PATIENT INFORMATION LEAFLET

Zitromax 500 mg powder for solution for infusion

Azithromycin

Read this leaflet carefully before you start taking this medicine

• 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 personally and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you think you are having any side effects, tell your doctor or pharmacist. If any of the following happen, stop taking your medicine and tell your doctor or pharmacist.

Azithromycin belongs to a group of antibiotics called macrolides. It eliminates bacteria causing infections.

It is used for the treatment of infections in the lungs (pneumonia) or infections in the upper female genital tract (pelvic inflammatory disease)

Do not take Zitromax powder

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

Warnings and precautions

Consult your doctor or pharmacist before starting this medication

• During treatment with Zitromax, allergic reactions (itching, redness, skin rash, swelling, or difficulty breathing, or an allergic reaction to the medication characterized by increased white blood cell count 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 white of your eyes turns yellow, inform 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 ergotism.
• During treatment with this medication, there is a possibility of developing an overinfection by resistant germs, including fungi. In this case, inform your doctor.
• During or after treatment with Zitromax, symptoms may appear that suggest antibiotic-associated colitis (diarrhea). If so, treatment should be discontinued, and your doctor will prescribe the most suitable treatment.
• If you have any kidney function alterations, inform your doctor.
• If you have arrhythmias or factors that predispose you to them (certain heart diseases, alterations in blood electrolyte levels, or certain medications), inform your doctor, as this medication may exacerbate or trigger these alterations.
• If you have myasthenia gravis or if muscle weakness and fatigue appear during treatment, inform your doctor, as Zitromax may trigger or worsen symptoms of this disease.

Children and adolescents

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

Use of Zitromax 500 mg powder with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to take any other medication.

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

• Antacids (medications used for digestive problems). It is recommended to avoid simultaneous administration of both medications at the same time of day.
• Ergotamine derivatives (such as ergotamine, used to treat migraines), as simultaneous administration with azithromycin may cause ergotism (a potentially severe adverse effect characterized by numbness or tingling in the extremities, muscle cramps, headaches, convulsions, or abdominal or chest pain).
• Digoxin (a medication used to treat heart arrhythmias), as azithromycin may increase digoxin levels in the blood, and levels should be monitored.
• Colchicine (used to treat gout and familial Mediterranean fever).
• Ciclosporin (a medication used in transplant patients), as azithromycin may increase ciclosporin levels in the blood, and levels should be monitored.
• Anticoagulant dicumarins (medications used to prevent blood clotting), as azithromycin may potentiate the effect of these anticoagulants. Your doctor should control coagulation parameters (prothrombin time).
• Nelfinavir, zidovudine (medications used to treat HIV infections), as they may increase azithromycin levels in the blood.
• Fluconazole (medications used to treat fungal infections), as they may increase azithromycin levels in the blood.
• Terfenadine (a medication used to treat allergies), as the combination may cause heart problems.
• Rifabutin (a medication used to treat pulmonary and non-pulmonary tuberculosis caused by mycobacteria), as it may cause a decrease in white blood cell count.
• Medications with active substances that prolong the QT interval, such as antiarrhythmic class IA (quinidine and procainamide) and class III (dofetilide, amiodarone, and sotalol) medications, cisapride, antipsychotics (such as pimozide), antidepressants (such as citalopram), and antifungals (fluoroquinolones such as moxifloxacin or levofloxacin and chloroquine), as they may cause severe cardiac rhythm alterations and even cardiac arrest.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, inform your doctor or pharmacist before using this medication.

Your doctor will assess whether this medication should be administered during pregnancy, whether the benefits of treatment outweigh the potential risks.

Azithromycin is excreted in breast milk. Due to potential adverse reactions in the infant, it is not recommended to use azithromycin during breastfeeding, although breastfeeding may be continued two days after completing treatment with Zitromax.

Driving and operating machinery

The influence of this medication on the ability to drive or operate machinery is negligible or insignificant.

Zitromax 500 mg powder contains sodium

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

Your doctor will determine the most suitable dose and duration of treatment for you, based on your condition and response to treatment.

As a general rule, the recommended dose of medication and administration frequency 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 daily dose orally for at least 5 consecutive days.

