Azithromycin Pensapharma 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Azithromycin pensa pharma 500 mg film-coated tablets EFG

Azithromycin (as 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 must not be given 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 they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

1. What Azitromicina pensa pharma is and what it is used for

Azitromicina contains the active substance azithromycin. Azitromicina is an antibiotic that belongs to a group of antibiotics known as macrolides, which inhibit the growth of susceptible bacteria.

Azithromycin pensa pharma is indicated for the treatment of the following infections:

Adults and adolescents weighing over 45 kg:

• Pneumonia (community-acquired pneumonia, not contracted in hospital)
• Bacterial infection of the sinuses (sinusitis)
• Bacterial infection of the tonsils (tonsillitis) or throat (pharyngitis) caused by streptococcal bacteria
• Bacterial middle ear infection (otitis media)
• Bacterial skin and underlying tissue infection
• 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 you start taking Azitromicina pensa pharma

Do not take Azitromicina pensa 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).

Do not take this medicine if you have any of the above conditions. If you are unsure, consult your doctor or pharmacist before using Azitromicina pensa pharma.

Warnings and precautions

Talk to your doctor or pharmacist before starting Azitromicina pensa pharma if you have or have had any of the following conditions:

• liver disorders: your doctor may need to monitor your liver function or discontinue treatment;
• heart problems (e.g., irregular heartbeat or heart failure) or low levels of potassium or magnesium in the blood: these conditions may increase the risk of serious cardiac side effects with azithromycin;
• 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 taking any ergot-derived medications such as ergotamine (used to treat migraines), as these medicines should not be taken with Azitromicina pensa pharma.

Stop taking this medicine and contact your doctor (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 pensa pharma;
• 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 returns 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 Azitromicina pensa pharma (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 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 Azitromicina pensa pharma

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

Using Azitromicina pensa pharma with other medicines may cause 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 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 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:
  • Cisapride (for gastrointestinal disorders)
  • Quinidine, procainamide, dofetilide, amiodarone, and sotalol (for treating heart rhythm disorders, such as abnormally fast or slow heartbeats: cardiac arrhythmia)
  • Pimozide (for treating mental illnesses)
  • Citalopram (for treating depression)
  • Moxifloxacin and levofloxacin (antibacterial agents)
  • Hydroxychloroquine or chloroquine (for treating certain autoimmune diseases such as rheumatoid arthritis, or for treating or preventing malaria)

Taking Azitromicina pensa pharma with food and drink

This medicine may be taken with or without food.

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 any potential risks.

Breastfeeding

Azitromicina pensa pharma is excreted in breast milk. Therefore, your doctor will decide together with you whether you should discontinue breastfeeding or avoid treatment with Azitromicina pensa pharma, 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 Azitromicina pensa pharma on the ability to drive and operate machinery is moderate. Dizziness, drowsiness, and seizures, as well as vision and hearing problems, have been reported with Azitromicina pensa pharma in some individuals. These possible adverse effects may affect your ability to drive and operate machinery.

Azitromicina pensa pharma contains lactose

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

3. How to take Azithromycin pensa pharma

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

The amount of Azithromycin pensa pharma you need to take each day will depend on the bacterial infection being treated and the specific treatment regimen 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, please 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 pensa pharma should be administered as a single daily dose orally. The tablets should be swallowed whole with water, with or without food. Taking this medicine just before a meal may help improve stomach tolerability.

If you take more Azitromicina pensa pharma than you should

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

If you forget to take Azitromicina pensa pharma

If you forget to take Azitromicina pensa pharma, 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 missed doses.

If you stop taking Azitromicina pensa pharma

If you stop treatment with Azitromicina pensa pharma too early, your infection may return. Take Azitromicina pensa pharma 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 or pharmacist.

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 pensa 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 stools or fever, which may indicate an infection of the large intestine (antibiotic-associated colitis, frequency not known). Do not take anti-diarrhoeal medicines that inhibit intestinal movements (antiperistaltics).
• Flat red spots, target-shaped or circular skin lesions on the trunk, often with central blisters, skin peeling, mouth ulcers in the mouth, throat, nose, genitals and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (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 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 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 tract inflammation, respiratory disorder, nasal mucosal 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 sensation (somnolence), changes in taste sensation (dysgeusia), tingling or numbness sensation (paraesthesia)
• Loss of vision
• Ear disorder
• Sensation of spinning (vertigo)
• Sensation of rapid or strong 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, burping, 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 (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 complications

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 paleness of the skin (haemolytic anaemia)
• Reduction in platelet count in the blood, which may cause bleeding and bruising (thrombocytopenia)
• Feeling of irritability, 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 of hyperactivity
• Changes in sense of smell (anosmia, parosmia)
• Complete loss of taste sensation (ageusia)
• Muscle weakness (myasthenia gravis)
• Abnormal electrocardiogram (ECG) trace (prolongation of 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 adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines. Website: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Azithromycin pensa pharma

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

This medicine does not require any special storage conditions. Do not transfer the tablets to another container.

Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Azitromicina pensa pharma 500 mg film-coated tablets

The active substance is azithromycin. Each tablet contains 500 mg of azithromycin (as azithromycin dihydrate).

The other components (excipients) are:

• Tablet core: pregelatinized corn starch, crospovidone, anhydrous calcium hydrogen phosphate, sodium lauryl sulfate, magnesium stearate
• Film coating: hypromellose, titanium dioxide (E-171), monohydrate lactose, glycerol triacetate.

Appearance of the product and contents of the pack

Azitromicina pensa pharma 500 mg is presented as white, oval-shaped, biconvex, film-coated tablets, scored on one side.

The tablets are packaged in unit-dose sachets made of coated paper composite and in PVC blisters sealed with an aluminum foil.

Clinical packs containing 150 tablets in PVC blisters sealed with an aluminum foil.

Packs containing 3 tablets in PVC blisters sealed with an aluminum foil.

Packs containing 3 tablets in unit-dose sachets made of coated paper composite.

Unit-dose sachet made of coated paper composite.

Only some pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer:

Bluepharma Industria Farmacêutica S.A.

S. Martinho do Bispo 3045-016

Coimbra

Portugal

or

Sincrofarm, S.L.

C/ Mercurio Nº 10,

Pol. Ind. Almeda, 08940

Cornellá de Llobregat, 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/