Azithromycin Alter 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Azithromycin Alter 500 mg film-coated tablets EFG

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

• Keep this leaflet. 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 pass it on to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Azitromicina Alter 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 more 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
• 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 infection Bacterial infection of the genital area with painful ulcers (chancroid)

Adults

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

Bacterial infection of the uterus, fallopian tubes, and ovaries (pelvic inflammatory disease), always in combination with another antibiotic selected by your doctor or pharmacist.

2. What you need to know before taking Azithromycin Alter

Do not take Azithromycin Alter:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Azithromycin Alter if you have or have had any of the following conditions:

• heart disorders (e.g., heart rhythm problems 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 disorders: 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;
• or if you are being treated with any ergot derivative such as ergotamine (used to treat migraines), since these medicines should not be taken with Azithromycin Alter.

Stop taking this medicine and contact your doctor immediately (see also “Serious adverse effects” 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, for example, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP);
• if you think your heartbeat is irregular or you experience palpitations, dizziness, or fainting during treatment with Azithromycin Alter;
• 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 speaking 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 Alter (superinfection).

Sexually transmitted infections

Your doctor may perform tests to rule out possible syphilis, 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

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

Other medicines and Azithromycin Alter

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

Using Azithromycin Alter 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 reduce cholesterol levels in the blood 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 used to thin the blood (anticoagulants)

• Medicines that may cause the heart muscle to take longer than normal to contract and relax (QT interval prolongation), such as:

• Quinidine, procainamide, dofetilide, amiodarone, and sotalol (for the treatment of heart rhythm disorders, 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 the potential risks.

Breastfeeding

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

Azithromycin Alter contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially “sodium-free”.

3. How to take Azithromycin Alter

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

The amount of Azithromycin Alter 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, ask 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 dose orally. The tablet score is intended solely for dividing the tablet if you find it difficult to swallow it whole. The two halves should 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 Alter 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 immediately the nearest hospital emergency department.

If you forget to take Azitromicina Alter

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 a missed dose.

If you stop taking Azitromicina Alter

If you stop treatment with Azitromicina Alter 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 wheezing in the chest, difficulty breathing, swelling of the eyelids, face or lips, rash or itching especially affecting 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 intestinal movements (antiperistaltics).

• flat red spots, target-shaped or circular rashes on the trunk, often with central blisters, peeling of the skin, or 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 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 in 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, inflammation of the digestive tract, respiratory disorder, inflammation of the nasal mucosa, vaginal infection
• Changes in white blood cell count (leukopenia, neutropenia, eosinophilia)
• Increased platelet count
• Reduction in the proportion of all blood cells in 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 loss

• Ear disorder

• Sensation of spinning (vertigo)

• Awareness of 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, belching, 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

• 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 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 destruction, which may cause fatigue and pale skin (hemolytic anemia)
• Reduced platelet count 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 (prolonged 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 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 or pharmacist, even if it is a possible adverse effect 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 Alter

Keep this medicine out of sight and reach of children.

Store below 30°C.

Do not use Azithromycin Alter after the expiry date stated on the packaging, after EXP. The expiry date refers to 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 at your pharmacy. If you are unsure, 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 Alter

The active substance is azithromycin. Each tablet contains 500 mg of azithromycin (as dihydrate).

The other components (excipients) are: pregelatinized starch (from corn), corn starch, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate, anhydrous calcium hydrogen phosphate, hypromellose (hydroxypropylmethylcellulose), titanium dioxide (E171), glyceryl triacetate (triacetin), and purified water.

Appearance of the medicine and contents of the pack

Azithromycin Alter 500 mg are white, film-coated, capsule-shaped tablets with a breakline.

The tablets are available in packs containing 3 tablets and clinical packs containing 500 tablets.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Alter, S.A.

C/Mateo Inurria, 30

28036 Madrid

Spain

Manufacturer

Laboratorios Alter, S.A.

C/Mateo Inurria, 30

28036 Madrid

Spain

or

Laboratorios Alter, S.A.

C/ Zeus, 6

Polígono Industrial R2

28880 Meco (Madrid)

Spain

Date of the most recent review of this leaflet: February 2026

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