ARATRO 200 mg/5 ml POWDER FOR ORAL SUSPENSION IN A BOTTLE

Introduction

Package Leaflet: Information for the User

Aratro200mg/5 ml powder for oral suspension in EFG bottle

azithromycin

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

• Keep this leaflet, as 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 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 further information

1. What is Aratro and what is it used for

Aratro contains azithromycin, an antibiotic that belongs 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 againsttreatingviral infections such as the flu or thecommon cold.

It is essential that you follow the instructions regarding dosage, administration interval, and treatment duration 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 for proper 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).
• Urethra (urethritis) or cervix (cervicitis) infections, 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, any other macrolide or ketolide 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 interrupt 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, inform your doctor immediately, so that they can 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 adverse reaction called ergotism.

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

• During or after treatment with this medication, symptoms suggesting antibiotic-associated colitis (diarrhea) may appear. If this is the case, 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 a condition called myasthenia gravis or if during treatment with this medication, 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 disorders (arrhythmias) or if you have factors that predispose you to them (certain heart diseases, electrolyte level alterations in the blood, or certain medications), inform your doctor, as this medication may contribute to worsening these disorders or triggering them.

Children and adolescents

Weight less than 15 kg.

The dose in this patient group should be measured as accurately as possible. It should not be administered to children under 6 months.

Weight over 45 kg.

Same dose as adults, so it is recommended to use other pharmaceutical forms that are more suitable and available on the market.

Sinusitis: treatment is indicated in adults and adolescents over 16 years.

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 concomitant 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 severe adverse effect with numbness or tingling in the extremities, muscle cramps, headaches, convulsions, or abdominal or chest pain).
• Cyclosporin (a medication used in transplanted patients), as azithromycin may increase cyclosporin levels in the blood, and its levels should be monitored.
• Digoxin (a medication used to treat heart arrhythmias), as azithromycin may increase digoxin levels in the blood, and its levels should be monitored.
• Colchicine (used to treat gout and familial Mediterranean fever).
• Anticoagulant dicumarinics (medications used to prevent blood clots), as azithromycin may potentiate the effect of these anticoagulants. Your doctor should monitor coagulation parameters (prothrombin time).

• Nelfinavir, zidovudine (medications for the treatment of infections caused by the human immunodeficiency virus), 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 tuberculosis and non-pulmonary infections caused by mycobacteria), 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 antiinfectives (fluoroquinolones such as moxifloxacin or levofloxacino and chloroquine), as they may cause severe heart rhythm disorders 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

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 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 child.

Azithromycin is excreted in breast milk. Due to potential adverse reactions in the infant, the use of azithromycin is not recommended during breastfeeding, although breastfeeding can continue 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 nonexistent.

Aratro contains sucrose

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

It may damage teeth.

Aratro contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per 5 ml of reconstituted suspension; that is, it is essentially "sodium-free".

Aratro contains ethanol

This medication contains 0.002% ethanol (alcohol), which corresponds to 0.063 mg/dose.

Aratro contains glucose

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

Aratro contains sulfites

This medication may cause severe allergic reactions and bronchospasm (sudden feeling of suffocation) because it contains sulfites.

3. How to take Aratro

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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 medication dose and administration frequency are as follows:

Children andadolescents weighing less than 45 kg:

The dosage regimen based on weight would be as follows:

*The dose in children with a weight of less than 15 kg should be measured as accurately as possible.

Adults:

To adjust the dose more easily, it is convenient to use other presentations.

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 route.

The medication must be reconstituted before use. To facilitate administration, each bottle comes with a dosing syringe with three incorporated scales that allows dosing based on kg (from 0 to 40 kg) according to body weight; in ml (from 0 to 10 ml) according to suspension volume; and in mg (from 0 to 400 mg) according to the amount of active ingredient.

• Preparation of the suspension:
  1. Invert the bottle and gently shake it until all the powder moves freely. The powder for suspension may exceed the marked level on the bottle. This is normal and due to the specific density of the preparation.
  2. Open the bottle and add the following amount of water, depending on the bottle size, using the dosing syringe provided:

• 15 ml bottle: add 10 ml of water.
• 30 ml bottle: add 15 ml of water.

1. Place the plastic perforated cap and press it until it is fully inserted into the bottle mouth.
2. Close the bottle with the metal cap.
3. Shake vigorously until a homogeneous suspension is achieved. The suspension level will be at the mark on the label.
4. Do not forget to shake the suspension before each administration.

