ARATRO 500 mg ORAL SUSPENSION POWDER IN SACHET

Introduction

Package Leaflet: Information for the User

Aratro 500 mg Powder for Oral Suspension in EFG Sachet

azithromycin

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:

1. What is Aratro and what is it used for
2. What you need to know before you take Aratro
3. How to take Aratro
4. Possible side effects
5. Storage of Aratro
6. Contents of the pack and further 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.

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 Aratro

Do not take Aratro

• If you are allergic (hypersensitive) 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 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 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 medicine, your skin and/or the whites of your eyes turn yellow, inform your doctor immediately, so that they can 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 medicine, there is a possibility of fungal overinfection. If this is the case, inform your doctor.

• During or after treatment with this medicine, symptoms suggesting antibiotic-associated colitis (diarrhea) may appear. If so, treatment should be suspended, 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, muscle weakness and fatigue appear, inform your doctor, as this medicine 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 in the blood, or certain medications), inform your doctor, as this medicine may contribute to worsening the symptoms of this disease or triggering it.

Children and adolescents

Weight less than 45 kg.

The sachets may not be indicated for this patient group. Other pharmaceutical forms of azithromycin can be used. This medicine should not be administered to children under 6 months.

Weight over 45 kg.

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

Other medicines and Aratro

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

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, or abdominal or chest pain).
• Cyclosporin (a medicine used in transplanted patients), as azithromycin may increase cyclosporin levels in the blood, and their levels should be monitored.
• Digoxin (a medicine used to treat heart arrhythmias), as azithromycin may increase digoxin levels in the blood, and their levels should be monitored.
• Colchicine (used for gout and familial Mediterranean fever).
• 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 infections caused by the human immunodeficiency virus), as they may increase azithromycin levels in the blood.
• Fluconazole (medicines for treating 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 for the treatment of pulmonary and non-pulmonary tuberculosis and infections caused by mycobacteria), 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 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

This medicine should be administered as a single daily dose. The contents of the sachet should be added to a glass with a little water and mixed well. The resulting suspension should be taken immediately, 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, ask your doctor or pharmacist for advice before taking this medicine.

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 during breastfeeding is not recommended, although breastfeeding can be resumed two days after completing treatment with azithromycin.

Driving and using machines

The influence of this medicine on the ability to drive and use machines is negligible or nonexistent.

Aratro contains sucrose

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

It may harm your teeth.

Aratro contains sodium

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

Aratro contains ethanol

This medicine contains 0.007% ethanol (alcohol), which corresponds to 0.4 mg/dose.

Aratro contains glucose

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

Aratro contains sulfites

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

3. How to take Aratro

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of 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 dose of medicine and the 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 into 3 or 5 days as follows:

• When taken for 3 days, 500 mg per day.
• When taken for 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 in adults can be administered. However, if they have heart rhythm disturbances, your doctor will closely monitor them.

Urethra or cervix 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 in weight:

The sachets may not be indicated for this patient group. Other pharmaceutical forms of azithromycin can be used. This medicine should not be administered to children under 6 months.

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 use.

Pour the contents of the sachet into a glass, add a little water, and mix well. The resulting suspension should be taken immediately.

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, telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Aratro

In case of forgetting a dose, take 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 doses. Continue using the medicine 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 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.

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

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

• Diarrhea.

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

• Infection with 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 (angioedema).
• Alteration of eating behavior (anorexia).
• Nervousness, insomnia.
• Somnolence, dizziness, alteration of taste, loss of tactile sensation.
• Alteration of vision.
• Alteration of hearing, vertigo.
• Palpitations.
• Hot flashes.
• Alteration of 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 of 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 of sodium and potassium levels, decrease in hematocrit.
• Complications after surgery.

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

• Agitation
• Liver function alteration, 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 pustules (small blisters filled with white/yellow liquid).

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

• Clostridium difficile-associated diarrhea.
• Decrease in the number of platelets 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).
• Hearing alteration, including deafness and tinnitus.
• 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 rarely 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, talk to your doctor or pharmacist, even if it is possible side effects 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 Aratro

No special storage conditions are required.

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

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

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Packaging contents and additional information

Composition of Aratro

• The active ingredient is azithromycin (dihydrate). Each sachet contains 500 mg of azithromycin.
• The other components 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 packaging contents

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

Each package contains 3 or 100 sachets.

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:April 2024

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