Azitromicina sandoz 200 mg/5 ml polvo para suspensiÓn oral efg

Package Insert: Information for the Patient

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

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

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

3.How to take Azithromycin Sandoz

4.Possible adverse effects

5.Storage of Azithromycin Sandoz

6.Contents of the package and additional information

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

This medication is typically prescribed to treat:

• lung infections such as chronic bronchitis, pneumonia,
• tonsillitis, throat (pharyngitis) and nasal sinus infections,
• ear infections (acute otitis media),
• skin and soft tissue infections, excluding burns infections,

• urethra and cervix infections caused byClamidia.

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

• azitromicina,
• eritromicina,
• other macrolide or ketolide antibiotics,
• any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting azitromicina if you have:

• liver problems:your doctor may need to monitor your liver function or interrupt treatment,
• kidney problems:if you have severe kidney problems, your doctor may need to adjust the dose,
• nervous system problems (neurológicos) ormental health problems (psiquiátricos),
• heart problemssuch as:
• • heart failure (insuficiencia cardiaca),
  • slow heart rate,
  • irregular heartbeat, or
  • a condition called “prolongation QT syndrome” (detected by an electrocardiogram) as azitromicina may increase the risk of abnormal heart rhythm,
• low levels of potassiumormagnesiumin the blood,
• myasthenia gravis, a type of muscle weakness,
• if you have had infections with azitromicina, eritromicina, lincomicina, and/or pathogens resistant to clindamicina 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 medication to treat your diarrhea without consulting your doctor first. If your diarrhea continues, inform your doctor.

Inform your doctor

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

Azitromicina is not suitable for treating severe infections, in which high concentrations of antibiotics need to be reached in the blood quickly.

Other medications and Azitromicina Sandoz

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This includes medications obtained without a prescription.

It is especially important to mention that you are taking:

• theophylline(used to treat asthma): the effect of theophylline may increase,
• blood thinners, 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 taking azitromicina as well,

• 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,
• ciclosporina(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 ciclosporina blood levels 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),
• antacids(used for indigestion): may make azitromicina less effective when used concomitantly, see section 3,
• cisaprida(used for stomach problems),terfenadina(used to treat hay fever),pimozida(used in some mental disorders),citalopram(used in depression),fluoroquinolones(antibiotics such as moxifloxacino and levofloxacino, used in bacterial infections): concomitant use with azitromicina may cause cardiac problems, therefore not recommended,
• certainmedications for controlling irregular heart rhythm(called antiarrhythmics, such as quinidina, amiodarona, sotalol). Concomitant use is not recommended,
• zidovudina(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,
• alfentanilo(used for anesthesia) orastemizol(used to treat hay fever): concomitant use with azitromicina may increase the effect of these medications,
• rifabutina(used to treat tuberculosis): your doctor will monitor your blood and medication levels,
• statins(such as atorvastatina, used to lower blood lipids): concomitant use may cause muscle disorders,
• certain medications (such as hydroxychloroquine) known to cause abnormal heart rhythm,e.g., prolonged QT interval detected by an electrocardiogram: concomitant use may increase the risk of arrhythmia.

Taking Azitromicina Sandoz with food and drinks

Azitromicina Sandoz can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Do not use this medication during pregnancy and whenbreastfeedingunless your doctor has specifically recommended it.

This medication is excreted through breast milk. Consult your doctor before taking this medication if you are breastfeeding.

Driving and operating machines

Azitromicina is not expected to alter your ability to drive and operate machines.

Visual disturbances and blurred vision may affect your ability to drive or operate machines. However, if you experience adverse effects such as dizziness, somnolence, or convulsions, you should exercise caution when driving or operating machines.

Azitromicina Sandoz contains sacarosa, sodium, aspartamo, alcohol bencílico, and sulfitos

Sacarosa

This medication contains 3.71 g of sacarosa 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 certain sugars, consult with them before taking this medication.

Aspartamo

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

Sodium

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

Alcohol bencílico

This medication contains up to 410 nanograms of alcohol bencílico per 5 ml of suspension. Alcohol bencílico may cause allergic reactions.

Do not administer this medication to your newborn (up to 4 weeks old) 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 recommended it. Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of alcohol bencílico may accumulate in your body and cause adverse effects (metabolic acidosis).

