AZITHROMYCIN TEVA 250 mg FILM-COATED TABLETS

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 other macrolide or ketolide antibiotics, such as erythromycin or telithromycin.

Warnings and precautions

Consult your doctor before taking 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): azithromycin 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 abnormal heart rhythms), 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, levofloxacino): Azitromicina Teva 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.

• If you have myasthenia gravis, a condition characterized by muscle weakness and fatigue, as azithromycin may worsen the symptoms of this condition or trigger it.

If you experience 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 experience 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 Azitromicina Teva or if you notice any new and persistent symptoms, inform your doctor.

Children and adolescents

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 Azitromicina Teva 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 taken at the same time, as ergotism (a potentially serious side effect with numbness or tingling in the extremities, 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 or zidovudine 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 sedative): the effect of alfentanil may be increased.
• fluconazole (for fungal infections): azithromycin levels may be reduced.
• atorvastatin (a cholesterol-lowering medication). 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), theophylline (for asthma), or trimethoprim/sulfamethoxazole (a combination antibiotic).

Pregnancy and breastfeeding

If you are pregnant, 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, considering whether the benefits of treatment outweigh the potential risks.

Breastfeeding

Azithromycin has been reported to be excreted in breast milk. No serious adverse reactions to azithromycin have been observed in babies.

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 recommended dose is:

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

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

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

Urethritis or cervicitis caused by Chlamydia:

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

Children and adolescents weighing less than 45 kg:

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.

If you take more Azitromicina Teva than you should

If you (or someone else) ingest many tablets at once or 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 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 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 go to your doctor immediately or to the emergency department of the nearest hospital.

Uncommon: may affect up to 1 in 100 people

• Angioedema: swelling of the lips, face, or neck, which causes 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 that causes difficulty breathing or dizziness
• Severe liver disorders or liver failure (rarely life-threatening): signs may include fatigue associated with yellowing of the skin or the 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 on the 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 some 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 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, 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 (yellowish skin pigmentation)
• 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)
• Abnormalities in hearing including deafness and/or ringing in the ears
• Change in heart rate, changes in heart rhythm detected on 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 produced 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 leaflet. You can also report them directly through the Spanish Medicines Agency's 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 down the drain or into the trash. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. 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 250 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, titanium dioxide (E171), polysorbate 80, and talc.

Appearance of the Product and Package Contents

• Azithromycin Teva 250 mg film-coated tablets are white, biconvex, oblong tablets, marked with AI 250 on one side.
• The 250 mg tablets are available in pack sizes of: 2, 4, 6, or 10 tablets.

Only some 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 leaflet: 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 smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/67335/P_67335.html

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