Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

azitromicina cinfa 500 mg powder for oral suspension EFG

azithromycin dihydrate

Read this 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 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 reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

1. What azithromycin cinfa is and what it is used for

Azithromycin cinfa 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 cinfa 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 cinfa 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

• Infection of the urethra and cervix caused by bacteria of the species Neisseria gonorrhoeae; azithromycin cinfa should be used in combination with another antibacterial agent selected by your doctor or pharmacist

• Bacterial genital infection with painful ulcers (chancroid)

• Adults with prolonged lung inflammation (chronic bronchitis)

2. What you need to know before taking azithromycin cinfa

Do not take azithromycin cinfa:

• 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

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

• Heart disorders (e.g., problems with heart rhythm 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 adjust your treatment;
• Severe diarrhoea 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), as these medicines should not be taken with azithromycin cinfa.

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 feel your heartbeat is irregular or you experience palpitations, dizziness, or fainting during treatment with azithromycin cinfa;
• If you develop 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 diarrhoea during or after treatment. Do not take any medicine for diarrhoea without speaking to your doctor first. If your diarrhoea continues or recurs in 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 cinfa (superinfection).

Sexually transmitted infections

Your doctor may perform tests to rule out possible syphilis, 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

Consult your doctor or pharmacist if your child is under 6 months of age, as the efficacy and safety of this medicine have not been established in these infants, or if they weigh less than 16 kg, as there are other more suitable medicines available for their treatment.

Infantile hypertrophic pyloric stenosis (IHPS)

If your child is under 6 months of age and your doctor has prescribed treatment with azithromycin, stop giving this medicine and contact your doctor immediately if your child experiences projectile vomiting or irritability during or shortly after feeding.

Other medicines and azithromycin cinfa

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

Taking azithromycin cinfa 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 medicines in the statin group (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 clots [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 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 abnormally fast or slow heartbeats: 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 is excreted in breast milk. Therefore, your doctor will decide together with you whether you should stop breastfeeding or avoid treatment with azithromycin, 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 on the ability to drive and use machines is moderate. Dizziness, drowsiness, and seizures, as well as vision and hearing disturbances, have been reported with azithromycin. These possible adverse effects may affect your ability to drive and use machines.

Azithromycin cinfa contains sucrose, sodium, benzyl alcohol, ethanol, and propylene glycol

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

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

This medicine contains 1.94 mg of benzyl alcohol in each tablet.

Benzyl alcohol may cause allergic reactions. This product should not be used for longer than one week in children under 3 years of age unless directed by your doctor or pharmacist.

Benzyl alcohol has been associated with the risk of serious adverse effects including breathing problems ("gasping syndrome") in children. Do not administer this medicine to your newborn (up to 4 weeks of age) unless specifically recommended by your doctor.

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

This medicine contains 0.02 mg of ethanol in each tablet. The amount in mg of this medicine is equivalent to less than 0.0005 ml of beer or 0.0002 ml of wine. The small amount of alcohol contained in this medicine produces no perceptible effect.

This medicine contains 11.3 mg of propylene glycol (E-1520) in each tablet.

3. How to take azithromycin cinfa

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 from 6 months of age and older weighing less than 45 kg

It is important to ensure that you take the amount of azithromycin cinfa indicated in the table below according to the patient's body weight, the infection being treated, and the specific treatment cycle (1 day, 3 days, 5 days, 10 days) prescribed by your doctor or pharmacist.

#do not exceed the daily dose of 500 mg in adults

If your child weighs less than 16 kg, the oral suspension powder in bottle is more suitable. Consult your doctor or pharmacist.

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

The recommended doses and duration of treatment are as follows:

• For adult patients only.

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

Use in children and adolescents

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

Method of administration

For oral use after reconstitution.

This medicine should be administered orally as a single daily dose.

Add the contents of the sachet to half a glass of water and mix well. Take immediately after preparation.

The oral suspension may be taken with or without food. Taking this medicine just before a meal may improve stomach tolerance.

If you take more azithromycin cinfa 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.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take azitromycin cinfa

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 forgotten doses.

If you stop azitromycin cinfa treatment early

If you stop treatment with azithromycin 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, 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 (liver failure or hepatic necrosis [frequency not known]).
• Severe diarrhoea with abdominal cramps, blood in the stool or fever, which may indicate an infection in the large intestine (antibiotic-associated colitis, frequency not known). Do not take anti-diarrhoea medicines that inhibit intestinal movements (antiperistaltics).
• Flat red spots, target-shaped or circular skin rashes, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. 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 lumps 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 more than 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, numbness sensation (somnolence), changes in taste sensation (dysgeusia), tingling or numbness sensation (paraesthesia)

? Vision loss

• Ear disorder

• Sensation of spinning (vertigo)

• Sensation of rapid or strong heartbeat (palpitations)

• Hot flushes

• Sudden wheezing in the chest, nosebleeds

• Constipation, flatulence, indigestion (dyspepsia), inflammation of the stomach lining (gastritis), difficulty swallowing (dysphagia), bloated abdomen, dry mouth, burping, mouth ulceration, increased salivation

• Skin rash, itching, hives (urticaria), dermatitis, dry skin, abnormally increased 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 destruction, which may cause fatigue and pale skin (haemolytic anaemia)
• Reduction in blood platelet count, 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)
• Reduced 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
• 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 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 cinfa

Keep this medicine out of sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine 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 containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to 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 azitromicina cinfa

• The active substance is azithromycin dihydrate.
• The other components are: sucrose, hydroxypropylcellulose (E-463), anhydrous trisodium phosphate (E-339iii), xanthan gum (E-415), cherry flavor, vanilla flavor, and banana flavor.

Appearance of the product and contents of the pack

azitromicina cinfa is an off-white dry powder for oral suspension with a fruity odor, which forms a milky-looking suspension when reconstituted.

The powder is packed in sachets made of a laminate composed of PET/ALU/LLDPE and is available in packs containing 3 and 100 sachets (clinical pack).

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta.

31620 Huarte (Navarra) - Spain

Date of the most recent revision of this package leaflet: December 2025

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/65601/P_65601.html

QR code to: https://cima.aemps.es/cima/dochtml/p/65601/P_65601.html