Sulfitos

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

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

Azitromicina 200mg/5ml:

Adults and children over45 kgweight:

Azitromicina can be taken in treatments of 3 or 5 days.

• Treatment of 3 days: take 12.5 ml (500 mg) once a day each day.
• Treatment of 5 days:
• • Take 12.5 ml (500 mg) on day 1
  • Take6.25ml (250 mg) on days 2, 3, 4 and 5.

In urethra and cervix infections caused byClamidiathe treatment is 1 day:

• Treatment of 1 day: 25 ml (1,000 mg).

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

Children under45 kgweight:

Azitromicina is not recommended for use in children under 1 year.

Azitromicina can be taken in treatments of 3 or 5 days. The daily dose is established according to the child's weight.

The following tables constitute a guide to the most common doses

Treatment of 3 days

Treatment of5 days

Patients with renal or hepatic insufficiency

Inform your doctor if you have kidney or liver problems as you may need a modification of your normal dose.

Dose in advanced age

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

Take this medication once a day. You can take it with or without food.

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

Administration of Azitromicina Sandoz with antacids

If you need to take an antacid, such as an antacid, take azitromicina with a two-hour interval before or after the antacid.

How to measure the dose

This medication comes with a 10 ml dosing syringe with marks every0.25ml. It presents an adapter that fits the bottle. To measure the medication:

• shake the bottle,
• put the adapter on the mouth of the bottle,
• insert the tip of the syringe into the adapter,
• invert the bottle,
• pull the plunger to measure the necessary dose,
• invert the bottle again, remove the syringe, leave the adapter in place on the bottle and close it.

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

Administration of the medication using the syringe:

• confirm that the child is upright,
• carefully insert the tip of the dosing syringe into the child's mouth. Point the tip of the syringe towards the inside of the cheek,
• slowly push the plunger of the syringe: do not empty it quickly. The medication will enter the child's mouth,
• give the child time to swallow the medication.

How to prepare this medication

A doctor, nurse or pharmacist will prepare this medication for you. To open the bottle, you must 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 size of the bottle 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 introduced the correct amount of water. The suspension should only be prepared once, at the beginning of treatment.

If you take more Azitromicina Sandoz than you should

If you take too much, you may feel sick.You may also experience other adverse reactions such as temporary hearing loss, nausea, vomiting and diarrhea.

For overdose or accidental ingestionconsult your doctor, pharmacist or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forget to take Azitromicina Sandoz

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

If you interrupt treatment with Azitromicina Sandoz

Continue taking the oral suspension until the treatment is completed, even if you feel better. If you stop taking the oral suspension too soon, the infection may recur. Also, the bacteria may become resistant to the medication and be more difficult to treat.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can have side effects, although not everyone will experience them.

Severe side effects:

If you have any of the following symptoms of asevere allergic reaction, stop treatment and consult your doctor immediatelyor go to the nearest hospital emergency department:

• sudden difficulty breathing, speaking, and swallowing,
• inflammation of the lips, tongue, face, and neck,
• severe dizziness or fainting,
• 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 side effects,contact your doctor as soon as possible:

• severe diarrhea, lasting a long time, or with blood, abdominal pain, or fever. This may be a sign of severe intestinal inflammation. This can occur exceptionally after antibiotic administration,
• yellowing of the skin or white of the eyes caused by liver problems,
• pancreatitis, which causes severe abdominal and back pain,
• increased or decreased urine volume, or blood in the urine,
• skin rash caused by sensitivity to sunlight,
• bruising or bleeding,
• irregular heart rhythm.

All these are severe side effects. You may need urgent medical attention. Severe side effects are rare (can affect up to 1 in 100 people), rare (can affect up to 1 in 1,000 people), or frequency unknown: cannot be estimated from available data.

Other possible side effects:

Side effectsvery common(can affect more than 1 in 10 people):

• diarrhea.

Side effectscommon(can affect up to 1 in 10 people):

• headache,
• nausea, vomiting, abdominal pain,
• change in white blood cell counts (low leukocyte count, high eosinophil count, high basophil count, monocytosis, and neutrophilia),
• decreased bicarbonate in the blood (indicating too many acidic substances in the blood).

