AZITHROMYCIN TEVA 200 mg/5ml ORAL SUSPENSION POWDER

2. What you need to know before taking Azitromicina Teva

Do not take Azitromicina Teva:

• If you are allergic to azithromycin or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to any other macrolide or ketolide antibiotic, for example, erythromycin or telithromycin.

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Azitromicina Teva if you:

• have ever had a severe allergic reaction with facial and throat swelling with possible breathing difficulties.

• suffer from kidney problems, your doctor may need to adjust the dose.
• suffer from liver problems, your doctor may need to monitor your liver function or interrupt treatment.
• know that you have or have been diagnosed with a prolonged QT interval (a heart condition): azithromycin is not recommended.

• know that you have a slow or irregular pulse or reduced heart function: azithromycin is not recommended.
• know that you have low potassium or magnesium levels in your blood: azithromycin is not recommended.
• are taking medications known as antiarrhythmics (used to treat abnormal heart rhythm), hydroxychloroquine (used to treat rheumatic diseases or malaria), cisapride (used for stomach problems), or terfenadine (an antihistamine used to treat allergies), antipsychotics (e.g., pimozide), antidepressants (e.g., citalopram), or certain antibiotics (e.g., moxifloxacin, levofloxacin). Azithromycin should be used with caution.
• are taking medications known as ergot alkaloids (such as ergotamine), used to treat migraines: azithromycin is not recommended (see "Other medications and Azitromicina Teva" below)
• have been diagnosed with a neurological disorder, a brain disorder, or a nervous system disorder.

• have mental, emotional, or behavioral problems.
• if you suffer from a disease called myasthenia gravis, with muscle weakness and fatigue, as azithromycin may contribute to worsening the symptoms of this disease or triggering it.

If you experience any symptoms of liver dysfunction, such as loss of appetite, yellowing of the skin or the whites of the eyes, dark urine, itching, or abdominal pain, stop taking Azitromicina Teva and inform your doctor immediately.

If you have an allergic reaction (e.g., difficulty breathing, dizziness, facial or throat swelling, skin rash, hives, blisters), stop taking Azitromicina Teva and contact a doctor immediately.

If you experience severe and persistent diarrhea, especially with blood or mucus, during or after treatment, consult your doctor immediately.

If symptoms persist after completing treatment with azithromycin or if you notice any persistent or new symptoms, contact your doctor.

Azitromicina Teva is not indicated in children under 6 months of age.

Other medications and Azitromicina Teva

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications.

Inform your doctor if you are taking any of the following medications:

• antacids, for example, aluminum hydroxide: take azithromycin at least 1 hour before or 2 hours after taking an antacid.
• ergotamine derivatives, such as ergotamine, (used to treat migraines): should not be administered at the same time as azithromycin, as ergotism (a potentially serious side effect with numbness or tingling in the limbs, muscle cramps, headaches, seizures, or abdominal or chest pain) may develop.

• oral anticoagulants, such as warfarin (used to prevent blood clots): may increase the risk of bleeding.
• digoxin (used to treat heart failure) or colchicine (used for gout and familial Mediterranean fever): may increase digoxin/colchicine levels in the blood.
• zidovudine, nelfinavir (used to treat HIV): azithromycin or zidovudine levels may increase.

• rifabutin (used to treat HIV and bacterial infections, including tuberculosis): a decrease in white blood cell count in the blood may occur.

• cyclosporin (an immunosuppressant used after organ transplantation): cyclosporin levels may increase. Your doctor will need to monitor your cyclosporin levels in the blood.
• hydroxychloroquine (used to treat rheumatic diseases or malaria): heart problems may occur.

• cisapride (used to treat stomach problems), heart problems may occur.
• astemizole, terfenadine (antihistamines used to treat allergic reactions), their effects may be increased.

• alfentanil (a medication for pain treatment): the effect of alfentanil may increase.
• fluconazole (for fungal infections): azithromycin levels may be reduced.
• atorvastatin (a medication to lower cholesterol). Concomitant use of azithromycin and atorvastatin has been associated with an increased risk of muscle tissue breakdown (rhabdomyolysis) leading to muscle pain and dark urine.

No interactions have been observed between azithromycin and cetirizine (an antihistamine); didanosine, efavirenz, indinavir (for HIV infection); carbamazepine (for epilepsy), cimetidine (an antacid); methylprednisolone (to suppress the immune system); midazolam, triazolam (sedatives); sildenafil (for impotence), theophylline (for asthma), and trimethoprim/sulfamethoxazole (a combination antibiotic).

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 assess whether you should take this medicine during pregnancy, if the benefit of treatment outweighs the potential risks.

