Azithromycin Sandoz 200 mg/5 ml powder for oral suspension EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Azithromycin Sandoz 200 mg/5 ml powder for oral suspension EFG

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Azitromicina 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.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as influenza or the common cold. It is important to follow the instructions regarding dosage, administration interval, and duration of treatment as indicated by your doctor. Do not store or reuse this medication. If you have any leftover antibiotics after completing the treatment, return them to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

This medicine is commonly prescribed to treat:

• lung infections such as chronic bronchitis, pneumonia,

• infections of the tonsils, throat (pharyngitis), and sinuses,

• ear infections (acute otitis media),

• skin and soft tissue infections, except for wounds from infected burns,

• infections of the urethra and cervix caused by Chlamydia.

2. What you need to know before taking Azithromycin Sandoz

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

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

Warnings and precautions

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

• azithromycin may cause allergic reactions (itching, rash). You may recognize a serious allergic reaction if you experience sudden swelling of the face or throat (angioedema) making breathing difficult, or if you suddenly feel very unwell (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 serious allergic reaction. If you experience any of these symptoms, contact your doctor immediately.
• liver problems: inform your doctor before starting azithromycin. Cases of extremely severe liver inflammation with potentially life-threatening effects have been observed. Contact your doctor immediately 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 assess your liver function and may advise you to stop taking azithromycin.
• kidney problems: if you have severe renal impairment, dose adjustment may be necessary,
• neurological or psychiatric conditions,
• heart problems such as:
  • weakened heart (heart failure),
  • very slow heart rate,
  • irregular heartbeat, or
  • a condition called “QT prolongation syndrome” (detected by electrocardiogram), as azithromycin may increase the risk of abnormal heart rhythms,
• low levels of potassium or magnesium in the blood,
• myasthenia gravis, a type of muscle weakness,
• if you have previously had infections treated with azithromycin, erythromycin, lincomycin and/or pathogens resistant to clindamycin or methicillin-resistant staphylococci (possibility of cross-resistance).

If you develop diarrhea or loose stools during or after treatment, inform your doctor immediately. Do not take any medication for your diarrhea without first consulting your doctor. If your diarrhea persists, inform your doctor.

Tell your doctor

• if you notice your symptoms worsening during or shortly after treatment (possible superinfection/resistance).

Azithromycin is not suitable for treating severe infections where high antibiotic blood concentrations must be achieved rapidly.

Children and adolescents under 18 years of age

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

Other medicines and Azithromycin Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to 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 clotting parameters more frequently while you are also taking azithromycin,
• ergotamine, dihydroergotamine (used to treat migraine): ergotism (e.g., itching in the limbs, muscle cramps, and gangrene of hands and feet due to poor blood circulation) may occur. Therefore, concomitant use is not recommended,
• cyclosporine (used to suppress the immune system to prevent and treat organ or bone marrow transplant rejection): if concomitant use is necessary, your doctor will monitor your blood levels of cyclosporine and may adjust the dose,
• digoxin (used for heart failure): concomitant use may increase digoxin levels. Your doctor will monitor these blood levels,
• colchicine (used for gout and familial Mediterranean fever): blood levels of colchicine should be monitored more frequently, and the colchicine dose may need to be adjusted,
• antacids (used for indigestion): may reduce the effectiveness of azithromycin when used concomitantly; see section 3,
• cisapride (used for stomach problems), terfenadine (used to treat hay fever), pimozide (used in some psychiatric disorders), citalopram (used for depression), fluoroquinolones (antibiotics such as moxifloxacin and levofloxacin, used for bacterial infections): concomitant use with azithromycin may cause heart problems and is therefore 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 blood levels of medicines,
• statins (such as atorvastatin, used to lower blood lipids): concomitant use may cause muscle disorders,
• certain medicines (such as hydroxychloroquine) known to cause abnormal heart rhythms, e.g., prolonged QT interval detected by 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, your blood clotting may need to be checked more frequently and your medicine dose may need adjustment.

