Azithromycin Teva 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Azithromycin Teva 500 mg film-coated tablets EFG

Azithromycin (dihydrate)

Read this entire 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, and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Azithromycin belongs to a group of antibiotics known as macrolide antibiotics.

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

It is important to follow your doctor's instructions regarding dose, dosing interval, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left after completing the treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via wastewater or household waste.

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

• Exacerbations of bronchitis and pneumonia (mild to moderate severity)
• Infections of the sinuses, throat, tonsils, or ears
• Mild to moderate skin and soft tissue infections, for example infection of the hair follicles (folliculitis), bacterial infection of the skin and underlying layers (cellulitis), skin infection with swelling and bright red coloration (erysipelas)

Infections caused by a bacterium called Chlamydia trachomatis, which can cause inflammation of the tube carrying urine from the bladder (urethra) or of the area where the uterus joins the vagina (cervix).

2. What you need to know before taking Azithromycin Teva

Do not take Azithromycin Teva

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

Warnings and precautions

Talk to your doctor before taking Azithromycin Teva if you:

• have ever had a severe allergic reaction with swelling of the face and throat, possibly causing breathing difficulties.
• have liver problems. Your doctor may need to monitor your liver function or stop treatment.
• are taking medicines known as ergot alkaloids (such as ergotamine), used to treat migraine. Azithromycin Teva is not recommended (see “Other medicines and Azithromycin Teva”).
• have severe kidney problems. Your doctor may need to adjust the dose.
• have been diagnosed with or know you have long QT interval (a heart condition). Azithromycin Teva is not recommended.
• know you have a slow or irregular heartbeat or reduced heart function. Azithromycin Teva is not recommended.
• know you have low levels of potassium or magnesium in your blood: azithromycin is not recommended.
• are taking medicines 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. moxifloxacin, levofloxacin). Azithromycin should be used with caution.
• have been diagnosed with a neurological disease, or a disease affecting the brain or nervous system.
• have mental, emotional, or behavioural problems.
• have a condition called myasthenia gravis, which causes muscle weakness and fatigue, as azithromycin may worsen symptoms or trigger the condition.

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

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

If you develop severe and persistent diarrhoea, 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 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 medicines and Azithromycin Teva

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

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

• antacids, for example, aluminium hydroxide: take azithromycin at least 1 hour before or 2 hours after taking an antacid.
• ergot derivatives, for example, ergotamine (used to treat migraine). Azithromycin Teva should not be taken at the same time, as ergotism (a potentially serious adverse effect with numbness or tingling in the limbs, muscle cramps, headaches, seizures, or abdominal or chest pain) may occur.
• coumarin derivatives, for example, 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 blood levels.
• zidovudine, nelfinavir (used in the treatment of AIDS): levels of zidovudine or azithromycin may increase.
• rifabutin (used in the treatment of AIDS and bacterial infections including tuberculosis): a decrease in white blood cell count may occur.
• cyclosporine (an immunosuppressant used after organ transplant): cyclosporine levels may rise. Your doctor will need to monitor your blood levels of cyclosporine.
• cisapride (used to treat stomach problems): heart problems may occur.
• hydroxychloroquine (used to treat rheumatic diseases or malaria): heart problems may occur.
• astemizole, terfenadine (antihistamines used to treat allergic reactions): their effects may be increased.
• alfentanil (a painkiller): the effect of alfentanil may increase.
• fluconazole (for fungal infections): azithromycin levels may be reduced.
• atorvastatin (a medicine 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); atorvastatin (for cholesterol and heart problems); carbamazepine (for epilepsy); cimetidine (an antacid); methylprednisolone (to suppress the immune system); midazolam, triazolam (sedatives); sildenafil (for erectile dysfunction); and trimethoprim/sulfamethoxazole (an antibiotic combination).

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Your doctor will assess whether you should take this medicine during pregnancy, if the benefit of treatment outweighs the possible risks.

Breast-feeding

It has been reported that azithromycin is excreted in breast milk. No serious adverse reactions of azithromycin have been observed in infants.

Driving and using machines

This medicine may cause adverse effects such as dizziness or convulsions. This may affect your ability to drive or operate machinery.

Azithromycin Teva contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take Azithromycin Teva

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Take the tablets preferably with a glass of water. They may be taken with or without food.

The tablet may be divided into equal doses.

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 once daily from day 2 to day 5.

In cases of urethritis or cervicitis caused by Chlamydia:

1000 mg taken as a single dose on 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 your dose may need to be adjusted.

The tablet may be divided into equal doses.