Breastfeeding

Azithromycin has been reported to be excreted in breast 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 dizziness or convulsions. This may affect your ability to drive or operate machinery.

Azitromicina Teva contains benzyl alcohol, sodium, sucrose, glucose, sulfur dioxide, sulfites, and wheat starch

This medicine contains 0.65 micrograms of benzyl alcohol in each 5 ml of suspension.

Benzyl alcohol may cause allergic reactions.

Benzyl alcohol has been linked to the risk of serious side effects, including respiratory problems ("gasping syndrome") in children.

It should not be used for more than one week in children under 3 years of age unless advised by your doctor or pharmacist.

This medicine contains 35.2 mg of sodium (the main component of table salt) in each 5 ml of the reconstituted suspension. This is equivalent to 1.8% of the maximum recommended daily intake of sodium for an adult.

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

Patients with diabetes mellitus should note that this medicine contains 3.75 g of sucrose per 5 milliliters.

This medicine contains glucose (in maltodextrin from wheat and corn). If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

This medicine contains sulfites. It may cause severe allergic reactions and bronchospasm.

This medicine contains sulfur dioxide. It may cause severe allergic reactions and bronchospasm.

This medicine contains wheat starch. It is suitable for patients with celiac disease. Patients with a wheat allergy (other than celiac disease) should not take this medicine.

3. How to take Azitromicina Teva

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Preparation of the suspension

By yourself:You can prepare the suspension yourself using the included dosing syringe.

First, tap the bottle gently to loosen the powder well.

For 15 ml bottles (600 mg): Add 9.5 ml of water.

For 22.5 ml bottles (900 mg): Add 12.0 ml of water.

For 30 ml bottles (1200 mg): Add 16.5 ml of water.

For 37.5 ml bottles (1500 mg): Add 20.0 ml of water.

Shake vigorously until a homogeneous suspension is obtained.

Dose

Azithromycin suspension should be administered in a single dose once a day, with or without food.

Shake the bottle vigorously before using the suspension.

The recommended dose is as follows:

Use in children and adolescents over 45 kg in weight, adults, and the elderly

The total dose of azithromycin is 37.5 ml (1500 mg) administered in a single dose for 3 consecutive days (12.5 ml (500 mg) once a day). Alternatively, the same total dose can be administered over 5 days (12.5 ml (500 mg) as a single dose on the first day and 6.25 ml (250 mg) once a day).

In cases of urethritis or cervicitis caused by Chlamydia trachomatis, the dose is 25 ml (1000 mg) in a single dose.

Sinusitis

Treatment of sinusitis is only indicated for adults and adolescents over 16 years of age.

Use in children and adolescents under 45 kg in weight

Treatment with azithromycin suspension should be measured carefully, with the help of the dosing syringe provided, and should be administered according to the following table:

For the treatment of tonsillitis/pharyngitis in children 2 years of age or older: the recommended dose of azithromycin is 10 mg/kg or 20 mg/kg for 3 days, not exceeding a maximum daily dose of 500 mg.

Sinusitis

For the treatment of sinusitis, data in children under 16 years of age are limited.

Patients with liver or kidney problems:

You should inform your doctor if you have liver or kidney problems, as you may need to adjust the normal dose.

Instructions for using the syringe

Filling the syringe with the medication

1. Shake the bottle before use and remove the child-resistant cap
2. Place the bottle on a flat, stable surface and hold it firmly with one hand. With the other hand, insert the syringe tip into the adapter.
3. Slowly pull the syringe plunger until the graduation line on the plunger is level with the top edge of the cylinder.
4. If you see large bubbles, slowly press the syringe plunger. This will cause the medication to return to the bottle. Repeat step 3.
5. Remove the syringe from the bottle.

Using the medication with the syringe

1. Make sure the child is in an upright position before giving the medication.
2. Carefully insert the syringe tip into the child's mouth. Aim the syringe towards the inside of the cheek.
3. Slowly press the syringe plunger: Do not expel the medication quickly. The medication will be administered inside the child's mouth.
4. Allow the child to swallow the medication.
5. Put the cap back on the bottle. Wash the syringe following the instructions below.

1. When doses of less than 5 ml have been administered for three days, some suspension will remain

in the bottle. The remaining suspension should be discarded.

Cleaning and storage of the syringe

Remove the plunger from the syringe and wash both parts with hot running water or by immersing them in a sterilizing solution used for baby feeding bottles, etc.

Dry both parts. Put the plunger back into the syringe. Store it in a clean, safe place with the medication. After you have given the last dose of medication to the child, wrap the syringe in paper and discard it.

