Leaflet: information for the user

Aratro200mg/5 ml powder for oral suspension in EFG bottle

azitromicina

Read 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 questions, consult your doctor or pharmacist.
• This medicine has been prescribedonlyfor you, and you must not give it to others,evenif they have the same symptoms as you, as it mayharm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of theleaflet:

1. What Aratro is and for what it isused

2. What you need to know before taking Aratro

3. How to take Aratro

4. Possible sideeffects

5. Storage of Aratro

6. Contents of the container and additionalinformation

Aratro contains azithromycin, an antibiotic that belongs to a group ofantibioticscalled macrolide antibiotics. It eliminates bacteria that cause infections.

Antibiotics are used to treat bacterial infections and do not work fortreatviral infections such as the flu or thecommon cold.

It is essential to follow the instructions regarding the dose, administration interval, and treatment duration indicated by your doctor.

Do not storeorre-use this medication. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not dispose ofmedicinesdown the drain or in thetrash.

It is used for the treatment of the followinginfections:

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

Do not take Aratro

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

Warnings and precautions

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

• During treatment with azithromycin, 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 generalised symptoms) may occur, which could be serious. Inform your doctor, who may decide to stop the treatment and start the appropriate treatment.

• If you have liver problems or during treatment with this medicine your skin and/or the white of your eyes turns yellow, inform your doctor immediately, so that he/she can confirm whether you should stop the treatment or if you need to have 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 medicine, there is a possibility of fungal over-infection. If this is the case, inform your doctor.

• During or after treatment with this medicine, symptoms may occur that suggest antibiotic-associated colitis (diarrhea). If this is the case, the treatment must be stopped and your doctor will put you on the treatment they consider most appropriate.

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

• If you have a condition called myasthenia gravis or if during treatment with this medicine you experience muscle weakness and fatigue, inform your doctor, as this medicine may exacerbate the symptoms of this condition or trigger it.

• If you have heart rhythm disorders (arrhythmias) or if you have factors that predispose you to them (certain heart diseases, alterations in the level of electrolytes in the blood, or certain medications), inform your doctor, as this medicine may exacerbate these disorders or trigger them.

Children and adolescents

Weight less than 15 kg.

The dose in this group of patients must be measured as accurately as possible.Do not administer to children under 6 months.

Weight over 45 kg.

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

Sinusitis: the treatment is indicated for adults and adolescents over 16 years old.

Other medicines and Aratro

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

You must especially 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 simultaneous administration with azithromycin may cause ergotism (a potentially serious adverse effect with numbness or tingling in the extremities, muscle cramps, headaches, convulsions, or abdominal or chest pain).
• Ciclosporin (a medicine used in transplant patients) as azithromycin may increase ciclosporin levels in the blood and its levels must be monitored.
• Digoxin (a medicine used to treat heart arrhythmias) as azithromycin may increase digoxin levels in the blood and its levels must be monitored.
• Colchicine (used to treat gout and familial Mediterranean fever).
• Anticoagulant dicumarins (medicines used to prevent the formation of blood clots) as azithromycin may potentiate the effect of these anticoagulants. Your doctor must control the coagulation parameters (prothrombin time).

• Nelfinavir, zidovudine (medicines used to treat infections caused by the human immunodeficiency virus), as they may increase azithromycin levels in the blood.
• Fluconazole (a medicine used to treat fungal infections), as they 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 used to treat pulmonary tuberculosis and non-pulmonary infections caused by mycobacteria) as it may cause a decrease in white blood cells in the blood.
• Medicines with active substances that prolong the QT interval, such as antiarrhythmic class IA (quinidine and procainamide) and class III (dofetilide, amiodarone, and sotalol) drugs, cisapride, antipsychotics (such as pimozide), antidepressants (such as citalopram), and antifungals (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 (used to treat allergic reactions); didanosine, efavirenz, indinavir (used to treat HIV infection); atorvastatin (used to treat high cholesterol and heart problems); carbamazepine (used to treat epilepsy), cimetidine (used to treat excessive acid in the stomach); methylprednisolone (used to suppress the immune system); theophylline (used to treat respiratory problems); midazolam, triazolam (used to induce sedation); sildenafil (used to treat impotence) and trimethoprim/sulfamethoxazole (used to treat infections).

