AZITHROMYCIN ARISTO 500 mg FILM-COATED TABLETS

Introduction

PATIENT INFORMATION LEAFLET

AzithromycinAristo500 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What Azithromycin Aristo is and what it is used for
2. What you need to know before you take Azithromycin Aristo
3. How to take Azithromycin Aristo
4. Possible side effects
5. Storing Azithromycin Aristo
6. Pack contents and further information

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

Azithromycin belongs to a group of antibiotics called macrolide antibiotics. It eliminates bacteria that cause infections.

Azithromycin Aristo is used to treat infections caused by bacteria in different parts of the body, in adults and children weighing over 45 kg.

It is used to treat the following infections:

• Throat, tonsil, ear, or sinus infections.
• Bronchitis and pneumonia (mild to moderate severity).
• Skin and soft tissue infections (mild to moderate severity).
• Urethra (urethritis) or cervix (cervicitis) infections, see section 3.
• Sexually transmitted infections (chancroid), see section 3.

2. What you need to know before you take Azithromycin Aristo

Do not take Azithromycin Aristo

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

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with this medicine.

• During treatment with Azithromycin Aristo, allergic reactions (itching, redness, skin rash, swelling, or difficulty breathing, or an allergic reaction to the medicine 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 interrupt treatment and initiate appropriate treatment.
• If you have liver problems or during treatment, your skin and/or the whites of your eyes turn yellow, discuss this with your doctor to confirm whether you should interrupt treatment or undergo liver function tests.
• If you are being treated with ergotamine derivatives (used to treat migraines), inform your doctor, as concomitant treatment with azithromycin may cause a potentially serious adverse reaction called ergotism.
• During treatment with this medicine, there is a possibility of developing a superinfection with resistant germs, including fungi. In this case, inform your doctor.
• During or after treatment with Azithromycin Aristo, symptoms suggesting antibiotic-associated colitis (diarrhea) may appear. If so, treatment should be suspended, and your doctor will provide the most appropriate treatment.
• If you have severe kidney function impairment, inform your doctor.
• If you have heart rhythm disorders or factors that predispose you to them (certain heart diseases, electrolyte level alterations in the blood, or certain medications), inform your doctor, as this medicine may contribute to worsening or triggering these disorders.
• If you have a disease called myasthenia gravis or if muscle weakness and fatigue appear during treatment, inform your doctor, as Azithromycin Aristo may trigger or worsen the symptoms of this disease.

Children and adolescents

Children and adolescents weighing less than 45 kg.

Tablets are not indicated for this patient group. Other pharmaceutical forms of azithromycin can be used. It should not be administered to children under 6 months.

Children and adolescents weighing over 45 kg.

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

Other medicines and azithromycin

Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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

• Antacids (medicines used for digestive problems). It is recommended to avoid simultaneous administration of both drugs at the same time of day.
• Ergotamine derivatives (such as ergotamine, used to treat migraines), as concomitant administration with azithromycin may cause ergotism (a potentially serious adverse effect with numbness or tingling in the limbs, muscle cramps, headaches, convulsions, abdominal or chest pain).
• Digoxin (a medicine used to treat heart rhythm disorders), as azithromycin may increase digoxin levels in the blood, and these levels should be monitored.
• Colchicine (used for gout and familial Mediterranean fever).
• Cyclosporin (a medicine used in transplant patients), as azithromycin may increase cyclosporin levels in the blood, and these levels should be monitored.
• Oral anticoagulants (medicines used to prevent blood clots), as azithromycin may enhance the effect of these anticoagulants. Your doctor should monitor coagulation parameters (prothrombin time).
• Nelfinavir, zidovudine (medicines for the treatment of HIV infections), as they may increase azithromycin levels in the blood.
• Fluconazole (medicines for the treatment of fungal infections), as it may increase azithromycin levels in the blood.
• Terfenadine (a medicine used to treat allergies), as the combination of both may cause heart problems.
• Rifabutin (a medicine for the treatment of pulmonary and non-pulmonary tuberculosis and mycobacterial infections), as it may cause a decrease in the number of white blood cells in the blood.
• Medicines with active substances that prolong the QT interval, such as antiarrhythmic drugs of class IA (quinidine and procainamide) and class III (dofetilide, amiodarone, and sotalol), cisapride, terfenadine, antipsychotic agents (such as pimozide), antidepressants (such as citalopram), and anti-infectives (fluoroquinolones such as moxifloxacin or levofloxacin and chloroquine), as they may cause serious heart rhythm disorders and even cardiac arrest.

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

Taking Azithromycin Aristo with food and drinks

Tablets should be taken whole with water and 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, consult your doctor or pharmacist before using this medicine.

There is insufficient information regarding the safety of azithromycin during pregnancy. Consequently, the use of azithromycin is not recommended if you are pregnant or wish to become pregnant, unless it is strictly necessary according to medical judgment.

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

Driving and using machines

The influence of this medicine on the ability to drive or use machines is negligible or non-existent.

