Leaflet: information for the user

Azitromicina Aurovitas 500 mg film-coated tablets EFG

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, consult your doctor or pharmacist.

-This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Azitromicina Aurovitas and what it is used for

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

3.How to take Azitromicina Aurovitas

4.Possible side effects

5.Storage of Azitromicina Aurovitas

6.Contents of the pack and additional information

Azitromicina belongs to a group of antibiotics called macrolides. Antibiotics are used to treat infections caused by microorganisms such as bacteria.

It is used to treat some infections caused by bacteria that are sensitive to it, such as:

• Chest, throat, or nasal infections (such as bronchitis, pneumonia, tonsillitis, sore throat (pharyngitis), and sinusitis).
• Ear infections.
• Skin and soft tissue infections,.

Urinary tract infections caused by a tube leading from the bladder (urethra) or the cervix caused by a bacteria calledChlamydia trachomatis.

Do not take Azitromicina Aurovitas:

• if you areallergicto azithromycin dihydrate, erythromycin, another macrolide antibiotic, or ketolide.
• if you are allergic to any of the other components 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 facial and throat inflammation, possibly with respiratory problems, skin rash, fever, swollen lymph nodes, or increased eosinophils (a certain type of white blood cell).
• you develop persistent and intense diarrhea during or after treatment.
• you have a severe liver or kidney disease.
• you have severe heart problems or heart rhythm problems, such as prolonged QT interval (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

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

• 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 as azithromycin because it can cause severe adverse effects (ergotism – e.g., itching in the extremities, muscle spasms, and gangrenous hands and feet due to poor blood circulation).
• Cholesterol-lowering medications(statins).
• Warfarin or similar medications– used to prevent blood clots: simultaneous 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 as azithromycin because it can cause severe heart problems (as shown on an electrocardiogram or ECG machine).
• Zidovudine or nelfinavir– used for treating HIV infections. Taking nelfinavir with azithromycin may mean you have more adverse effects mentioned 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 organ or bone marrow transplant rejection. Your doctor will regularly check your ciclosporin blood levels and may change your dose.

Inform 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– an 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

There is not enough information available about the use of azithromycin during pregnancy. Therefore, azithromycin should not be used during pregnancy unless your doctor explicitly indicates it.

Azithromycin is partially excreted through breast milk.It is unknown whether azithromycin can have adverse effects on the infant. Therefore, breastfeeding should be interrupted during azithromycin treatment. Discard milk during treatment and for 2 days afterinterrupting treatment. Breastfeeding can be resumed afterwards.

Driving and operating machinery

There is no evidence that azithromycin affects the ability to drive or operate machinery. However, azithromycin may cause dizziness and convulsions, so make sure you are not affected before driving or operating machinery.

Azitromicina Aurovitas contains lactose

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

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.

The recommended dose is:

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

Azithromycin is taken over a period 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 byChlamydia 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:

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

Patients with liver or kidney problems

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

Older patients

The same dose as for adult patients should be applied for older patients.

The tablet can be divided into equal doses.

Administration form

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

The tablets can be taken with or without food.

If you take more Azithromycin Aurovitas than you should

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

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

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

If you forgot to take Azithromycin Aurovitas

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

If you interrupt the treatment with Azithromycin Aurovitas

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

If you have any other doubts 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 severe allergic reactions, stop taking this medicine immediately and inform your doctor or go to the nearest hospital emergency department.

The frequency of these reactions isunknown(cannot be estimated from available data):

• Sudden difficulty breathing, speaking, or swallowing.
• Swelling of the lips, tongue, face, and neck.
• Dizziness or excessive fainting.
• 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 (NET)).
• 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, itchy bumps (drug reaction with eosinophilia and systemic symptoms (DRESS)).

If you experience any of the following side 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 patches with small white/yellow-filled blisters.

Unknown frequency (cannot be estimated from available data):

• Severe diarrhea, lasting a long time or containing blood, with stomach pain or fever. This may be a sign of severe intestinal inflammation. This can occur rarely after taking antibiotics.
• Yellowing of the skin or the white of the eyes(jaundice)caused by liver problems.
• Inflammation of the pancreas (pancreatitis), causing severe abdominal and back pain.
• Increased or decreased urine production, or blood in the urine.
• Sunlight-induced skin rash.
• Unusual bleeding or bruising.
• Irregular heartbeat.

These are all the severe side effects. You may need urgent medical attention.

Other side effects include:

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

• Diarrhea.

•Abdominal pain.

•Nausea.

•Flatulence.

Common(may affect up to 1 in 10 people)

• Loss of appetite (anorexia).
• Headache.
• Dizziness.
• Paraesthesia (tingling or numbness).
• Changes in taste.
• Visual problems.
• Deafness.
• Vomiting, abdominal pain, or cramps, loss of appetite, difficulty digesting food.
• Skin rash and itching.
• Joint pain (arthritis).
• Fatigue.
• Changes in white blood cell count and bicarbonate concentration in blood.

