Label: information for theuser

Aratro500 mg film-coated tablets EFG

azitromycin

Read this label carefully before starting to take thismedicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor orpharmacist.
• This medicine has been prescribed to you alone, and you must not give it to other people,althoughthey may have the same symptoms as you, as it mayharm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Contents of thelabel:

1. What Aratro is and for what it isused

2. What you need to know before taking Aratro

3. How to takeAratro

4. Possible adverse effects

5. Storage of Aratro

6. Contents of the package and additionalinformation

Azithromycin contains azitromicina, a type of antibiotic that belongs to a group of antibiotics known as macrolides.It eliminates bacteria that cause infections.

Antibiotics are used to treat bacterial infections and do not work for viral infections such as the flu or a cold.

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

Do not store or reuse this medication.If once the treatment is completed, you have leftover antibiotic, return it to the pharmacy for proper disposal. Do not dispose of the medication through the drain or in the trash.

This medication is used for the treatment of the following infections:

• Throat, tonsil, ear, or nasal sinus infections.
• Mild to moderate bronchitis and pneumonia.
• Mild to moderate skin and soft tissue infections.
• Urethritis or cervicitis, see section 3.
• 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 to 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 combined 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 suggesting antibiotic-associated colitis (diarrhea). If this is the case, treatment should be suspended and your doctor will initiate 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 exacerbate symptoms of this condition or trigger it.

• If you have arrhythmias or factors that predispose you to them (such as certain heart diseases, alterations in blood electrolyte levels, or certain medications), inform your doctor, as this medication may exacerbate these conditions or trigger them.

Children and adolescents

Weight less than 45 kg.

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

Weight over 45 kg.

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

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 characterized by 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 blood clotting), 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 (a medication used to treat 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 used to treat pulmonary and non-pulmonary tuberculosis 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, terfenadine, antipsychotic agents (such as pimozide), antidepressants (such as citalopram), and antifungal medications (fluoroquinolones such as moxifloxacin or levofloxacin and chloroquine), as they may cause severe heart rhythm alterations 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 excessive stomach acid); 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).

Taking Aratro with food

The tablets should be taken whole with a glass of water and may 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 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 child.

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

Driving and operating machines

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

Aratro contains lactose

This medication contains lactose. If your doctor has indicated 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".

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.

If the infection is caused by N. gonorrhoea, 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 under 45 kg of weight:

The tablets are not recommended for these patients. Other commercially available pharmaceutical forms can be used.

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.

This medication should be administered as a single daily dose. The 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, 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 forgot 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 doses. 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 doubt about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects,although not everyone will experience them.

The side effects reported during clinical trials and aftercommercialization 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:

• Vomiting, abdominal pain, nausea.

• Headache.

•Alteration of the numberofsome types of white blood cells (lymphocytes, eosinophils, basophils, monocytes, and neutrophils), decrease inbicarbonate.

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.
• Decrease in the number of some types of white blood cells (leukocytes, neutrophils, and eosinophils).
• Allergic reaction, including a deep inflammatory process of the skin (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, edema on the face, 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, decrease in 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), drug 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 byClostridiumdifficile
• Decrease in the 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 pointescardiac rhythm alterations, prolongation of the QTc interval in the electrocardiogram.
• Decrease in blood pressure.
• Pancreatitis, change in tongue color.
• Severe liver damage and liver 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 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.

No requires special conservation conditions.Conservation.

Keep this medication out of the sightand reach of children.

Do not use this medication after the expiration date that appears on thecontainerafter CAD. The expiration date is the last day of the month that isindicated.

Do not use this medication if you observe visible signs ofdegradation.

Medications should not be disposed of through drains or in the trash. Dispose of the containersandthe medication that you do not need at the SIGREpoint of the pharmacy. In case ofdoubt,ask your pharmacist how to dispose of the containers and the medication that you do not need. In this way, you will help to protect the environment.

Composition of Aratro

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

The other components (excipients) are:

• Core excipients:pregelatinized cornstarch, crospovidone, calcium hydrogen phosphate anhydrous, sodium lauryl sulfate, magnesium stearate
• Coating excipients:hydroxypropylmethylcellulose, titanium dioxide (E171), lactose, and triacetin

Appearance of the product and contents of the package

White-coated, capsule-shaped tablets.

Each package contains 3 or 150 tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Arafarma Group S.A.

C/ Fray Gabriel de San Antonio, 6-10

Pol. Ind. del Henares

19180 Marchamalo, Guadalajara, Spain

Last review date of this leaflet:June 2024

Further detailed information about this medication is available on the website of the Spanish Agency of Medicaments and Health Products (AEMPS)

http://www.aemps.es