ZITROMAX 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Zitromax 500 mg Film-Coated Tablets

Azithromycin

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

1. What Zitromax 500 mg film-coated tablets are and what they are used for
2. What you need to know before you take Zitromax 500 mg film-coated tablets
3. How to take Zitromax 500 mg film-coated tablets
4. Possible side effects
5. Storage of Zitromax 500 mg film-coated tablets
6. Further information

1. What Zitromax 500 mg film-coated tablets are and what they are used for

Azithromycin belongs to a group of antibiotics called macrolide antibiotics. It eliminates bacteria that cause infections.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as the flu or the common cold.

It is essential to follow the dosage instructions, administration intervals, and treatment duration indicated by your doctor.

Do not store or reuse this medication. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not dispose of medications down the drain or in the trash.

It is used to treat infections caused by bacteria in different parts of the body, in adults and children weighing over 45 kg.

It is used to treat the following infections:

• Throat, tonsil, ear, or sinus infections.
• Bronchitis and pneumonia (mild to moderate severity).
• Skin and soft tissue infections (mild to moderate severity).
• Urethra (urethritis) or cervix (cervicitis) infections, see section 3.
• Sexually transmitted infections (chancroid), see section 3.

2. What you need to know before you take Zitromax 500 mg film-coated tablets

Do not take Zitromax 500 mg film-coated tablets

• if you are allergic to azithromycin, erythromycin, any other macrolide or ketolide antibiotic, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine

• During treatment with Zitromax, 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 during treatment, your skin and/or the whites of your eyes turn yellow, 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 potentially serious adverse reaction called ergotism.
• During treatment with this medicine, there is a possibility of developing a superinfection with resistant germs, including fungi. In this case, inform your doctor.
• During or after treatment with Zitromax, symptoms suggesting antibiotic-associated colitis (diarrhea) may appear. If so, treatment should be suspended, and your doctor will provide the most suitable treatment.
• If you have any kidney function disorders, inform your doctor.
• If you have heart rhythm disorders or factors that predispose you to them (certain heart diseases, electrolyte level disorders in the blood, or certain medications), inform your doctor, as this medicine may contribute to worsening or triggering these disorders.
• If you have a disease called myasthenia gravis or if muscle weakness and fatigue appear during treatment, inform your doctor, as Zitromax may trigger or worsen the symptoms of this disease.

Children and adolescents

Children and adolescents weighing less than 45 kg.

The tablets are not indicated for this group of patients. Other pharmaceutical forms of azithromycin can be used. It should not be administered to children under 6 months.

Children and adolescents weighing over 45 kg.

This medicine is not suitable for children who are unable to swallow the tablets whole. Other pharmaceutical forms of azithromycin can be used.

Using Zitromax 500 mg film-coated tablets with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Especially, you must inform your doctor or pharmacist if you are being treated with any of the following medicines:

• Antacids (medicines used for digestive problems). It is recommended to avoid simultaneous administration of both drugs at the same time of day.
• Ergotamine derivatives (such as ergotamine, used to treat migraines), as concomitant administration with azithromycin may cause ergotism (a potentially serious adverse effect with numbness or tingling in the limbs, muscle cramps, headaches, convulsions, or abdominal or chest pain).
• Digoxin (a medicine used to treat heart arrhythmias), as azithromycin may increase digoxin levels in the blood, and its levels should be monitored.
• Colchicine (used for gout and familial Mediterranean fever).
• Cyclosporin (a medicine used in transplant patients), as azithromycin may increase cyclosporin levels in the blood, and its levels should be monitored.
• Anticoagulant dicumarolics (medicines used to prevent blood clots), as azithromycin may potentiate the effect of these anticoagulants. Your doctor should monitor coagulation parameters (prothrombin time).
• Nelfinavir, zidovudine (medicines for the treatment of infections caused by the human immunodeficiency virus), as they may increase azithromycin levels in the blood.
• Fluconazole (medicines for treating fungal infections), as they may increase azithromycin levels in the blood.
• Terfenadine (a medicine used to treat allergies), as the combination of both may cause heart problems.
• Rifabutin (a medicine for the treatment of pulmonary and non-pulmonary tuberculosis and mycobacterial infections), as it may cause a decrease in the number of white blood cells in the blood.
• Medicines with active substances that prolong the QT interval, such as antiarrhythmics 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-infectives (fluoroquinolones such as moxifloxacin or levofloxacino and chloroquine), as it may cause serious heart rhythm disorders and even cardiac arrest.

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

Taking Zitromax 500 mg film-coated tablets 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 medicine during pregnancy, if the benefit of treatment outweighs the potential risks. Azithromycin is excreted in breast milk. Due to potential adverse reactions in the breastfed infant, the use of azithromycin is not recommended during breastfeeding, although you may continue breastfeeding two days after completing treatment with Zitromax.