Uncommon(may affect up to 1 in 100 people)

• Oral candidiasis – a fungal infection.
• Bacterial infection.
• Pharyngitis (inflammation of the throat).
• Respiratory disorder (shortness of breath, chest pain, wheezing, and cough).
• Rhinitis (inflammation of the nasal mucosa).
• Gastroenteritis (stomach flu).
• Vaginitis (inflammation of the vagina).
• Pneumonia.
• Decreased white blood cell count.
• Angioedema.
• Hypersensitivity.
• Nervousness.
• Decreased sense of touch (hypoesthesia).
• Drowsiness.
• Insomnia.
• Auditory disorder.
• Dizziness.
• Abnormal sensation of movement (vertigo).
• Palpitations.
• Hot flashes.
• Shortness of breath.
• Nasal bleeding.
• Gastritis (inflammation of the stomach lining).
• Constipation.
• Dysphagia (difficulty swallowing).
• Abdominal distension.
• Dry mouth.
• Belching.
• Mouth ulcer.
• Increased salivation.
• Liver problems such as hepatitis.
• Skin reactions such as sun sensitivity, redness, peeling, and inflamed skin.
• Skin rash.
• Itching.
• Dermatitis (inflammation of the skin).
• Dry skin.
• Increased sweating.
• Joint pain, swelling, and decreased mobility (osteoarthritis).
• Muscle pain.
• Back pain.
• Neck pain.
• Increased urea levels in blood.
• Painful or difficult urination.
• Renal pain.
• Irregular bleeding.
• Testicular disorder.
• Urticaria.
• Chest pain.
• Swelling of the face.
• 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.
• Complications following the procedure.

•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)

• Restlessness, feeling unreal.
• Abnormal liver function.
• Skin allergic reactions.
• Skin rash characterized by the rapid appearance of red skin patches with small white/yellow-filled blisters.

•Angioneurotic edema (inflammation of the hands, feet, lips, genitals, or throat).

•Renal problems.

Unknown frequency(cannot be estimated from available data)

• Colitis pseudomembranosa (inflammation of the colon).
• Anemia hemolytica (reduction in red blood cell count due to destruction); thrombocytopenia (reduction in platelet count).
• Anaphylactic reaction.
• Feeling angry, aggressive.
• Anxiety.
• Confusion.
• Alucination.
• Syncope (fainting).
• Seizures.
• Decreased sense of touch (hypoesthesia).
• Feeling hyperactive.
• Changes in sense of smell (anosmia, parosmia).
• Changes in sense of taste (ageusia).
• Exacerbation or worsening of muscle weakness (myasthenia gravis).
• Blurred vision.
• Auditory problems, including hearing loss, tinnitus.
• Irregular heartbeat (ventricular tachycardia) or arrhythmia, sometimes life-threatening, changes in heart rhythm detected by an electrocardiogram (prolongation of the QT interval and torsades de pointes).
• Low blood pressure.
• Pancreatitis (inflammation of the pancreas).
• Change in tongue color.
• Liver insufficiency.
• Severe skin allergic reactions.
• Renal inflammation.

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

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

• Diarrhea.
• Abdominal pain.
• Nausea.
• Flatulence.
• Abdominal discomfort.
• Loose stools.

Common(may affect up to 1 in 10 people)

• Loss of appetite (anorexia).
• Dizziness.
• Headache.
• Paraesthesia (tingling or numbness).
• Changes in sense of taste.
• Visual problems.
• Deafness.
• Vomiting, abdominal pain, or cramps, loss of appetite, difficulty digesting food.
• Skin rash and itching.
• Joint pain (arthritis).
• Fatigue.

Uncommon(may affect up to 1 in 100 people)

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

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use: https://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.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the 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.

Composition of Azitromicina Aurovitas

• The active ingredient is azithromycin dihydrate.

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

• The other components are:

Tablet core: calcium hydrogen phosphate, pregelatinized cornstarch, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate.

Tablet coating: lactose monohydrate, hypromellose, titanium dioxide (E 171), triacetin.

Appearance of the product and contents of the package

Film-coated tablet.

Azitromicina Aurovitas 500 mg film-coated tablets EFG:

Oval-shaped tablet, white to off-white, film-coated, marked with “6” and “7” on the sides of the groove 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/Aluminium blisters..

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

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer:

APL Swift Services (Malta) Limited

HF26, Half Far Industrial Estate, Hal Far,

Birzebbuggia, BBG 3000

Malta

O

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

Bélgica:Azithromycin AB 500 mg filmomhulde tabletten

Spain: Azitromicina Aurovitas 500 mg film-coated tablets EFG

Holanda:Azitromycine Aurobindo 500 mg, filmomhulde tabletten

Hungary: Azitromicin Aurovitas 500 mg filmtabletta

Poland: Azithromycin Aurovitas

Portugal: Azitromicina Aurovitas

Czech Republic: Azithromycin Aurovitas 500 mg potahované tablety

Last review date of this leaflet:December 2022

Further information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)