PATIENT INFORMATION LEAFLET

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

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 serious 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 nasal sinus infections.
• Mild to moderate bronchitis and pneumonia.
• Mild to moderate skin and soft tissue infections.
• Urethritis or cervicitis, see section 3.
• Sexually transmitted infections (chancroid), see section 3.

Do not take Zitromax200 mg/5 mlpowder

• if you are allergic to azithromycin, erythromycin, other macrolide or ketolide antibiotics, or any of the other ingredients in 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 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 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 occur 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 alterations, 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 occur during treatment, inform your doctor, as Zitromax may trigger or worsen symptoms of this disease.

Children and adolescents

Weight less than 15 kg.

The dose in this patient group should be measured as accurately as possible. Do not administer to children under 6 months.

Weight over 45 kg

The 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.

Use of Zitromax 200 mg/5 ml powder with other medications

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

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 elevate 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 elevate 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 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 cells in the blood.
• Medications with active substances that prolong the QT interval, such as antiarrhythmic class IA (quinidine and procainamide) and class III (dofetilide, amiodarone, and sotalol), 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 (for treating allergic reactions); didanosine, efavirenz, indinavir (for treating HIV infections); 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 drinksand beverages

The reconstituted suspension can be ingested 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 can continue 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 200 mg/5 ml 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% ethanol (alcohol), which corresponds to 0.60 mg/5 ml of oral suspension.

This medication contains less than 1 mmol of sodium (23 mg) per dose; 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:

Children and adolescents weighing less than 45 kg:

The dosing regimen based on weight would be as follows:

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

Use in patients with liver insufficiency

Inform your doctor if you have severe liver problems, as it may be necessary to adjust the normal dose.

Use in patients with renal insufficiency

Inform your doctor if you have severe kidney problems, as it may be necessary to adjust the normal dose.

Administration form

Oral route.

The medication must be reconstituted before use.The reconstituted suspension is almost white with a cherry/plantain odor and a light vanilla odor.Measure the amount of the suspension with the syringe included in the package and administer the suspension. This medication 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 size of the bottle, while shaking gently at the same time (you can use the dosing syringe that comes with it).

3. Place the plastic stopper with a hole and press it until it is inserted into the mouth of the bottle. 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 usable 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 the reconstituted suspension vigorously before each use for approximately 2 minutes.

1. Open the bottle

2. Insert the oral syringe into the neck of the bottle.

3. Turn the bottle with the oral syringe down and remove the prescribed amount of suspension.

4. Remove the oral syringe from the bottle.

5. The medication can be administered directly into the mouth with the oral syringe. The patient should remain upright during administration. Point the oral syringe for use at the inside of the cheek and slowly release the suspension into the patient's mouth.

6. Rinse the oral syringe.

7. Close the bottle with the safety closure; 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, 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 200 mg/5 ml powder

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

If you stop 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 effectsfrequent (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 of 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 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

Side effectsrare (in at least 1 in 10,000 people)are:

• Agitation.
• Liver function alteration, 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).
• Characterized by the rapid appearance of red skin areas dotted with small white/yellow-filled blisters (small pustules).

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

• Diarrhea caused byClostridium 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 kidney failure and 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 the 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.

Before reconstitution

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

After reconstitution:

Expiration date: 10 days. Store below 25°C. Do not refrigerate.

Indicate the reconstitution date on the bottle label.

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

Do not use this medication after the expiration date that appears on the container 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 your pharmacy.In case of doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition

• The active principle 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 tribasic anhydrous phosphate, hydroxypropylcellulose, 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 contents of the package

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

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

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Pfizer, S.L. Avda. de Europa, 20 B

Parque Empresarial La Moraleja.

28108 Alcobendas.

Spain

Responsible for manufacturing:

Farmasierra Manufacturing S.L.

Ctra. N-1, Km26,200.

28709 San Sebastián de los Reyes.

Spain.

Last review date of this leaflet:June 2023

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