Aratro 200 mg/5 ml powder for oral suspension in bottle EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Aratro 200 mg/5 ml powder for oral suspension in bottle EFG

azithromycin

Read the entire 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 other people, 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.

Leaflet contents:

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 adverse 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 known as macrolide antibiotics. It kills bacteria that cause infections.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu or colds.

It is important that you follow your doctor's instructions regarding dosage, dosing intervals, and duration of treatment.

Do not keep or reuse this medicine. If you have leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via wastewater or household waste.

It is used to treat the following infections:

• Infections of the throat, tonsils, ears, or 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, any other 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 to take this medicine.

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

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

• There is a possibility of fungal superinfection occurring during treatment with this medicine. If this occurs, inform your doctor.

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

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

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

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

Children and adolescents

Weight below 15 kg

The dose in this patient group must be measured as precisely as possible. Should 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.

Sinusitis: treatment is indicated in adults and adolescents over 16 years of age.

Other medicines and Aratro

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.

You should 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 with numbness or tingling sensations in the extremities, 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 therefore be monitored.
• Digoxin (a medicine used to treat heart arrhythmias), as azithromycin may increase digoxin blood levels, which should therefore be monitored.
• Colchicine (used for gout and familial Mediterranean fever).
• Dicoumarin 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 infections caused by the human immunodeficiency virus), as they may increase azithromycin blood levels.
• Fluconazole (a medicine for treating fungal infections), as it may increase azithromycin blood levels.
• Terfenadine (a medicine used to treat allergies), as the combination of both may cause heart problems.
• Rifabutin (a medicine for treating pulmonary tuberculosis and non-pulmonary infections caused by mycobacteria), as it may cause a decrease in white blood cell count.
• Medicines containing active substances that prolong the QT interval, such as class IA antiarrhythmics (quinidine and procainamide) and class III (dofetilide, amiodarone, and sotalol), cisapride, terfenadine, antipsychotic agents (such as pimozide), antidepressants (such as citalopram), and anti-infective agents (fluoroquinolones such as moxifloxacin or levofloxacin and chloroquine), as they may cause serious disturbances in heart rhythm 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 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 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 child.

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

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.

May harm 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); this small amount corresponds to 0.063 mg per 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 as 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 response to treatment.

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

Children and adolescents weighing less than 45 kg:

The dosing schedule based on body weight would be as follows:

*The dose in children weighing less than 15 kg should be measured as precisely as possible.

Adults:

To adjust the dose more easily, it is advisable to use other presentations.

Use in patients with hepatic impairment

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

Use in patients with renal impairment

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

Method of administration

Oral use.

The medicine must be reconstituted before use. To facilitate administration, each vial is supplied with a dosing syringe featuring three integrated scales allowing dosing based on kg (from 0 to 40 kg) according to body weight; in ml (from 0 to 10 ml) according to the volume of suspension; and in mg (from 0 to 400 mg) according to the amount of active substance.

• Preparation of the suspension:

  1. Invert the vial and gently shake until all the powder moves freely. The powder for suspension may exceed the level mark indicated on the vial. This is normal and due to the specific density of the preparation.
  2. Open the vial and add the following amount of water depending on the vial size, using the supplied dosing syringe:

• 15 ml vial: add 10 ml of water.

• 30 ml vial: add 15 ml of water.

1. Place the perforated plastic cap and press it down until it is fully inserted into the vial neck.
2. Close the vial with the metal cap.
3. Shake vigorously until a homogeneous suspension is obtained. The suspension level will reach the calibration mark on the label.
4. Do not forget to shake the suspension before each dose.

• Administration of the preparation:
  1. Open the metal safety cap. Insert the syringe into the perforated plastic cap.
  2. While keeping the syringe inserted, invert the vial so that it remains in a vertical position.
  3. Fill the syringe to the mark corresponding to the dose prescribed by your doctor.
  4. Invert the vial again, remove the syringe, and proceed with administration.
  5. Wash the syringe after each administration. This syringe should not be used for any other medication. The graduations on this syringe are specific to this medicine.
  6. Close the vial with the safety cap; the adapter will remain in the bottle neck.

Remember that the dose prescribed by your doctor should be taken only once daily.

If you take more Aratro than you should

In case of overdose, you may experience reversible hearing loss, severe nausea, vomiting, and diarrhea. Contact your doctor or pharmacist immediately. In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone: 91 562 04 20, indicating the medication 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 it is almost time for your next dose, it is better not to take the missed dose and wait until the next scheduled dose. Do not take a double dose to make up for a missed dose. Continue using the medicine as directed by your doctor.

If you stop treatment with Aratro

If you stop treatment earlier than recommended by your doctor, 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 may cause adverse effects, although not everyone will experience 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:

• Diarrhoea.

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.

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

• Fungal infection by Candida in the mouth or generalized, vaginal infection, pneumonia, fungal or bacterial infection, pharyngitis, gastroenteritis, breathing disorders, rhinitis.
• Decrease in the number of certain types of white blood cells (leukocytes, neutrophils and eosinophils).
• Allergic reaction, including deep skin inflammation (angioedema).
• Changes in eating behaviour (anorexia).
• Nervousness, insomnia.
• Drowsiness, dizziness, taste disturbances, loss of tactile sensation.
• Visual disturbances.
• Hearing disturbances, vertigo.
• Constipation, flatulence, indigestion, gastritis, difficulty swallowing, abdominal distension, dry mouth, burping, 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 oedema, chest pain, fever, pain and swelling of limbs.
• Abnormal liver function tests (increased liver enzymes GOT and GPT and alkaline phosphatase) and increased bilirubin, urea, creatinine, chloride, glucose, bicarbonate and platelets in blood, changes in sodium and potassium levels, decreased haematocrit.
• Complications following surgical procedures.

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

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

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

• Diarrhoea caused by Clostridium difficile.
• Decreased number of platelets in blood, anaemia.
• Severe allergic reaction.
• Aggression-related reactions, anxiety, delirium, hallucinations.
• Loss of consciousness, seizures, decreased sensitivity, hyperactivity, disturbances and/or loss of smell, loss of taste, muscle weakness and fatigue.
• Hearing disturbances including deafness and tinnitus.
• Torsade de pointes, cardiac rhythm disturbances, QTc interval prolongation on electrocardiogram.
• Decreased blood pressure.
• Pancreatitis, change in tongue colour.
• Severe liver injury and liver failure, which rarely may be fatal, liver tissue death, fulminant hepatitis.
• Appearance of raised red spots, generalized rash with blisters and peeling skin, 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 renal tubules (interstitial nephritis).

Reporting of adverse effects

If you experience any 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 Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Aratro

Before reconstitution: Do not store above 25°C.

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

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

Do not use this medicine after the expiry date stated on the label after EXP. The expiry date is the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be returned to the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Aratro

• The active substance 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 flavour (contains ethanol, sodium, glucose (derived from maltodextrin) and sulphites), vanilla flavour (contains ethanol, sodium, glucose (derived from maltodextrin) and sulphites) and banana flavour (contains ethanol, sodium, glucose (derived from maltodextrin) and sulphites).

Appearance of the product and contents of the pack

It is presented as a powder for oral suspension in a bottle.

Each pack contains 1 or 20 bottles of 15 ml or 30 ml.

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 review of this leaflet: June 2024

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