Side effectsuncommon(can affect up to 1 in 100 people):

• yeast infections, especially in the mouth, throat, nose, lungs, stomach, intestines, and vagina,
• changes in white blood cell counts (low leukocyte count, low neutrophil count, high eosinophil count),
• swelling, allergic reactions of varying severity,
• loss of appetite (anorexia),
• nervousness, drowsiness, insomnia, dizziness, taste disturbances, tingling or numbness in the hands or feet,
• hearing problems, sensation of spinning (vertigo),
• irregular heartbeat,
• sensation of intense heat with sweating and rapid heartbeat (hot flashes),
• difficulty breathing, nasal bleeding,
• constipation, flatulence, indigestion, stomach inflammation, difficulty swallowing, swelling, dry mouth, gas, mouth sores, increased saliva production,
• skin rash, itching, urticaria, skin inflammation, dry skin, sweating,
• inflammation of bones and joints, muscles, neck, and back pain,
• difficulty and pain urinating, kidney pain,
• uterine bleeding, testicular disorders,
• swelling of the skin, weakness, general feeling of illness, fatigue, facial swelling, chest pain, fever, pain, swelling of the extremities,
• abnormal laboratory test results (e.g., blood test results, liver, and kidney function tests),
• surgical complications.

Rare side effects(can affect up to 1 in 1,000 people):

-agitation,

-abnormal liver function,

-sensitivity to sunlight,

-skin rash characterized by the rapid appearance of red areas with small pustules (small blisters filled with white or yellowish liquid),

-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 unknown (cannot be estimated from available data):

• low red blood cell count, which can cause pale yellowish skin and cause weakness or difficulty breathing,
• reduction in platelet count, which can increase the risk of bleeding or bruising,
• severe allergic reaction,
• aggression, anxiety, severe confusion, hallucinations,
• syncope, cramps, decreased skin sensitivity, feeling hyperactive, altered sense of smell, loss of sense of smell and taste, muscle weakness (myasthenia),
• hearing loss, deafness, or ringing in the ears,
• arrhythmia, abnormal electrocardiogram (ECG),
• low blood pressure,
• discoloration of the tongue,
• liver failure, severe liver inflammation,
• joint pain,
• kidney failure, kidney inflammation,
• visual disturbances,
• vision problems (blurred vision).

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

Adverse reactionsvery common(can affect more than 1 in 10 people):

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

Adverse reactionscommon(can affect up to 1 in 10 people):

• loss of appetite (anorexia),
• dizziness,
• headache,
• tingling or numbness (paresthesia),
• changes in taste (dysgeusia),
• vision disturbances,
• deafness,
• skin rash,
• itching (urticaria),
• joint pain (arthritis),
• fatigue.

Adverse reactionsrare(can affect up to 1 in 1,000 people):

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

• blistering or bleeding of the lips, eyes, nose, mouth, and genital areas, which can be caused by Stevens-Johnson syndrome,
• allergic reactions such as sensitivity to sunlight, redness, peeling, and skin swelling,
• weakness (asthenia),
• general feeling of illness 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 that does not appear in this prospectus. You can also report them directly through the national notification system: Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.

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

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

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

Unopened vial with dry powder: Do not store at a temperature above 30 °C.

Reconstituted suspension: Do not store at a temperature 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 indicated on the pharmacy label.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and the

medicines you no longer need at the SIGRE drop-off pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and the medicines you no longer need. This will help protect the environment.

Composition of Azitromicina Sandoz

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

Appearance of the product and contents of the package

Azitromicina Sandoz is a white or almost white crystalline powder.

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

Azitromicina 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 divisions of 0.25 ml, is included.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

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 with the following names:

Austria:Azithromycin Sandoz 200 mg/5 ml - Powder for the preparation of a suspension for oral administration

Belgium:Azithromycine Sandoz 200mg/5ml powder for oral suspension

Finland:Azithromycin Sandoz 40 mg/ml powder for oral suspension

Hungary:Azithromycin Sandoz 40 mg/ml powder for oral suspension

Italy:AZITROMICINA Sandoz GmbH

Netherlands:Azitromycine Sandoz 200 mg/5 ml, powder for oral suspension

Poland:AzitroLEK

Romania:AZITROMICINA SANDOZ200 mg/ 5 ml powder for oral suspensiona

Slovakia:Azithromycin Sandoz 200mg/5ml powder for oral suspension

United Kingdom

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

Last review date of thisleaflet:August2022

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