Azithromycin Kern Pharma 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Azithromycin Kern Pharma 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, 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 must not give it 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 these effects are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Azithromycin Kern Pharma tablets are and what they are used for
2. What you need to know before taking Azithromycin Kern Pharma tablets
3. How to take Azithromycin Kern Pharma tablets
4. Possible side effects
5. How to store Azithromycin Kern Pharma tablets
6. Contents of the pack and other information

1. What is Azithromycin Kern Pharma and what is it used for?

Azithromycin Kern Pharma 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.

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 the instructions regarding dose, dosing interval, and duration of treatment as directed by your doctor.

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

Azithromycin Kern Pharma 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 nasal sinuses (sinusitis)
• Bacterial middle ear infection (otitis media)
• Pneumonia (community-acquired pneumonia, not contracted in 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 Kern Pharma should be used in combination with another antibiotic selected by your doctor or pharmacist.
• Bacterial infection of the genitals causing 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 Kern Pharma

Do not take Azithromycin Kern Pharma:

• 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 Kern Pharma 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 discontinue 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 taking any ergotamine derivative such as ergotamine (used to treat migraines), as these medicines must not be taken with Azithromycin Kern Pharma.

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 Azithromycin Kern Pharma;
• 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 diarrhoea during or after treatment. Do not take any medicine for diarrhoea without speaking to your doctor first. Also inform your doctor if your diarrhoea continues or returns in the first few weeks after treatment.

Superinfection

Your doctor may monitor you for signs of additional bacterial or fungal infections that cannot be treated with Azithromycin Kern Pharma (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 carry out 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 Kern Pharma

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

Taking Azithromycin Kern Pharma 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 blood cholesterol levels and prevent heart disease, 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 prolong the time it takes for the heart muscle 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, breastfeeding, and fertility

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

Azithromycin Kern Pharma 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 benefits of breastfeeding for your child and the benefits of treatment for you.

Driving and using machines

The effect of Azithromycin Kern Pharma on the ability to drive and operate machinery is moderate. Dizziness, somnolence, and convulsions, as well as vision and hearing problems, have been reported with Azithromycin Kern Pharma in some people. These possible adverse effects may affect your ability to drive and operate machinery.

Azithromycin Kern Pharma contains lactose and sodium

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

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

3. How to take Azithromycin Kern Pharma

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

The amount of Azithromycin Kern Pharma 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, consult your doctor or pharmacist, as there are other azithromycin-containing medicines that may be more suitable for you.

Instructions for administration

For oral use. This medicine should be taken once daily by mouth. The tablets must be swallowed whole with water, with or without food. Taking this medicine just before a meal may help improve stomach tolerance.

If you take more Azithromycin Kern Pharma than you should

If you take more Azithromycin Kern Pharma than you should, you may feel unwell. Typical signs of overdose include vomiting, diarrhoea, abdominal pain, and nausea. Inform your doctor or contact the nearest hospital emergency department immediately.

If you forget to take Azithromycin Kern Pharma

If you forget to take Azithromycin Kern Pharma, 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 scheduled time. Do not take a double dose to make up for a missed dose.

If you stop taking Azithromycin Kern Pharma too early

If you stop treatment with Azithromycin Kern Pharma too early, the infection may return. Take Azithromycin Kern Pharma for the full duration of the prescribed 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.

The adverse effects reported during clinical trials and after marketing, classified by frequency, are:

Serious adverse effects

Stop taking Azithromycin Kern Pharma and seek immediate medical attention if you notice any of the following symptoms:

• sudden chest pain, 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, 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-diarrhoeal medicines that inhibit intestinal movements (antiperistaltics).
• raised red spots, target-shaped or circular rash on the trunk, often with central blisters, skin peeling, and sores 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 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 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)
• anorexia
• nervousness, difficulty sleeping (insomnia)
• dizziness, numbness sensation (somnolence), altered sense of taste (dysgeusia), tingling or numbness sensation (paraesthesia)
• vision loss
• ear disorder
• sensation of spinning (vertigo)
• sensation of rapid or forceful 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, 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 red blood cell count due to increased destruction, 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)
• 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)
• sensation 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 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 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 Kern Pharma

Keep this medicine out of sight and reach of children.

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

Do not use this medicine 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 the SIGRE Point at your pharmacy. If 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 Kern Pharma

• Each tablet contains 500 mg of the active substance azithromycin (as dihydrate).
• The other components (excipients) are:

Tablet core: pregelatinized corn starch, crospovidone, calcium hydrogen phosphate, sodium lauryl sulfate, and magnesium stearate.

Tablet coating: hypromellose, titanium dioxide (E171), lactose, and triacetin.

See section 2 Azithromycin Kern Pharma contains lactose and sodium.

Appearance of the medicinal product and contents of the container

Film-coated white, capsule-shaped tablets, with a score line on one side.

The tablets are packaged in PVC-aluminum blisters.

Available in packs of 3 and 150 tablets (hospital pack).

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

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

Detailed 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