AZITHROMYCIN TEVA 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Azitromicina Teva 500 mg film-coated tablets EFG

Azithromycin (dihydrate)

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

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

Contents of the Package Leaflet

1. What is Azitromicina Teva
2. What you need to know before taking Azitromicina Teva
3. How to take Azitromicina Teva
4. Possible side effects
5. Storage of Azitromicina Teva
6. Contents of the pack and further information

1. What is Azitromicina Teva and what is it used for

Azithromycin belongs to a group of antibiotics called macrolide antibiotics.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as the flu or common cold.

It is essential to follow the instructions regarding dosage, administration interval, and treatment duration as indicated by your doctor.

Do not store or reuse this medication. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not dispose of medications down the drain or in the trash.

It is used to treat bacterial infections caused by microorganisms such as bacteria. These infections include:

• Worsening of bronchitis and pneumonia (mild to moderate severity)
• Infections of the paranasal sinuses, throat, tonsils, or ears
• Mild to moderate skin and soft tissue infections, such as hair follicle infection (folliculitis), bacterial skin infection and its deeper layers (cellulitis), or skin infection with redness and swelling (erysipelas).

Infections caused by a bacterium called Chlamydia trachomatis, which can cause inflammation of the urethra or cervix.

2. What you need to know before taking Azitromicina Teva

Do not take Azitromicina Teva

• if you are allergic to azithromycin or any other component of this medication (listed in section 6)
• if you are allergic to another macrolide or ketolide antibiotic, such as erythromycin or telithromycin.

Warnings and precautions

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

• have ever experienced a severe allergic reaction with facial and throat swelling, potentially leading to respiratory problems.
• have liver problems. Your doctor may need to monitor your liver function or interrupt treatment.
• are taking medications known as ergot alkaloids (such as ergotamine), used to treat migraines. Azitromicina Teva is not recommended (see "Other medications and Azitromicina Teva")
• have severe kidney problems. Your doctor may need to adjust the dose.
• have been diagnosed with a prolonged QT interval (a heart condition). Azitromicina Teva is not recommended.
• have a slow or irregular heartbeat or reduced cardiac function. Azitromicina Teva is not recommended.
• have low potassium or magnesium levels in your blood: azithromycin is not recommended.
• are taking medications known as antiarrhythmics (used to treat irregular heartbeat), hydroxychloroquine (used to treat rheumatic diseases or malaria), cisapride (used to treat 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). Azitromicina should be used with caution.
• have been diagnosed with a neurological disorder, a brain disorder, or a nervous system disorder.
• have mental, emotional, or behavioral problems.
• have a condition called myasthenia gravis, with muscle weakness and fatigue, as Azitromicina may worsen the symptoms of this condition or trigger it.

If you experience any symptoms of liver dysfunction, such as loss of appetite, yellowing of the skin or 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, swelling of the face or throat, 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 your symptoms persist after completing treatment with Azitromicina or if you notice any new and persistent symptoms, inform your doctor.

Children and adolescents

The tablets are not recommended for children and adolescents weighing less than 45 kg (see section 3).

Other medications and Azitromicina Teva

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

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

• antacids, such as 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). Azitromicina Teva should not be administered at the same time, 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.
• cumarin derivatives, such as warfarin (used to prevent blood clots): may increase the risk of bleeding.
• digoxin (used to treat heart failure) or colchicine (used to treat gout or familial Mediterranean fever): may increase digoxin/colchicine levels in the blood.
• zidovudine, nelfinavir (used to treat AIDS): azithromycin levels may increase.
• rifabutin (used to treat AIDS and bacterial infections, including tuberculosis): may lead to a decrease in white blood cell count.
• cyclosporin (an immunosuppressant used after organ transplantation): cyclosporin levels may increase. Your doctor will need to monitor your cyclosporin levels in the blood.
• cisapride (used to treat stomach problems): may lead to heart problems.
• hydroxychloroquine (used to treat rheumatic diseases or malaria): may lead to heart problems.
• astemizole, terfenadine (antihistamines used to treat allergic reactions): their effects may be increased.
• alfentanil (a pain reliever): the effect of alfentanil may be increased.
• fluconazole (for fungal infections): azithromycin levels may be reduced.
• atorvastatin (a medication to lower cholesterol). The 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); atorvastatin (for cholesterol and heart problems); carbamazepine (for epilepsy), cimetidine (an antacid); methylprednisolone (to suppress the immune system); midazolam, triazolam (sedatives); sildenafil (for impotence), and trimethoprim/sulfamethoxazole (a combination antibiotic).

Pregnancy and breastfeeding

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

Pregnancy

Your doctor will assess whether you should take this medication 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 infants.

Driving and using machines

This medication may cause side effects such as dizziness or seizures. This may affect your ability to drive or operate machinery.

Azitromicina Teva contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

3. How to take Azitromicina Teva

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

Take the tablets preferably with a glass of water; they can be taken with or without food.

The tablet can be divided into equal doses.

The recommended dose is:

Adults (including elderly patients) and children weighing more than 45 kg:

The usual dose is 1500 mg divided over 3 or 5 days as follows:

• When taken for 3 days, 500 mg once a day.
• When taken for 5 days, 500 mg on the first day and 250 mg from the 2nd to the 5th day, once a day.

In cases of urethral or cervical inflammation caused by Chlamydia:

1000 mg taken as a single dose, in one day.