Taking Azithromycin Sandoz with food and drink

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 plan to become pregnant, consult your doctor or pharmacist before using 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 of azithromycin in infants have been observed.

Driving and using machines

This medicine may cause adverse effects such as visual disturbances, blurred vision, dizziness, and somnolence. These may affect your ability to drive or operate machinery.

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 considered in patients with diabetes mellitus.

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

Aspartame

This medicine contains 0.030 g of aspartame per 5 ml of suspension. Aspartame contains a source of phenylalanine, which may be harmful in individuals with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

Sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; hence, it 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 advised by your doctor. This product should not be used for more than one week in children under 3 years of age unless directed by your doctor or pharmacist. Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Sulfites

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

3. How to take Azithromycin Sandoz

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

Azithromycin 200mg/5ml:

Adults and children over 45 kg body weight:

Azithromycin can be taken in 3-day or 5-day treatment regimens.

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

For infections of the urethra and cervix caused by Chlamydia, the treatment is 1 day:

• 1-day treatment: 25 ml (1,000 mg).

The dose for treating sore throat is an exception. Your doctor may prescribe a different dose.

Children under 45 kg body weight:

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

Azithromycin can be administered in 3-day or 5-day treatment regimens. The daily dose is determined according to the child's body weight.

The following tables provide a guide to the most commonly used doses.

3-day treatment

Weight	Day 1-3
10 kg	2.5 ml (100 mg)
12 kg	3 ml (120 mg)
14 kg	3.5 ml (140 mg)
16 kg	4 ml (160 mg)
17-25 kg	5 ml (200 mg)
26-35 kg	7.5 ml (300 mg)
36-45 kg	10 ml (400 mg)
> 45 kg	12.5 ml (500 mg)

5-day treatment

Weight	Day 1	Day 2-5
10 kg	2.5 ml (100 mg)	1.25 ml (50 mg)
12 kg	3 ml (120 mg)	1.5 ml (60 mg)
14 kg	3.5 ml (140 mg)	1.75 ml (70 mg)
16 kg	4 ml (160 mg)	2 ml (80 mg)
17-25 kg	5 ml (200 mg)	2.5 ml (100 mg)
26-35 kg	7.5 ml (300 mg)	3.75 ml (150 mg)
36-45 kg	10 ml (400 mg)	5 ml (200 mg)
> 45 kg	12.5 ml (500 mg)	6.25 ml (250 mg)

Patients with renal or hepatic impairment

Inform your doctor if you have kidney or liver problems, as you may require an adjustment of your normal dose.

Dosage in elderly patients

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

Take this medicine once daily. You may take it with or without food.

The aftertaste can be avoided by drinking some juice after swallowing.

Taking Azithromycin Sandoz with medicines for indigestion

If you need to take a medicine for indigestion, such as an antacid, take azithromycin at least two hours before or after the antacid.

How to measure the dose

A 10 ml dosing syringe with markings every 0.25 ml is provided with this medicine. It comes with an adapter that fits onto the bottle. To measure the medicine:

• shake the bottle,
• place the adapter onto the mouth of the bottle,
• insert the tip of the syringe into the adapter,
• turn the bottle upside down,
• pull back the plunger to measure the required dose,
• turn the bottle back upright, remove the syringe, leave the adapter attached to the bottle, and close it.

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

Administration of the medicine using the syringe:

• ensure the child is in an upright position,
• carefully insert the tip of the dosing syringe into the child's mouth, directing it towards the inside of the cheek,
• slowly push the syringe plunger: do not empty it rapidly. The medicine will enter the child's mouth,
• allow the child time to swallow the medicine.

How to prepare this medicine

This medicine will be prepared for you by a doctor, nurse, or pharmacist. To open the bottle, press the cap down while simultaneously turning it.

