Package Insert: Information for the User

Azithromycin 500 mg Film-Coated Tablets EFG

Azithromycin (dihydrate)

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:

• Chest infections such as acute exacerbation of bronchitis and pneumonia.
• Paranasal sinus, throat, tonsil, 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 swelling and bright red color.
• Infections caused by a bacterium called Chlamydia trachomatis, which can cause inflammation of the urethra or the cervix.

Do not take Azitromicina ratio

• if you are allergic to azitromicina, or to any of the other components of this medication (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 before starting to take Azitromicina ratio if you:

• have ever had a severe allergic reaction with facial and throat inflammation and possible respiratory problems.
• have severe kidney problems. Your doctor may adjust the dose.
• have liver problems. Your doctor may need to monitor your liver function or stop treatment.
• know that you have or have been diagnosed with prolonged QT interval (a heart disease). Azitromicina ratio is not recommended.
• know that you have a slow or irregular pulse or reduced heart function. Azitromicina ratio is not recommended.
• know that you have low levels of potassium or magnesium in your blood. Azitromicina ratio 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 ratio should be used with caution.
• are taking medications known as ergot alkaloids (such as ergotamine), used to treat migraine: Azitromicina ratio is not recommended (see "Use of Azitromicina ratio with other medications")
• 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, as azitromicina may worsen the 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 ratio 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 ratio 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 ratio or if you notice any new and persistent symptoms, inform your doctor.

Other medications and Azitromicina ratio

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

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

• antacids, for example, aluminum hydroxide: take azitromicina at least 1 hour before or 2 hours after taking an antacid.
• ergotamine derivatives, for example, ergotamine, (used to treat migraine): Do not administer 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 clotting): 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 azitromicina levels may increase.
• rifabutin (used to treat HIV and bacterial infections including tuberculosis): may occur a decrease in the number of white blood cells in the blood.
• ciclosporina (an immunosuppressant used after organ transplant): ciclosporina levels may increase. Your doctor will need to monitor your ciclosporina 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.
• alfentanilo (sedative): the effect of alfentanilo may increase.
• fluconazol (for fungal infections): azitromicina levels may be reduced.
• atorvastatina (cholesterol-lowering medication). The concomitant use of azitromicina and atorvastatina has been associated with an increased risk of muscle tissue deterioration (rhabdomyolysis) leading to muscle pain and dark urine.

No interactions have been observed between azitromicina and cetirizine (an antihistamine); didanosina, efavirenz, indinavir (for HIV infection); carbamazepina (for epilepsy), cimetidina (an antacid); metilprednisolona (to suppress the immune system); midazolam, triazolam (sedatives); sildenafilo (for impotence), teofilina (for asthma) and trimetoprim/sulfametoxazol (a combination antibiotic).

Pregnancy and breastfeeding

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

There is not enough information about the safety of azitromicina during pregnancy. Therefore, azitromicina is not recommended if you are pregnant, or wish to become pregnant. However, your doctor may prescribe it in serious circumstances.

Talk to your doctor before taking Azitromicina ratio if you are breastfeeding. Your doctor will decide if Azitromicina Teva can be used during breastfeeding.

Azitromicina is excreted in breast milk. No severe adverse reactions to azitromicina have been observed in babies.

Azitromicina ratio, as it may cause side effects such as diarrhea and infection in the baby.

Driving and operating machinery

This medication may cause drowsiness and dizziness. If it affects you, do not drive or operate machinery.

Azitromicina ratio 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 for this medication as indicated by your doctor. If in 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 tablet can be divided into equal doses.

The recommended dose is:

Adults (including elderly patients) and children with a weight of over 45 Kg:

The recommended 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 one day.

Children and adolescents under 45 kg of weight:

The tablets are not recommended for these patients. Other pharmaceutical forms containing azitromicina (for example, 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 Azitromicina ratio than you should

If you (or someone) ingest 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 Azitromicina ratio

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 the missed dose.

If you interrupt treatment with Azitromicina ratio

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 Azitromicina ratio for the time your doctor has indicated, as the infection may recur if you stop.

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 Azitromicina ratio and seek medical attention immediately or visit the nearest hospital emergency room.

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.