Children and adolescents weighing less than 45 kg:

The tablets are not recommended for these patients. Other pharmaceutical forms containing azithromycin (e.g., suspensions) may be used.

Patients with liver or kidney problems

Inform your doctor if you have liver or kidney problems, as the normal dose may need to be adjusted.

The tablet can be divided into equal doses.

If you take more Azitromicina Teva than you should

If you (or someone else) ingest many tablets at once, or if you think a child has swallowed some tablets, contact your doctor or pharmacist immediately. Overdose may cause reversible hearing loss, severe nausea, vomiting, and diarrhea.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. Bring this package leaflet, any remaining tablets, and the packaging to the hospital or your doctor so they know what tablets you have taken.

If you forget to take Azitromicina Teva

If you forget to take a tablet, take it as soon as you remember, unless it is almost time for your 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 essential to continue taking Azitromicina Teva for the duration indicated by your doctor; otherwise, the infection may recur.

If you have any further questions about the use of this medication, 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 you experience any of the following, stop taking the tablets and consult your doctor immediately or go to the emergency room of the nearest hospital.

Uncommon: may affect up to 1 in 100 people

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

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)

Unknown: 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 necrosis, which are serious diseases.
• Changes in heart rate, changes in heart rhythm detected on an electrocardiogram (prolongation of the QT interval, ventricular tachycardia, and torsades de pointes)
• Prolonged diarrhea with blood and mucus (pseudomembranous colitis).

These are serious but rare 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, stomach pain, nausea
• Alteration of the number of certain types of white blood cells and bicarbonate in blood

Uncommon: may affect up to 1 in 100 people

• Fungal infection, for example, in the mouth (thrush), vaginal infection, pneumonia, bacterial infection
• Sore throat, inflammation of the stomach and intestinal 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, taste disturbances, tingling or numbness
• Vision disorders
• Hearing problems
• Vertigo (feeling 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)
• Skin rash, itching, hives (itchy rash)
• Skin inflammation, dry skin, increased sweating.
• Joint inflammation, muscle pain, back pain, neck pain
• Difficulty urinating
• Vaginal inflammation, irregular menstrual bleeding, testicular disorder
• Chest pain, swelling, discomfort, weakness, fatigue
• Facial inflammation, fever, pain.
• Changes in liver enzymes and blood test values

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

• Agitation
• Feeling that things are unreal.
• Confusion, especially in elderly patients.
• Discoloration of teeth
• Abnormal liver function, jaundice (yellow pigmentation of the skin)
• Allergic reactions including angioneurotic edema
• Photosensitivity (redness and blistering of the skin when exposed to sunlight
• Skin rash characterized by the rapid appearance of red skin areas sprinkled with small pus-filled blisters (small blisters filled with white/yellow liquid)

Unknown: frequency cannot be estimated from available data

• Blood disorders characterized by uncommon bleeding or unexplained bruising, decrease in blood cell count causing weakness or fatigue
• Aggression, anxiety, confusion, seeing or hearing things that are not real
• Fainting, seizures, decreased sensitivity, hyperactivity, alteration or loss of sense of smell, alteration or loss of sense of taste, myasthenia gravis (muscle weakness and fatigue, see "Warnings and Precautions" above)
• Changes in hearing including deafness and/or ringing in the ears
• Change in heart rate, changes in heart rhythm detected on an electrocardiogram (prolongation of the QT interval and Torsade de Pointes)
• Decrease in blood pressure (which may be associated with weakness, dizziness, and fainting)

• Discoloration of the tongue, pancreas inflammation that produces nausea, vomiting, abdominal pain, back pain - Liver failure (rarely fatal)

• Skin rash with spots and blisters
• Kidney problems
• Severe intestinal inflammation (pseudomembranous colitis)
• Severe allergic reaction that can cause shock (anaphylactic reaction)

The following adverse effects have been reported in patients treated with azithromycin for the prevention of Mycobacterium Avium Complex (MAC) infections:

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)
• Feeling of dizziness (dizziness)
• Headache
• Feeling of tingling or numbness (paresthesia)
• Changes in taste (dysgeusia)
• Visual impairment
• 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.
• Skin allergic reactions such as sensitivity to sunlight, red, scaly, and inflamed skin
• Weakness (asthenia)
• Feeling of general discomfort

Reporting of 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 them 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 the sight and reach of children.

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

No special storage conditions are required.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the 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

Composition of Azithromycin Teva

• The active ingredient is: azithromycin. Each tablet contains 500 mg of the active ingredient azithromycin (as dihydrate).
• The other ingredients are calcium hydrogen phosphate, hypromellose, corn starch, pregelatinized corn starch, microcrystalline cellulose, magnesium stearate, sodium lauryl sulfate, indigo carmine lake (E132), titanium dioxide (E171), polysorbate 80, and talc.

Appearance of the Product and Package Contents

• Azithromycin Teva 500 mg tablets are film-coated, pale blue, biconvex, oblong tablets, marked with AI 500 and a score line on one side. The tablet can be divided into equal doses.
• The 500 mg tablets are available in pack sizes of: 1, 2, 3, 6, or 30 tablets.

Not all pack 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

Manufacturer:

Teva Operations Poland Sp. z.o.o.

ul. Mogilska 80

31-546 Cracovia

Poland

or

Merckle GmbH

Ludwig Merckle Straβe 3

89143 Blaubeuren

Germany

or

Pliva Croatia Ltd (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 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/67370/P_67370.html

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