Azithromycin Alter 500 mg granules for oral suspension EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Azithromycin Alter 500 mg granules for oral suspension EFG

Read all of this 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 may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

Azithromycin is indicated for the treatment of the following infections:

• 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

Adults and adolescents weighing at least 45 kg who have difficulty swallowing:

• 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

In addition to the infections listed above, Azithromycin Alter may also be administered for the treatment of the following infections:

• 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 Alter should be used in combination with another antibacterial agent selected by your doctor or pharmacist
• Bacterial infection of the genitals with painful ulcers (chancroid)

2. What you need to know before taking Azithromycin Alter

Do not take Azithromycin Alter

• 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 Alter if you have or have had any of the following conditions:

• Heart disorders (e.g., problems with heart rhythm 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 disorders: your doctor may need to monitor your liver function or discontinue treatment;
• Severe diarrhoea 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 derivatives such as ergotamine (used to treat migraines), as these medicines should not be taken with Azithromycin Alter.

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 heart rhythm is abnormal or you experience palpitations, dizziness, or fainting during treatment with Azithromycin Alter;
• 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 diarrhoea during or after treatment. Do not take any medicine for diarrhoea without first talking to your doctor. If your diarrhoea continues or returns 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 Alter (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

Talk to your doctor or pharmacist if your child is under 6 months of age, as the efficacy and safety of this medicine have not been established in infants of this age, or if your child weighs less than 16 kg, as other more suitable medicines are available for treatment.

Infantile hypertrophic pyloric stenosis (IHPS)

If your child is under 6 months of age and your doctor has prescribed azithromycin treatment, stop giving this medicine and contact your doctor immediately if your child experiences projectile vomiting or becomes irritable during or shortly after feeding.

Other medicines and Azithromycin Alter

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

Using Azithromycin Alter 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 cholesterol levels in the blood 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 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 (prolongation of QT interval), such as:

• Quinidine, procainamide, dofetilide, amiodarone, and sotalol (for the treatment of heart rhythm disorders, such as abnormally fast or slow heartbeats: cardiac arrhythmia)

• Pimozide (for the treatment of mental disorders)

• 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 are planning 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 possible risks.

Breastfeeding

Azithromycin Alter is excreted in breast milk. Therefore, your doctor will decide together with you whether you should stop breastfeeding or avoid treatment with Azithromycin Alter, 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 Alter 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 Alter in some people. These possible adverse effects may affect your ability to drive and use machines.

Azithromycin contains sucrose

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

Azithromycin contains alcohol

This medicine contains 0.000076% ethanol (alcohol), corresponding to 0.0044 mg per sachet. The amount of alcohol in one sachet of this medicine is equivalent to less than 1 mL of beer.

The small amount of alcohol in this medicine does not produce any noticeable effect.

Azithromycin contains sodium

This medicine contains 23.958 mg of sodium (main component of table/cooking salt) in each sachet. This corresponds to 1.2% of the maximum recommended daily sodium intake for an adult.

Azithromycin contains benzyl alcohol

This medicine contains 1.12 mg of benzyl alcohol in each sachet. Benzyl alcohol may cause allergic reactions.

Benzyl alcohol has been associated with the risk of serious adverse effects, including breathing problems ("gasping syndrome") in children. Do not administer this medicine to your newborn (up to 4 weeks of age) unless advised by your doctor.

This product should not be used for longer than one week in children under 3 years of age unless directed by your doctor or pharmacist.

Consult your doctor or pharmacist if you have liver or kidney disease, or if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (metabolic acidosis).

3. How to take Azithromycin Alter

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

The recommended doses and duration of treatment are as follows:

For adult and adolescent patients weighing at least 45 kg who have difficulty swallowing

The recommended doses and duration of treatment are as follows

• For adult patients only.

• For adult patients, initial intravenous treatment may be followed by oral therapy.

Use in children and adolescents

The safety and efficacy of azithromycin have not been established in children under 6 months of age for any of the indications listed in section 1.

Method of administration

For oral use after reconstitution.

Azithromycin Alter should be administered orally as a single daily dose. The oral suspension may be taken with or without food. Taking this medicine just before a meal may improve gastrointestinal tolerability.

If you take more Azithromycin Alter 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 Azithromycin Alter

If you forget to take Azithromycin, 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 forgotten doses.

If you stop taking Azithromycin Alter

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 experiences them.

Stop taking Azithromycin 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, especially affecting 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, 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-like or circular rashes on the trunk, often with central blisters, skin peeling, or 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 and scaly rash with swellings 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)

• diarrhea

Common (may affect up to 1 in 10 people)

• headache
• vomiting
• 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 the total blood volume

(decreased hematocrit)

• allergic reactions, swelling of the hands, feet, and face (angioedema)
• nervousness, difficulty sleeping (insomnia)
• drowsiness (somnolence), tingling sensation
• vision loss
• ear disorder
• sensation of spinning (vertigo)
• sensation of rapid or strong heartbeat (palpitations)
• hot flushes
• sudden chest noises, nosebleeds
• constipation, indigestion (dyspepsia), inflammation of the stomach lining (gastritis), difficulty swallowing (dysphagia), bloated abdomen, dry mouth, burping, mouth ulcers, increased salivation
• 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 (edema, facial edema, peripheral edema)
• weakness, general feeling of discomfort, 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

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 (hemolytic anemia)
• reduced number of platelets in the blood, which may lead to bleeding and bruising (thrombocytopenia)
• feeling irritable, aggression, feeling of fear or worry (anxiety), acute state of confusion (delirium)
• hallucinations
• fainting (syncope)
• seizures (convulsions)
• feeling of hyperactivity
• changes in the sense of smell (anosmia, parosmia)
• complete loss of taste (ageusia)
• muscle weakness (myasthenia gravis)
• abnormal electrocardiogram (ECG) trace (prolonged QT interval)
• low blood pressure
• inflammation of the pancreas causing severe abdominal and back pain (pancreatitis)
• change in tongue color
• kidney inflammation (interstitial nephritis) and kidney failure

Reporting of adverse effects

If you experience any type of 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 via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Azithromycin Alter

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

Store below 30°C.

Do not use Azithromycin Alter after the expiry date stated on the packaging, 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 Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Azithromycin Alter

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

The other components (excipients) are: sucrose, trisodium phosphate, sodium lauryl sulfate, xanthan gum (E415), artificial cherry flavour (contains benzyl alcohol), vanilla flavour (contains ethanol and benzyl alcohol), banana flavour, sodium carboxymethylstarch type A (derived from potato), and sodium saccharin.

Appearance of the medicinal product and contents of the pack

Azithromycin Alter 500 mg is an ivory-coloured granule with a cherry odour, for oral suspension in a sachet.

Sachets are available in packs of 3 sachets.

Marketing Authorisation Holder and Manufacturer

Laboratorios Alter, S.A.
C/Mateo Inurria, 30
28036 Madrid
Spain

Date of the most recent revision of this leaflet: March 2026

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