Aratro with food

This medicine 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 medicine.

There is not enough information about the safety of azithromycin during pregnancy. Therefore, azithromycin should not be used during pregnancy unless, at the doctor's discretion, the benefits outweigh the risks for the baby.

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

Driving and operating machines

The influence of this medicine on the ability to drive or operate machines is negligible or insignificant.

Aratro contains saccharose

This medicine contains saccharose.If your doctor has told you that you have an intolerance to certain sugars, consult with him/her before taking this medicine.

It may harm your teeth.

Aratro contains sodium

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

Aratro contains ethanol

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

Aratro contains glucose

This medicine contains glucose. If your doctor has told you that you have an intolerance to certain sugars, consult with him/her before taking this medicine.

Aratro contains sulfites

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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 dose of medication and administration frequency is the following:

Children and adolescents under 45 kg of weight:

The dosing 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 advisable to use other presentations.

Use in patients with liver insufficiency:

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

Use in patients with renal insufficiency:

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

Administration form:

Oral route.

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

•Preparation of the suspension:

1. Invert the bottle and shake it gently until all the powder moves freely. The powder for suspension may exceed the level mark on the bottle. This is a normal fact and is due to the specific density of the preparation.
2. Open the bottle and add the following amount of water according to the size of the bottle, using the dosing syringe that comes with it:

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

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

•Administration of the prepared:

1. Open the safety metal cap. Insert the syringe into the plastic stopper with a hole.
2. Maintaining the syringe inserted, invert the bottle so that it remains in a vertical position.
3. Fill the syringe to the dose corresponding to the dose prescribed by your doctor.
4. Return the bottle to its original position, extract the syringe from it, and proceed with the administration.
5. Wash the syringe after each administration. This syringe should not be used for another medication. The graduations of this syringe are specific to this medication.
6. Close the bottle with the safety cap; the adapter will remain at the neck of the bottle.

Remember that the dose prescribed 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, intense nausea, vomiting, and diarrhea.Consult your doctor or pharmacist immediately. In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Aratro:

In case of forgetting 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 compensate for the missed doses. Continue using the medication as your doctor has indicated.

If you interrupt the treatment with Aratro:

If you interrupt the treatment before what your doctor has recommended, the 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 causeside effects, although not everyone willexperience them.

The side effects reported during clinical trials and aftermarketing have been classified byfrequency:

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

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

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

The side effectsrare (in at least 1 in 10,000 patients)are:

The side effectsof unknown frequency(cannot be estimated from available data)are:

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 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.

Before reconstitution: Do not store at a temperature above25°C.

After reconstitution: Store at room temperature for a maximum of 10días.

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

Do not use this medication after the expiration date that appears onthelabel after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you observe visible signs of deterioration in thefrasco.

Medications should not be disposed of through drains or in the trash. Dispose of the containersandthe medication that you do not need at the SIGRE collection pointof the pharmacy. In case ofdoubt,ask your pharmacist how to dispose of the containers and the medication thatyoudo not need. By doing so, you will help protect the environment.

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 contents of thepackaging

It is presented in the form of an oral suspension powder in a bottle.

Each package contains1 or 20bottles of 15 ml or 30ml.

Only some package sizes may be commercially marketed.

Holder of the marketing authorization and responsible for themanufacturing

Arafarma Group,S.A.

C/ Fray Gabriel de San Antonio,6-10

Pol. Ind. delHenares

19180 Marchamalo, Guadalajara,Spain.

Date of the last review of this leaflet:June 2024

The detailed information about this medicine is available on thewebsiteof the Spanish Agency for Medicines and Medical Devices(AEMPS)http://www.aemps.gob.es/