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

• 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 immediately after adding the correct amount of water. The suspension should only be prepared once, at the beginning 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 adverse reactions such as temporary hearing loss, nausea, vomiting, and diarrhea.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Azithromycin Sandoz

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

If you stop treatment with Azithromycin Sandoz

Always continue taking the oral suspension until the treatment is completed, even if you feel better. If you stop taking the oral suspension too early, the infection may return. In addition, bacteria may become resistant to the medicine and become harder to treat.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Serious adverse effects:

If you experience any of the following symptoms of a severe allergic reaction, stop treatment immediately and contact your doctor right away or go to the nearest hospital emergency department:

• sudden difficulty breathing, speaking, or swallowing,
• swelling 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 diarrhea, or diarrhea with blood, accompanied by stomach pain or fever. This may be a sign of a serious intestinal inflammation. This may exceptionally occur after antibiotic administration,
• yellowing of the skin or whites of the eyes due to liver problems,
• inflammation of the pancreas causing severe abdominal and back pain,
• increased or decreased urine volume, or blood in the urine,
• skin rash caused by sensitivity to sunlight,
• appearance of bruises or bleeding,
• irregular heartbeat.

All of these are serious adverse reactions. You may require urgent medical attention. Serious adverse reactions are uncommon (may affect up to 1 in 100 people), rare (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 pins and needles without apparent cause (paresthesia),
• vision problems,
• hearing loss,
• burping and stomach acidity (dyspepsia),
• skin rash, itching (pruritus),
• joint pain (arthralgia),
• fatigue,
• changes in white blood cell levels (low white blood cell count, high eosinophil count, high basophil count, monocytes, and neutrophils),
• decreased bicarbonate in blood (indicating excess acid in the blood).

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

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

Rare adverse effects (may affect up to 1 in 1,000 people):

• irritability,
• jaundice,
• restlessness,
• skin rash characterized by rapid appearance of red areas with small pustules (small blisters filled with white/yellow fluid) (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, swollen glands, and abnormal 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 may cause pale yellowish skin and lead to weakness or difficulty breathing,
• reduced platelet count, which may increase the risk of bleeding or bruising,
• severe allergic reaction,
• aggression, anxiety, severe confusion, hallucinations,
• fainting, muscle cramps, feeling hyperactive, altered sense of smell, loss of smell and taste, muscle weakness (myasthenia gravis),
• arrhythmia, abnormal electrocardiogram (ECG),
• low blood pressure,
• discoloration of the tongue, discoloration of teeth,
• kidney failure, severe liver inflammation,
• toxic epidermal necrolysis,
• erythema multiforme.

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

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

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

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

• loss of appetite (anorexia),
• feeling dizzy (dizziness),
• headache,
• tingling or numbness sensation (paresthesia),
• changes in taste sensation (dysgeusia),
• vision disorder,
• deafness,
• 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 disorder or ringing in the ears (tinnitus),
• abnormal heart rhythm or awareness of heartbeats (palpitations),
• liver problems such as hepatitis,
• blisters/bleeding of lips, eyes, nose, mouth, and genitals, which may 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 malaise or being unwell (malaise).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system: Spanish System for Pharmacovigilance of Human Medicines: https://www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Azithromycin Sandoz

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.

Vial containing dry powder: Do not store above 30 °C.

Reconstituted suspension: Do not store above 25 °C.

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

If the suspension is dispensed to you by the pharmacy: do not use it more than 10 days after the date of dispensing. The dispensing date is indicated on the pharmacy label.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Azithromycin Sandoz

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

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

Appearance of the product and contents of the container

Azithromycin Sandoz is a white or almost white crystalline powder.

After reconstitution, a white or almost white homogeneous 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 dosing syringe (10 ml) graduated in 0.25 ml increments is included.

Only certain 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

Novartis Pharmaceuticals S.R.L. Str. Livezeni nr. 7A

RO-540472 Targu-Mures

Romania

This medicinal product 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 most recent revision of this leaflet: December 2024

Detailed 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/