PATIENT INFORMATION LEAFLET

Zitromax 500 mg powder for oral suspension in a packet

Azithromycin

Read this leaflet carefully before starting to take the medicine

• Keep this leaflet as you may need to read it again.
• If you have any doubts, consult 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 consider that any of the side effects you are experiencing is severe or if you notice any side effect not mentioned in this leaflet, inform 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 caused by bacteria in different parts of the body, in adults and in children with a weight of 45 kg or more.

It is used for the treatment of the following infections:

• Throat, tonsil, ear, or sinus infections.
• Mild to moderate bronchitis and pneumonia.
• Mild to moderate skin and soft tissue infections.
• Urethritis or cervicitis, see section 3.
• Chancroid, see section 3.

Do not take Zitromax 500 mg powder

• if you are allergic to azithromycin, erythromycin, other macrolide antibiotics, or ketolide antibiotics, or any of the other ingredients of 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 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 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 a condition called ergotism.
• During treatment with this medication, there is a possibility of 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 impairment, 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 conditions.
• 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

Children and adolescents weighing less than 45 kg.

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

Weight over 45 kg

The 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 old.

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.

You must 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 with 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 levels of azithromycin in the blood may be increased.
• Fluconazole (medications used to treat fungal infections), as levels of azithromycin in the blood may be increased.
• Terfenadine (a medication used to treat allergies), as the combination of both 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 heart 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).

Taking Zitromax 500 mg powder with food and drinks

This medication should be taken 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 intend to become pregnant, inform your doctor or pharmacist before using this medication.

Your doctor will assess whether you should take this medication 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 saccharose, glucose, ethanol, and sodium

This medication contains saccharose and glucose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains 0.014% (p/p) of ethanol (alcohol), which corresponds to 0.76 mg per sachet.

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

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

Your doctor will establish the most suitable dose and treatment duration 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) and children with a body weight of over 45 kg:

The usual dose is 1500 mg divided 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 the 2nd to the 5th day.

Urethral or cervical infection (cervicitis):

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

In the case of an infection caused by N. gonorrohea, 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 a single day.

Sinusitis:

Treatment is indicated for adults and adolescents over 16 years old.

Children and adolescents weighing less than 45 kg:

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

Use in patients with liver insufficiency

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

Use in patients with renal insufficiency

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

Administration form

Oral route.

This medication should be taken 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 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, administration of activated charcoal 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 the amount ingested.

If you forget to take Zitromax 500 mg powder

In case of forgotten dose, use the medication as soon as possible, continuing 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 compensate for the missed dose. Continue using Zitromax as your doctor has indicated.

If you interrupt treatment with Zitromax 500 mg powder

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

If you have any other doubts 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 effectscommon (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.
• 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 effectsrare (in at least 1 in 10,000 people)are:

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

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

• Diarrhea caused by Clostridium difficile.
• Decrease in platelets 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 QTc interval in electrocardiogram.
• Decrease in blood pressure.
• Pancreatitis, change in color of the tongue.
• Severe liver damage and hepatic failure that rarely can 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 renal failure and inflammation of the tissue between renal tubules (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 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.

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

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.

Medications should not be disposed of through drains or in the trash.Deposit the containers and medications you no longer need at the SIGRE point of the pharmacy.Ask your pharmacist if you are unsure how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition

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

Appearance of the product and contents of the package

It is presented in the form of an oral suspension powder, white in color.

It is packaged in sachetswith an outer-to-inner composition: paper / low-density polyethylene (LDPE)/ aluminum / heat-sealed resin. Each package contains 3 single-dose sachets.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Pfizer, S.L.

Avda. de Europa, 20 B

Parque Empresarial La Moraleja.

28108 Alcobendas.

Spain.

Responsible manufacturer:

Farmasierra Manufacturing S.L.

Ctra. N-1, Km26,200.

28709 San Sebastián de los Reyes.

Spain.

Last review date of this leaflet:June 2023

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