Azithromycin Sandoz 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Azithromycin Sandoz 500 mg film-coated tablets 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, 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 adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Azithromycin Sandoz 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.

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 skin infection and underlying tissues
• Infection of the urethra and cervix caused by Chlamydia trachomatis bacteria
• Infection of the urethra and cervix caused by Neisseria gonorrhoeae bacteria. Azithromycin Sandoz 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 Sandoz

Do not take Azithromycin Sandoz

• 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

Talk to your doctor or pharmacist before taking Azithromycin Sandoz if you have or have previously had any of the following conditions:

• heart problems (e.g., irregular heartbeat or heart failure) or low levels of potassium or magnesium in your 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 after taking 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 ergot derivative such as ergotamine (used to treat migraines), as these medicines should not be taken with Azithromycin Sandoz.

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, 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 heartbeat is irregular or you experience palpitations, dizziness, or fainting while taking Azithromycin Sandoz;
• 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 talking 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 Sandoz (superinfection).

Sexually transmitted infections

Your doctor may perform tests to rule out possible syphilis, a sexually transmitted infection that could otherwise progress undetected and be diagnosed late. In addition, in cases of sexually transmitted bacterial infections, your doctor will initiate follow-up laboratory tests to monitor treatment success.

Children and adolescents

If you weigh less than 45 kg, other azithromycin-containing medicines may be more suitable for your treatment.

Other medicines and Azithromycin Sandoz

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

Taking Azithromycin Sandoz with other medicines may cause 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 reduce cholesterol levels in the blood and prevent heart disease, including heart attacks and stroke)
• Cyclosporine (to prevent organ transplant rejection)
• Colchicine (for the treatment of gout and familial Mediterranean fever)
• Dabigatran (to prevent and treat blood clots [anticoagulant])
• Digoxin (for the treatment of heart conditions)
• Warfarin or similar medicines used to thin the blood (anticoagulants)
• Medicines that may prolong the QT interval (i.e., delay the heart muscle's ability to contract and relax normally), such as:
  • Quinidine, procainamide, dofetilide, amiodarone, and sotalol (for treating irregular heartbeat, 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 ensuring that the benefits of treatment outweigh any possible risks.

Breastfeeding

Azithromycin Sandoz is excreted in breast milk. Therefore, your doctor will decide whether you should discontinue breastfeeding or avoid treatment with Azithromycin Sandoz, 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 Sandoz 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 Sandoz in some people. These possible adverse effects may affect your ability to drive and operate machinery.

Azithromycin Sandoz contains lactose and sodium

If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

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

3. How to take Azithromycin Sandoz

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 amount of Azithromycin Sandoz you need to take each day will depend on the bacterial infection being treated and the specific treatment course your doctor or pharmacist has instructed you to follow.

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

For oral use.

Sandoz Azithromycin should be taken as a single daily dose orally. The tablets must be swallowed whole with water, with or without food. Taking this medicine just before a meal may help improve stomach tolerance.

If you take more Sandoz Azithromycin than you should

If you take more Sandoz Azithromycin than you should, you may feel unwell. Typical signs of overdose include vomiting, diarrhoea, 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 at 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to bring the medicine’s packaging and leaflet to the healthcare professional.

If you forget to take Sandoz Azithromycin

If you forget to take Sandoz 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 Sandoz Azithromycin

If you stop treatment with Sandoz Azithromycin too early, the infection may recur. Take Sandoz 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 experiences them.

Serious adverse effects

Stop taking Azithromycin Sandoz and seek immediate medical attention if you notice 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).
• 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 defecation (antiperistaltics).
• Raised red rash resembling a target or circular spots 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 bumps 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)

• 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 white blood cell count (leucopenia, neutropenia, eosinophilia).
• Increased platelet count.
• Reduction in the proportion of all blood cells in the total blood volume (decreased haematocrit).
• Allergic reactions, swelling of the hands, feet and face (angioedema).
• Loss of appetite.
• Nervousness, difficulty sleeping (insomnia).
• Dizziness, numbness (somnolence), changes in taste sensation (dysgeusia), tingling or numbness (paraesthesia).
• Vision disturbances.
• Ear disorder.
• Sensation of spinning (vertigo).
• Awareness of heartbeats (palpitations).
• Hot flushes.
• Sudden chest tightness, nosebleeds.
• Constipation, flatulence, indigestion (dyspepsia), inflammation of the stomach lining (gastritis), difficulty swallowing (dysphagia), bloated abdomen, dry mouth, belching, mouth ulcers, increased salivation.
• Skin rash, itching, hives (urticaria), dermatitis, dry skin, abnormal increase in 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 (oedema, facial oedema, peripheral oedema).
• 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 (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).
• Decreased sensitivity to touch, pain and temperature (hypoesthesia).
• Feeling of hyperactivity.
• Changes in sense of smell (anosmia, parosmia).
• Complete loss of taste (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, consult your doctor, pharmacist or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them 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 Sandoz

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the container, after CAD/EXP. The expiry date is 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 properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Azithromycin Sandoz

• The active substance is azithromycin. Each tablet contains 500 mg of azithromycin (as dihydrate).
• The other components (excipients) are:

Core: pregelatinized maize starch, crospovidone, anhydrous calcium hydrogen phosphate, sodium lauryl sulfate, magnesium stearate.

Coating: hypromellose (hydroxypropylmethylcellulose) (E-464), titanium dioxide (E171), lactose monohydrate, and triacetin (E-1518).

Appearance of the medicinal product and contents of the pack

The tablets are packaged in PVC/aluminum blisters.

Azithromycin Sandoz 500 mg film-coated tablets are white, capsule-shaped tablets with a score line on one side only.

Available in packs of 3 and 150 tablets (hospital pack).

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Sandoz Farmacéutica, S.A.
Parque Norte Business Centre
Roble Building
C/ Serrano Galvache, 56
28033 Madrid
Spain

Manufacturer:

Kern Pharma, S.L.
Colón II Industrial Estate, Venus, 72
08228 Terrassa (Barcelona)
Spain

Date of the most recent review of this leaflet: 09/2025

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