AZITHROMYCIN SANDOZ 200 mg/5 ml ORAL SUSPENSION POWDER

Introduction

Package Leaflet: Information for the Patient

Azithromycin Sandoz 200 mg/5 ml Powder for Oral Suspension EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Azithromycin Sandoz is and what it is used for
2. What you need to know before you take Azithromycin Sandoz
3. How to take Azithromycin Sandoz
4. Possible side effects
5. Storage of Azithromycin Sandoz
6. Contents of the pack and other information

1. What Azithromycin Sandoz is and what it is used for

Azithromycin is an antibiotic. It belongs to a group of antibiotics called macrolides. It is used to treat infections caused by bacteria.

This medicine is usually prescribed to treat:

• lung infections such as chronic bronchitis, pneumonia,
• infections of the tonsils, throat (pharyngitis), and paranasal sinuses,
• ear infections (acute otitis media),
• skin and soft tissue infections, with the exception of burn wound infections,

• urethra and cervix infections caused by Chlamydia.

2. What you need to know before you take Azithromycin Sandoz

Do not take Azithromycin Sandoz if you are allergic (hypersensitive) to:

• azithromycin,
• erythromycin,
• other macrolide or ketolide antibiotics,
• any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take azithromycin if you have:

• azithromycin may cause allergic reactions (itching, skin rash). You may know that an allergic reaction is severe if you experience sudden swelling of the face or throat (angioedema) that makes breathing difficult or if you suddenly feel very ill (shock). High fever, skin rash, blisters on the skin, skin peeling, joint pain, and/or eye inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS syndrome, or acute generalized exanthematous pustulosis) may also be signs of a severe allergic reaction. If you experience any of these symptoms, contact your doctor immediately.
• if you have liver problems, you must inform your doctor before starting to take azithromycin. Cases of extremely severe liver inflammation with potentially fatal effects have been observed. You should contact your doctor if you experience symptoms such as:
• sudden physical weakness (asthenia) accompanied by jaundice, dark urine, tendency to bleed, or reduced level of consciousness (hepatic encephalopathy). Your doctor will review your liver function and will probably instruct you to stop taking azithromycin.kidney problems:if you have severe kidney problems, it may be necessary to adjust the dose,
• nervous system problems(neurological) or mental problems(psychiatric),
• heart problemssuch as:
• • weakened heart (heart failure),
  • very slow heart rate,
  • irregular heartbeat, or
  • a disorder called "prolonged QT syndrome" (detected by an electrocardiogram) since azithromycin may increase the risk of abnormal heart rhythm,
• low potassiumor magnesiumlevels in the blood,
• myasthenia gravis, a type of muscle weakness,
• if you have had infections with azithromycin, erythromycin, lincomycin, and/or pathogens resistant to clindamycin or methicillin-resistant staphylococci (possibility of cross-resistance).

If you develop diarrhea or soft stools during or after treatment, inform your doctor immediately. Do not take any medicine to treat your diarrhea without consulting your doctor first. If your diarrhea continues, inform your doctor.

Tell your doctor

• if you notice that your symptoms worsen during or shortly after your treatment (possibility of superinfection/resistance).

Azithromycin is not suitable for treating severe infections, where high concentrations of antibiotics in the blood need to be achieved rapidly.

Children and adolescents up to 18 years.

If you give this medicine to a newborn baby (less than 6 weeks) and the baby vomits or becomes agitated during breastfeeding, inform your doctor immediately.

Other medicines and Azithromycin Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines obtained without a prescription.

