Zithromax 1000 mg powder for oral suspension in sachet

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Zitromax 1000 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 must not be given to others, even if they have the same symptoms, as it may harm them.
• If you think any of the side effects you experience is serious or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What Zitromax 1000 mg powder is and what it is used for
2. What you need to know before taking Zitromax 1000 mg powder
3. How to take Zitromax 1000 mg powder
4. Possible side effects
5. How to store Zitromax 1000 mg powder
6. Further information

1. What Zitromax 1000 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 wastewater or household waste.

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

It is used to treat the following infections:

• Throat, tonsil, ear, or sinus infections.
• 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 taking 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 to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting this medicine

• During treatment with Zitromax, allergic-type reactions (itching, redness, skin rash, swelling, or difficulty breathing, or an allergic reaction to the medicine characterized by increased white blood cells in blood and generalized symptoms) may occur, which could be severe. Inform your doctor, who may decide to discontinue 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 stop treatment 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 so, treatment must be discontinued and your doctor will prescribe the most appropriate treatment.
• 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 diseases, electrolyte imbalances in the blood, 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 if you 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 dosage 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 1000 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 drugs 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 sensations 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 infections caused by 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 antiarrhythmics (quinidine and procainamide) and class III (dofetilide, amiodarone, and sotalol), cisapride, terfenadine, antipsychotic agents (such as pimozide), antidepressants (such as citalopram), and anti-infective agents (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 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 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 if the benefit of treatment outweighs the potential risks.

Azithromycin is excreted in breast milk. Due to potential adverse reactions in the nursing 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 negligible or none.

Zitromax 1000 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 or her before taking this medicine.

Patients with diabetes mellitus should be aware that this medicine contains 9,642.43 mg of sucrose per sachet.

This medicine contains 0.014% (w/w) ethanol (alcohol), corresponding to a small amount of 1.51 mg per sachet.

This medicine contains 36.83 mg of sodium (the main component of table/cooking salt) per sachet. This corresponds to 1.84% of the maximum daily recommended sodium intake for an adult.

3. How to take Zitromax 1000 mg powder

Follow exactly the instructions for use provided in this leaflet or those given 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 response to treatment. As a general rule, the recommended dose of the medicine and frequency of administration is as follows:

Infection of the urethra or cervix (cervicitis):

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

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 only.

Children and adolescents weighing less than 45 kg:

The 1000 mg sachets are not indicated for this patient group. Other pharmaceutical forms of azithromycin may be used. Not to 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 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.

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 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, 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 medicine and the amount ingested.

If you forget to take Zitromax 1000 mg powder

If you miss a dose, take the medicine as soon as possible and continue the treatment as prescribed. However, if the next dose is due soon, 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 the missed dose. Continue using Zitromax as directed by your doctor.

If you stop treatment with Zitromax 1000 mg powder

If you stop 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, Zitromax can 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 (affects at least 1 in 10 people):

• Diarrhea.

Common adverse effects (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 adverse effects (affects at least 1 in 1,000 people):

• Fungal infection caused by Candida in the mouth or generalized, vaginal infection, pneumonia, fungal or bacterial infection, pharyngitis, gastroenteritis, breathing difficulties, rhinitis.
• Decrease in 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, belching, mouth ulcers, increased salivation.
• Rash, pruritus, appearance of raised red rashes, dermatitis, dry skin, excessive sweating, redness.
• Joint swelling, 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), increased bilirubin, urea, creatinine, chloride, glucose, bicarbonate, and platelets in blood, changes in sodium and potassium levels, decreased hematocrit.
• Complications following surgery.

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

• Agitation.
• Liver function disturbances, yellowing of the skin (jaundice).
• Sensitivity to sunlight (photosensitivity), drug reaction with increased eosinophils (eosinophilia) and systemic 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.

• Aggression, anxiety, delirium, hallucinations.

• Loss of consciousness, seizures, decreased sensitivity, 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, 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 Medicines: www.notificaRAM.es.

By reporting adverse 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 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 unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Additional information.

Composition

• The active substance is azithromycin. Each sachet contains 1000 mg of azithromycin (as dihydrate).
• The other components (excipients) are: sucrose, anhydrous trisodium phosphate, hydroxypropyl cellulose, xanthan gum, cherry flavour (contains pregelatinized corn starch [E1450]), vanilla flavour (contains glucose, pregelatinized corn starch [E1450] and ethanol) and banana flavour (contains pregelatinized corn starch [E1450]).

Appearance of the product and contents of the container

It is presented as a white powder for oral suspension.

It is packaged in a sachet with a structure from outer to inner layer: paper / LDPE polyethylene / aluminium / heat-sealing resin. Each pack 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 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 Health Products (AEMPS) http://www.aemps.gob.es/.