Azithromycin Stada 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

Contents of the leaflet

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

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

Azitromicina STADA 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.

Azitromicina STADA 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 infection of the middle ear (otitis media)
• Pneumonia (community-acquired pneumonia, not contracted in a hospital)
• Bacterial infection of the skin and underlying tissues
• Infection of the urethra and cervix caused by bacteria of the species Chlamydia trachomatis

Adults

• Bacterial infection in patients with prolonged inflammation of the lungs (chronic bronchitis)

2. What you need to know before taking Azithromycin STADA

Do not take Azithromycin STADA:

• 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 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 after taking any other antibacterial agent;
• localized muscle weakness (myasthenia gravis), as symptoms of this disease may worsen during treatment;
• 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.

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, 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 if you experience palpitations, dizziness, or fainting during treatment with azithromycin;
• if you show 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 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 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. In addition, 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 Azithromycin STADA

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

Using azithromycin 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 lower blood cholesterol levels and prevent heart disease, including heart attacks and stroke)

• Cyclosporine (to prevent rejection of organ transplants)

• Colchicine (for treatment of gout and familial Mediterranean fever)

• Dabigatran (to prevent and treat blood clots [anticoagulant])

• Digoxin (for 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 treatment of irregular heartbeat, such as too fast or too slow: cardiac arrhythmia)
  • Pimozide (for treatment of mental illnesses)
  • Citalopram (for treatment of depression)
  • Moxifloxacin and levofloxacin (antibacterial agents)
  • Cisapride (for treatment of gastrointestinal disorders)
  • Hydroxychloroquine or chloroquine (for treatment of certain autoimmune diseases such as rheumatoid arthritis, or for 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 whether you should 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 on the ability to drive and operate machinery 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 operate machinery.

Azithromycin STADA contains sodium

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

3. How to take Azithromycin STADA

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 you need to take each day will depend on the bacterial infection being treated and the specific treatment course prescribed by your doctor or pharmacist.

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

How to take Azitromicina STADA

Azitromicina STADA should be taken as a single daily oral dose. The tablet score is intended only for dividing the tablet if you find it difficult to swallow it whole. The two 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 STADA 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.

If you forget to take Azitromicina STADA

If you forget to take azithromycin, take it as soon as possible, provided that it is at least 12 hours 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 taking Azitromicina STADA

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 chest tightness, 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], 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-shaped 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 swellings under the skin and blisters accompanied by fever. Symptoms usually occur 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, inflammation of the nasal mucosa, 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 or tingling sensation (paraesthesia), altered sense of taste (dysgeusia), sensation of pins and needles or numbness (paraesthesia)
• vision disturbances
• ear disorder
• sensation of spinning (vertigo)
• awareness of heartbeats (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, abnormal increase in 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)

• 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 cell breakdown, 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, aggressive, fearful or worried (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 (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 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 may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Azithromycin STADA

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 STADA after the expiry date stated on the container, after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, 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 STADA

• Each tablet contains 500 mg of the active substance azithromycin (as dihydrate).
• The other components are: calcium hydrogen phosphate, pregelatinized corn starch, sodium croscarmellose, sodium lauryl sulfate (E 487), magnesium stearate, 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 notch on one side and the imprint “500” on the other.

Supplied in blisters made of polyvinyl chloride (PVC) sealed with a heat-sealable aluminum foil, in packs of 3 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer:

Neuraxpharm Pharmaceuticals S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

Date of the most recent review of this leaflet: September 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