Azithromycin Qualigen 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Azithromycin Qualigen 500 mg film-coated tablets EFG

azithromycin dihydrate

Read the entire leaflet carefully before starting to take 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, consult 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 may harm them.
• If you experience any adverse effects, consult your doctor, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Azitromicina Qualigen 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 Qualigen 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 skin and underlying tissue infection
• Infection of the urethra and cervix caused by bacteria of the species Chlamydia trachomatis

Adults:

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

2. What you need to know before taking Azitromicina Qualigen

Do not take Azitromicina Qualigen

• 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 Azitromicina Qualigen 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;
• or if you are taking any ergot derivative such as ergotamine (used to treat migraines), as these medicines must not be taken with Azitromicina Qualigen.

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 Azitromicina Qualigen;
• 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 Azitromicina Qualigen (superinfection).

Sexually transmitted infections

Your doctor may perform tests to rule out possible syphilis, a sexually transmitted infection that may 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 Azitromicina Qualigen

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

Using Azitromicina Qualigen 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 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 clots [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 irregular heartbeat, such as 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

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

Azitromicina Qualigen contains sodium

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

3. How to take Azithromycin Qualigen

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 Qualigen 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 , consult your doctor or pharmacist, as there are other azithromycin-containing medicines that may be more suitable for you.

How to take Azitromicina Qualigen

Azitromicina Qualigen should be taken as a single daily dose by mouth. The tablet score line is intended only to facilitate splitting the tablet if you have difficulty swallowing it whole. The 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 Qualigen than you should

If you take more Azitromicina Qualigen than prescribed, you may feel unwell. Typical signs of overdose include vomiting, diarrhoea, abdominal pain, and nausea. Inform your doctor or contact immediately the nearest hospital's 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 Azitromicina Qualigen

If you forget to take a dose of Azitromicina Qualigen, 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 scheduled time. Do not take a double dose to make up for missed doses.

If you stop taking Azitromicina Qualigen

If you stop treatment with Azitromicina Qualigen too early, the infection may recur. Take Azitromicina Qualigen 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 Qualigen 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, skin 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 of the large intestine (antibiotic-associated colitis, frequency not known). Do not take anti-diarrhoeal medicines that inhibit defecation (antiperistaltics).
• Flat, red, target-shaped or circular skin lesions 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 swollen 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 generalised 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, nasal mucosal 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, numbness sensation (somnolence), altered sense of taste (dysgeusia), tingling or numbness sensation (paraesthesia)
• Visual disturbances
• Ear disorder
• Sensation of spinning (vertigo)
• Awareness of heartbeat (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 cells 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)
• Irritability, 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
• Pancreas inflammation 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 it is a possible adverse effect not listed in this leaflet. You may also report them through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Azithromycin Qualigen

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

No special storage conditions are required. Store in the original packaging.

Do not use Azithromycin Qualigen after the expiry date stated on the container, 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 a SIGRE collection point at your pharmacy. If you are in doubt, 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 Qualigen

• Each tablet contains 500 mg of the active substance azithromycin (as dihydrate).
• The other components are: core (calcium hydrogen phosphate, pregelatinized corn starch, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate) and coating (hypromellose, polydextrose, titanium dioxide (E-171), macrogol 4000).

Appearance of the product and contents of the pack

Film-coated tablets, white, elongated, with biconvex faces, a score line on one side and the inscription "500" on the other.

Each pack contains 3 tablets in PVC/aluminum blisters.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Manufacturer:

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí

(Barcelona)

Spain

Date of the most recent revision of this leaflet: November 2025

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