Leaflet: information for the user

Aratro 500 mg powder for oral suspension in EFG sachet

azitromicina

Read this leaflet carefully before you start taking this medicine, as 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 prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What Aratro is and for what it is used

2. What you need to know before taking Aratro

3. How to take Aratro

4. Possible side effects

5.Storage of Aratro

6. Contents of the pack and additional information

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

It is used for the treatment of the followinginfections:

• Throat, tonsil, ear, or nasal 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 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 white of your eyes turns yellow, inform your doctor immediately, so that they can confirm whether you should interrupt treatment or if you need to undergo liver function tests.

• If you are being treated with ergotamine derivatives (used to treat migraines), inform your doctor, as concurrent treatment with azithromycin may cause a condition 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 may appear that suggest antibiotic-associated colitis (diarrhea). If this is the case, treatment should be suspended and your doctor will prescribe 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 azithromycin, muscle weakness and fatigue appear, inform your doctor, as this medication may exacerbate the symptoms of this disease or trigger it.

• If you have arrhythmias or if you have factors that predispose you to them (such as certain heart diseases, alterations in the level of electrolytes in the blood, or certain medications), inform your doctor, as this medication may exacerbate the symptoms of this disease or trigger it.

Children and adolescents

Weight less than 45 kg.

The sachets may not be indicated for this group of patients. Other pharmaceutical forms of azithromycin may be used.This medication should not be administered 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 available on the market.

Other medications and Aratro

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

Especially, 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 simultaneous 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).
• Ciclosporin (a medication used in transplant patients) as azithromycin may increase ciclosporin levels in the blood and levels should be monitored.
• Digoxin (a medication used to treat heart arrhythmias) as azithromycin may increase digoxin levels in the blood and levels should be monitored.
• Colchicine (used to treat gout and familial Mediterranean fever).
• Anticoagulant dicumarins (medications used to prevent the formation of blood clots) as azithromycin may potentiate the effect of these anticoagulants. Your doctor should control coagulation parameters (prothrombin time).
• Nelfinavir, zidovudine (medications used to treat HIV infections) as they may increase azithromycin levels in the blood.
• Fluconazole (medications used to treat fungal infections) as they 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 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.
• Medications with active substances that prolong the QT interval, such as antiarrhythmic class IA (quinidine and procainamide) and class III (dofetilide, amiodarone, and sotalol) medications, cisapride, antipsychotics (such as pimozide), antidepressants (such as citalopram), and antifungals (fluoroquinolones such as moxifloxacin or levofloxacin and chloroquine), as they may cause severe heart rhythm disturbances 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 infections); atorvastatin (used to treat high cholesterol and heart problems); carbamazepine (used to treat epilepsy), cimetidine (used to treat excess 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).

Administration of Aratro with food

This medication should be taken as a single daily dose. The contents of the sachet should be added to a glass with a little water, mixing well. The 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 intend to become pregnant, consult your doctor or pharmacist before using this medication.

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

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 machinery

The influence of this medication on the ability to drive or operate machinery is negligible or insignificant.

Aratro contains saccharose

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

It may harm your teeth.

Aratro contains sodium

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

Aratro contains ethanol

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

Aratro contains glucose

This medication contains glucose. If your doctor has indicated 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 choking) due to the presence of 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 medication dose and administration frequency is as follows:

Adults (including elderly patients) and children with a weight of 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, in the case of patients with cardiac rhythm disorders, your doctor will closely monitor you.

Urethral or cervical infection (cervicitis):

The usual dose is 1,000 mg taken as a single dose, on a single day.

In the case of an infection caused byN. gonorrohea, your doctor will administer the same dose in combination with another antibiotic (ceftriaxone, 250 mg).

Chancroid:

The usual dose is 1,000 mg taken as a single dose, on a single day.

Sinusitis:

Treatment is indicated for adults and adolescents over 16 years old.

Children and adolescents weighing less than 45 kg:

The sachets may not be indicated for this group of patients. Other pharmaceutical forms of azithromycin may be used. Do not administer to children under 6 months.

Use in patients with liver insufficiency

Inform your doctor if you have severe liver problems, as the normal dose may need to be adjusted.

Use in patients with kidney insufficiency

Inform your doctor if you have severe kidney problems, as the normal dose may need to be adjusted.

Administration form

Oral route.

Empty the contents of the sachet into a glass and add a little water and mix well. The resulting suspension must be ingested immediately.

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, contact the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Aratro

In case of forgotten dose, take the medication as soon as possible and continue treatment as prescribed. However, if the next dose is near, it is better not to take the forgotten dose and wait for the next one. Do not take a double dose to compensate for the forgotten dose. Continue using the medication as your doctor has indicated.

If you interrupt treatment with Aratro

If you interrupt treatment before your doctor has recommended, 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 can cause side effects, although not everyone will experience them.

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

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

• Diarrhea.

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

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

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

• Fungal infectionCandidain the mouth or generalized, vaginal infection, pneumonia, fungal or bacterial infection, pharyngitis, gastroenteritis, alteration of breathing, rhinitis.
• Decreased number of some types of white blood cells (leukocytes, neutrophils, and eosinophils).
• Allergic reaction, including a deep skin inflammatory process (angioedema).
• Alteration of eating behavior (anorexia).
• Nervousness, insomnia.
• Drowsiness, dizziness, alteration of taste, loss of tactile sensation.
• Alteration of vision.
• Alteration of hearing, vertigo.
• Palpitations.
• Hot flashes.
• Alteration of breathing, nasal hemorrhage.
• Constipation, flatulence, indigestion, gastritis, difficulty swallowing, abdominal distension, dry mouth, belching, mouth ulcers, increased salivation.
• Rash, pruritus, appearance of red, elevated papules, dermatitis, dry skin, excessive sweating, erythema.
• Joint inflammation, muscle pain, back pain, neck pain.
• Difficulty urinating, kidney pain.
• Vaginal hemorrhage, alteration in 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, GPT, and alkaline phosphatase) and increase in bilirubin, urea, creatinine, chloride, glucose, bicarbonate, and platelets in blood, alteration of sodium and potassium levels, decreased hematocrit.
• Complications after surgical intervention.

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

• Agitation
• Liver function alteration, yellow discoloration of the skin.
• Sensitivity to sunlight (photosensitivity), allergic reaction with increase of a type of white blood cell (eosinophilia) and generalized symptoms (multi-organ compromise) (DRESS syndrome).
• Skin rash characterized by rapid appearance of red skin areas dotted with small white/yellow-filled blisters.

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

• Diarrhea caused byClostridium difficile.
• Decreased number of platelets in blood, anemia.
• Severe allergic reaction
• Aggressive behavior, 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 of hearing including deafness and tinnitus.
• Torsade de pointes, cardiac rhythm alterations, prolongation of QTc interval in electrocardiogram.
• Decreased blood pressure.
• Pancreatitis, change in color of the tongue.
• Severe liver damage and hepatic failure that rarely can be fatal, liver tissue death, fulminant hepatitis.
• Appearance of red, elevated papules, generalized rash with blisters and peeling skin, 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 interstitial nephritis.

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 prospectus.

You can also report them directly through the Spanish System of 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.

This product does not require special conditions for conservation.

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

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.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

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 contents of the packaging

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

Each package contains 3 or 100 sachets.

Only some package sizes may be commercially marketed.

Holder of the marketing authorization and responsible 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 review of this leaflet:April 2024

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