It is especially important that you mention if you are taking:

• theophylline(used to treat asthma): the effect of theophylline may increase,
• blood-thinning medicines, such as warfarin, phenprocoumon:

concomitant use may increase the risk of bleeding. Your doctor may need to monitor your blood coagulation parameters more frequently when also taking azithromycin,

• ergotamine, dihydroergotamine(used to treat migraine): ergotism (e.g., itching in the extremities, muscle cramps, and gangrene of hands and feet due to poor blood circulation) may occur. Therefore, concomitant use is not recommended,
• cyclosporin(used to suppress the immune system to prevent and treat organ rejection or bone marrow transplantation): if concomitant use is necessary, your doctor will monitor the cyclosporin levels in your blood and may adjust the dose,
• digoxin(used for heart failure): concomitant use may increase digoxin levels. Your doctor will monitor these levels in your blood,
• colchicine(used for gout and familial Mediterranean fever), the amount of colchicine in the blood should be monitored more frequently and it may be necessary to adjust the dose of colchicine,
• antacids(used for indigestion): may make azithromycin less effective when used concomitantly, see section 3,
• cisapride(used for stomach problems), terfenadine(used to treat hay fever), pimozide(used in some mental disorders), citalopram(used in depression),fluoroquinolones(antibiotics such as moxifloxacin and levofloxacin, used in bacterial infections): concomitant use with azithromycin may cause heart problems, therefore it is not recommended,
• certain medicines to control irregular heartbeat(called antiarrhythmics, such as quinidine, amiodarone, sotalol). Concomitant use is not recommended,
• zidovudine(used to treat HIV infections): concomitant use may increase the risk of adverse reactions,
• nelfinavir(used to treat HIV infections): concomitant use may increase the risk of adverse effects,
• alfentanil(used for anesthesia) or astemizole(used to treat hay fever): concomitant use with azithromycin may increase the effect of these medicines,
• rifabutin(used to treat tuberculosis): your doctor should monitor your blood and the levels of these medicines,
• statins(such as atorvastatin, used to lower blood lipids): concomitant use may cause muscle disorders,
• certain medicines (such as hydroxychloroquine) that are known to cause abnormal heart rhythm, e.g., a prolonged QT interval detected by an electrocardiogram: concomitant use may increase the risk of arrhythmia,
• coumarin anticoagulants(prevent blood clot formation); although azithromycin does not appear to alter the anticoagulant effect of coumarin medicines, it may be necessary to check your coagulation more frequently and adjust the dose of your medication.

Taking Azithromycin Sandoz with food and drinks

Azithromycin Sandoz can 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 have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Your doctor will decide whether you should take this medicine during pregnancy, only after ensuring that the benefits outweigh the possible risks.

Breastfeeding

It has been reported that azithromycin is excreted in human milk. No serious adverse reactions to azithromycin have been observed in breastfed infants.

Driving and using machines

This medicine may cause side effects such as visual disturbances, blurred vision, dizziness, and drowsiness. This may affect your ability to drive and use machines.

Azithromycin Sandoz contains sucrose, sodium, aspartame, benzyl alcohol, and sulfites

Sucrose

This medicine contains 3.71 g of sucrose per 5 ml of suspension, which should be taken into account in patients with diabetes mellitus.

If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

Aspartame

This medicine contains 0.030 g of aspartame per 5 ml of suspension. Aspartame is a source of phenylalanine, which may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly.

Sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; this is essentially "sodium-free".

Benzyl alcohol

This medicine contains up to 410 nanograms of benzyl alcohol per 5 ml of suspension. Benzyl alcohol may cause allergic reactions.

Do not administer this medicine to your newborn (up to 4 weeks of age) unless your doctor has recommended it. This product should not be used for more than one week in children under 3 years of age unless your doctor or pharmacist has indicated it. Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol can accumulate in the body and cause adverse effects (metabolic acidosis).

Sulfites

This medicine contains up to 85 nanograms of sulfites per 5 ml of suspension. It may rarely cause severe allergic reactions and bronchospasm.

3. How to take Azithromycin Sandoz

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Azithromycin 200mg/5ml:

Adults and children over 45 kg in weight:

Azithromycin can be taken in 3 or 5-day treatments.

• 3-day treatment: take 12.5 ml (500 mg) once a day each day.
• 5-day treatment:
• • take 12.5 ml (500 mg) on day 1
  • take 6.25 ml (250 mg) on days 2, 3, 4, and 5.

