AZITHROMYCIN AUROVITAS 500 mg FILM-COATED TABLETS

2. What you need to know before you take Azitromicina Aurovitas

Do not take Azitromicina Aurovitas:

• If you are allergicto azithromycin dihydrate, erythromycin, or any other macrolide or ketolide antibiotic.
• If you are allergic to any of the other ingredients of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take azithromycin if:

• You have ever had a severe allergic reaction with swelling of the face and throat, possibly with breathing difficulties, skin rash, fever, swollen glands, or increased eosinophils (a type of white blood cell).
• You develop persistent and severe diarrhea during or after treatment.
• You have severe liver or kidney disease.
• You have serious heart problems or heart rhythm problems, such as a prolonged QT interval (as shown on an electrocardiogram or ECG machine).
• Your potassium or magnesium levels are too low.
• You develop signs of another infection.
• You take ergot derivatives such as ergotamine (for migraine treatment) because these medications should not be taken with azithromycin (see section "Taking Azitromicina Aurovitas with other medications").
• You have a certain type of muscle weakness called myasthenia gravis.
• You have neurological or psychiatric problems.
• Your newborn baby has vomiting and irritability during feeding.

Other medications and Azitromicina Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications:

• Antacids- used for heartburn and indigestion. Azithromycin should be taken at least 1 hour before or 2 hours after the antacid.
• Ergotamine- dihydroergotamine (for migraine treatment) should not be taken at the same time because serious side effects can develop (ergotism - e.g., itching in the extremities, muscle spasms, and gangrene of hands and feet due to poor blood circulation).
• Cholesterol-lowering medications(statins).
• Warfarin or similar medications- used to prevent blood clots: concurrent use may increase the risk of bleeding.
• Hydroxychloroquine(for treating rheumatic diseases or malaria): may cause heart problems.
• Cisapride- (for treating stomach problems) or terfenadine (for treating allergic rhinitis): should not be taken at the same time because this can cause serious heart problems (as shown on an electrocardiogram or ECG machine).
• Zidovudine or nelfinavir- used for treating HIV infections. Taking nelfinavir with azithromycin may mean that you have more side effects than those listed in this leaflet.
• Rifabutin- used for treating tuberculosis (TB).
• Quinidine- used for treating heart rhythm problems (called antiarrhythmics).
• Ciclosporin- used to suppress the immune system to prevent and treat rejection of a transplanted organ or bone marrow. Your doctor will regularly check your ciclosporin blood levels and may change your dose.

Tell your doctor or pharmacist if you are taking any of the following medications.

Azitromicina Aurovitas may enhance the effects of other medications. Your doctor may change your dose:

• Alfentanil- analgesic used, for example, during operations.
• Theophylline- used for treating respiratory problems such as asthma or chronic obstructive pulmonary disease (COPD).
• Digoxin- used for treating heart failure.

• Colchicine- used for treating gout and familial Mediterranean fever.

• Astemizole- used for allergic rhinitis.
• Pimozide- used for treating mental problems.

Taking Azitromicina Aurovitas with food and drinks

This medication can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medication.

There is not enough information available on the use of azithromycin during pregnancy. Therefore, azithromycin is not recommended during pregnancy unless your doctor explicitly indicates it.

Azithromycin is partially excreted into breast milk. It is unknown if azithromycin can have adverse effects on the infant. Therefore, breastfeeding should be interrupted during treatment with azithromycin. It is recommended to discard breast milk during treatment and up to 2 days after stopping treatment. Breastfeeding can be resumed after this period.

Driving and using machines

There is no evidence that azithromycin affects the ability to drive or use machines. However, azithromycin can cause dizziness and convulsions, so make sure you are not affected before driving or using machines.

Azitromicina Aurovitas contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medication.

Sodium

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

3. How to take Azitromicina Aurovitas

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

For adults and children with 45 kg or more of body weight:

Azithromycin is taken over a course of 3 or 5 days:

• 3 days: take 500 mg (two 250 mg tablets or one 500 mg tablet) once a day.
• 5 days:

• Take 500 mg on the first day (two 250 mg tablets).
• Take 250 mg (one 250 mg tablet) on days 2, 3, 4, and 5.

For infections of the cervix and urethra caused by Chlamydia trachomatis

A single dose of 1,000 mg (four 250 mg tablets or two 500 mg tablets), taken as a single dose.

Children and adolescents under 45 kg:

Tablets are not recommended. Other pharmaceutical forms of this medication should be used for children with a body weight below 45 kg.

Patients with liver or kidney problems

Tell your doctor if you have liver or kidney problems, as your doctor may modify the normal dose.

Elderly patients

For elderly patients, the same dose applies as for adult patients.

The tablet can be divided into equal doses.

Method of administration

The tablets should be taken with half a glass of water.

