ARATRO 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for theuser

Aratro500 mg film-coated tablets EFG

azithromycin

Read the entire package leaflet carefully before starting to take thismedication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of thepackage leaflet:

1. What is Aratro and what is it used for
2. What you need to know before taking Aratro
3. How to take Aratro
4. Possible side effects
5. Storage of Aratro
6. Package contents and additional information

1. What is Aratro and what is it used for

Aratro contains azithromycin, an antibiotic belonging to a group of antibiotics called macrolide antibiotics. It eliminates bacteria that cause infections.

Antibiotics are used to treat bacterial infections and are not effective againstviral infections such as the flu or thecommon cold.

It is essential that you follow the instructions regarding dosage, administration, anddurationof treatment as indicated by your doctor.

Do not store or reuse this medication.If you have any leftover antibiotic after completing treatment, return it to the pharmacy forproper disposal. Do not dispose of medications down the drain or in the trash.

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).
• Urethral infections (urethritis) or cervical infections (cervicitis), see section 3.
• Sexually transmitted infections (chancroid), see section 3.

2. What you need to know before taking Aratro

Do not take Aratro

If you are allergic (hypersensitive) to azithromycin, erythromycin, another macrolide antibiotic, or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

• During treatment with azithromycin, 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 with this medication, your skin and/or the whites of your eyes turn yellow, immediately inform your doctor, who will 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 concomitant treatment with azithromycin may cause a potentially serious adverse reaction called ergotism.

• During treatment with this medication, there is a possibility of developing a fungal overinfection. If this occurs, inform your doctor.

• During or after treatment with this medication, symptoms suggesting antibiotic-associated colitis (diarrhea) may appear. If this occurs, treatment should be discontinued, and your doctor will provide the most suitable treatment.

• If you have severe kidney function impairment, inform your doctor.

• If you have a condition called myasthenia gravis or if, during treatment with azithromycin, you experience muscle weakness and fatigue, inform your doctor, as this medication may contribute to worsening the symptoms of this disease or triggering it.

• If you have heart rhythm disturbances (arrhythmias) or if you have factors that predispose you to them (such as certain heart diseases, electrolyte imbalances, or certain medications), inform your doctor, as this medication may contribute to worsening these disturbances or triggering them.

Children and adolescents

Weight 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.

Weight over 45 kg.

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

Othermedicines and Aratro

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

Especially, you should 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 concomitant administration with azithromycin may cause ergotism (a potentially serious adverse reaction).

• Cyclosporin (a medication used in transplant patients), as azithromycin may increase cyclosporin levels in the blood, and these levels should be monitored.

• Digoxin (a medication used to treat heart arrhythmias), as azithromycin may increase digoxin levels in the blood, and these levels should be monitored.

• Colchicine (used for gout and familial Mediterranean fever).
• Oral anticoagulants (medications used to prevent blood clots), as azithromycin may enhance the effect of these anticoagulants. Your doctor should monitor coagulation parameters (prothrombin time).
• Nelfinavir, zidovudine (medications for the treatment of HIV infections), as they may increase azithromycin levels in the blood.
• Fluconazole (a medication for treating fungal infections), as it may increase azithromycin levels in the blood.
• Terfenadine (a medication used to treat allergies), as the combination of both may cause heart problems.
• Rifabutin (a medication 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.

• Medications with active substances that prolong the QT interval, such as antiarrhythmic agents 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-infective agents (fluoroquinolones such as moxifloxacin or levofloxacino and chloroquine), as they may cause serious heart rhythm disturbances 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 sedation); sildenafil (for treating impotence), and trimethoprim/sulfamethoxazole (for treating infections).

Taking Aratro with food

Tablets should be taken whole with a glass of 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

There is insufficient information regarding the safety of azithromycin during pregnancy. Consequently, azithromycin is not recommended during pregnancy unless, in the doctor's judgment, the benefit outweighs the risk to the fetus.

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

Driving and usingmachines

The influence of this medication on the ability to drive or use machines is negligible or minimal.

Aratro contains lactose

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

Aratro contains sodium

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

3. How to take Aratro

Follow your doctor's or pharmacist's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

Your doctor will determine the most suitable dose and duration of treatment for you, based on your condition and response to treatment.

As a general rule, the dose of medication and frequency of administration are as follows:

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

The usual 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 250 mg from the 2nd to the 5th day.

In elderly patients, the same dose as for adults can be administered. However, if the patient has heart rhythm disturbances, your doctor will closely monitor them.

Urethral or cervical infection (cervicitis):

The usual dose is 1000 mg taken as a single dose in one day.

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

Chancroid:

The usual dose is 1000 mg taken as a single dose in one day.

Sinusitis:

Treatment is indicated in adults and adolescents over 16 years.

Children and adolescents under 45 kg:

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

Use in patients with liver impairment

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

Use in patients with kidney impairment

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

Method of administration

Oral route.

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

If you take more Aratro than you should

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

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

If you forget to take Aratro

If you forget a dose, take the medication as soon as possible and continue 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 doses. Continue using the medication as your doctor has indicated.

If you stop taking Aratro

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Side effects reported during clinical trials and after marketing have been classified by frequency:

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

• Diarrhea.

The side effects are common (at least 1 in 100 patients):

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

The side effects are uncommon (at least 1 in 1000 patients):

• Infection with the fungus Candidain the mouth or generalized, vaginal infection, pneumonia, fungal or bacterial infection, pharyngitis, gastroenteritis, alteration in breathing, rhinitis.
• Decrease in the number of certain types of white blood cells (leukocytes, neutrophils, and eosinophils).
• Allergic reaction, including an inflammatory process in the deep skin (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, ulcers in the mouth, 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 are rare (at least 1 in 10,000 patients):

• 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 are of unknown frequency(cannot be estimated from the available data):

• Clostridium difficile-associated diarrhea
• Decrease in platelet count in the blood, anemia.
• Severe allergic reaction
• Aggressive reactions, 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 ringing in the ears.
• Torsade de pointes, heart rhythm disturbances, 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 tissue 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, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet.

You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Aratro

No special storage conditions are required.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you notice visible signs of deterioration.

Medications should not be disposed of down the drain or in the trash. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Additional Information

Composition of Aratro

The active ingredient is azithromycin (dihydrate). Each tablet contains 500 mg of azithromycin.

The other components (excipients) are:

• Core excipients: pregelatinized corn starch, crospovidone, anhydrous calcium hydrogen phosphate, sodium lauryl sulfate, magnesium stearate
• Coating excipients: hydroxypropylmethylcellulose, titanium dioxide (E171), lactose, and glycerol triacetate.

Appearance of the product and packaging content

White, film-coated tablets with a capsule shape.

Each package contains 3 or 150 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Arafarma Group S.A.

C/ Fray Gabriel de San Antonio, 6-10

Pol. Ind. del Henares

19180 Marchamalo, Guadalajara, Spain

Date of the last revision of this leaflet:June 2024

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