AZITHROMYCIN ALTER 500 mg FILM-COATED TABLETS

2. What you need to know before you take Azithromycin Alter

Do not take Azithromycin Alter:

If you are allergic (hypersensitive) to azithromycin, to any other macrolide antibiotic, or to any of the components of this medication (including those listed in section 6) or to any other macrolide or ketolide antibiotic, such as erythromycin or telithromycin.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Azithromycin Alter if you:

• During treatment with azithromycin, allergic reactions (itching, redness, skin rash, swelling, or difficulty breathing or an allergic reaction to the medication characterized by an increase in white blood cells in the blood and generalized symptoms) may occur, which could be severe. Inform your doctor, who may decide to discontinue treatment and initiate appropriate treatment.
• If you have liver problems or if your skin and/or the whites of your eyes turn yellow during treatment, discuss this with your doctor to confirm whether you should discontinue treatment or undergo liver function tests.
• If you are being treated with ergotamine derivatives (used to treat migraines), inform your doctor, as concomitant treatment with azithromycin may cause a adverse reaction called ergotism.
• During treatment with this medication, there is a possibility of developing a superinfection with resistant germs, including fungi. In this case, inform your doctor.
• During or after treatment with azithromycin, symptoms suggesting antibiotic-associated colitis (diarrhea) may appear. If so, treatment should be discontinued, and your doctor will provide the most suitable treatment.
• If you have any kidney function impairment, inform your doctor.
• If you have heart rhythm disturbances or factors that predispose you to them (certain heart diseases, electrolyte level alterations in the blood, or certain medications), inform your doctor, as this medication may contribute to worsening or triggering these disturbances.
• If you have a disease called myasthenia gravis or if muscle weakness and fatigue appear during treatment, inform your doctor, as azithromycin may trigger or worsen the symptoms of this disease.

Children and adolescents

Children and adolescents weighing less than 45 kg

Tablets are not indicated for this patient group. Other pharmaceutical forms containing azithromycin (e.g., suspensions) may be used.

Children and adolescents weighing more than 45 kg

This medication is not suitable for children who are unable to swallow the tablets whole. Other pharmaceutical forms containing azithromycin may be used.

Other medications and Azithromycin Alter

Inform your doctor if you are taking, have recently taken, or may take any other medication, including those obtained without a prescription.

Azithromycin may interact with other medications. Inform your doctor or pharmacist if you are taking any of the following medications:

• Antacids. If you are taking antacids (e.g., aluminum hydroxide) and Azithromycin Alter, it is recommended to avoid simultaneous administration of both medications at the same time of day: take azithromycin at least 1 hour before or 2 hours after taking an antacid.
• Ergotamine derivatives, e.g., ergotamine (used to treat migraines): should not be administered concomitantly, as ergotism (a potentially serious adverse effect with numbness or tingling in the extremities, muscle cramps, headaches, convulsions, or abdominal or chest pain) may develop.
• Digoxin (used to treat heart failure and heart arrhythmias): may increase digoxin levels in the blood, and levels should be monitored.
• Colchicine (used for gout and familial Mediterranean fever).
• Cyclosporin (an immunosuppressant used after organ transplantation): cyclosporin levels may increase. Your doctor will need to monitor your cyclosporin blood levels.
• Dicumarol anticoagulants (medications used to prevent blood clots) since azithromycin may potentiate the effect of these anticoagulants. Your doctor should monitor coagulation parameters (prothrombin time).
• Nelfinavir, zidovudine (medications for the treatment of HIV infections), as azithromycin levels in the blood may increase.
• Fluconazole (medications for treating fungal infections), as azithromycin levels in the blood may increase.
• Terfenadine (a medication used to treat allergies) since the combination of both may cause heart problems.
• Rifabutin (a medication for the treatment of pulmonary and non-pulmonary tuberculosis and infections caused by mycobacteria) since it may cause a decrease in the number of white blood cells in the blood.
• Medications with active substances that prolong the QT interval, such as antiarrhythmic agents of class IA (quinidine and procainamide) and class III (dofetilide, amiodarone, and sotalol), cisapride, terfenadine, antipsychotic agents (such as pimozide), antidepressants (such as citalopram), and anti-infective agents (fluoroquinolones such as moxifloxacin or levofloxacin and chloroquine), as it may cause serious heart rhythm disturbances and even cardiac arrest.

