PATIENT INFORMATION LEAFLET

AzithromycinAristo500 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, do not give it to others even if they have similar symptoms, 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.

Azitromicina belongs to a group of antibiotics called macrolides. It eliminates bacteria that cause infections.

It is used for the treatment of infections caused by bacteria in different parts of the body, in adults, and in children with a weight of 45 kg or more.

It is used for the treatment of the following infections:

• Throat, tonsil, ear, or sinus infections.
• Mild to moderate bronchitis and pneumonia.
• Mild to moderate skin and soft tissue infections.
• Urethritis or cervicitis, see section 3.
• Chancroid, see section 3.

Do not take Azitromicina Aristo

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

Warnings and precautions

Consult your doctor or pharmacist before starting this medication.

• During treatment with Azitromicina Aristo, allergic reactions (itching, redness, skin rash, swelling, or difficulty breathing, or an allergic reaction to the medication characterized by an increase in white blood cells in the blood and generalized symptoms) may occur, which could be severe. Inform your doctor, who may decide to discontinue treatment and initiate appropriate treatment.
• If you have liver problems or during treatment your skin and/or the white part of your eyes turn yellow, inform your doctor to confirm whether you should discontinue treatment or undergo liver function tests.
• If you are being treated with ergotamine derivatives (used to treat migraines), inform your doctor as the combined treatment with azithromycin may cause a condition called ergotism.
• During treatment with this medication, there is a possibility of developing an overinfection by resistant germs, including fungi. In this case, inform your doctor.
• During or after treatment with Azitromicina Aristo, symptoms may appear that suggest antibiotic-associated colitis (diarrhea). If this is the case, treatment should be discontinued and your doctor will prescribe the most suitable treatment.
• If you have severe kidney function impairment, inform your doctor.
• If you have arrhythmias or factors that predispose you to them (certain heart diseases, alterations in blood electrolyte levels, or certain medications), inform your doctor, as this medication may exacerbate or trigger these conditions.
• If you have myasthenia gravis or if muscle weakness and fatigue occur during treatment, inform your doctor, as Azitromicina Aristo may trigger or worsen symptoms of this disease.

Children and adolescents

Children and adolescents weighing less than 45 kg.

The tablets are not indicated for this group of patients. Other forms of azithromycin may be used. Do not administer to children under 6 months.

Children and adolescents weighing more than 45 kg.

This medication is not suitable for children who are unable to swallow the tablets whole. Other forms of azithromycin may be used.

Other medications and azithromycin

Inform your doctor or pharmacist if you are using, have used recently, or may need to take any other medication.

Especially inform your doctor or pharmacist if you are being treated with any of the following medications:

• Antacids (medications used for digestive problems). It is recommended to avoid simultaneous administration of both medications at the same time of day.
• Ergotamine derivatives (such as ergotamine, used to treat migraines), as simultaneous administration with azithromycin may cause ergotism (a potentially severe adverse effect with numbness or tingling in the extremities, muscle cramps, headaches, convulsions, abdominal or chest pain).
• Digoxin (a medication used to treat heart arrhythmias) as azithromycin may increase digoxin levels in the blood and levels should be monitored.
• Colchicine (used to treat gout and familial Mediterranean fever).
• Ciclosporin (a medication used in transplant patients) as azithromycin may increase ciclosporin levels in the blood and levels should be monitored.
• Anticoagulant dicumarins (medications used to prevent blood clots) as azithromycin may potentiate the effect of these anticoagulants. Your doctor should control coagulation parameters (prothrombin time).
• Nelfinavir, zidovudine (medications used to treat HIV infections), as they may increase azithromycin levels in the blood.
• Fluconazole (medications used to treat fungal infections), as they may increase azithromycin levels in the blood.
• Terfenadine (a medication used to treat allergies) as the combination may cause heart problems.
• Rifabutin (a medication used to treat tuberculosis and non-pulmonary infections caused by mycobacteria) as it may cause a decrease in white blood cell count.
• Medications with active substances that prolong the QT interval, such as antiarrhythmic class IA (quinidine and procainamide) and class III (dofetilide, amiodarone, and sotalol), cisapride, antipsychotics (such as pimozide), antidepressants (such as citalopram), and antifungals (fluoroquinolones such as moxifloxacin or levofloxacin and chloroquine), as they may cause severe heart rhythm alterations and even cardiac arrest.

