Zithromax 500 mg powder for solution for infusion

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Zitromax 500 mg powder for solution for infusion

Azithromycin

Read all of this leaflet carefully before you start using 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; do not give it to others, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be serious, or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

Contents of the leaflet:

1. What Zitromax 500 mg powder is and what it is used for
2. What you need to know before using Zitromax 500 mg powder
3. How to use Zitromax 500 mg powder
4. Possible side effects
5. How to store Zitromax 500 mg powder
6. Further information

1. What Zitromax 500 mg powder is and what it is used for

Azithromycin belongs to a group of antibiotics known as macrolide antibiotics. It kills bacteria that cause infections.

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

It is important that you follow your doctor's instructions regarding dose, dosing interval, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left over after completing your treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines down the drain or in the household waste.

It is used to treat infections of the lungs (pneumonia) or infections of the upper female genital tract (pelvic inflammatory disease).

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 to 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

• Allergic-type reactions (itching, redness, skin rash, swelling, difficulty breathing, or an allergic drug reaction characterized by increased white blood cells and generalized symptoms) may occur during treatment with Zitromax and could be severe. Inform your doctor, who may decide to discontinue treatment and initiate appropriate therapy.
• If you have liver problems or if during treatment your skin and/or the whites of your eyes turn yellowish, tell your doctor so they can determine whether treatment should be stopped or if liver function tests are needed.
• If you are being treated with ergot derivatives (used to treat migraine), inform your doctor, as concomitant treatment with azithromycin may cause an adverse reaction known as ergotism.
• During treatment with this medicine, there is a possibility of superinfection by resistant organisms, including fungi. If this occurs, inform your doctor.
• Diarrhea or other symptoms suggesting antibiotic-associated colitis may appear during or after treatment with Zitromax. If this happens, treatment should be discontinued and your doctor will prescribe the most appropriate therapy.
• If you have any kidney function impairment, inform your doctor.
• If you have heart rhythm disorders (arrhythmias) or factors that predispose you to them (certain heart conditions, electrolyte imbalances in the blood, or certain medications), inform your doctor, as this medicine may contribute to worsening or triggering such disorders.
• If you have a disease called myasthenia gravis or experience muscle weakness and fatigue during treatment, inform your doctor, as Zitromax may trigger or worsen symptoms of this condition.

Children and adolescents

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

Use of Zitromax 500 mg powder with other medicines

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

You should especially inform your doctor or pharmacist if you are taking any of the following medicines:

• Antacids (medicines used for digestive problems). It is recommended to avoid administering both medicines at the same time of day.
• Ergot derivatives (such as ergotamine, used to treat migraine), as concomitant administration with azithromycin may cause ergotism (a potentially serious adverse effect including numbness or tingling in the limbs, muscle cramps, headaches, seizures, or abdominal or chest pain).
• Digoxin (a medicine used to treat heart arrhythmias), as azithromycin may increase digoxin blood levels, which should be monitored.
• Colchicine (used for gout and familial Mediterranean fever).
• Cyclosporine (a medicine used in transplant patients), as azithromycin may increase cyclosporine blood levels, which should be monitored.
• Dicoumarol anticoagulants (medicines used to prevent blood clots), as azithromycin may enhance the effect of these anticoagulants. Your doctor should monitor coagulation parameters (prothrombin time).
• Nelfinavir, zidovudine (medicines for treating HIV infections), as azithromycin blood levels may increase.
• Fluconazole (medicines used to treat fungal infections), as azithromycin blood levels may increase.
• Terfenadine (a medicine used to treat allergies), as the combination may cause heart problems.
• Rifabutin (a medicine used to treat pulmonary tuberculosis and non-pulmonary mycobacterial infections), as it may cause a decrease in white blood cell count.
• Medicines containing active substances that prolong the QT interval, such as class IA antiarrhythmics (quinidine and procainamide) and class III (dofetilide, amiodarone, and sotalol), cisapride, terfenadine, antipsychotics (such as pimozide), antidepressants (such as citalopram), and anti-infectives (fluoroquinolones such as moxifloxacin or levofloxacin and chloroquine), as they may cause serious cardiac rhythm disturbances 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, plan to become pregnant, or are breastfeeding, inform your doctor or pharmacist before using this medicine.

Your doctor will assess whether this medicine should be administered during pregnancy, based on whether the benefit of treatment outweighs the potential risks.

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

Driving and using machines

The effect of this medicine on the ability to drive or operate machinery is none or negligible.

Zitromax 500 mg powder contains sodium

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

3. How to use Zitromax 500 mg powder

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

As a general rule, the recommended dosage and frequency of administration are as follows:

Adults (including elderly patients):

Pneumonia (infection in the lungs)

Administer 500 mg once daily as a single daily infusion for at least 1 or 2 consecutive days. Then administer 500 mg once daily as a single daily oral dose for at least 5 consecutive days.

The total duration of treatment is 7 to 10 days.

Pelvic inflammatory disease (infection in the female genital tract)

Administer 500 mg once daily as a single daily infusion for 1 or 2 consecutive days. Then administer 250 mg once daily as a single daily oral dose for at least 5 consecutive days.

The total duration of treatment is 7 days.

Method of administration

It will be administered to you as an intravenous infusion over at least 60 minutes.

Use in patients with hepatic impairment

Inform your doctor if you have severe liver problems, as the normal dose may need to be adjusted.

Use in patients with renal impairment

Inform your doctor if you have kidney problems, as the normal dose may need to be adjusted.

