Azithromycin Normon 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Azithromycin Normon 500 mg film-coated tablets EFG

azithromycin

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, 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 may 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.

Contents of the leaflet

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

1. What Azithromycin Normon is and what it is used for

Azithromycin Normon is an antibiotic belonging to the group of macrolides. It works by stopping the growth of bacteria that cause infections. This medicine is used to treat various types of bacterial infections, such as those affecting the respiratory tract (e.g. bronchitis, pneumonia, sinusitis), skin and soft tissue infections, and certain types of ear infections. It may also be used to treat infections of the genital tract caused by specific bacteria.

Azithromycin Normon is indicated for the treatment of the following infections:

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 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 of the genitals with painful ulcers (chancroid)
• Adults
• Bacterial infection in patients with prolonged lung inflammation (chronic bronchitis)

2. What you need to know before taking Azithromycin Normon

Do not take Azithromycin Normon:

• 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

Talk to your doctor or pharmacist before taking
Azithromycin Normon 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 adverse effects of azithromycin;
• Liver problems: 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 Normon.

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 Azithromycin;
• 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 Azithromycin (superinfection).

Sexually transmitted infections

Your doctor may perform tests to rule out possible syphilis, a sexually transmitted infection that could 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 the effectiveness of treatment.

Children and adolescents

This medicine is not recommended if:

• You are under 18 years of age and have been diagnosed with pelvic inflammatory disease;
• You are under 12 years of age and have an infection or are at risk of infection with microorganisms belonging to the Mycobacterium avium complex, which typically affect people with HIV who have weakened immune systems, as efficacy and safety have not been studied in these cases.

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 Normon

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

Using Azithromycin Normon 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 treating 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 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 Normon is excreted in breast milk. Therefore, your doctor will decide whether to discontinue 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 Normon 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 Normon in some people. These possible adverse effects may affect your ability to drive and use machines.

Azithromycin Normon contains lactose and sodium

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

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

3. How to take Azithromycin Normon

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 Normon you need to take each day will depend on the bacterial infection being treated and the specific treatment cycle your doctor or pharmacist has instructed you to follow.

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.

Method of administration

For oral use.

Azitromicina Normon should be administered as a single daily dose orally. The tablets may be taken with or without food. Taking this medicine just before a meal may help improve stomach tolerability.

The tablets can be divided into two equal halves, which may be used to adjust the dose as directed by your doctor or pharmacist.

If you take more Azitromicina Normon than you should

If you take more Azitromicina Normon 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 Azitromicina Normon

If you forget to take Azitromicina Normon, take it as soon as possible, provided that it is at least 12 hours 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 taking Azitromicina Normon treatment prematurely

If you stop treatment with Azitromicina Normon too early, the infection may recur. Take Azitromicina Normon 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 Normon 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 (liver failure or hepatic necrosis [frequency not known], hepatitis* [uncommon: may affect up to 1 in 100 people]).
• • 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 defecation (antiperistaltics).
• • flat red spots, target-like or circular skin lesions 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 enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome, rare [may affect up to 1 in 1,000 people]).
• • widespread red, scaly rash with bumps 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
• • abdominal discomfort*
• 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 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 hands, feet and face (angioedema)
• • loss of appetite#
• • nervousness, difficulty sleeping (insomnia)
• • dizziness# , numbness or tingling sensation (paraesthesia) # , altered sense of taste (dysgeusia) # , drowsiness (somnolence)
• • visual disturbances#
• • ear disorder
• • spinning sensation (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, burping, mouth ulcers, increased salivation
• • skin rash# , itching# , hives (urticaria), dermatitis, dry skin, abnormally increased 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 (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)
• • reduced number of red blood cells due to increased cell breakdown, which may cause fatigue and pale skin (haemolytic anaemia)
• • reduced 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 hyperactive
• • 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# , reduced hearing# 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
• * These adverse effects have only been observed during administration of azithromycin for prophylaxis or treatment of infection caused by Mycobacterium avium complex in people with HIV infection and inadequate immune system recovery. # These adverse effects are more common during administration of azithromycin for prophylaxis or treatment of infection caused by Mycobacterium avium complex in people with HIV infection and inadequate immune system recovery.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist or nurse, even if it is a side effect not listed in this leaflet. You may 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 Normon

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 this medicine after the expiry date stated on the container following 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 you are 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 Azithromycin Normon

• The active substance is azithromycin (as dihydrate). Each tablet contains 500 mg of azithromycin.
• The other components (excipients) are: Core: pregelatinized corn starch, crospovidone, calcium hydrogen phosphate, sodium lauryl sulfate, magnesium stearate. Coating: hypromellose (hydroxypropyl methylcellulose), titanium dioxide (E171), monohydrate lactose, triacetin (E1518).

Appearance of the medicinal product and contents of the pack

Film-coated tablets, white in color and capsule-shaped.

The tablets are packed in PVC-aluminum blisters. Pack sizes of 3 and 150 tablets (hospital pack) are available.

Marketing Authorization Holder and Manufacturer

Laboratorios Normon, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the most recent review of this leaflet: October 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.