Zitromax 200 mg/5 ml powder for oral suspension in bottle

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Zitromax 200 mg / 5 ml powder for oral suspension in bottle

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 other people, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What Zitromax 200 mg/5 ml powder is and what it is used for
2. What you need to know before taking Zitromax 200 mg/5 ml powder
3. How to take Zitromax 200 mg/5 ml powder
4. Possible side effects
5. How to store Zitromax 200 mg/5 ml powder
6. Further information

1. What Zitromax 200 mg/5 ml 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 influenza 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 your treatment, return it to the pharmacy for proper disposal. Medicines should not be disposed of down the sink 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).
• Infections of the urethra (urethritis) or cervix (cervicitis), see section 3.
• Sexually transmitted infections (chancroid), see section 3.

2. What you need to know before starting to 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 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 (such as itching, redness, skin rash, swelling, or difficulty breathing, or an allergic reaction characterized by increased white blood cells in blood and generalized symptoms) may occur during treatment with Zitromax, which could be severe. Inform your doctor, who may decide to discontinue treatment and initiate appropriate therapy.
• If you have liver problems, or if 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 require liver function tests.
• If you are taking 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 developing superinfection by resistant organisms, including fungi. If this occurs, inform your doctor.
• During or after treatment with Zitromax, symptoms suggesting antibiotic-associated colitis (diarrhea) may appear. If so, 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 that predispose you to them (certain heart conditions, 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 condition.

Children and adolescents

Weight below 15 kg

The dose in this patient group must be measured as precisely as possible. It must not be administered to children under 6 months of age.

Weight above 45 kg

Same dose as adults; therefore, 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 of age.

Taking Zitromax 200 mg/5 ml 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). Simultaneous administration of both drugs at the same time of day should be avoided.
• 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 HIV infections), 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 of both 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-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 200 mg/5 ml powder with food and drinks

The reconstituted suspension may 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 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 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 using machines

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

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

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

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

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

3. How to take Zitromax 200 mg/5 ml 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 dosage and frequency of administration are as follows:

Children and adolescents weighing less than 45 kg:

The dosing regimen based on body weight is as follows:

*The dose in children weighing less than 15 kg should be measured as precisely as possible.

Use in patients with hepatic impairment

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

Use in patients with renal impairment

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

Method of administration

Oral use.

The medicine must be reconstituted before use. The reconstituted suspension is almost white with a cherry/banana odor and a slight vanilla scent. The amount of suspension should be measured using the syringe provided in the package, and the suspension should then be administered. This medicine may be taken with or without food.

• Instructions for reconstitution

  1. Invert the vial and shake vigorously to loosen the powder.
  2. Slowly add the following amount of water: 10 ml, 15 ml, or 19 ml, depending on the vial size, while gently shaking (you may use the provided dosing syringe for this).
  3. Place the perforated plastic cap onto the vial and press it down until it is fully inserted into the mouth of the vial. Close the vial with the metal cap. Shake vigorously for 1 to 2 minutes to obtain a homogeneous suspension.
  4. After reconstitution, the usable volume will be 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 for approximately 2 minutes before each use.

  1. Open the vial.
  2. Attach the oral syringe to the neck of the vial.
  3. Turn the vial upside down with the oral syringe facing downward and withdraw the amount of suspension prescribed by the doctor.
  4. Remove the oral syringe from the vial.
  5. The medicine may be administered directly into the mouth using the oral syringe. The patient should remain upright during administration. Direct the oral syringe toward the inside of the cheek and slowly release the suspension into the patient's mouth.
  6. Rinse the oral syringe.
  7. Close the vial with the safety cap; the adapter will remain in the neck of the bottle.

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, 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 200 mg/5 ml powder

If you miss a dose, take the medicine as soon as possible and continue treatment as prescribed. However, if the next dose is due soon, it is better not to take the missed dose and simply 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 200 mg/5 ml powder

If you discontinue 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 (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.

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

• Candida fungal infection in the mouth or generalized, vaginal infection, pneumonia, fungal or bacterial infection, pharyngitis, gastroenteritis, breathing difficulties, rhinitis.
• Decreased number of 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 spots, 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 extremities.
• Abnormal liver function tests (increased liver enzymes GOT, GPT, and alkaline phosphatase) and increased bilirubin, urea, creatinine, chloride, glucose, bicarbonate, and platelets in blood; altered levels of sodium and potassium; decreased hematocrit.
• Post-surgical complications.

Rare (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 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.

• Aggression, anxiety, delirium, hallucinations.

• Loss of consciousness, seizures, decreased sensation, hyperactivity, disturbance 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 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 adverse effect, consult your doctor, pharmacist, or nurse, even if it is an adverse 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 200 mg/5 ml

Before reconstitution

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

After reconstitution:

Shelf life: 10 days. Store below 25°C. Do not refrigerate.

Indicate the date of reconstitution on the label of the bottle.

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 refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Information for the user

Composition

• The active substance 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, anhydrous tribasic sodium phosphate, hydroxypropylcellulose, 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 medicinal product and contents of the container

It is presented as a white powder for oral suspension.

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

It is available 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 press-in adapter for the bottle is included.

Marketing Authorisation Holder and Manufacturer

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