In urethra and cervix infections caused by Chlamydiathe treatment is for 1 day:

• 1-day treatment: 25 ml (1,000 mg).

The dose for the treatment of sore throat is an exception. Your doctor may prescribe a different dose.

Children under 45 kg in weight:

Azithromycin is not recommended for use in children under 1 year of age.

Azithromycin can be taken in 3 or 5-day treatments. The daily amount is determined based on the child's weight.

The following tables are a guide to the most common doses

3-day treatment

5-day treatment

Patients with kidney or liver failure

Tell your doctor if you have kidney or liver problems, as you may need a modification of your usual dose.

Dose in elderly

The dose for elderly patients is the same as for adults.

Take this medicine once a day. It can be taken with or without food.

The bitter aftertaste can be avoided by taking a little juice after swallowing.

Taking Azithromycin Sandoz with indigestion medicines

If you need to take an indigestion medicine, such as an antacid, take azithromycin with a 2-hour interval before or after the antacid.

How to measure the dose

This medicine is provided with a 10 ml dosing syringe with marks every 0.25 ml. It has an adapter that fits onto the bottle. To measure the medicine:

• shake the bottle,
• put the adapter on the bottle mouth,
• insert the syringe tip into the adapter,
• turn the bottle upside down,
• pull the plunger to measure the required dose,
• turn the bottle back up, remove the syringe, leave the adapter in place, and close the bottle.

Consult your doctor or pharmacist if you need advice on how to measure the medicine.

Administration of the medicine using the syringe:

• make sure the child is sitting up,
• carefully insert the syringe tip into the child's mouth. Point the syringe tip towards the inside of the cheek,
• slowly push the syringe plunger: do not empty it quickly. The medicine will enter the child's mouth,
• give the child time to swallow the medicine.

How to prepare this medicine

A doctor, nurse, or pharmacist will prepare this medicine for you. To open the bottle, press the cap down and turn it at the same time.

If you need to prepare it yourself, you must shake the dry powder and add the correct amount of cold water. You can measure the correct amount of water with the 10 ml syringe. The amount of water depends on the bottle size and is as follows:

• For 15 ml of suspension (600 mg) add 8.0 ml of water
• For 20 ml of suspension (800 mg) add 10.5 ml of water
• For 22.5 ml of suspension (900 mg) add 11 ml of water
• For 30 ml of suspension (1,200 mg) add 15 ml of water
• For 37.5 ml of suspension (1,500 mg) add 18.5 ml of water

Shake the bottle well as soon as you have added the correct amount of water. The suspension should only be prepared once, at the start of treatment.

If you take more Azithromycin Sandoz than you should

If you take too much, you may feel unwell. You may also experience other side effects such as temporary hearing loss, nausea, vomiting, and diarrhea.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount used.

If you forget to take Azithromycin Sandoz

If you forget to take a dose, take it as soon as possible and continue the treatment. Do not take more than one dose per day.

If you stop taking Azithromycin Sandoz

Keep taking the oral suspension until the treatment is finished, even if you feel better. If you stop taking the oral suspension too soon, the infection may come back. Also, the bacteria may become resistant to the medicine and be harder to treat.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can have adverse effects, although not all people suffer from them.

Severe Adverse Effects:

If you experience any of the following symptoms of a severe allergic reaction, discontinue treatment and consult your doctor immediatelyor go to the emergency department of the nearest hospital:

• sudden difficulty breathing, speaking, and swallowing,
• inflammation of the lips, tongue, face, and neck,
• severe dizziness or collapse,
• severe skin rash or itching, especially if accompanied by a burning sensation and pain in the eyes, mouth, or genital organs.

If you experience any of the following adverse effects, contact your doctor as soon as possible:

• severe, prolonged, or bloody diarrhea, with stomach pain or fever. This can be a sign of severe intestinal inflammation. This can occur exceptionally after antibiotic administration,
• yellowing of the skin or whites of the eyes caused by liver problems,
• pancreatitis, which causes severe abdominal and back pain,
• increased or decreased urine output, or blood in the urine,
• skin rash caused by sensitization to sunlight,
• appearance of bruises or bleeding,
• irregular heartbeat.

