Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Azithromycin Qualigen 200 mg/5 ml powder for oral suspension 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 and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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 side 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:

Children aged 6 months or older weighing less 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 a hospital)
• Bacterial skin infection and underlying tissues

Adults and adolescents weighing at least 45 kg who have difficulty swallowing

In addition to the infections listed above, Azithromycin Qualigen may also be administered for the treatment of the following infections:

• Infection of the urethra and cervix caused by bacteria of the species Chlamydia trachomatis
• Adults 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, another 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 to take Azitromicina Qualigen 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 adverse effects of azithromycin;
• liver disorders: 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 being treated with 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 heart rhythm is abnormal or you experience palpitations, dizziness, or fainting during treatment with Azitromicina Qualigen;
• if you show signs of liver disorders (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 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 infection, a sexually transmitted disease that could 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

Ask your doctor or pharmacist if your child is less than 6 months old, as the efficacy and safety of this medicine have not been established in these children.

Infantile hypertrophic pyloric stenosis (IHPS)

If your child is less than 6 months old and your doctor has recommended treatment with azithromycin, stop giving this medicine and contact your doctor immediately if your child experiences projectile vomiting or irritability when eating or shortly after eating.

Other medicines and Azitromicina Qualigen

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

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 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 (to thin the blood [anticoagulants])

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

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

Breastfeeding

Azitromicina Qualigen is excreted in breast milk. Therefore, your doctor will decide together with you 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 use machines is moderate. Dizziness, drowsiness, and seizures, as well as vision and hearing problems, have been reported with Azitromicina Qualigen in some people. These possible adverse effects may affect your ability to drive and use machines.

Azitromicina Qualigen contains sucrose, glucose, and benzyl alcohol

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

Patients with diabetes mellitus should be aware that this medicine contains 3.869 g of sucrose per 5 ml of reconstituted suspension.

This medicine contains 0.0017 mg of benzyl alcohol in each 5 ml of suspension. Benzyl alcohol may cause allergic reactions.

Benzyl alcohol has been associated with the risk of serious adverse effects, including respiratory problems ("gasping syndrome"), in children.

Do not administer this medicine to your newborn (up to 4 weeks of age) unless recommended by your doctor.

This product should not be used for more than one week in children under 3 years of age unless directed by your doctor or pharmacist.

Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (metabolic acidosis).

This medicine contains less than 23 mg of sodium (1 mmol) per 12.5 ml of reconstituted suspension; thus, 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 recommended doses and duration of treatment are as follows:

Children aged 6 months or older weighing less than 45 kg

It is important to ensure that you use the amount of Azithromycin Qualigen indicated in the table below, based on the patient's body weight, the infection being treated, and the specific treatment course (1 day, 3 days, 5 days, 10 days) prescribed by your doctor or pharmacist.

^ After reconstitution, the oral suspension concentration is 40 mg/mL and the total volume of suspension in the vial is 15 mL (600 mg) or 30 mL (1200 mg).

+Doses have been rounded to obtain the appropriate dose to be administered.

++ Doses have been rounded to obtain the appropriate dose to be administered.

*Azithromycin 20 mg/mL (100 mg/5 mL) powder for oral suspension is more suitable for treating these patients.

do not exceed the adult daily dose of 500 mg

Adult and adolescent patients weighing at least 45 kg who have difficulty swallowing

• For adult patients only.

In adult patients, initial intravenous treatment may be followed by oral therapy.

Use in children and adolescents

The safety and efficacy of azithromycin have not been established in children under 6 months of age for any of the indications listed in section 1.

Method of administration

For oral use after reconstitution.

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

Preparation of the suspension:

Each 5 ml of reconstituted suspension contains 200 mg of Azithromycin.

If the bottle of Azitromicina Qualigen you receive from your doctor or pharmacist contains only powder and no liquid, you must add a specific volume of water to the bottle before the medicine is ready for use. If your doctor or pharmacist has already dissolved the powder, proceed directly to the next section, “Instructions for administering daily doses of Azitromicina Qualigen oral suspension”.

Instructions for administering daily doses of Azitromicina Qualigen oral suspension:

Before each daily administration, shake the bottle well. The dosing syringe is also graduated to allow administration of the dose according to the child's weight. Once the syringe is prepared, administer the dose immediately.

Administer the medicine slowly to the child and make sure it is swallowed completely. This will help avoid the risk of choking.

If you take more Azitromicina Qualigen than you should

If you take more Azitromicina Qualigen than you should, you may feel unwell. Typical signs of overdose include vomiting, diarrhea, 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 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 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 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 will experience 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).
• 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 intestinal movements (antiperistaltics).
• flat red spots, target-shaped or circular skin rashes on the trunk, often with central blisters, peeling of the skin, mouth ulcers, and sores in the 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 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)

• 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 inflammation, respiratory disorder, nasal mucosal inflammation, vaginal infection
• changes in white blood cell count (leukopenia, neutropenia, eosinophilia)
• increased platelet count
• reduced 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 (paraesthesia)
• loss of vision
• ear disorder
• sensation of spinning (vertigo)
• sensation of rapid or forceful 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 ulceration, increased salivation
• skin rash, itching, hives (urticaria), dermatitis, dry skin, abnormally increased 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 (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)

• sensation of irritation
• liver problems, yellowing of the skin or eyes
• increased sensitivity to sunlight

Frequency not known (cannot be estimated from available data)

• reduction in the number of red blood cells due to increased destruction, 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
• 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, 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: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Azithromycin Qualigen

Closed bottles: No special storage conditions required. Keep in the original packaging.

Reconstituted solution: 10 days. Write the date and month of reconstitution in the box provided for this purpose on both the carton and the bottle label. Do not use the medicine after 10 days from reconstitution; discard any remaining solution.

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

Do not use Azithromycin Qualigen 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 packaging at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Azithromycin Qualigen 200 mg / 5 ml powder for oral suspension

• The active substance is azithromycin (as dihydrate). Each 5 ml of reconstituted suspension contains 200 mg of azithromycin (as dihydrate). Each ml of reconstituted suspension contains 40 mg of azithromycin (as dihydrate).
• The other components (excipients) are: sucrose, anhydrous trisodium phosphate, hydroxypropylcellulose, xanthan gum, banana flavour (contains glucose and maize starch), strawberry flavour (contains glucose and benzyl alcohol).

Appearance of the medicine and contents of the pack

This medicine is a powder for oral suspension, almost white in colour with a banana-strawberry odour. It is packaged in amber glass bottles of type III, closed with a polyethylene cap and a polyethylene plug.

Each cardboard box contains one 15 ml or 30 ml bottle.

A dosing syringe made of polypropylene/polyethylene with a polyethylene plunger is included.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. de Barcelona, 69.

08970 Sant Joan Despí – Barcelona

Spain

Date of latest revision of this leaflet: January 2026

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