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

• A skin rash characterized by the rapid appearance of red skin patches with small white or yellow pustules (small blisters filled with a white or yellow liquid)

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

• Drug reaction with eosinophilia and systemic symptoms (DRESS): a hypersensitivity reaction with skin rash, fever, lymph node inflammation, and possible organ damage.

Unknown: the frequency cannot be estimated from available data

• Anaphylactic reaction: a 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, and a 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 the electrocardiogram (prolongation of the QT interval, ventricular tachycardia, and torsades de pointes).
• Prolonged diarrhea with blood and mucus (pseudomembranous colitis).

These are very serious 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 people

• 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 people

• Fungal infection, for example in the mouth (aphthae), vaginal infection, pneumonia, bacterial infection
• Sore throat, inflammation of the stomach lining and intestine
• 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
• Auditory problems,
• Dizziness (sensations of spinning)
• Abnormal heart rhythm or frequency and heart palpitations
• Hot flashes
• Difficulty breathing
• Nasal bleeding
• Inflammation of the stomach, constipation, gas, indigestion, difficulty swallowing
• Sensation of being bloated, dry mouth
• Belching, mouth ulcers, increased salivation, soft stools
• Liver problems (such as liver inflammation, hepatitis)
• Itchy skin rash, hives (itchy rash)
• Skin inflammation, dry skin, increased sweating
• Inflammation of the bones and joints, muscle pain, back pain, neck pain
• Difficulty and pain urinating, back pain (kidney pain)
• Vaginal inflammation, irregular menstrual bleeding, testicular disorders
• Chest pain, swelling, discomfort, weakness, fatigue
• Inflammation of the face, hands, legs, and/or feet, fever, pain.
• Changes in liver enzymes and blood values

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

• Agitation
• Sensation that things are unreal.
• Confusion, especially in elderly patients.
• Teeth discoloration
• Abnormal liver function, jaundice (yellowish pigmentation of the skin)
• Photosensitivity: redness and blistering of the skin upon exposure to sunlight

Unknown: the frequency cannot be estimated from available data

• Blood disorders characterized by rare bleeding or unexplained petechiae, decreased red blood cell count causing weakness or fatigue
• Sensation of bad mood, anxiety, confusion, seeing or hearing things that are not happening
• Loss of consciousness, convulsions, decreased sensitivity, hyperactivity, alteration or loss of sense of smell, loss of sense of taste, myasthenia gravis (muscle weakness and fatigue, see 2 "Warnings and precautions")
• Alteration in hearing, including deafness and/or tinnitus.
• Decreased blood pressure (which may be associated with weakness, loss of consciousness, and fainting)
• Yellowing of the tongue, pancreatitis that causes nausea, vomiting, abdominal pain, back pain
• Itchy skin rash with blisters and pustules
• Joint pain (arthralgia)
• Renal problems

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 people

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

Rare: may affect up to 1 in 100 people

• Reduced sensitivity (hypoaesthesia)
• Loss of hearing or tinnitus
• Abnormal heart rhythm or frequency and heart 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 sensitivity to sunlight, red, scaly, and inflamed skin
• Weakness (asthenia)
• Sensation of general 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 prospectus. 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 trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Azitromicina ratio Composition

• The active ingredient is azitromicina.

Each film-coated tablet contains 500 mg of azitromicina (as dihydrate).

• The other components are calcium hydrogen phosphate, anhydrous, hypromellose, cornstarch, pregelatinized cornstarch, microcrystalline cellulose, magnesium stearate, sodium lauryl sulfate, indigo carmine (E132), titanium dioxide (E171), polisorbate 80, and talc.

Appearance of the product and contents of the package

• Azitromicina ratio 500 mg tablets are pale blue, oblong, biconvex, film-coated tablets marked with AI 500 and scored on one side.
• 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 11, Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid (Spain)

Manufacturer:

Teva Operations Poland Sp. z.o.o.

ul. Mogilska 80

31-546 Cracovia

Poland

Merckle GmbH

Ludwig Merckle Street 3

89143 Blaubeuren

Germany

Pharmachemie B.V.

Swensweg, 5

Haarlem

Netherlands

or

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

Prilaz Baruna Filipovica 25

10000 Zagreb

Croatia

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

Last review date of this leaflet: July 2022

For detailed and updated information on this medicinal product, please consult the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es