ZITROMAX 500 mg POWDER FOR SOLUTION FOR INFUSION

2. Before using Zitromax 500 mg powder

Do not take Zitromax powder

• 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 medicine characterized by an increase in white blood cells in the blood and generalized symptoms) may appear, which could be severe. Inform your doctor, who may decide to interrupt treatment and initiate appropriate treatment.
• If you have liver problems or during treatment, your skin and/or the white of your eyes turn yellow, discuss this with your doctor to confirm whether you should interrupt 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 medicine, there is a possibility of developing a superinfection by 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 kidney problems, inform your doctor, as it may be necessary to adjust the normal dose.
• If you have arrhythmias or factors that predispose you to them (certain heart diseases, alterations in electrolyte levels in the blood, or certain medications), inform your doctor, as this medicine may contribute to worsening or triggering these alterations.
• 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

Zitromax 500 mg powder for solution for infusion is not indicated for use in children.

Using Zitromax 500 mg powder 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 concomitant 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).
• Ciclosporin (a medicine used in transplanted patients), as azithromycin may increase ciclosporin 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 tuberculosis and non-pulmonary infections caused by mycobacteria), 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 antiinfectives (fluoroquinolones such as moxifloxacin or levofloxacino and chloroquine), as they may cause serious heart rhythm alterations 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).

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 be given 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 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 powder contains sodium

This medicine contains 114 mg of sodium (the main component of table/cooking salt) per vial. This is equivalent to 5% of the maximum daily recommended sodium intake for an adult.

3. How to use Zitromax 500 mg powder

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 is as follows:

Adults (including elderly patients):

Pneumonia (lung infection)

Administer 500 mg per day in a single daily infusion for at least 1 or 2 consecutive days. Then, administer 500 mg per day in a single oral dose for at least 5 consecutive days.

The total treatment duration is 7 to 10 days.

Pelvic inflammatory disease (infection in the female genital tract)

Administer 500 mg per day in a single daily infusion for 1 or 2 consecutive days. Then, administer 250 mg per day in a single oral dose for at least 5 consecutive days.

The total treatment duration is 7 days.

Method of administration

You will be administered this medicine through intravenous infusion for at least 60 minutes.

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 are given more Zitromax 500 mg powder 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 at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Zitromax 500 mg powder

Given that you will receive this medicine under close medical supervision, it is unlikely that you will forget a dose. Nevertheless, inform your doctor or pharmacist if you think you have missed a dose.

If you stop using Zitromax 500 mg powder

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.

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 in 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:

• Infection by the fungus Candida in the mouth or generalized, vaginal infection, pneumonia, fungal or bacterial infection, pharyngitis, gastroenteritis, alteration of breathing, rhinitis.
• Decrease in the number of some types of white blood cells (leukocytes, neutrophils, and eosinophils).
• Allergic reaction, including an inflammatory process in the deep skin (angioedema).
• Alteration of eating behavior (anorexia).
• Nervousness, insomnia.
• Somnolence, dizziness, alteration of taste, loss of tactile sensation.
• Alteration of vision.
• Alteration of hearing, vertigo.
• Palpitations.
• Hot flashes.
• Alteration of breathing, 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.
• Difficulty urinating, kidney pain.
• Vaginal bleeding, alteration in the testicles.
• Pain or swelling at the injection site, generalized swelling, weakness, discomfort, 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.
• Alteration of 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 pustules (small blisters filled with white/yellow liquid).

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

• Diarrhea caused by Clostridium difficile.
• 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).
• Alteration of hearing, including deafness and ringing.
• Torsades de pointes, heart rhythm alterations, 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 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 powder

Before reconstitution: Store below 30°C.

After reconstitution: The concentrated solution should be used within 8 hours after reconstitution, stored at room temperature, or 24 hours after reconstitution when stored between 2 and 8°C.

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

Do not use this medicine after the expiry date stated on the carton 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 no longer required. This will help protect the environment.

6. Additional Information

Composition of Zitromax powder

• The active ingredient is azithromycin. Each vial contains 500 mg of azithromycin (as dihydrate). Each ml of reconstituted solution contains 100 mg of azithromycin.
• The other components (excipients) are: citric acid and sodium hydroxide.

Appearance of the product and packaging content

It is presented as a lyophilized powder in 1 glass vial of type I with a capacity of 10 ml, provided with a gray butyl rubber stopper and closed with an aluminum cap. Each package contains 1 vial.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Pfizer, S.L.

Avda. de Europa, 20 B

Parque Empresarial La Moraleja.

28108 Alcobendas. Spain.

Manufacturer:

Fareva Amboise.

Zone industrielle. 29 Route des Industries.

37530, Pocé-sur-Cisse. France

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/.

Information intended for healthcare professionals:

For single use. Discard unused solution. It is administered by intravenous infusion for at least 60 minutes once reconstituted. To do this, the following instructions must be followed:

Reconstitution: prepare the initial solution of Zitromax500 mg powder for solution for infusion by adding 4.8 ml of sterilized water for injectable preparations to the 500 mg vial and shake the vial until all the powder is dissolved. The use of a standard 5 ml syringe (not automatic) is recommended to ensure that the exact amount of 4.8 ml of sterilized water for injectable preparations is introduced. Each ml of reconstituted solution contains 100 mg of azithromycin.

Parenteral administration products must be visually inspected before administration for any foreign particles; if this happens, being evident in the reconstituted fluid, the solution must be discarded.

Dilute the solution before administration as indicated below.

Dilution: to achieve a concentration of 1.0 or 2.0 mg/ml of azithromycin, transfer 5 ml of the azithromycin solution of 100 mg/ml to the respective amounts of diluent indicated below:

Respect the recommended infusion time. The reconstituted solution can be diluted in:

Sodium chloride 0.9%

Sodium chloride 0.45%

Glucose 5% in water

Ringer's lactate solution

Glucose 5% in sodium chloride 0.45% with 20 mEq of KCl

Glucose 5% in Ringer's lactate solution

Glucose 5% in sodium chloride 0.3%

Glucose 5% in sodium chloride 0.45%.

After dilution, the unused solution must be discarded. For single use

It must not be administered as a bolus or by intramuscular injection.