The tablets can be taken with or without food.

If you take more Azitromicina Aurovitas than you should

If you take more azithromycin than you should, consult your doctor, pharmacist, or go to the emergency department immediately.

The symptoms of overdose are hearing loss, feeling unwell, and diarrhea. In case of overdose, hospitalization may be necessary.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Azitromicina Aurovitas

If you forget to take azithromycin, take your dose as soon as possible. If it is almost time for your next dose, skip that dose and take the next one when it is due. In case of doubt, please contact your doctor or pharmacist. If you have to miss a dose, still take all your tablets. This means that you will finish your treatment one day later. Do not take a double dose to make up for forgotten doses.

If you stop taking Azitromicina Aurovitas

Never stop taking azithromycin treatment on your own, first consult your doctor. If the prescribed treatment is not completed, the infection may come back.

If you have any further questions on 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 symptoms of a severe allergic reaction, stop taking this medicine and inform your doctor immediately or go to the emergency department of the nearest hospital.

The frequency of these reactions is unknown(cannot be estimated from the available data):

• Sudden difficulty breathing, speaking, or swallowing.
• Swelling of the lips, tongue, face, and neck.
• Excessive dizziness or collapse.
• Severe skin rash or itching, especially if it shows blisters and if there are discomforts in the eyes, mouth, or genital organs.
• Severe skin reactions:

• Appearance of blisters on the skin, mouth, eyes, and genitals (Stevens-Johnson Syndrome (SSJ)).
• Appearance of blisters on the skin, severe skin reaction (Toxic Epidermal Necrolysis (TEN)).
• Skin rash accompanied by other symptoms such as fever, inflammation of the glands, and increased eosinophils (a type of white blood cell). The rash appears as small red and itchy bumps (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)).

If you experience any of the following adverse effects, contact your doctor as soon as possible.

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

• Increased or decreased urine production, or blood in the urine.
• Skin rash characterized by the rapid appearance of red skin areas sprinkled with small pustules (small blisters filled with white/yellow liquid).

Frequency unknown (cannot be estimated from the available data):

• Severe diarrhea, lasting a long time or containing blood, with stomach pain or fever. This can be a sign of severe intestinal inflammation. This is something that can rarely occur after taking antibiotics.
• Yellowish color of the skin or the whites of the eyes (jaundice) caused by liver problems.
• Pancreatitis (inflammation of the pancreas), which causes severe abdominal and back pain.
• Increased or reduced urine production or blood in the urine.
• Skin rash caused by sensitivity to sunlight.
• Unusual bleeding or bruising.
• Irregular heartbeat.

These are all serious adverse effects. You may need urgent medical attention.

Other adverse effects include:

Very common(may affect more than 1 in 10 people)

• Diarrhea.

• Abdominal pain.
• Nausea.
• Gas (flatulence).

Common(may affect up to 1 in 10 people)

• Lack of appetite (anorexia).
• Headache.
• Dizziness.
• Feeling of tingling or numbness (paresthesia).
• Changes in taste.
• Visual problems.
• Deafness.
• Being sick (vomiting), stomach pain or cramps, loss of appetite, problems digesting food.
• Skin rash and itching.
• Joint pain (arthralgia).
• Fatigue.
• Changes in the number of white blood cells and bicarbonate concentration in the blood.

Uncommon(may affect up to 1 in 100 people)

• Oral candidiasis - a fungal infection.
• Bacterial infection.
• Inflammation of the throat (pharyngitis).
• Shortness of breath, chest pain, wheezing, and cough (respiratory disorder).
• Inflammation of the nasal mucosa (rhinitis).
• Gastroenteritis.
• Vaginitis.
• Pneumonia.
• Decrease in the number of white blood cells in the blood.
• Angioedema.
• Hypersensitivity.
• Nervousness.
• Decreased sense of touch (hypoesthesia).
• Feeling of sleepiness (somnolence).
• Difficulty sleeping (insomnia).
• Hearing disorder.
• Dizziness.
• Feeling of abnormal movement (vertigo).
• Palpitations.
• Hot flashes.
• Shortness of breath.
• Nosebleed (epistaxis).
• Inflammation of the stomach lining (gastritis).
• Constipation.
• Difficulty swallowing.
• Abdominal swelling.
• Dry mouth.
• Belching.
• Mouth ulcer.
• Increased saliva flow.
• Liver problems such as hepatitis.
• Skin allergic reactions such as sensitivity to sunlight, redness, peeling, and inflamed skin.
• Skin rash.
• Itching.
• Skin inflammation (dermatitis).
• Dry skin.
• Increased sweating.
• Pain, swelling, and decreased mobility of the joints (osteoarthritis).
• Muscle pain.
• Back pain.
• Neck pain.
• Increased urea levels in the blood.
• Painful or difficult urination.
• Pain in the upper back (renal pain).
• Irregular bleeding.
• Testicular disorder.
• Urticaria.
• Chest pain.
• Facial swelling.
• Fever.
• Pain.
• Swelling of the extremities (peripheral edema).
• Inflammation (edema).
• General feeling of discomfort (discomfort).