The total duration of treatment is 7 to 10 days.

Pelvic inflammatory disease (female genital tract infection)

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 daily dose orally for at least 5 consecutive days.

The total duration of treatment is 7 days.

Administration form

You will be administered , via intravenous infusion for at least 60 minutes.

Use in patients with liver insufficiency

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

Use in patients with renal insufficiency

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

If you are administered more Zitromax 500 mg powder than you should

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

Information for the prescriber

In case of overdose, activated charcoal administration is indicated, and general supportive measures and vital function support should be applied.

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

If you forget to use Zitromax 500 mg powder

Considering that you will receive this medication under close medical supervision, it is unlikely that you will forget a dose. However, inform your doctor or pharmacist if you think you have forgotten a dose.

If you interrupt treatment with Zitromax 500 mg powder

If you discontinue treatment with Zitromax before your doctor has recommended, symptoms may worsen or reappear.

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

Like all medicines, Zitromax can cause side effects, although not everyone will experience them.

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

Side effectsvery frequent (in at least 1 in 10 people)are:

• Diarrhea.

Side effectsfrequent (in 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).

Side effectsinfrequent (in at least 1 in 1,000 people)are:

• Candida fungal infection in the mouth or generalized, vaginal infection, pneumonia, fungal or bacterial infection, pharyngitis, gastroenteritis, respiratory alteration, rhinitis.
• Decrease in the number of some types of white blood cells (leukocytes, neutrophils, and eosinophils).
• Allergic reaction, including a deep skin inflammatory process (angioedema).
• Alteration in eating behavior (anorexia).
• Nervousness, insomnia.
• Drowsiness, dizziness, alteration of taste, loss of tactile sensation.
• Visual alteration.
• Auditory alteration, vertigo.
• Palpitations.
• Hot flashes.
• Respiratory alteration, nasal hemorrhage.
• Constipation, flatulence, indigestion, gastritis, difficulty swallowing, abdominal distension, dry mouth, belching, mouth ulcers, increased salivation.
• Rash, pruritus, appearance of red, elevated papules, dermatitis, dry skin, excessive sweating, erythema.
• Joint inflammation, muscle pain, back pain, neck pain.
• Difficulty urinating, kidney pain.
• Vaginal hemorrhage, alteration in testicles.
• Pain or swelling at the injection site, 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 blood, alteration of sodium and potassium levels, decrease in hematocrit.
• Complications after surgical intervention.

Side effectsare rare (in at least 1 in 10,000 people)are:

• Agitation.
• Liver function alteration, yellow discoloration of the skin.
• Sensitivity to sunlight (photosensitivity), allergic reaction with increase in a type of white blood cell (eosinophilia) and generalized symptoms (multi-organ compromise) (DRESS syndrome).
• Characterized by the rapid appearance of red skin areas dotted with small white/yellow-filled blisters (small pustules).

Side effectsof unknown frequency(cannot be estimated from available data) are:

• Diarrhea caused by Clostridium difficile.
• Decrease in platelet count in blood, anemia.
• Severe allergic reaction
• Aggressive behavior, 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).
• Auditory alteration including deafness and tinnitus.
• Torsade de pointes alterations of heart rhythm, prolongation of the QTc interval in the electrocardiogram.
• Decrease in blood pressure.
• Pancreatitis, change in color of the tongue.
• Severe liver damage and hepatic failure that can rarely be fatal, liver tissue death, fulminant hepatitis.
• Appearance of red, elevated papules, generalized rash with blisters and peeling skin, 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 interstitial nephritis.

Reporting of side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

Before reconstitution: Store below 30°C.

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

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medicines. In this way, you will help protect the environment.

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 contents of the package

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Pfizer, S.L.

Avda. de Europa, 20 B

Parque Empresarial La Moraleja.

28108 Alcobendas. Spain.

Responsible for manufacturing: :

Fareva Amboise.

Zone industrielle. 29 Route des Industries.

37530, Poce-sur -Cisse. France

Last review date of this leaflet: June 2023.

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/ .

Information for healthcare professionals:

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

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

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

Dilute the solution before administration as indicated below.

Dilution : To achieve a final 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: