Azithromycin Tarbis 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Azithromycin Tarbis 500 mg film-coated tablets EFG

Azithromycin (dihydrate)

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 other people, 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 Azithromycin Tarbis 500 mg is and what it is used for
2. What you need to know before taking Azithromycin Tarbis 500 mg
3. How to take Azithromycin Tarbis 500 mg
4. Possible side effects
5. How to store Azithromycin Tarbis 500 mg
6. Contents of the pack and other information

1. What is Azithromycin Tarbis 500 mg and what is it used for

Azithromycin Tarbis 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 Tarbis 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 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 Tarbis 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 taking Azitromicina Tarbis 500 mg

Do not take Azitromicina Tarbis:

• 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 Azitromicina Tarbis 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 your blood: these conditions may contribute to serious cardiac side effects of azithromycin;
• liver disorders: 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 condition 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 Azitromicina Tarbis.

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 Azitromicina Tarbis;
• 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 medicine for diarrhea without first talking 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 Azitromicina Tarbis (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. In addition, 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

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 Tarbis

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

Using Azithromycin Tarbis together 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 belonging to the statin group (used to lower blood cholesterol levels and prevent heart diseases, including myocardial infarction and stroke).
• Cyclosporine (used to prevent organ transplant rejection by the body).
• Colchicine (used to treat gout and familial Mediterranean fever).
• Dabigatran (used to prevent and treat blood clot formation [anticoagulant]).
• Digoxin (used to treat 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 (prolongation of the QT interval), such as the following:
  • Quinidine, procainamide, dofetilide, amiodarone, and sotalol (used to treat heart rhythm disorders, such as heartbeats that are too fast or too slow: cardiac arrhythmia).
  • Pimozide (used to treat mental illnesses).
  • Citalopram (used to treat depression).
  • Moxifloxacin and levofloxacin (antibacterial agents).
  • Cisapride (used to treat gastrointestinal disorders).
  • Hydroxychloroquine or chloroquine (used to treat 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 Tarbis is excreted in breast milk. Therefore, your doctor will decide whether you should discontinue breastfeeding or avoid treatment with Azithromycin Tarbis, 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 Tarbis on the ability to drive and operate machinery is moderate. Dizziness, somnolence, and convulsions, as well as visual and hearing disturbances, have been reported in some individuals. These possible adverse effects may affect your ability to drive and operate machinery.

Azithromycin Tarbis contains lactose

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

3. How to take Azithromycin Tarbis 500 mg

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The amount of Azithromycin Tarbis you need to take each day will depend on the bacterial infection being treated and the specific treatment course indicated by your doctor or pharmacist.

Adults and adolescents weighing at least 45 kg

Use in children and adolescents

If your body 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

Azithromycin should be taken as a single daily oral dose. The score line on the tablets is intended solely to facilitate breaking the tablet if you have difficulty swallowing it whole. The 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 gastric tolerability.

If you take more Azitromicina Tarbis than you should

If you take more Azitromicina Tarbis than prescribed, 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.

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, stating the name of the medicine and the amount ingested.

If you forget to take Azitromicina Tarbis

If you forget to take Azitromicina Tarbis, take it as soon as possible, provided that at least 12 hours remain before the next scheduled 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 a missed dose.

If you stop treatment with Azitromicina Tarbis

If you stop treatment with Azitromicina Tarbis too early, the infection may recur. Take Azitromicina Tarbis 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 experiences them.

Serious adverse effects

Stop taking Azithromycin Tarbis 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]).
• 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 peristaltic movements (antiperistaltics).
• Flat, red, target-shaped or circular skin rashes 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 raised areas 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, inflammation of the digestive tract, respiratory disorder, inflammation of the nasal mucosa, vaginal infection
• Changes in white blood cell count (leukopenia, neutropenia, eosinophilia)
• Increased platelet count
• Reduction in the 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, feeling of numbness (somnolence), altered sense of taste (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, burping, mouth ulcers, 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 (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)

• Irritated feeling
• 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 platelet count in the blood, which may cause bleeding and bruising (thrombocytopenia)
• Feeling of irritability, aggression, 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 (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, consult your doctor or pharmacist, 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 Tarbis 500 mg

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

Do not use this medicine after the expiry date stated on the blister and packaging 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 unused medicines and their containers at the pharmacy's collection point. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This way, you will help protect the environment.

6. Contents of the pack and other information

1. Composition of Azithromycin Tarbis 500 mg

• The active substance is azithromycin. Each tablet contains 500 mg of azithromycin (dihydrate).
• The other components (excipients) are: pregelatinized corn starch, crospovidone, anhydrous calcium hydrogen phosphate, sodium lauryl sulfate, magnesium stearate, hydroxypropylmethylcellulose (E-464), titanium dioxide (E-171), lactose, and glyceryl triacetate.

Appearance of the product and contents of the pack

Azithromycin Tarbis 500 mg are film-coated tablets. Each pack contains 3 tablets.

Marketing Authorization Holder and Manufacturing Responsibility Marketing Authorization Holder:

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028-BARCELONA (Spain)

Manufacturer:

KERN PHARMA, S.L.

Polígono Ind. Colón II Venus, 72

08228 Terrassa (Barcelona)

Industria Quimica y Farmaceutica VIR, S.A.

C/ Laguna 66-68-70, Polígono Industrial Urtinsa II

28923 Alcorcón (Madrid)

Spain

Date of the most recent review of this leaflet: February 2026

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