Azithromycin Mabo 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Azithromycin Mabo 500 mg film-coated tablets EFG

azithromycin dihydrate

Read the entire 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 must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult 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 Mabo is and what it is used for
2. What you need to know before taking Azithromycin Mabo
3. How to take Azithromycin Mabo
4. Possible adverse effects
5. How to store Azithromycin Mabo
6. Contents of the pack and other information

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

Azitromicina Mabo 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.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as influenza or the common cold.

It is important that you follow your doctor's instructions regarding dosage, dosing intervals, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left after completing treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via wastewater or household waste.

Azitromicina Mabo is indicated for the treatment of the following infections:

Adults and adolescents weighing more than 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 hospital)
• Bacterial skin and underlying tissue 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. Azitromicina Mabo 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 starting to take Azithromycin Mabo

Do not take Azithromycin Mabo

• 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 Mabo 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 after taking any other antibacterial agent;
• localized muscle weakness (myasthenia gravis), as symptoms of this condition may worsen during treatment;
• or if you are taking any ergot derivatives such as ergotamine (used to treat migraines), since these medicines should not be taken with Azithromycin Mabo.

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 heartbeat is irregular or you experience palpitations, dizziness, or fainting during treatment with Azithromycin Mabo;
• if you show 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 continues or returns 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 Mabo (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 bacterial sexually transmitted infections, your doctor will carry out 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 Mabo

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

Using Azithromycin Mabo 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 medicines in the statin group (to reduce blood cholesterol levels 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 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:
  • Quinidine, procainamide, dofetilide, amiodarone, and sotalol (for the treatment of irregular heartbeat, such as heartbeats 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 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 potential risks.

Breastfeeding

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

Azithromycin Mabo 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.

Azithromycin Mabo contains sodium

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

3. How to take Azithromycin Mabo

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

The amount of Azithromycin Mabo 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 body weight is less than 45 kg or you are unable to swallow this medicine, ask your doctor or pharmacist, as there are other azithromycin-containing medicines that may be more suitable for you.

Method of administration

For oral use.

Azithromycin Mabo should be administered as a single daily dose orally. The tablets may be taken with or without food. Taking this medicine just before a meal may help improve stomach tolerance.

The tablets can be divided into two equal halves, which can be used to adjust the dose as directed by your doctor or pharmacist.

If you take more Azithromycin Mabo than you should

If you take more Azithromycin Mabo 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.

If you forget to take Azithromycin Mabo

If you forget to take Azithromycin Mabo, 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 a missed dose.

If you stop taking Azithromycin Mabo

If you stop treatment with Azithromycin Mabo too early, the infection may recur. Take Azithromycin Mabo 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 Mabo 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, skin 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, target-shaped or circular skin rashes on the trunk, often with central blisters, skin peeling, and ulcers 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 to up to 10 people per 10)

• 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, gastrointestinal tract inflammation, respiratory disorder, nasal mucosa inflammation, vaginal infection
• Changes in white blood cell count (leucopenia, neutropenia, eosinophilia)
• Increased platelet count
• Reduction in the proportion of all blood cells in total blood volume (decreased haematocrit)
• Allergic reactions, swelling of the hands, feet and face (angioedema)
• Loss of appetite
• Nervousness, difficulty sleeping (insomnia)
• Dizziness, drowsiness, changes in taste sensation (dysgeusia), tingling or numbness sensation (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 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 cause 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
• Pancreatitis causing severe abdominal and back pain
• Change in tongue colour
• Joint pain (arthralgia)
• Kidney inflammation (interstitial nephritis) and kidney failure

Reporting of adverse effects

If you experience any 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 Mabo

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 empty containers and unused medicines at the SIGRE collection point at your usual pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Azithromycin Mabo

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

Appearance of the product and contents of the pack

Film-coated tablets, white, capsule-shaped, with a single transverse line imprint on one side. Each pack contains 3 or 150 tablets (hospital pack).

Only certain pack sizes may be marketed.

Marketing Authorization Holder

MABO-FARMA S.A.

Calle Vía de los Poblados, 3, Edificio 6

28033 Madrid,

Spain.

Manufacturer

KERN PHARMA, S.L.

Polígono Ind. Colón II. Venus, 72

08228 Terrasa (Barcelona)

Spain

or

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/ Laguna 66-70. Polígono Industrial Urtinsa II.

28923 Alcorcón. Madrid

Spain

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

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