Azitromicina teva 250 mg comprimidos recubiertos con pelicula efg

Package Leaflet: Information for the User

Azitromicina Teva 250 mg Film-Coated Tablets EFG

Azitromicina (dihidrate)

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as 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. Do not pass it on to others even if they have the same symptoms, as it may harm them.
• If you experience any side effects, talk to your doctor, even if they appear in this leaflet. See section 4.

1. What isAzitromicina Tevaand what it is used for

2. What you need to know before takingAzitromicina Teva

3. How to takeAzitromicina Teva

4. Possible side effects

5. Storage ofAzitromicina Teva

6. Contents of the pack and additional information

Azitromicina belongs to a group of antibiotics called macrolide antibiotics.

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

• Mild to moderate worsening of bronchitis and pneumonia
• Upper respiratory tract infections, throat, tonsils, or ear infections
• Mild to moderate skin and soft tissue infections, for example, folliculitis, bacterial skin infection, and cellulitis, or erysipelas, a skin infection with redness and swelling.

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

Do not take Azitromicina Teva

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

Warnings and precautions

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

• have ever had a severe allergic reaction with facial and throat inflammation, and possible respiratory problems.
• have liver problems. Your doctor may need to monitor your liver function or stop 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 modify the dose.
• know that you have or have been diagnosed with prolonged QT interval (a heart disease): azithromycin is not recommended.
• know that you have a slow or irregular pulse or reduced heart function. Azitromicina Teva is not recommended.
• know that you have low levels of potassium or magnesium 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 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. moxifloxacino, levofloxacino): Azitromicina should be used with caution.
• have been diagnosed with any neurological disease, brain or nervous system disease.
• have mental, emotional, or behavioral problems.

• If you have a disease called myasthenia gravis, with muscle weakness and fatigue, azithromycin may worsen symptoms of this disease or trigger it.

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

If you have an allergic reaction (for example, 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 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 taken recently, or may need to take any other medication.

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

• antacids, for example, aluminum hydroxide: take Azitromicina Teva at least 1 hour before or 2 hours after taking an antacid.
• ergotamine derivatives, for example, ergotamine (used to treat migraines). Azitromicina Teva should not be administered at the same time as it may develop ergotism (a potentially serious adverse effect with numbness or tingling in the extremities, muscle cramps, headaches, convulsions, or abdominal or chest pain).
• cumarin derivatives, for example, warfarin (used to prevent blood clots): may increase the risk of bleeding.
• digoxin (used to treat heart failure) or colchicine (used to treat gout and familial Mediterranean fever): may increase digoxin/colchicine levels in the blood.
• zidovudine, nelfinavir (used to treat HIV): zidovudine or azithromycin levels may increase.
• rifabutin (used to treat HIV and bacterial infections, including tuberculosis): may decrease the number of white blood cells in the blood.
• ciclosporin (an immunosuppressant used after organ transplantation): ciclosporin levels may increase. Your doctor will need to monitor your ciclosporin levels in the blood.
• cisapride (used to treat stomach problems): may cause heart problems.
• hydroxychloroquine (used to treat rheumatic diseases or malaria): may cause heart problems.
• astemizol, terfenadine (antihistamines used to treat allergies): their effects may be increased.
• alfentanil (sedative): the effect of alfentanil may be increased.
• fluconazole (for fungal infections): azithromycin levels may be reduced.
• atorvastatin (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); 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) and trimethoprim/sulfamethoxazole (a combination antibiotic).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be 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 benefits of treatment outweigh the possible risks.

Breastfeeding

Azithromycin has been excreted in breast milk. No serious adverse reactions have been observed in babies.

Driving and operating machinery

This medication may cause adverse effects such as dizziness or convulsions. 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”.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, 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 with a body weight of more than 45 kg:

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

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

Urethral or cervical inflammation caused by Chlamydia:

1,000 mg taken as a single dose, on a single day.

Children and adolescents weighing less than45 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 modified.

If you take more Azithromycin Teva than you should

If you (or someone) have ingested many tablets at once or if you think a child has swallowed a tablet, 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 Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount ingested. Bring this leaflet, some of the remaining tablets, and the packaging to the hospital or to your doctor so they know what tablets you have taken.

If you forget to take Azithromycin Teva

If you forget to take a tablet, take it as soon as you remember, unless it is almost time to take the next one. Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Azithromycin Teva

Do not stop taking your medication without consulting your doctor first, even if you feel better. It is very important that you continue to take Azithromycin Teva for the time your doctor has indicated, as the infection may recur if you do not.

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

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

If you experience any of the following, stop taking the tablets and seek medical attention immediately or go to the nearest hospital emergency department.