WARNING: ADMINISTER THE MEDICATION SLOWLY TO THE CHILD AND MAKE SURE THEY ARE SITTING UP OR IN A VERTICAL POSITION. THIS WILL HELP PREVENT THE RISK OF CHOKING.

If you take more Azitromicina Teva than you should

If you or someone else takes more azithromycin than recommended, inform your doctor or pharmacist immediately. A overdose is likely to cause temporary hearing loss, severe nausea (discomfort), vomiting, and diarrhea.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20. Bring this leaflet, the remaining medication, and the packaging to the hospital or your doctor so they know what medication has been taken.

If you forget to take Azitromicina Teva

If you have forgotten to take a dose, take it as soon as possible, unless it is almost time for the next dose. Do not take a double dose to make up for forgotten doses.

If you stop taking Azitromicina Teva

Do not stop taking your medication without consulting your doctor first, even if you feel better. It is very important that you continue taking Azitromicina Teva for the time indicated by your doctor, or the infection may recur.

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

4. Possible Adverse Effects

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

If any of the following adverse effects appear, stop using Azithromycin Teva andinform your doctor immediately or go to the nearest hospital emergency department:

Uncommon: may affect up to 1 in 100 people

• Angioedema: allergic reaction with swelling of the lips, face, or neck, causing severe breathing difficulties; rash or hives on the skin.

Rare: may affect up to 1 in 10,000 people

• Skin rash characterized by the rapid appearance of red skin areas sprinkled with small blisters (small bumps filled with white/yellow liquid)

Very rare: (may affect up to 1 in 10,000 people)

• Hypersensitivity reaction with skin rash, fever, lymph node inflammation, and possible organ damage (DRESS)

Frequency not known: frequency cannot be estimated from available data

• Anaphylactic reaction: severe allergic reaction causing difficulty breathing or dizziness
• Severe liver disorders or liver failure (rarely life-threatening): signs may include fatigue associated with yellowing of the skin or whites of the eyes (jaundice), dark urine, tendency to bleed
• Blisters/bleeding of lips, eyes, nose, mouth, and genitals, which may be caused by Stevens-Johnson syndrome, erythema multiforme, or toxic epidermal necrolysis, which are serious diseases.
• Changes in heart rate, changes in heart rhythm on the electrocardiogram (QT interval prolongation, ventricular tachycardia, and torsades de pointes)

• Prolonged diarrhea with blood and mucus (pseudomembranous colitis)

These are very serious adverse effects. You may need urgent medical attention or hospitalization.

Other Adverse Effects

Very common (may affect more than 1 in 10 people)

• Diarrhea

Common (may affect up to 1 in 10 people)

• Headache
• Vomiting, abdominal pain, nausea
• Alteration of the number of some types of white blood cells and bicarbonate in blood

Uncommon (may affect up to 1 in 100 people)

• Fungal infection, e.g., in the mouth (thrush), vaginal infection, pneumonia, bacterial infection
• Sore throat, inflammation of the stomach and intestine lining
• Shortness of breath, chest pain, wheezing, and cough (respiratory disorders), congested nose
• Blood disorders characterized by fever or chills, sore throat, ulcers in the mouth or throat
• Allergic reactions
• Lack of appetite
• Nervousness, difficulty sleeping
• Dizziness, drowsiness, alteration of taste, tingling, or numbness
• Vision disorders
• Hearing disorders
• Vertigo (sensation of spinning)
• Abnormality in heart rhythm or frequency and detection of heartbeat (palpitations)
• Hot flashes
• Difficulty breathing
• Nosebleeds
• Stomach inflammation, constipation, gas, indigestion, difficulty swallowing
• Feeling of being bloated, dry mouth
• Belching, mouth ulcers, increased salivation, soft stools
• Hepatitis (liver inflammation)
• Rash, itching, hives (itchy rash)
• Skin inflammation, dry skin, increased sweating
• Inflammation of bones and joints, muscle pain, back pain, neck pain
• Pain and difficulty urinating, pain in the kidneys (kidney pain)
• Vaginal inflammation, irregular menstrual bleeding, testicular disorders
• Chest pain, generalized swelling, discomfort, weakness, fatigue
• Facial inflammation, hand, leg, and foot swelling, fever, pain.
• Changes in liver enzymes and blood test values

Rare (may affect up to 1 in 1000 people)

• Agitation
• Feeling of unreality.
• Discoloration of teeth
• Abnormal liver function, jaundice (yellowish skin pigmentation)
• Photosensitivity (redness and blistering of the skin when exposed to sunlight)