No interactions have been observed between azithromycin and cetirizine (for treating allergic reactions); didanosine, efavirenz, indinavir (for HIV infection); atorvastatin (for treating high cholesterol and heart problems); carbamazepine (for epilepsy), cimetidine (for treating excess stomach acid); methylprednisolone (for suppressing the immune system); midazolam, triazolam (sedatives); sildenafil (for impotence), theophylline (for asthma), and trimethoprim/sulfamethoxazole (for treating infections).

Taking Azithromycin Alter 500 mg with food and drinks

The tablets should be taken whole with water and can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Your doctor will assess whether you should take this medication during pregnancy, if the benefit of treatment outweighs the potential risks. Azithromycin is excreted in breast milk. Due to potential adverse reactions in the infant, the use of azithromycin is not recommended during breastfeeding, although you may continue breastfeeding two days after completing treatment with Azithromycin Alter.

Driving and using machines

The influence of this medication on the ability to drive or use machines is negligible or non-existent.

Azithromycin Alter contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet, i.e., it is essentially "sodium-free".

3. How to take Azithromycin Alter

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

Your doctor will determine the most suitable dose and treatment duration for you, according to your condition and response to treatment. As a general rule, the dose of medication and frequency of administration is as follows:

Adults (including elderly patients) and children weighing more than 45 kg:

The usual dose is 1500 mg divided over 3 or 5 days as follows:

• When taken over 3 days, 500 mg per day.
• When taken over 5 days, 500 mg on the first day and 250 mg from the 2nd to the 5th day.

In elderly patients, the same dose as for adults may be administered. However, if you have heart rhythm disturbances, your doctor will closely monitor you.

Urethral or cervical infection (cervicitis)

The usual dose is 1000 mg taken as a single dose on one day.

If the infection is caused by N. gonorrhoeae, your doctor will administer the same dose in combination with another antibiotic (ceftriaxone, 250 mg).

Chancroid

The usual dose is 1000 mg taken as a single dose on one day.

Sinusitis

Treatment is indicated in adults and adolescents over 16 years of age.

Children and adolescents weighing less than 45 kg:

Tablets are not recommended for these patients. Other pharmaceutical forms containing azithromycin (e.g., suspensions) may be used.

Use in patients with hepatic impairment

Inform your doctor if you have severe liver problems, as it may be necessary to adjust the normal dose.

Use in patients with renal impairment

Inform your doctor if you have kidney problems, as it may be necessary to adjust the normal dose.

If you think the effect of azithromycin is too strong or too weak, talk to your doctor or pharmacist.

Method of administration

This medication is administered orally as a single daily dose. Take the tablets with a glass of water; they can be taken with or without food. Other presentations are available for different dosing regimens.

If you take more Azithromycin Alter than you should

In case of overdose, you may experience reversible hearing loss, severe nausea, vomiting, and diarrhea.

Information for the prescriber

In case of overdose, activated charcoal administration is indicated, and general symptomatic and supportive measures for vital functions should be applied.

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

If you forget to take Azithromycin Alter

If you miss a dose, use the medication as soon as possible, continuing with the treatment as prescribed. However, if the next dose is near, it is better not to take the missed dose and wait for the next one. Do not take a double dose to make up for the missed dose. Continue using this medication as your doctor has indicated.

If you stop taking Azithromycin Alter

If you stop treatment before your doctor recommends, symptoms may worsen or reappear.

If you have any further questions on the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everybody gets them.

Side effects reported during clinical trials and after marketing have been classified by frequency:

Very common (at least 1 in 10 people):

• Diarrhea.

Common (at least 1 in 100 people)

• Headache.
• Vomiting, stomach pain, nausea.
• Alteration in the number of certain types of white blood cells (lymphocytes, eosinophils, basophils, monocytes, and neutrophils), decrease in bicarbonate.