Rare: may affect up to 1 in 100 peoplepeople

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

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

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

Unknown: the frequency cannot be estimated from available data

• Anaphylactic reaction: severe allergic reaction that causes difficulty breathing or dizziness
• Severe liver damage or liver failure (rarely life-threatening): symptoms may include fatigue associated with yellowing of the skin or white of the eyes (jaundice), dark urine, tendency to bleed
• Blisters/blood in the 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 electrocardiogram heart rhythm (prolongation of the QT interval, ventricular tachycardia, and torsades de pointes)
• Prolonged diarrhea with blood and mucus (pseudomembranous colitis).

These are serious but rare side effects. You may need urgent medical attention or hospitalization

Other side effects

Very common: may affect more than 1 in 10 people

• Diarhea

Common: may affect up to 1 in 10 peoplepeople

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

Rare: may affect up to 1 in 100 peoplepeople

• Fungal infection, for example in the mouth (aphthae), vaginal infection, pneumonia, bacterial infection
• Sore throat, inflammation of the stomach and intestinal lining
• Shortness of breath, chest pain, wheezing, and cough (respiratory disorders), nasal congestion
• Blood disorders characterized by fever or chills, sore throat, mouth or throat ulcers
• Allergic reactions
• Loss of appetite
• Nervousness
• Difficulty sleeping
• Dizziness, somnolence, taste alterations, tingling or numbness
• Eye disorders
• Ear problems
• Dizziness (sensation of spinning)
• Abnormal heart rhythm or frequency and detection of heartbeats (palpitations)
• Hot flashes
• Difficulty breathing
• Nasal bleeding
• Stomach inflammation, constipation, gas, indigestion, difficulty swallowing
• Sensation of being bloated, dry mouth
• Belching, mouth ulcers, increased salivation, soft stools
• Jaundice (inflammation of the liver)
• Skin rash, itching, hives (skin eruption with itching)
• 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
• Face inflammation, fever, pain.
• Changes in liver enzymes and blood values

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

• Agitation
• Sensation that things are unreal.
• Confusion, especially in elderly patients.
• Teeth discoloration
• Abnormal liver function, jaundice (yellowing of the skin)
• Allergic reactions including angioneurotic edema
• Sun sensitivity (redness and blistering of the skin when exposed to sunlight
• Urticaria characterized by the rapid appearance of red skin areas with small white/yellow blisters

Unknown: the frequency cannot be estimated from available data

• Blood disorders characterized by rare bleeding or unexplained bruising, decreased blood count causing weakness or fatigue
• Aggression, anxiety, confusion, seeing or hearing things that are not real
• Loss of consciousness, convulsions, 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)
• Alteration in hearing including deafness and/or ringing in the ears
• Change in heart rate, changes in electrocardiogram heart rhythm (prolongation of the QT interval and Torsade de Pointes)
• Decreased blood pressure (which may be associated with weakness, dizziness, and loss of consciousness)

• Teeth discoloration, pancreatitis that causes 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 may cause shock (anaphylactic reaction)

The following side 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

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

Common: may affect up to 1 in 10 peoplepeople

• Loss of appetite (anorexia)
• Dizziness (dizziness)
• Headache
• Sensation of tingling or numbness (paresthesia)
• Changes in taste (dysgeusia)
• Visual impairment
• Deafness
• Skin rash
• Itching (pruritus)
• Joint pain (arthritis)
• Fatigue

Rare: may affect up to 1 in 100 peoplepeople

• Reduced sensitivity (hypoesthesia)
• Loss of hearing or ringing in the ears
• Abnormal heart rhythm or frequency and detection of heartbeats (palpitations)
• Liver problems such as hepatitis
• Blisters/blood in the lips, eyes, nose, mouth, and genitals, which may be caused by Stevens-Johnson syndrome.
• Allergic skin reactions such as sun sensitivity, red, scaly, and inflamed skin
• Weakness (asthenia)
• General feeling of discomfort

Reporting of side effects

If you experience any type of side effect, consult your doctor, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish Medicines for Human Use Pharmacovigilance System Website:www.notificaram.es. By reporting side 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. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of the packaging and medications you no longer need if you are unsure. By doing so, you will help protect the environment.

Composition ofAzitromicina Teva

• The active ingredient is: azitromicina. Each tablet contains 250mg of the active ingredient azitromicina (as dihydrate).
• The other components are calcium hydrogen phosphate, hypromellose, cornstarch, pregelatinized cornstarch, microcrystalline cellulose, magnesium stearate, sodium lauryl sulfate, titanium dioxide (E171), polisorbate 80, and talc.

Appearance of the product and contents of the package

• Azitromicina Teva 250mg tablets are film-coated 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 commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid

Responsible manufacturer:

TevaOperations Poland Sp. z.o.o.

ul. Mogilska 80

31-546 Cracovia

Poland

or

Merckle GmbH

Ludwig Merckle Straße 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 with the following names:

Last review date of this leaflet: November 2024

More detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (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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