Aratro 500 mg powder for oral suspension in sachet EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Aratro 500 mg powder for oral suspension sachet EFG

azithromycin

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

1. What Aratro is and what it is used for

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

It is used to treat the following infections:

• Infections of the throat, tonsils, ears, or paranasal sinuses.
• Bronchitis and pneumonia (mild to moderate severity).
• Skin and soft tissue infections (mild to moderate severity).
• Infections of the urethra (urethritis) or cervix (cervicitis), 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, another macrolide or ketolide antibiotic, or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before starting this medicine.

• Allergic-type reactions (itching, redness, skin rash, swelling, or difficulty breathing) or a drug allergy characterized by increased white blood cells and generalized symptoms may occur during treatment with azithromycin and could be serious. Inform your doctor, who may decide to stop treatment and start appropriate therapy.

• If you have liver problems, or if during treatment with this medicine your skin and/or the whites of your eyes turn yellow, inform your doctor immediately so they can determine whether treatment should be stopped or liver function tests are needed.

• If you are being treated with ergot derivatives (used to treat migraine), inform your doctor, as concomitant treatment with azithromycin may cause an adverse reaction called ergotism.

• During treatment with this medicine, there is a possibility of developing a fungal superinfection. If this occurs, inform your doctor.

• Symptoms suggesting antibiotic-associated colitis (diarrhea) may appear during or after treatment with this medicine. If so, treatment should be stopped and your doctor will prescribe the most appropriate therapy.

• Inform your doctor if you have severe kidney function impairment.

• If you have a condition called myasthenia gravis, or if you develop muscle weakness and fatigue during treatment with azithromycin, inform your doctor, as this medicine may worsen symptoms of this disease or trigger its onset.

• If you have heart rhythm disorders (arrhythmias) or have risk factors for them (such as certain heart conditions, electrolyte imbalances in the blood, or certain medications), inform your doctor, as this medicine may worsen or trigger such symptoms.

Children and adolescents

Weight below 45 kg.

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

Weight above 45 kg.

Same dose as adults; therefore, 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 taking, have recently taken, or might need to take any other medicines.

Especially inform your doctor or pharmacist if you are taking any of the following medicines:

• Antacids (medicines used for digestive problems). It is recommended to avoid administering both medicines at the same time of day.
• Ergot derivatives (such as ergotamine, used to treat migraine), as simultaneous administration with azithromycin may cause ergotism (a potentially serious adverse effect including numbness or tingling in the limbs, muscle cramps, headaches, seizures, or abdominal or chest pain).
• Cyclosporine (a medicine used in transplant patients), as azithromycin may increase blood levels of cyclosporine, which should be monitored.
• Digoxin (a medicine used to treat heart arrhythmias), as azithromycin may increase digoxin blood levels, which should be monitored.
• Colchicine (used for gout and familial Mediterranean fever).
• Dicoumarol 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 treating HIV infection), as azithromycin blood levels may increase.
• Fluconazole (medicines for treating fungal infections), as azithromycin blood levels may increase.
• Terfenadine (a medicine used to treat allergies), as the combination may cause heart problems.
• Rifabutin (a medicine for treating pulmonary tuberculosis and non-pulmonary mycobacterial infections), as it may reduce the number of white blood cells in the blood.
• Medicines containing active substances that prolong the QT interval, such as class IA (quinidine and procainamide) and class III (dofetilide, amiodarone, and sotalol) antiarrhythmics, cisapride, terfenadine, antipsychotics (such as pimozide), antidepressants (such as citalopram), and anti-infectives (fluoroquinolones such as moxifloxacin or levofloxacin and chloroquine), as they may cause serious cardiac 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 taken as a single daily dose. The contents of the sachet should be added to a glass of water and mixed 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

There is insufficient information regarding the safety of azithromycin during pregnancy. Therefore, azithromycin is not recommended during pregnancy unless, in the physician’s judgment, the benefit outweighs the risk to the fetus.

Azithromycin is excreted in breast milk. Due to potential adverse reactions in the infant, the use of azithromycin during breastfeeding is not recommended; however, breastfeeding may be resumed two days after completing azithromycin treatment.

Driving and using machines

The influence of this medicine on the ability to drive or use machines is none or negligible.

Aratro contains sucrose

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

It may harm teeth.

Aratro contains sodium

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

Aratro contains ethanol

This medicine contains 0.007% ethanol (alcohol), corresponding to a small amount of 0.4 mg/dose.

Aratro contains glucose

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

Aratro contains sulfites

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

3. How to take Aratro

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will determine the most appropriate dose and duration of treatment for you, depending on your condition and your response to treatment.

As a general rule, the dosage and frequency of administration are as follows:

Adults (including elderly patients) and children weighing more than 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 second to the fifth day.