No interactions have been observed between azithromycin and cetirizine (for treating allergic reactions); didanosine, efavirenz, indinavir (for treating HIV infection); atorvastatin (for treating high cholesterol and heart problems); carbamazepine (for treating epilepsy), cimetidine (for treating excess stomach acid); methylprednisolone (for suppressing the immune system); theophylline (for respiratory problems); midazolam, triazolam (for inducing sedation); sildenafil (for treating impotence) and trimethoprim/sulfamethoxazole (for treating infections).

Taking Azitromicina Aristo with food and drinks

The tablets should be swallowed whole with water and may 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, inform your doctor or pharmacist before using this medication.

There is not enough information regarding the safety of azithromycin during pregnancy. Therefore, azithromycin is not recommended for use during pregnancy, or if you wish to become pregnant, unless it is strictly necessary according to medical criteria.

Azithromycin is excreted in breast milk. Due to potential adverse reactions in the infant, azithromycin is not recommended during breastfeeding, although breastfeeding may be continued two days after completing treatment with Azitromicina Aristo.

Driving and operating machinery

The influence of this medication on the ability to drive or operate machinery is negligible or insignificant.

Azitromicina Aristo contains lactose and sodium

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

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

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

Your doctor will establish the most suitable dose and treatment duration for you, according to your condition and response to treatment. As a general rule, the recommended dose of medication and administration frequency is as follows:

Adults (including elderly patients) and children with a weight of over45 kg:

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

• When taken over 3 days, 500 mg per day.
• When taken over 5 days, 500 mg on the first day and then 250 mg on days 2 to 5.

In elderly patients, the same dose as for adults can be administered. However, in the case of patients with cardiac rhythm disorders, your doctor will closely monitor you.

Urethral or cervical infection (cervicitis):

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

In the case of an infection caused byN. gonorrohea, your doctor will administer the same dose in combination with another antibiotic (ceftriaxone (250 mg)).

Chancroid:

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

Sinusitis:

Treatment is indicated for adults and adolescents over 16 years old.

Children and adolescents weighing less than 45 kg:

The tablets are not recommended for these patients. Other pharmaceutical forms of azithromycin may be used.

Use in patients with liver insufficiency

Inform your doctor if you have severe liver problems, as the normal dose may need to be adjusted.

Use in patients with renal insufficiency

Inform your doctor if you have severe kidney problems, as the normal dose may need to be adjusted.

Administration form

Oral route.

This medication should be taken as a single daily dose. Tablets should be swallowed whole with water and can be taken with or without food.

If you take more azithromycin than you should

In case of overdose, you may experience reversible hearing loss, intense nausea, vomiting, and diarrhea.

Information for the prescriber

In case of overdose, administration of activated charcoal is indicated, and general symptomatic and supportive measures for vital function should be applied.

If you (or another person) ingest many tablets at once, or if you believe a child has ingested any of the tablets, contact your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount used. It is recommended to bring the packaging and leaflet to the healthcare professional. An overdose may cause reversible hearing loss, intense nausea (dizziness), vomiting, and diarrhea.

If you forget to take azithromycin

In case of forgotten dose, use the medication as soon as possible and continue treatment as prescribed. However, if the next dose is near, it is better not to take the forgotten dose and wait for the next one. Do not take a double dose to compensate for the forgotten dose. Continue using azithromycin as your doctor has indicated.

If you interrupt treatment with azithromycin

If you abandon treatment with azithromycin before your doctor has recommended, symptoms may worsen or reappear.

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

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

The side effects reported during clinical trials and after marketing, classified by frequency, are:

The side effectsvery frequent (affecting at least 1 in 10 people)are:

• Diarrhea.

The side effectscommon (may affect up to 1 in 100 people)are:

• Headache.
• Vomiting, abdominal pain, nausea.
• Alteration in the number of some types of white blood cells (lymphocytes, eosinophils, basophils, monocytes, and neutrophils, decrease in bicarbonate).