If you take more Azithromycin Teva than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested. Take this leaflet, any remaining tablets and the packaging with you to the hospital or to your doctor so they know which tablets have been 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 for your next dose. Do not take a double dose to make up for forgotten doses.

If you stop taking Azithromycin Teva

Do not stop taking this medicine without first consulting your doctor, even if you feel better. It is very important that you continue taking Azithromycin Teva for the full duration prescribed by your doctor; otherwise, the infection may return.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

If you experience any of the following, stop taking the tablets and contact your doctor immediately or go to the nearest hospital emergency department.

Uncommon: may affect up to 1 in 100 people

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

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

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

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, or 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—serious conditions
• Changes in heart rate, changes in heart rhythm on electrocardiogram (prolongation of QT interval, ventricular tachycardia, and torsades de pointes)
• Prolonged diarrhoea with blood and mucus (pseudomembranous colitis)

These are serious but rare adverse effects. You may require urgent medical attention or hospitalization.

Other adverse effects

Very common: may affect more than 1 in 10 people

• Diarrhoea

Common: may affect up to 1 in 10 people

• Headache
• Vomiting, stomach pain, nausea
• Changes in the number of certain types of white blood cells and blood bicarbonate levels

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 lining of the stomach and intestines
• 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, drowsiness, taste disturbances, tingling or numbness
• Vision disorders
• Hearing problems
• Vertigo (spinning sensation)
• Abnormality in heart rhythm or rate and awareness of heartbeat (palpitations)
• Hot flushes
• Difficulty breathing
• Nosebleeds
• Inflammation of the stomach, constipation, gas, indigestion, difficulty swallowing
• Bloating sensation, 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, malaise, weakness, fatigue
• Facial swelling, 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 (yellowing of the skin)
• Allergic reactions including angioneurotic edema
• Photosensitivity (redness and blistering of the skin upon exposure to sunlight)
• Skin rash characterized by the rapid appearance of red skin areas with small pustules (small blisters filled with white/yellow fluid)

Not known: frequency cannot be estimated from available data

• Blood disorders characterized by unusual bleeding or unexplained bruising, decreased blood cell count causing unusual weakness or fatigue
• Aggression, anxiety, confusion, seeing or hearing things that are not real
• Fainting, seizures, decreased sensation, hyperactivity, altered or loss of sense of smell, altered or loss of sense of taste, myasthenia gravis (muscle weakness and fatigue, see “Warnings and precautions” above)
• Hearing disturbances including deafness and/or ringing in the ears (tinnitus)
• Changes in heart rate, changes in heart rhythm detected on electrocardiogram (prolongation of QT interval and Torsade de Pointes)
• Decreased blood pressure (which may be associated with weakness, dizziness, and fainting)
• Discoloration of the tongue, inflammation of the pancreas causing nausea, vomiting, abdominal pain, back pain – liver failure (rarely fatal)
• Skin rash with spots and blisters
• Kidney problems
• Severe inflammation of the intestine (pseudomembranous colitis)
• Severe allergic reaction which may lead to shock (anaphylactic reaction)

The following adverse effects have been reported in patients receiving azithromycin for the prevention of Mycobacterium avium complex (MAC) infections:

Very common: may affect more than 1 in 10 people

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

Common: may affect up to 1 in 10 people

• Loss of appetite (anorexia)
• Dizziness
• Headache
• Tingling or numbness sensation (paraesthesia)
• Taste changes (dysgeusia)
• Visual disturbances
• Deafness
• Skin rash
• Itching (pruritus)
• Joint pain (arthralgia)
• Fatigue

Uncommon: may affect up to 1 in 100 people

• Reduced sensation (hypoesthesia)
• Hearing loss or ringing in the ears
• Abnormality in heart rhythm or rate and awareness 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)
• General feeling of malaise

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines website: www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the container, after EXP. The expiry date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Azithromycin Teva

• The active substance is: azithromycin. Each tablet contains 500 mg of the active substance azithromycin (as dihydrate).
• The other components 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 contents of the pack

• Azithromycin Teva 500 mg tablets are pale blue, biconvex, oblong, film-coated 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.

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, 1st floor

28108 Alcobendas, Madrid

Manufacturer:

Teva Operations Poland Sp. z.o.o.

ul. Mogilska 80

31-546 Kraków

Poland

or

Merckle GmbH

Ludwig Merckle Straße 3

89143 Blaubeuren

Germany

or

Pliva Croatia Ltd (PLIVA KRVATSKA D.O.O)

Prilaz Baruna Filipovića 25

10000 Zagreb

Croatia

This medicinal product is authorized in the European Economic Area member states under the following names:

Date of the most recent review of this leaflet: November 2024

Detailed information on this medicinal product 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 up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the packaging. 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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