All these are severe adverse reactions. You may need urgent medical attention. Severe adverse reactions are rare (may affect up to 1 in 100 people), uncommon (may affect up to 1 in 1,000 people), or frequency not known: cannot be estimated from available data.

Other Possible Adverse Effects:

Adverse effects very common(may affect more than 1 in 10 people):

• diarrhea,
• abdominal pain,
• nausea,
• gas (flatulence).

Adverse effects common(may affect up to 1 in 10 people):

• headache,
• vomiting,
• altered taste (dysgeusia),
• dizziness,
• drowsiness,
• tingling, itching, or numbness without apparent reason (paresthesia),
• vision problems,
• hearing loss,
• belching and stomach acid (dyspepsia),
• skin rash, itching (pruritus),
• joint pain (arthralgia),
• fatigue,
• changes in white blood cell counts (low leukocyte count, high eosinophil count, high basophil count, monocytes, and neutrophils),
• decrease in blood bicarbonate (indicating too many acidic substances in the blood).

Adverse effects uncommon(may affect up to 1 in 100 people):

• fungal infections, especially in the mouth, throat, nose, lungs, stomach, intestine, and vagina,
• low white blood cell count (type of white blood cells), low neutrophil count (type of white blood cells), high eosinophil count (type of white blood cells)-,
• swelling, allergic reactions of varying severity (angioedema),
• loss of appetite (anorexia),
• nervousness, insomnia, tingling or numbness of hands or feet,
• hearing problems, ringing in the ears (tinnitus), sensation of spinning (vertigo),
• strong heartbeats,
• sensation of intense heat with sweating and rapid heartbeat (hot flashes),
• difficulty breathing, nosebleeds,
• constipation, flatulence, indigestion, stomach inflammation, difficulty swallowing, bloating, dry mouth, gas, mouth sores, increased saliva production,
• hives, skin inflammation, dry skin, sweating,
• Stevens-Johnson syndrome,
• inflammation of bones and joints, muscles, neck and back pain,
• difficulty and pain when urinating, kidney pain,
• uterine bleeding, testicular disorders,
• skin swelling, weakness, general feeling of discomfort, fatigue, facial swelling, chest pain, fever, pain, swelling of limbs,
• laboratory test abnormalities (e.g., blood test results, liver, and kidney tests),
• post-surgical complications,
• throat inflammation (pharyngitis)
• hypersensitivity to light or sunlight, possibly with development of skin anomalies (photosensitivity reaction)
• abnormal liver function
• reduced sensory sensitivity (hypoesthesia).

Rare Adverse Effects(may affect up to 1 in 1,000 people):

• irritability,
• jaundice,
• agitation,

-

• skin rash characterized by the rapid appearance of red areas with small blisters (small white/yellow fluid-filled bumps), (acute generalized exanthematous pustulosis [AGEP])
• delayed allergic reaction (up to several weeks after exposure) with skin rash and other possible symptoms, such as facial swelling, inflamed glands, and altered test results (e.g., liver tests and elevated levels of certain white blood cells) (drug reaction with eosinophilia and systemic symptoms [DRESS])

Frequency Not Known (cannot be estimated from available data)

• low red blood cell count, which can cause pale yellowish skin and weakness or difficulty breathing,
• reduced platelet count, which can increase the risk of bleeding or bruising,
• severe allergic reaction,
• aggression, anxiety, severe confusion, hallucinations,
• fainting, seizures, feeling hyperactive, altered sense of smell, loss of sense of smell and taste, muscle weakness (myasthenia gravis),
• arrhythmia, abnormal electrocardiogram (ECG),
• low blood pressure,
• discoloration of the tongue, discoloration of the teeth,
• renal failure, severe liver inflammation,
• toxic epidermal necrolysis
• erythema multiforme,

The following adverse reactions have been reported in prophylaxis and treatment against Mycobacterium Avium Complex (MAC):

Adverse reactions very common(may affect more than 1 in 10 people)

• diarrhea,
• abdominal pain,
• feeling of discomfort (nausea),
• gas (flatulence),
• abdominal discomfort,
• loose stools.

