ZITROMAX 1000 mg ORAL SUSPENSION POWDER IN SACHET

2. Before you take Zitromax 1000 mg powder

Do not take Zitromax 1000 mg 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 increased 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 potentially serious 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 kidney function impairment, inform your doctor.
• If you have heart rhythm disturbances (arrhythmias) or factors that predispose you to them (certain heart diseases, electrolyte level alterations 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

Children and adolescents weighing less than 45 kg.

The sachets may not be indicated for this group of patients. Other pharmaceutical forms of azithromycin can be used. 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 more suitable pharmaceutical forms available on the market.

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

Using Zitromax 1000 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 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 extremities, 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).
• Cyclosporin (a medicine used in transplanted patients), as azithromycin may increase cyclosporin levels in the blood, and its levels should be monitored.
• Anticoagulant dicumarolics (medicines used to prevent blood clots), as azithromycin may enhance the effect of these anticoagulants. Your doctor should control 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 it 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 and non-pulmonary tuberculosis and 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 antiarrhythmic drugs 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 levofloxacin and chloroquine), as it 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 1000 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 with a little water, mixing 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, or are planning to have a baby, consult your doctor or pharmacist before using 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 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 1000 mg 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.

Patients with diabetes mellitus should note that this medicine contains 9.642,43 mg of sucrose per sachet.

This medicine contains 0.014% (w/w) ethanol (alcohol), which corresponds to 1.51 mg per sachet.

This medicine contains 36.83 mg of sodium (a major component of table salt) per sachet. This is equivalent to 1.84% of the maximum recommended daily intake of sodium for an adult.

3. How to take Zitromax 1000 mg powder

Follow the instructions for administration 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:

Urethra or cervix infection (cervicitis):

The usual dose is 1,000 mg taken as a single dose, in one day.

In case 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, in one day.

Children and adolescents weighing less than 45 kg:

The 1000 mg sachets are not indicated for this group of patients. Other pharmaceutical forms of azithromycin can be used. It should not be administered to children under 6 months.

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.

Method of administration

Oral route.

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

If you take more Zitromax 1000 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 on 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Zitromax 1000 mg powder

In case of missed dose, use the medicine as soon as possible, continuing 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 1000 mg powder

If you stop treatment with Zitromax before your doctor recommends, 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 side effects

Like all medicines, Zitromax can cause side effects, although not everybody gets them.

The 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 of 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:

• Candida fungal infection 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 a deep skin inflammation (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.
• 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 the blood, alteration of sodium and potassium levels, decrease in hematocrit.
• Complications after surgical intervention

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

• Agitation.
• Liver function alteration, yellowing of the skin.
• Sensitivity to sun exposure (photosensitivity), drug reaction with increased eosinophils and generalized symptoms (DRESS syndrome).
• Skin rash characterized by the rapid appearance of red skin areas with small pus-filled bumps (small blisters filled with white/yellow liquid).

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

• Clostridium difficile-associated diarrhea.
• 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).
• Hearing alteration, including deafness and ringing.
• Torsades de pointes, heart rhythm disturbances, 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, even if it is a side effect not listed in this leaflet. You can also report them 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 1000 mg powder

No special storage conditions are required. Store in the original package. 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 packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Additional Information.

Composition

• The active ingredient is azithromycin. Each sachet contains 1000 mg of azithromycin (as dihydrate).
• The other components (excipients) are: sucrose, anhydrous tribasic sodium phosphate, hydroxypropylcellulose, xanthan gum, cherry flavor (contains pregelatinized corn starch [E1450]), vanilla flavor (contains glucose, pregelatinized corn starch [E1450] and ethanol) and banana flavor (contains pregelatinized corn starch [E1450]).

Appearance of the product and packaging content

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

It is packaged in a sachet with a composition from outside to inside: paper / LDPE polyethylene / aluminum / heat-sealable resin. Each package contains 1 single-dose sachet.

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