Azithromycin Aristo contains lactose and sodium

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

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

3. How to take Azithromycin Aristo

Follow the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

Your doctor will determine 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 the medicine and the frequency of administration are as follows:

Adults (including elderly patients) and children weighing over 45 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 2-5.

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

Urethra or cervix infection (cervicitis):

The recommended dose is 1000 mg taken as a single dose on one day.

In case the infection is caused by N. gonorrhoeae, your doctor will administer the same dose in combination with another antibiotic (ceftriaxone, 250 mg).

Chancroid:

The recommended dose is 1000 mg taken as a single dose on one day.

Sinusitis:

Treatment is indicated in adults and adolescents over 16 years.

Children and adolescents weighing less than 45 kg:

Tablets are not recommended for these patients. Other pharmaceutical forms of azithromycin can be used.

Use in patients with hepatic impairment

Inform your doctor if you have severe liver problems, as it may be necessary to adjust the normal dose.

Use in patients with renal impairment

Inform your doctor if you have severe kidney problems, as it may be necessary to adjust the normal dose.

Method of administration

Oral use.

This medicine should be administered as a single daily dose. Tablets should be taken 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, severe nausea, vomiting, and diarrhea.

Information for the prescriber

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

If you (or someone else) have taken several tablets at once, or if you think a child has taken some of the tablets, contact your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount used. It is recommended to take the packaging and leaflet to the healthcare professional. An overdose can cause reversible hearing loss, severe nausea, vomiting, and diarrhea.

If you forget to take azithromycin

In case you forget a dose, use the medicine as soon as possible, continuing with the treatment as prescribed. However, if the next dose is near, it is better not to take the missed dose and wait for the next one. Do not take a double dose to make up for the missed dose. Continue using azithromycin as indicated by your doctor.

If you stop taking azithromycin

If you stop treatment with azithromycin before your doctor recommends, symptoms may worsen or reappear.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

The side effects very common (at least 1 in 10 people)are:

• Diarrhea.

The side effects common (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 effects uncommon (may affect up to 1 in 1,000 people)are:

• Candida infection in the mouth or generalized, vaginal infection, pneumonia, fungal or bacterial infection, pharyngitis, gastroenteritis, alteration in breathing, rhinitis.
• Decrease in the number of some types of white blood cells (leukocytes, neutrophils, and eosinophils).
• Allergic reaction, including a deep skin inflammation (angioedema).
• Alteration in eating behavior (anorexia).
• Nervousness, insomnia.
• Somnolence, dizziness, alteration in taste, loss of tactile sensation.
• Alteration in vision.
• Alteration in hearing, vertigo.
• Palpitations.
• Hot flashes.
• Alteration in breathing, nosebleeds.
• Constipation, flatulence, indigestion, gastritis, difficulty swallowing, abdominal distension, dry mouth, eructation, mouth ulcers, increased salivation.
• Rash, itching, appearance of red elevated patches, dermatitis, dry skin, excessive sweating, redness.
• Joint inflammation, muscle pain, back pain, neck pain.
• Difficulty urinating, kidney pain.
• Vaginal bleeding, alteration in the testicles.
• Generalized swelling, weakness, discomfort, fatigue, facial edema, chest pain, fever, pain and swelling of the limbs.
• 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 the blood, alteration in sodium and potassium levels, decrease in hematocrit.
• Complications after surgery

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

• Agitation.
• Alteration in liver function, yellowing of the skin.
• Sensitivity to sun exposure (photosensitivity), drug reaction with an increase in a type of white blood cells (eosinophilia) and generalized symptoms (multi-organ involvement) (DRESS syndrome).
• Skin rash characterized by the rapid appearance of red skin areas with small pus-filled bumps (small blisters filled with white/yellow liquid).

The side effects of unknown frequencyare:

• Clostridium difficile-associated diarrhea.
• Decrease in platelet count in the blood, anemia.
• Severe allergic reaction.
• Aggressive reactions, anxiety, delirium, hallucinations.
• Loss of consciousness, convulsions, 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, heart rhythm disorders, prolongation of the QTc interval in the electrocardiogram.
• Decrease in blood pressure.
• Pancreatitis, change in tongue color.
• Severe liver damage and liver failure, which can be fatal, liver cell death, fulminant hepatitis.
• Appearance of red elevated patches, generalized rash with blisters and peeling skin, which occurs 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 kidney tubules (interstitial nephritis).

Reporting of side effects:

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Azitromicina Aristo

Keep this medication out of 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 packaging after CAD. The expiration date is the last day of the month indicated.

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

6. Package Contents and Additional Information

Composition of Azitromicina Aristo

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

Appearance of the Product and Package Contents

Azitromicina Aristo 500 mg is presented in the form of film-coated tablets, white in color, oblong, biconvex, marked on one side.

Each package contains blisters with 3 or 150 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

Manufacturer:

Bluepharma – Indústria Farmacêutica, S.A.

• Martinho do Bispo. 3045-016 Coimbra

Portugal

Date of the Last Revision of this Leaflet:August 2023

"Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/"