Adverse reactions common(may affect up to 1 in 10 people)

• loss of appetite (anorexia),
• feeling of dizziness (dizziness),
• headache,
• tingling or numbness (paresthesia),
• changes in taste (dysgeusia),
• vision disorders,
• hearing loss,
• skin rashes,
• itching (urticaria),
• joint pain (arthralgia),
• fatigue.

Adverse reactions uncommon(may affect up to 1 in 100 people)

• reduced sense of touch (hypoesthesia),
• hearing disorders or ringing in the ears (tinnitus),
• abnormal heart rhythm or speed and awareness of heartbeats (palpitations),
• liver problems such as hepatitis,

• blisters/bleeding of the lips, eyes, nose, mouth, and genitals, which can be caused by Stevens-Johnson syndrome,
• allergic reactions such as sensitivity to sunlight, redness, peeling, and swelling of the skin,
• weakness (asthenia),
• general feeling of discomfort or being unwell (malaise).

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system: Spanish Medicines and Health Products Agency: https://www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Azithromycin Sandoz

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date stated on the packaging after CAD/EXP. The expiration date is the last day of the month indicated.

Closed vial with dry powder: Do not store above 30 °C.

Reconstituted suspension: Do not store above 25 °C.

Do not use the reconstituted suspension after more than 10 days.

If you are given the suspension at the pharmacy: do not use it after more than 10 days from the delivery date. The delivery date is stated on the pharmacy label.

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

6. Package Contents and Additional Information

Azithromycin Sandoz Composition

• The active ingredient is azithromycin. Each 5 ml of reconstituted suspension contains 209.6 mg of azithromycin dihydrate equivalent to 200 mg of azithromycin.

The other ingredients are: sucrose, xanthan gum (E415) hydroxypropylcellulose, trisodium phosphate anhydrous, colloidal anhydrous silica (E551), aspartame (E951), banana flavor (contains sulfites), vanilla flavor (contains benzyl alcohol), cherry flavor (contains sulfites).

Product Appearance and Package Contents

Azithromycin Sandoz is a white or almost white crystalline powder.

After reconstitution, a homogeneous white or almost white suspension is obtained.

Azithromycin Sandoz 200 mg/5 ml oral suspension is available in HDPE bottles containing 15 ml (600 mg); 20 ml (800 mg); 22.5 ml (900 mg); 30 ml (1,200 mg); and 37.5 ml (1,500 mg).

A 10 ml dosing syringe, graduated in 0.25 ml divisions, is included.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Verovškova, 57

SLO-1526 Ljubljana

Slovenia

or

Salutas Pharma GmbH,

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

or

Sandoz S. R. L.,

Str. Livezeni nr. 7A

RO-540472 Targu-Mures

Romania

This medicine is authorized in the Member States of the European Economic Area under the following names:

Austria: Azithromycin Sandoz 200 mg/5 ml - Pulver zur Herstellung einer Suspension zum Einnehmen

Belgium: Azithromycine Sandoz 200mg/5ml poeder voor orale suspensie

Finland: Azithromycin Sandoz 40 mg/ml jauhe oraalisuspensiota varten

Hungary: Azithromycin Sandoz 40 mg/ml por belsoleges szuszpenzióhoz

Italy: AZITROMICINA Sandoz GmbH

Netherlands: Azitromycine Sandoz 200 mg/5 ml, poeder voor orale suspensie

Poland: AzitroLEK

Romania: AZITROMICINA SANDOZ 200 mg/ 5 ml pulbere pentru suspensie orala

Slovakia: Azithromycin Sandoz 200mg/5ml prášok na perorálnu suspenziu

United Kingdom

(Northern Ireland): Azithromycin 200mg/5ml Powder for Oral Suspension

Date of the last revision of this leaflet:December 2024

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