Weakness (asthenia).

• Changes in liver enzyme levels and blood levels.
• Post-procedure complications.

• Skin more sensitive to sunlight than usual.
• Abnormal laboratory test results (e.g., blood tests or liver tests).

Rare(may affect up to 1 in 1,000 people)

• Feeling of agitation, feeling of unreality.
• Abnormal liver function.
• Skin allergic reactions.
• Skin rash characterized by the rapid appearance of red skin areas sprinkled with small pustules (small blisters filled with white/yellow liquid).

• Inflammation of the hands, feet, lips, genitals, or throat (angioedema).
• Kidney problems.

Frequency unknown(cannot be estimated from the available data)

• Abdominal infection (pseudomembranous colitis).
• Reduction in the number of red blood cells due to destruction (hemolytic anemia); reduction in the number of platelets (thrombocytopenia).
• Anaphylactic reaction.
• Feeling angry, aggressive.
• Anxiety.
• Confusion.
• Hallucination.
• Fainting (syncope).
• Seizures (convulsions).
• Decreased sense of touch (hypoesthesia).
• Feeling hyperactive.
• Changes in the sense of smell (anosmia, parosmia).
• Changes in the sense of taste (ageusia).
• Worsening of muscle weakness (myasthenia gravis).
• Blurred vision.
• Hearing problems, including hearing loss, ringing in the ears.
• Fast or irregular heartbeats (ventricular tachycardia) or sometimes life-threatening changes in heart rhythm detected on an electrocardiogram (prolonged QT interval and torsades de pointes).
• Low blood pressure.
• Pancreatitis.
• Change in tongue color.
• Liver failure.
• Severe skin allergic reactions.
• Kidney inflammation.

The following adverse effects have been reported in the prophylactic treatment of Mycobacterium Avium complex (MAC):

Very common(may affect more than 1 in 10 people)

• Diarrhea.
• Abdominal pain.
• Feeling of nausea.
• Gas (flatulence).
• Abdominal discomfort.
• Loose stools.

Common(may affect up to 1 in 10 people)

• Lack of appetite (anorexia).
• Feeling of dizziness.
• Headache.
• Feeling of tingling or numbness (paresthesia).
• Changes in taste.
• Visual impairment.
• Deafness.
• Being sick (vomiting), stomach pain or cramps, loss of appetite, problems digesting food.
• Skin rash and itching.
• Joint pain (arthralgia).
• Fatigue.

Uncommon(may affect up to 1 in 100 people)

• Decreased sense of touch (hypoesthesia).
• Hearing loss or ringing in the ears.
• Palpitations.
• Liver problems such as hepatitis.
• Severe skin redness.
• Skin allergic reactions such as sensitivity to sunlight, redness, peeling, and inflamed skin.
• General feeling of discomfort (discomfort).
• Weakness (asthenia).

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, 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: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Azitromicina Aurovitas

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.

This medicine does not require special storage conditions.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Azitromicina Aurovitas

• The active ingredient is azithromycin dihydrate.

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

• The other ingredients are:

Core of the tablet: calcium hydrogen phosphate, pregelatinized corn starch, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate.

Coating of the tablet: lactose monohydrate, hypromellose, titanium dioxide (E 171), triacetin.

Appearance of the product and package contents

Film-coated tablet.

Azitromicina Aurovitas 500 mg film-coated tablets EFG:

Oval-shaped tablet, between white and off-white, film-coated, marked with “6” and “7” on either side of the score line on one face, and with “D” on the other face. The size is 17.1 mm x 8.5 mm.

Azitromicina Aurovitas 500 mg film-coated tablets are available in transparent PVC/Aluminum blisters.

Package sizes: 2, 3, 4, 6, and 12 film-coated tablets.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Half Far Industrial Estate, Hal Far,

Birzebbuggia, BBG 3000

Malta

Or

This medicine is authorized in the Member States of the European Economic Area under the following names:

Belgium: Azithromycin AB 500 mg film-coated tablets

Spain: Azitromicina Aurovitas 500 mg film-coated tablets EFG

Netherlands: Azitromycine Aurobindo 500 mg, film-coated tablets

Hungary: Azitromicin Aurovitas 500 mg film tablet

Poland: Azithromycin Aurovitas

Portugal: Azitromicina Aurovitas

Czech Republic: Azithromycin Aurovitas 500 mg film-coated tablets

Date of the last revision of this prospectus:December 2022

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/)