The side effectsinfrequent (may affect up to 1 in 1,000 people)are:

• Candida fungal infection in the mouth or generalized, vaginal infection, pneumonia, fungal or bacterial infection, pharyngitis, gastroenteritis, respiratory alteration, rhinitis.
• Decrease in the number of some types of white blood cells (leukocytes, neutrophils, and eosinophils).
• Allergic reaction, including a deep skin inflammatory process (angioedema).
• Alteration in eating behavior (anorexia).
• Nervousness, insomnia.
• Drowsiness, dizziness, alteration in taste, loss of tactile sensation.
• Alteration in vision.
• Alteration in hearing, vertigo.
• Palpitations.
• Hot flashes.
• Alteration in breathing, nasal hemorrhage.
• Constipation, flatulence, indigestion, gastritis, difficulty swallowing, abdominal distension, dry mouth, belching, mouth ulcers, increased salivation.
• Rash, pruritus, appearance of red, elevated papules, dermatitis, dry skin, excessive sweating, erythema.
• Joint inflammation, muscle pain, back pain, neck pain.
• Difficulty urinating, kidney pain.
• Vaginal hemorrhage, alteration in testicles.
• Generalized swelling, weakness, discomfort, fatigue, facial edema, chest pain, fever, pain and swelling of the extremities.
• Alteration in liver function tests (increase in liver enzymes GOT, GPT, and alkaline phosphatase) and increase in bilirubin, urea, creatinine, chloride, glucose, bicarbonate, and platelets in blood, alteration in sodium and potassium levels, decrease in hematocrit.
• Complications after surgical intervention

The side effectsrare (may affect up to 1 in 10,000 people)are:

• Agitation.
• Alteration in liver function, yellow discoloration of the skin.
• Sensitivity to sunlight (photosensitivity), allergic reaction with increase in a type of white blood cell (eosinophilia) and generalized symptoms (multi-organ compromise) (DRESS syndrome).
• Skin rash characterized by the rapid appearance of red skin areas dotted with small white/yellow-filled blisters.

The side effectsof unknown frequency are:

• Diarrhea caused byClostridium difficile.
• Decrease in platelet count in blood, anemia.
• Severe allergic reaction.
• Aggressive behavior, anxiety, delirium, hallucinations.
• Loss of consciousness, seizures, decreased sensitivity, hyperactivity, alteration and/or loss of smell, loss of taste, muscle weakness and fatigue (myasthenia gravis).
• Alteration in hearing including deafness and tinnitus.
• Torsades de pointes alterations in heart rhythm, prolongation of the QTc interval in the electrocardiogram.
• Decrease in blood pressure.
• Pancreatitis, change in color of the tongue.
• Severe liver damage and liver failure that rarely can be fatal, liver tissue death, fulminant hepatitis.
• Appearance of red, elevated papules, generalized rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), severe skin reactions such as erythema multiforme, toxic epidermal necrolysis.
• Joint pain.
• Acute kidney failure and inflammation of the tissue between the renal tubules (interstitial nephritis).

Reporting of side effects:

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

This medication does not require special storage conditions.Do not change the tablets to another container.Do not use this medication after the expiration date that appears on the container after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Azithromycin Aristo

• The active ingredient is azithromycin. Each tablet contains 500 mg of azithromycin (as azithromycin dihydrate).
• The other components (excipients) are: tablet core: pregelatinized cornstarch (cornstarch), crospovidone, anhydrous calcium hydrogen phosphate, sodium lauryl sulfate, magnesium stearate ; tablet coating: hypromellose, titanium dioxide (E-171), lactose monohydrate (lactose) and glyceryl triacetate

Appearance of the product and content of the container

Azithromycin Aristo 500 mg is presented in the form of coated tablets with a white film coating, oblong, biconvex, marked on one face.

Each container contains blisters with 3 or 150 tablets.

Only some container sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid- Spain

Responsible for manufacturing:

Bluepharma – Indústria Farmacêutica, S.A.

S. Martinho do Bispo. 3045-016 Coimbra

Portugal

Last review date of this leaflet: August 2023

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