Azithromycin Almus 500 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

AZITHROMYCIN ALMUS 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, consult 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, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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

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

Azithromycin Almus 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 Almus 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.

Adults:

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

2. What you need to know before taking Azithromycin Almus

Do not take Azithromycin Almus

• 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

Consult your doctor or pharmacist before taking Azithromycin Almus if you have or have previously had any of the following conditions:

• heart disorders (e.g., heart rhythm problems or heart failure) or low blood levels of potassium or magnesium: 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 diarrhea following administration of 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 derivatives such as ergotamine (used to treat migraines), as these medicines should not be taken with Azithromycin Almus.

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 heartbeat is irregular or you experience palpitations, dizziness, or fainting during treatment with Azithromycin Almus;
• if you show signs of liver disorders (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 Almus (superinfection).

Sexually transmitted infections

Your doctor may perform tests to rule out possible syphilis, a sexually transmitted disease that may otherwise progress undetected and be diagnosed late. Additionally, 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, other azithromycin-containing medicines may be more suitable for your treatment.

Other medicines and Azithromycin Almus

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

Using Azithromycin Almus with other medicines may lead to adverse effects. Therefore, it is especially important to inform your doctor if you are taking any of the following medicines:

• Atorvastatin and other statins (to reduce blood cholesterol levels and prevent heart diseases, 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 (used to treat 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 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 Almus is excreted in breast milk. Therefore, your doctor will decide together with you whether to discontinue breastfeeding or avoid treatment with Azithromycin Almus, 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 Almus on the ability to drive and operate machinery is moderate. Dizziness, somnolence, and seizures, as well as vision and hearing disturbances, have been reported with Azithromycin Almus in some individuals. These possible adverse effects may impair your ability to drive or operate machinery.

Azithromycin Almus contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

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

3. How to take Azithromycin Almus

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 Almus 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.

Method of administration

For oral use.

Azithromycin Almus should be administered as a single daily oral dose. 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 Almus than you should

If you take more Azithromycin Almus 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.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Azithromycin Almus

If you forget to take Azithromycin Almus, 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 a missed dose.

If you stop treatment with Azithromycin Almus

If you stop treatment with Azithromycin Almus too early, the infection may recur. Take Azithromycin Almus 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 Almus and seek immediate medical attention if you notice any of the following symptoms:

• sudden wheezing in the chest, difficulty breathing, swelling of the eyelids, face or lips, skin rash or itching affecting especially the whole body (anaphylactic reaction, frequency not known).
• rapid 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, 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 intestinal movements (antiperistaltics).
• flat red spots, 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 enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome, rare [may affect up to 1 in 1,000 people]).
• widespread red, scaly rash with lumps 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 (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 (somnolence), changes in taste sensation (dysgeusia), tingling or numbness (paraesthesia)
• loss of vision
• ear disorder
• sensation of spinning (vertigo)
• sensation of rapid or forceful heartbeat (palpitations)
• hot flushes
• sudden wheezing in the chest, 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 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 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) #
• sensation of hyperactivity
• changes in sense of smell (anosmia, parosmia)
• complete loss of taste (ageusia)
• muscle weakness (myasthenia gravis)
• abnormal cardiac tracing on electrocardiogram (ECG) (prolongation of 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 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 Almus

Keep out of the reach and sight of children.

This medicine does not require any special storage conditions. Do not transfer the tablets to another container. Do not use azithromycin after the expiry date stated on the packaging after the abbreviation “Exp.”. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Azithromycin Almus

The active substance is azithromycin.

Each tablet contains 500 mg of azithromycin (as azithromycin dihydrate).

The other components are: pregelatinized maize starch, crospovidone, anhydrous calcium hydrogen phosphate, sodium lauryl sulfate, magnesium stearate, hypromellose, titanium dioxide (E-171), monohydrate lactose, glyceryl triacetate.

Appearance of the medicinal product and contents of the container

AZITHROMYCIN ALMUS 500 mg is presented as white, film-coated, oblong, biconvex tablets, marked on one side.

Each pack contains blisters with 3 or 150 tablets.

It is possible that not all pack sizes are marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Almus Farmacéutica S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Telephone: 93 739 71 80

Email: [email protected]

Manufacturer:

BLUEPHARMA – Indústria Farmacêutica, S.A.

• Martinho do Bispo. 3045-016 Coimbra

Portugal

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/