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

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

If you forget to use Zitromax 500 mg powder

Since you will be receiving this medication under close medical supervision, it is unlikely that you will miss a dose. However, inform your doctor or pharmacist if you think you have missed a dose.

If you stop treatment with Zitromax 500 mg powder

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

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

4. Possible adverse effects

Like all medicines, Zithromax may cause adverse effects, although not everyone experiences them.

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

Very common adverse effects (affecting at least 1 in 10 people):

• Diarrhea.

Common adverse effects (affecting at least 1 in 100 people):

• Headache.
• Vomiting, abdominal pain, nausea.
• Changes in the count of certain types of white blood cells (lymphocytes, eosinophils, basophils, monocytes, and neutrophils), decreased bicarbonate levels.

Uncommon adverse effects (affecting at least 1 in 1,000 people):

• Fungal infection by Candida in the mouth or systemic infection, vaginal infection, pneumonia, fungal or bacterial infection, pharyngitis, gastroenteritis, breathing difficulties, rhinitis.
• Decrease in the number of certain types of white blood cells (leukocytes, neutrophils, and eosinophils).
• Allergic reaction, including deep skin inflammation (angioedema).
• Changes in eating behavior (anorexia).
• Nervousness, insomnia.
• Drowsiness, dizziness, taste disturbances, loss of tactile sensation.
• Vision disturbances.
• Hearing disturbances, vertigo.
• Palpitations.
• Hot flushes.
• Breathing difficulties, nosebleeds.
• Constipation, flatulence, indigestion, gastritis, difficulty swallowing, abdominal distension, dry mouth, burping, mouth ulcers, increased salivation.
• Rash, pruritus, appearance of raised red rashes, dermatitis, dry skin, excessive sweating, redness.
• Joint inflammation, muscle pain, back pain, neck pain.
• Difficulty urinating, kidney pain.
• Vaginal bleeding, testicular disorders.
• Pain or swelling at the injection site, generalized swelling, weakness, malaise, fatigue, facial edema, chest pain, fever, pain and swelling of the extremities.
• Abnormal liver function tests (increased liver enzymes GOT, GPT, and alkaline phosphatase) and increased bilirubin, urea, creatinine, chloride, glucose, bicarbonate, and platelets in blood; changes in sodium and potassium levels; decreased hematocrit.
• Complications following surgical procedures.

Rare adverse effects (affecting at least 1 in 10,000 people):

• Agitation.
• Liver function disturbances, yellowing of the skin (jaundice).
• Sensitivity to sunlight (photosensitivity), drug reaction with increased levels of a type of white blood cells (eosinophilia) and systemic symptoms (multi-organ involvement) (DRESS syndrome).
• Skin rash characterized by the sudden appearance of red skin areas dotted with small pustules (small blisters filled with white/yellow fluid).

Adverse effects with unknown frequency (cannot be estimated from available data):

• Diarrhea caused by Clostridium difficile.
• Decreased platelet count in blood, anemia.
• Severe allergic reaction.
• Aggressive reactions, anxiety, delirium, hallucinations.
• Loss of consciousness, seizures, decreased sensation, hyperactivity, disturbances and/or loss of smell, loss of taste, muscle weakness and fatigue (myasthenia gravis).
• Hearing disturbances including deafness and tinnitus.
• Torsade de pointes, cardiac rhythm disturbances, QTc interval prolongation on electrocardiogram.
• Decreased blood pressure.
• Pancreatitis, change in tongue color.
• Severe liver injury and liver failure, which rarely may be fatal, death of liver tissue, fulminant hepatitis.
• Appearance of raised red rashes, generalized rash with blisters and peeling skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), serious skin reactions such as erythema multiforme, toxic epidermal necrolysis.
• Joint pain.
• Acute kidney failure and inflammation of the tissue between renal tubules (interstitial nephritis).

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is an effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es.

By reporting adverse 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 when stored at room temperature, or within 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 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. Ask your pharmacist how to dispose of unused medicines and their containers. This helps protect the environment.

6. Information for Healthcare Professionals

Composition of Zitromax powder

• The active substance 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 medicinal product and contents of the container

It is presented as a lyophilized powder in 1 vial made of neutral glass type I with a capacity of 10 ml, provided with a grey butyl rubber stopper and sealed 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, Poce-sur-Cisse. France

Date of the most recent revision of this leaflet: June 2023.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.

Information intended for healthcare professionals:

For single use only. Discard any unused solution. Administered by intravenous infusion over at least 60 minutes after reconstitution. Follow the instructions below:

Reconstitution: Prepare the initial solution of Zitromax 500 mg powder for infusion solution by adding 4.8 ml of sterile water for injections to the 500 mg vial and shake the vial until all the powder dissolves. Use of a standard 5 ml syringe (non-automatic) is recommended to ensure the exact volume of 4.8 ml of sterile water for injections is added. Each ml of reconstituted solution contains 100 mg of azithromycin.

Parenteral preparations should be inspected visually for foreign particles before administration; if any are observed 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 100 mg/ml azithromycin solution to the respective volumes of diluent as indicated below:

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

0.9% Sodium chloride

0.45% Sodium chloride

5% Glucose in water

Ringer lactate solution

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

5% Glucose in lactated Ringer's solution

5% Glucose in 0.3% sodium chloride

5% Glucose in 0.45% sodium chloride

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

Must not be administered as a bolus or by intramuscular injection.