• Administration of the preparation:
  1. Open the metal safety cap. Insert the syringe into the plastic perforated cap.
  2. While keeping the syringe inserted, invert the bottle so that it remains in a vertical position.
  3. Fill the syringe to the measure corresponding to the dose prescribed by your doctor.
  4. Invert the bottle again, remove the syringe, and proceed with administration.
  5. Wash the syringe after each administration. This syringe should not be used for any other medication. The graduations on this syringe are specific to this medication.
  6. Close the bottle with the safety cap; the adapter will remain in the bottle neck.

Remember that the prescribed dose by your doctor is administered once a day.

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

In case of a missed dose, take the medication 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 missed doses. Continue using the medication as indicated by your doctor.

If you interrupt treatment with Aratro

If you interrupt 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 Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

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

• Diarrhea.

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

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

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

• Infection by the fungus Candidain the mouth or generalized, vaginal infection, pneumonia, fungal or bacterial infection, pharyngitis, gastroenteritis, alteration of breathing, rhinitis.
• Decrease in the number of some types of white blood cells (leukocytes, neutrophils, and eosinophils).
• Allergic reaction, including an inflammatory process of the deep skin area (angioedema).
• Alteration of eating behavior (anorexia).
• Nervousness, insomnia.
• Somnolence, dizziness, alteration of taste, loss of tactile sensation.
• Alteration of vision.
• Alteration of hearing, vertigo.
• Constipation, flatulence, indigestion, gastritis, difficulty swallowing, abdominal distension, dry mouth, belching, mouth ulcers, increased salivation.
• Rash, itching, appearance of reddish raised patches, dermatitis, dry skin, excessive sweating, redness.
• Inflammation of the joints, muscle pain, back pain, neck pain.
• Difficulty urinating, pain in the kidneys.
• Vaginal bleeding, alteration in the testicles.
• Generalized swelling, weakness, discomfort, fatigue, facial edema, chest pain, fever, pain and swelling of the extremities.
• Alteration of liver function tests (increase in liver enzymes GOT and GPT and alkaline phosphatase) and increase in bilirubin, urea, creatinine, chloride, glucose, bicarbonate, and platelets in blood, alteration of sodium and potassium levels, decrease in hematocrit.
• Complications after surgical intervention.

The adverse effects rare (at least 1 in 10,000 patients)are:

• Agitation
• Alteration of liver function, yellowish discoloration of the skin.
• Sensitivity to sun exposure (photosensitivity), drug reaction with increased white blood cell count (eosinophilia) and generalized symptoms (multi-organ involvement) (DRESS syndrome).
• Skin rash characterized by the rapid appearance of red skin areas sprinkled with small pustules (small blisters filled with white/yellow liquid).

The adverse effects of unknown frequency(cannot be estimated from available data) are:

• Diarrhea caused by Clostridium difficile.
• Decrease in platelet count in 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.
• Alteration of hearing including deafness and ringing.
• Torsade de pointes, cardiac 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 that can rarely be fatal, liver tissue death, fulminant hepatitis.
• Appearance of reddish raised 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 renal tubules (interstitial nephritis).

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 does not appear in this prospectus.

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

5. Storage of Aratro

Before reconstitution: Do not store at a temperature above 25°C.

After reconstitution: store at room temperature for a maximum of 10 days.

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the label after CAD. The expiration date is the last day of the month indicated.

Do not use this medicine if you observe visible signs of deterioration in the vial.

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

6. Package Contents and Additional Information

Composition of Aratro

• The active ingredient is azithromycin (dihydrate). Each 5 ml of reconstituted suspension contains 200 mg of azithromycin.
• The other components (excipients) are: sucrose, hydroxypropylcellulose, anhydrous trisodium phosphate, xanthan gum, cherry flavor (contains ethanol, sodium, glucose (derived from maltodextrin) and sulfites), vanilla flavor (contains ethanol, sodium, glucose (derived from maltodextrin) and sulfites) and banana flavor (contains ethanol, sodium, glucose (derived from maltodextrin) and sulfites).

Appearance of the Product and Package Contents

It is presented in the form of powder for oral suspension in a vial.

Each package contains 1 or 20 vials of 15 ml or 30 ml.

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 Prospectus:June 2024

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