Zitromax 500 mg powder for oral suspension in sachet

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Zitromax 500 mg powder for oral suspension in sachet

Azithromycin

Read the entire 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 you should 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 listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What Zitromax 500 mg powder is and what it is used for
2. What you need to know before taking Zitromax 500 mg powder
3. How to take 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 treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via the drain or in household waste.

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

It is used to treat the following infections:

• Infections of the throat, tonsils, ears, or sinuses.
• Bronchitis and pneumonia (mild to moderate severity).
• Skin and soft tissue infections (mild to moderate severity).
• Urethral infections (urethritis) or cervical infections (cervicitis), see section 3.
• Sexually transmitted infections (chancroid), see section 3.

2. What you need to know before starting to take Zitromax 500 mg powder

Do not take Zitromax 500 mg 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 reaction characterized by increased white blood cells in blood and generalized symptoms) may occur during treatment with Zitromax and could be serious. Inform your doctor, who may decide to stop treatment and initiate appropriate therapy.
• If you have liver problems or during treatment your skin and/or the whites of your eyes turn yellowish, inform your doctor so they can determine whether you should discontinue treatment or require liver function tests.
• 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 microorganisms, including fungi. In such cases, inform your doctor.
• Symptoms suggesting antibiotic-associated colitis (diarrhea) may appear during or after treatment with Zitromax. If this occurs, treatment must 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 predisposing you to them (certain heart diseases, blood electrolyte imbalances, or certain medications), inform your doctor, as this medicine may contribute to worsening or triggering these conditions.
• 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 disease.

Children and adolescents

Children and adolescents weighing less than 45 kg.

The sachets may not be suitable for this patient group. Other pharmaceutical forms of azithromycin may be used. Do not administer to children under 6 months of age.

Weight above 45 kg

Same dose as adults; therefore, other more suitable pharmaceutical forms available on the market are recommended.

Sinusitis: treatment is indicated in adults and adolescents over 16 years of age.

Taking 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.

In particular, 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 simultaneous administration with azithromycin may cause ergotism (a potentially serious adverse effect including numbness or tingling in the extremities, 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 infections caused by the human immunodeficiency virus), as azithromycin blood levels may be increased.
• Fluconazole (medicines for treating fungal infections), as azithromycin blood levels may be increased.
• Terfenadine (a medicine used to treat allergies), as the combination may cause heart problems.
• Rifabutin (a medicine for treating pulmonary tuberculosis and non-pulmonary infections caused by mycobacteria), as it may cause a decrease in white blood cell count.
• Medicines containing active substances that prolong the QT interval, such as class IA (quinidine and procainamide) and class III (dofetilide, amiodarone, and sotalol) antiarrhythmics, 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 heart 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).

Taking Zitromax 500 mg powder with food and drinks

This medicine should be administered as a single daily dose. The contents of the sachet should be added to a glass of water and mixed well. The suspension should be taken immediately, with or without food.

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 you should take this medicine 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 nursing infant, the use of azithromycin during breastfeeding is not recommended, although breastfeeding may be resumed two days after completion of treatment with Zitromax.

Driving and use of machines

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

Zitromax 500 mg powder contains sucrose, glucose, ethanol and sodium

This medicine contains sucrose and glucose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains 0.014% (w/w) ethanol (alcohol); this small amount corresponds to 0.76 mg per sachet.

This medicine contains less than 1 mmol of sodium (23 mg) per sachet; therefore, it is essentially “sodium-free”.

3. How to take Zitromax 500 mg powder

Follow exactly the dosing instructions for the medicine provided in this leaflet or as directed by your doctor. If in doubt, consult your doctor or pharmacist.

Your doctor will determine the most appropriate dose and duration of treatment for you, depending on your condition and your response to treatment. As a general rule, the recommended dose of the medicine and frequency of administration is as follows:

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

The usual dose is 1500 mg taken 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 day 2 to day 5.

Urethral or cervical infection (cervicitis):

The usual dose is 1,000 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 1,000 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:

The sachets may not be suitable for this patient group. Other pharmaceutical forms of azithromycin may be used. It must not be administered to children under 6 months of age.

Use in patients with hepatic impairment

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

Use in patients with renal impairment

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

Method of administration

Oral use.

This medicine should be taken as a single daily dose. The contents of the sachet should be added to a glass containing a small amount of water and mixed well. The suspension should be taken immediately, with or without food.

If you take 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 to maintain 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 medicine and the amount ingested.

If you forget to take Zitromax 500 mg powder

If you miss a dose, take the medicine as soon as possible and continue treatment as prescribed. However, if it is almost time for the next dose, it is better not to take the missed dose and wait for the next scheduled dose. Do not take a double dose to make up for a missed dose. Continue using Zitromax as directed by your doctor.

If you stop treatment with Zitromax 500 mg powder

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

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 (affects at least 1 in 10 people):

• Diarrhea.

Common (affects at least 1 in 100 people):

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

Uncommon (affects at least 1 in 1,000 people):

• Candida fungal infection in the mouth or systemic, 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 tissue inflammation (angioedema).
• Changes in eating behavior (anorexia).
• Nervousness, insomnia.
• Drowsiness, dizziness, taste disturbances, loss of tactile sensation.
• Visual 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 spots, dermatitis, dry skin, excessive sweating, redness.
• Joint inflammation, muscle pain, back pain, neck pain.
• Difficulty urinating, kidney pain.
• Vaginal bleeding, testicular disorders.
• Generalized swelling, weakness, malaise, fatigue, facial edema, chest pain, fever, pain and swelling of the limbs.
• 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 intervention.

Rare (affects at least 1 in 10,000 people):

• Agitation.
• Impaired liver function, yellowing of the skin (jaundice).
• Sensitivity to sunlight (photosensitivity), drug reaction with increased levels of a type of white blood cells (eosinophilia) and generalized symptoms (multiorgan 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 ringing in the ears (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 spots, 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 inflammation of the tissue between the 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

No special storage conditions are required. Store in the original container. Do not refrigerate.

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

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Information for the user

Composition

• The active substance is azithromycin. Each sachet contains 500 mg of azithromycin (as dihydrate).
• The other components (excipients) are: sucrose, anhydrous tribasic sodium phosphate, hydroxypropyl cellulose, xanthan gum, cherry flavour (containing pregelatinized corn starch [E1450]), vanilla flavour (containing glucose, pregelatinized corn starch [E1450] and ethanol), and banana flavour (containing pregelatinized corn starch [E1450]).

Appearance of the medicinal product and contents of the pack

It is presented as a white powder for oral suspension.

It is packaged in a sachet with a laminate structure from outside to inside: paper / LDPE polyethylene / aluminum / heat-sealing resin. Each package contains 3 single-dose sachets.

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 latest 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 for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.