Frequency not known: frequency cannot be estimated from available data

• Blood disorders characterized by uncommon bleeding or unexplained bruising, decrease in red blood cell count causing weakness or uncommon fatigue
• Aggression, anxiety, confusion, seeing or hearing things that are not happening
• Fainting, seizures, decreased sensitivity, hyperactivity, alteration or loss of smell, loss of taste, myasthenia gravis (muscle weakness and fatigue, see section 2)
• Hearing impairment including deafness and/or tinnitus
• Decrease in blood pressure (which may be associated with weakness, fainting, and loss of consciousness)
• Discoloration of the tongue, pancreas inflammation causing nausea, vomiting, abdominal pain, back pain
• Rash with spots and blisters
• Joint pain
• Kidney problems

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

Very common (may affect more than 1 in 10 people):

• Diarrhea
• Abdominal pain
• Nausea
• Gas (flatulence)
• Abdominal discomfort
• Soft stools

Common (may affect up to 1 in 10 people)

• Lack of appetite (anorexia)
• Dizziness
• Headache
• Feeling of tingling or numbness (paresthesia)
• Changes in taste (dysgeusia)
• Visual disturbances
• Deafness
• Skin rash
• Itching (pruritus)
• Joint pain (arthralgia)
• Fatigue

Uncommon (may affect up to 1 in 100 people)

• Decreased sensitivity (hypoesthesia)
• Hearing loss or ringing in the ears
• Abnormality in heart rhythm or frequency and detection of heartbeat (palpitations)
• Liver problems such as hepatitis
• Blisters/bleeding of lips, eyes, nose, mouth, and genitals, which may be caused by Stevens-Johnson syndrome.
• Allergic skin reactions such as sensitivity to sunlight, red, flaky, and inflamed skin
• Weakness (asthenia)
• Feeling of general discomfort

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect that is not listed in this prospectus. You can also report it directly through the Spanish Pharmacovigilance System for Human Use Medicines Website: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Azithromycin Teva

Keep this medicine out of sight and reach of children.

Do not use azithromycin after the expiration date shown on the carton and bottle after CAD.

Powder for suspension: Store below 25°C

After reconstitution: store below 25°C and use within 5 days (azithromycin suspension 15 ml and 22.5 ml) or within 10 days (azithromycin suspension 30 ml and 37.5 ml).

Medicines should not be thrown away 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 Teva Composition

• The active ingredient is azithromycin.

Each ml contains 40 mg of azithromycin (as dihydrate) after reconstitution with water (equivalent to 200 mg of azithromycin per 5 ml of suspension).

• The other ingredients are: anhydrous colloidal silica, sucrose, xanthan gum (E415), anhydrous trisodium phosphate, hydroxypropylcellulose, cherry flavor (contains maltodextrin from wheat, gum arabic, benzyl alcohol, and sulfur dioxide E220), vanilla flavor (contains sulfites, maltodextrin from wheat and corn, and gum arabic), banana flavor (contains sulfites, maltodextrin from wheat), (see section 2).

Product Appearance and Package Contents

• The powder for suspension preparation is a white to yellowish-white powder. Once reconstituted with water, it forms a yellowish-white suspension.
• The oral suspension powder is packaged in bottles containing 600, 900, 1,200, or 1,500 mg of azithromycin, which after reconstitution with water provide 600 mg/15 ml, 900 mg/22.5 ml, 1,200 mg/30 ml, and 1,500 mg/37.5 ml of azithromycin suspension.

Package sizes:

Azithromycin 600 mg/15 ml: 12.555 g of powder for the preparation of 15 ml of suspension.

Azithromycin 900 mg/22.5 ml: 18.8325 g of powder for the preparation of 22.5 ml of suspension.

Azithromycin 1,200 mg/30 ml: 25.11 g of powder for the preparation of 30 ml of suspension.

Azithromycin 1,500 mg/37.5 ml: 31.3875 g of powder for the preparation of 37.5 ml of suspension.

A dosing syringe is included with the bottles.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, Edificio Albatros B, 1º planta

28108 Alcobendas, Madrid

Spain

Manufacturer:

Teva Operations Poland Sp. Z.o.o.

ul. Mogilska 80

31-546 Cracovia

Poland

or

Merckle GmbH

Ludwig Merckle Straβe 3

89143 Blaubbeuren

Germany

or

PLIVA CROATIA LIMITED (PLIVA KRVATSKA D.O.O.)

Prilaz Baruna Filipovica, 25

10000 Zagreb, Croatia

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of the last revision of this prospectus: November 2024

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

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/69516/P_69516.html

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