ZITROMAX 200 mg/5 ml ORAL SUSPENSION POWDER IN A BOTTLE

2. What you need to know before you take Zitromax 200 mg/5 ml powder

Do not take Zitromax 200 mg/5 ml 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 occur, 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 whites 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 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 impairment, inform your doctor.
• If you have any heart rhythm disturbances (arrhythmias) or factors that predispose you to them (certain heart diseases, electrolyte disturbances in the blood, or certain medications), inform your doctor, as this medicine may contribute to worsening or triggering these disturbances.
• 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

Weight less than 15 kg.

The dose in this group of patients should be measured as accurately as possible. It should not be administered to children under 6 months.

Weight over 45 kg

Same dose as adults, so it is recommended to use other pharmaceutical forms that are more suitable and available on the market.

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

Using Zitromax 200 mg/5 ml powder with other medicines

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

Especially, you should 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, seizures, 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 transplanted patients), as azithromycin may increase cyclosporin levels in the blood, and its levels should be monitored.
• Anticoagulant dicumarinics (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 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 anti-infectives (fluoroquinolones such as moxifloxacin or levofloxacino 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 200 mg/5 ml powder with food and drinks

The reconstituted suspension 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 infant, the use of azithromycin during breastfeeding is not recommended, 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.

Zitromax 200 mg/5 ml powder contains sucrose, glucose, ethanol, and sodium

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

This medicine contains 0.014% ethanol (alcohol), which corresponds to 0.60 mg/5 ml of oral suspension.

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

3. How to take Zitromax 200 mg/5 ml powder

Follow exactly the administration instructions 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:

Children and adolescents weighing less than 45 kg:

The dosage regimen based on weight would be as follows:

*The dose in children with weight less than 15 kg should be measured as accurately as possible.

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 severe kidney problems, as it may be necessary to adjust the normal dose.

Method of administration

Oral route.

The medicine must be reconstituted before use. The reconstituted suspension is almost white with a cherry/banana odor and a slight vanilla odor. The amount of suspension should be measured with the included syringe and administered. This medicine can be taken with or without food.

• Instructions for reconstitution
  1. Invert the bottle and shake it vigorously to release the powder.
  2. Slowly add the following amount of water: 10 ml, 15 ml, or 19 ml, depending on the bottle size, shaking gently at the same time (you can use the included dosing syringe for this).
  3. Place the plastic cap and press it until it is fully inserted into the bottle mouth. Close the bottle with the metal cap. Shake vigorously for 1 or 2 minutes to obtain a homogeneous suspension.
  4. After reconstitution, there will be a useful volume of 15 ml, 30 ml, or 37.5 ml.

• Instructions for using the syringe to administer the previously reconstituted suspension: Shake the closed bottle of reconstituted suspension vigorously before each use for approximately 2 minutes.
  1. Open the bottle
  2. Insert the oral syringe into the bottle neck.
  3. Turn the bottle upside down with the oral syringe and withdraw the prescribed amount of suspension.
  4. Remove the oral syringe from the bottle.
  5. The medicine can be administered directly into the mouth with the oral syringe. The patient should remain upright during administration. Point the oral syringe to the inside of the cheek and release the suspension slowly into the patient's mouth.
  6. Rinse the oral syringe.
  7. Close the bottle with the safety cap; the adapter will remain in the bottle neck.

If you take more Zitromax 200 mg/5 ml 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 take Zitromax 200 mg/5 ml powder

In case of a missed dose, use the medicine as soon as possible and continue 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 200 mg/5 ml powder

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

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

4. Possible Adverse Effects

Like all medicines, Zitromax can produce adverse effects, although not all people suffer from them.

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

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

• Diarrhea.

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

• Infection by the Candida fungus 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 of the deep skin area (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, belching, mouth ulcers, increased salivation.
• Rash, itching, appearance of raised red patches, dermatitis, dry skin, excessive sweating, redness.
• Inflammation of the joints, muscle pain, back pain, neck pain.
• Difficulty urinating, kidney pain.
• Vaginal bleeding, alteration in the testicles.
• Generalized swelling, weakness, discomfort, fatigue, facial edema, chest pain, fever, pain and swelling of the extremities.
• 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 blood, alteration of sodium and potassium levels, decrease in hematocrit.
• Complications after surgical intervention.

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

• Agitation.
• Alteration of liver function, yellowish skin discoloration.
• Sensitivity to sun exposure (photosensitivity), drug reaction with increased white blood cell count (eosinophilia) and generalized symptoms (multi-organ involvement) (DRESS syndrome).
• Skin rash characterized by the rapid appearance of red skin areas sprinkled with small pustules (small blisters filled with white/yellow liquid).

The adverse effects of 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 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, cardiac rhythm disorders, 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 raised red 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 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 adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es.

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

5. Conservation of Zitromax 200 mg/5 ml

Before reconstitution

It does not require special storage conditions. Store in the original container. Do not refrigerate.

After reconstitution:

Validity period: 10 days. Store below 25°C. Do not refrigerate.

Indicate the reconstitution date on the bottle label.

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

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

Medicines should not be thrown away through the sewers or in the trash. Deposit the containers and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This way, you will help protect the environment.

6. Additional Information

Composition

• The active ingredient is azithromycin. Each 1 ml of reconstituted suspension contains 40 mg of azithromycin (as dihydrate). Each 5 ml of reconstituted suspension contains 200 mg of azithromycin (as dihydrate).
• The other components (excipients) are: sucrose, sodium phosphate tribasic anhydrous, hydroxypropyl cellulose, xanthan gum, cherry flavor (contains pregelatinized cornstarch [E1450]), vanilla flavor (contains glucose, pregelatinized cornstarch [E1450], and ethanol), and banana flavor (contains pregelatinized cornstarch [E1450]).

Appearance of the product and container content

It is presented in the form of a white oral suspension powder.

It is packaged in amber glass bottles closed with an aluminum cap and packaged in a cardboard box.

It is presented in 3 container sizes. After reconstitution, the suspension volume is 15 ml, 30 ml, and 37.5 ml. A 10 ml dosing syringe with a pressure adapter to the bottle is included.

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