Driving and using machines

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

Zitromax 500 mg film-coated tablets contain lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

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

3. How to take Zitromax 500 mg film-coated tablets

Follow the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

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 recommended dose of the medicine and the frequency of administration are as follows:

Adults (including elderly patients) and children weighing over 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 can be administered. However, in case of patients with heart rhythm disorders, your doctor will closely monitor you.

Urethra or cervix infection (cervicitis):

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

In case 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, in one day.

Sinusitis:

Treatment is indicated in adults and adolescents over 16 years.

Children and adolescents weighing less than 45 kg:

The tablets are not recommended for these patients. Other pharmaceutical forms of Zitromax can 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.

Method of administration

Oral use.

This medicine should be administered as a single daily dose. The tablets should be taken whole with water and can be taken with or without food.

If you take more Zitromax 500 mg film-coated tablets 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, immediately consult your doctor or pharmacist or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Zitromax 500 mg film-coated tablets

In case you forget a dose, use the medicine 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 Zitromax as your doctor has indicated.

If you stop taking Zitromax 500 mg film-coated tablets

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

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

4. Possible side effects

Like all medicines, Zitromax can cause side effects, although not everybody gets them.

The side effects reported during clinical trials and after marketing, classified by frequency, are:

The side effects very common (at least 1 in 10 people)are:

• Diarrhea.

The side effects common (at least 1 in 100 people)are:

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

The side effects uncommon (at least 1 in 1,000 people)are:

• Candida infection in the mouth or generalized, vaginal infection, pneumonia, fungal or bacterial infection, pharyngitis, gastroenteritis, respiratory disorders, rhinitis.
• Decrease in the number of some types of white blood cells (leukocytes, neutrophils, and eosinophils).
• Allergic reaction, including a deep skin inflammation (angioedema).
• Alteration of eating habits (anorexia).
• Nervousness, insomnia.
• Somnolence, dizziness, alteration of taste, loss of tactile sensation.
• Visual disturbances.
• Hearing disturbances, vertigo.
• Palpitations.
• Hot flashes.
• Respiratory disorders, nosebleeds.
• Constipation, flatulence, indigestion, gastritis, difficulty swallowing, abdominal distension, dry mouth, eructation, mouth ulcers, increased salivation.
• Rash, itching, appearance of red elevated patches, dermatitis, dry skin, excessive sweating, redness.
• Joint inflammation, muscle pain, back pain, neck pain.
• Urination difficulties, kidney pain.
• Vaginal bleeding, testicular disorders.
• Generalized swelling, weakness, malaise, fatigue, facial edema, chest pain, fever, pain and swelling of the limbs.
• Alteration of 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 of sodium and potassium levels, decrease in hematocrit.
• Complications after surgery

The side effects rare (at least 1 in 10,000 people)are:

• Agitation.
• Liver function disorders, 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).
• A skin rash characterized by the rapid appearance of red skin areas with small pus-filled bumps (small blisters filled with white/yellow liquid).

The side effects of unknown frequency(cannot be estimated from the available data) are:

• Clostridium difficile-associated diarrhea.
• Decrease in platelet count 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).
• Hearing disturbances, including deafness and ringing in the ears.
• Torsades de pointes, heart rhythm disorders, prolongation of the QTc interval in the electrocardiogram.
• Decrease in blood pressure.
• Pancreatitis, tongue discoloration.
• Severe liver damage and liver failure, which can rarely be fatal, liver tissue death, fulminant hepatitis.
• Appearance of red 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es.

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

5. Storage of Zitromax 500 mg film-coated tablets

Store below 30°C. Store in the original package. Do not refrigerate.

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Additional Information.

Composition of Zitromax tablets

• The active ingredient is azithromycin. Each tablet contains 500 mg of azithromycin (as dihydrate).
• The other components (excipients) are: tablet core: pregelatinized corn starch, anhydrous calcium hydrogen phosphate, sodium croscarmellose, magnesium stearate, and sodium lauryl sulfate; tablet coating: Opadry white: lactose monohydrate, hydroxypropyl methylcellulose, titanium dioxide (E171), and triacetin.

Appearance of the product and packaging content

It is presented in the form of film-coated tablets, scored, white in color and capsule-shaped, with "ZTM 500" engraved on one side. The score line should not be used to divide the tablet.

It is presented in PVC blisters packaged in a cardboard box. Each package contains 3 or 150 tablets (clinical packaging).

Marketing authorization holder and manufacturer

Marketing authorization holder:

Pfizer, S.L. Avda. de Europa, 20 B

Parque Empresarial La Moraleja.

28108 Alcobendas.

Spain.

Manufacturer:

Farmasierra Manufacturing S.L.

Ctra. N-1, Km 26,200.

28709 San Sebastián de los Reyes.

Spain.

Date of the last revision of this prospectus:June 2023.

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