are allergic to azithromycin, erythromycin, 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 taking Azithromycin Vir if you have or have had any of the following conditions:

• heart problems (e.g., heart rhythm disorders or heart failure) or low levels of potassium or magnesium in the blood: these conditions may contribute to serious cardiac side effects of azithromycin;
• liver problems: 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;
• if you are being treated with any ergotamine derivative such as ergotamine (used to treat migraines), as 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 think your heart rhythm is irregular or you experience palpitations, dizziness, or fainting during treatment with azithromycin;
• if you develop signs of liver problems (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 infection, a sexually transmitted disease that might otherwise progress undetected and be diagnosed late. Additionally, in cases of sexually transmitted bacterial infections, your doctor will initiate follow-up laboratory tests to monitor treatment success.

Children and adolescents

I f you weigh less than 45 kg, there are other azithromycin-containing medicines that may be more suitable for your treatment.

Other medicines and Azithromycin Vir

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

Using Azithromycin Vir together 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 medicines in the statin group (to reduce blood cholesterol levels and prevent heart diseases, including heart attacks and stroke)
• Cyclosporine (to prevent the body from rejecting organ transplants)
• 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 used to thin the blood (anticoagulants)
• Medicines that may cause the heart muscle to take longer than normal to contract and relax (prolongation of the QT interval), such as the following:
  • Quinidine, procainamide, dofetilide, amiodarone, and sotalol (for the treatment of irregular heartbeat, such as beats that are too fast or too slow: cardiac arrhythmia)
  • Pimozide (for the treatment of mental illnesses)
  • Citalopram (for the treatment of depression)
  • Moxifloxacin and levofloxacin (antibacterial agents)
  • Cisapride (for the treatment of gastrointestinal disorders)
  • Hydroxychloroquine or chloroquine (for the treatment of certain autoimmune diseases such as rheumatoid arthritis, or for the treatment or prevention of malaria)

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 ensuring that the benefits of treatment outweigh the potential risks.

Breastfeeding

Azithromycin is excreted in breast milk. Therefore, your doctor will decide whether you should discontinue breastfeeding or avoid treatment with azithromycin, 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 use machines is moderate. Dizziness, somnolence, and seizures, as well as vision and hearing problems, have been reported in some individuals. These possible adverse effects may affect your ability to drive and use machines.

Azithromycin Vir contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Azithromycin Vir

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

The amount of azithromycin you need to take each day will depend on the bacterial infection being treated and the specific treatment course prescribed by your doctor or pharmacist.

Adults and adolescents weighing at least 45 kg

Use in children and adolescents

If your weight is less than 45 kg or you are unable to swallow this medicine, consult your doctor or pharmacist, as there are other azithromycin-containing medicines that may be more suitable for you.

Method of administration

Azithromycin should be taken as a single daily oral dose. The tablet score is intended solely for dividing the tablet if you find it difficult to swallow it whole. The halves must be taken one immediately after the other.

The tablets may be taken with or without food. Taking this medicine just before a meal may help improve stomach tolerance.

If you take more Azitromicina Vir than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Azitromicina Vir

If you forget to take Azitromicina Vir, take it as soon as possible, provided that at least 12 hours remain before the next dose. If less than 12 hours remain until 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 a missed dose.

If you stop treatment with Azitromicina Vir

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 Vir and seek immediate medical attention if you experience any of the following symptoms:

• sudden chest tightness, difficulty breathing, swelling of the eyelids, face or lips, rash or itching affecting especially the whole body (anaphylactic reaction, frequency not known).
• rapid 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 of the large intestine (antibiotic-associated colitis, frequency not known). Do not take anti-diarrhoeal medicines that inhibit defecation (antiperistaltics).
• flat red spots, target-like or circular skin 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 appear 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 to up to 10 people)

• Diarrhea

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, gastrointestinal tract inflammation, respiratory disorder, nasal mucosa inflammation, vaginal infection
• Changes in white blood cell count (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, numbness sensation (somnolence), changes in taste sensation (dysgeusia), tingling or numbness sensation (paresthesia)
• Vision disturbance
• Ear disorder
• Sensation of spinning (vertigo)
• Awareness of heartbeats (palpitations)
• Hot flushes
• Sudden chest noises, nosebleed
• Constipation, flatulence, indigestion (dyspepsia), inflammation of the stomach lining (gastritis), difficulty swallowing (dysphagia), bloated abdomen, dry mouth, burping, mouth ulcers, increased salivation
• Skin rash, itching, hives (urticaria), dermatitis, dry skin, abnormal increase in sweating (hyperhidrosis)
• Joint swelling and pain (osteoarthritis), muscle pain, back pain, neck pain
• Painful urination (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 complication

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 cell breakdown, which may cause fatigue and pale skin (hemolytic anemia)
• Reduction in blood platelet count, which may cause bleeding and bruising (thrombocytopenia)
• Feeling of irritability, aggression, fear or worry (anxiety), acute state of confusion (delirium)
• Hallucinations
• Fainting (syncope)
• Seizures (convulsions)
• Decreased sensitivity to touch, pain, and temperature (hypoesthesia)
• Feeling of hyperactivity
• Changes in 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
• Pancreas inflammation causing severe abdominal and back pain (pancreatitis)
• Change in tongue color
• Joint pain (arthralgia)
• Kidney inflammation (interstitial nephritis) and kidney failure

Reporting of adverse effects

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

5. Storage of Azithromycin Vir

This medicine does not require special storage conditions.

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

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in 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 container and additional information

Composition of Azitromicina Vir

• The active substance is azithromycin. Each tablet contains 500 mg of azithromycin (equivalent to 524 mg of azithromycin dihydrate).
• The other components (excipients) are: pregelatinized corn starch, crospovidone, anhydrous calcium hydrogen sulfate, sodium lauryl sulfate, magnesium stearate, hydroxypropylmethylcellulose, titanium dioxide (E171), lactose, and glyceryl triacetate.

Appearance of the product and contents of the container

Azitromicina Vir is presented as film-coated tablets, white in color, capsule-shaped, scored on one side and smooth on the other, in packs containing 3 and 150 tablets.

The score line is intended only to facilitate breaking the tablet and swallowing, but not for dividing the tablet into equal doses.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.
C/ Laguna, 66-68-70. Polígono Industrial Urtinsa II.
28923 Alcorcón (Madrid)
Spain

Date of the most recent review of this leaflet: October 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): https://www.aemps.gob.es