Uncommon (at least 1 in 1,000 people)

• Infection with the fungus Candida in the mouth or generalized, vaginal infection, pneumonia, fungal or bacterial infection, pharyngitis, gastroenteritis, alteration in breathing, rhinitis.
• Decrease in the number of certain types of white blood cells (leukocytes, neutrophils, and eosinophils).
• Allergic reaction, including an inflammatory process in the deep skin (angioedema).
• Alteration in eating behavior (anorexia).
• Nervousness, insomnia.
• Somnolence, dizziness, alteration in taste, loss of tactile sensation.
• Alteration in vision.
• Alteration in hearing, vertigo.
• Palpitations.
• Hot flashes.
• Alteration in breathing, nosebleeds.
• Constipation, flatulence, indigestion, gastritis, difficulty swallowing, abdominal distension, dry mouth, eructation, mouth ulcers, increased salivation.
• Rash, itching, appearance of reddish elevated patches, dermatitis, dry skin, excessive sweating, redness.
• Joint inflammation, muscle pain, back pain, neck pain.
• Difficulty urinating, kidney pain.
• Vaginal bleeding, alteration in the testicles.
• Generalized swelling, weakness, discomfort, fatigue, facial edema, chest pain, fever, pain and swelling of the extremities.
• Alteration in liver function tests (increase in liver enzymes GOT, GPT, and alkaline phosphatase) and increase in bilirubin, urea, creatinine, chloride, glucose, bicarbonate, and platelets in the blood, alteration in sodium and potassium levels, decrease in hematocrit.
• Complications after surgery.

Rare (at least 1 in 10,000 people)

• Agitation.
• Alteration in liver function, yellowing of the skin.
• Sensitivity to sun exposure (photosensitivity), drug reaction with an increase in a type of white blood cells (eosinophilia) and generalized symptoms (multi-organ involvement) (DRESS syndrome).
• Skin rash characterized by the rapid appearance of red skin areas with small pus-filled bumps (small blisters filled with white/yellow liquid).

Not known (cannot be estimated from the available data)

• Diarrhea caused by Clostridium difficile.
• Decrease in the number of platelets in the blood, anemia.
• Severe allergic reaction.
• Aggressive reactions, anxiety, delirium, hallucinations.
• Loss of consciousness, convulsions, decreased sensitivity, hyperactivity, alteration and/or loss of smell, loss of taste, muscle weakness and fatigue (myasthenia gravis).
• Alteration in hearing, including deafness and ringing in the ears. Torsade de pointes, heart rhythm disturbances, prolongation of the QTc interval in the electrocardiogram.
• Decrease in blood pressure.
• Pancreatitis, change in tongue color.
• Severe liver damage and liver failure, which can rarely be fatal, liver tissue death, fulminant hepatitis.
• Appearance of reddish elevated patches, generalized rash with blisters and peeling skin, which occurs especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), severe skin reactions such as erythema multiforme, toxic epidermal necrolysis.
• Joint pain.
• Acute kidney failure and inflammation of the tissue between the kidney tubules (interstitial nephritis).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines. https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storing Azithromycin Alter

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

Store below 30°C

Do not use Azithromycin Alter after the expiration date stated on the packaging, after EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of via wastewater or household waste. Place the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Packaging Contents and Additional Information

Composition of Azitromicina Alter

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

The other components (excipients) are: pregelatinized starch (from corn), corn starch, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate, anhydrous calcium hydrogen phosphate, hydroxypropyl methylcellulose (hypromellose), titanium dioxide (E171), glycerol triacetate (triacetin), and purified water.

Product Appearance and Packaging Contents

Azitromicina Alter 500 mg are film-coated tablets, white in color, scored, and capsule-shaped.

The tablets are available in packs of 3 and 500 tablets (clinical packaging).

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Alter, S.A.

C/Mateo Inurria, 30

28036 Madrid

Spain

Date of the Last Review of this Leaflet:August 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es