In elderly patients, the same dose as in adults may be administered. However, in patients with cardiac rhythm disorders, your doctor will closely monitor you.

Infection of the urethra or cervix (cervicitis):

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

Sinusitis:

Treatment is indicated in adults and adolescents over 16 years of age.

Children and adolescents weighing less than 45 kg:

The sachets may not be suitable for this patient group. Other pharmaceutical forms of azithromycin may be used. Aratro must not be administered to children under 6 months of age.

Use in patients with liver impairment

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

Use in patients with kidney impairment

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

Method of administration

Oral use.

Pour the contents of the sachet into a glass, add a small amount of 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 diarrhoea.

Contact your doctor or pharmacist immediately. In case of overdose or accidental ingestion, contact the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Aratro

If you miss a dose, take the medicine as soon as possible and continue treatment as prescribed. However, if the next dose is due soon, 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 a missed dose. Continue taking the medicine as directed by your doctor.

If you stop treatment with Aratro

If you stop treatment earlier than recommended by your doctor, your symptoms may worsen or reappear.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

Very common adverse effects (affecting at least 1 in 10 patients) are:

• Diarrhea.

Common adverse effects (affecting at least 1 in 100 patients) are:

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

Uncommon adverse effects (affecting at least 1 in 1,000 patients) are:

• Fungal infection by Candida in the mouth or systemic, vaginal infection, pneumonia, fungal or bacterial infection, pharyngitis, gastroenteritis, breathing difficulties, rhinitis.
• Decreased number of certain types of white blood cells (leukocytes, neutrophils, and eosinophils).
• Allergic reaction, including deep skin inflammation (angioedema).
• Changes in eating behavior (anorexia).
• Nervousness, insomnia.
• Drowsiness, dizziness, taste disturbances, loss of tactile sensation.
• Vision disturbances.
• Hearing disturbances, vertigo.
• Palpitations.
• Hot flushes.
• Breathing difficulties, nosebleeds.
• Constipation, flatulence, indigestion, gastritis, difficulty swallowing, abdominal distension, dry mouth, belching, mouth ulcers, increased salivation.
• Rash, pruritus, appearance of raised red spots, dermatitis, dry skin, excessive sweating, redness.
• Joint swelling, muscle pain, back pain, neck pain.
• Difficulty urinating, kidney pain.
• Vaginal bleeding, testicular disorders.
• Generalized swelling, weakness, malaise, fatigue, facial edema, chest pain, fever, pain and swelling of the extremities.
• Abnormal liver function tests (increased liver enzymes GOT, GPT, and alkaline phosphatase) and increased bilirubin, urea, creatinine, chloride, glucose, bicarbonate, and platelets in blood, changes in sodium and potassium levels, decreased hematocrit.
• Complications following surgical intervention.

Rare adverse effects (affecting at least 1 in 10,000 patients) are:

• Agitation
• Liver function disorders, yellowing of the skin (jaundice)
• Sensitivity to sunlight exposure (photosensitivity), drug reaction with increased levels of a type of white blood cells (eosinophilia) and systemic symptoms (multiorgan involvement) (DRESS syndrome)
• Skin rash characterized by the sudden appearance of red skin areas with small pustules (small blisters filled with white/yellow fluid)

Adverse effects with unknown frequency (cannot be estimated from available data) are:

• Diarrhea caused by Clostridium difficile
• Decreased number of platelets in blood, anemia
• Severe allergic reaction
• Aggressive reactions, anxiety, delirium, hallucinations
• Loss of consciousness, seizures, decreased sensitivity, hyperactivity, disturbances and/or loss of smell, loss of taste, muscle weakness and fatigue (myasthenia gravis)
• Hearing disturbances including deafness and tinnitus
• Torsade de pointes, cardiac rhythm disturbances, QTc interval prolongation on electrocardiogram
• Decreased blood pressure
• Pancreatitis, change in tongue color
• Severe liver injury and liver failure, which rarely may be fatal, death of liver tissue, fulminant hepatitis
• Appearance of raised red spots, generalized rash with blisters and skin peeling, particularly 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 not listed in this leaflet.

You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse 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 expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Package contents and other information

Composition of Aratro

• The active substance is azithromycin (dihydrate). Each sachet contains 500 mg of azithromycin.
• The other components are sucrose, hydroxypropylcellulose, anhydrous trisodium phosphate, xanthan gum, cherry flavour (containing ethanol, sodium, glucose (derived from maltodextrin) and sulphites), vanilla flavour (containing ethanol, sodium, glucose (derived from maltodextrin) and sulphites) and banana flavour (containing ethanol, sodium, glucose (derived from maltodextrin) and sulphites).

Appearance of the medicine and contents of the pack

It is presented as an oral suspension powder in sachets.

Each pack contains 3 or 100 sachets.

Only certain pack 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 most recent revision of this leaflet: April 2024

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