AZITHROMYCIN TARBIS 40 mg/ml ORAL SUSPENSION POWDER IN A BOTTLE

2. What you need to know before taking Azithromycin Tarbis 40 mg/ml

Do not take Azithromycin Tarbis:

• if you are allergic (hypersensitive) to azithromycin, another macrolide antibiotic, 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 Azithromycin Tarbis:

• If you have a severe liver disease. In this case, inform your doctor.
• If you experience diarrhea during treatment with this medication or after completing it, inform your doctor.
• It is possible that, as with other antibiotics, a fungal overinfection may occur during treatment with this medication. If this happens, inform your doctor.
• If you experience an allergic reaction during treatment with Azithromycin Tarbis, characterized by symptoms such as itching, redness, skin rash, swelling, or difficulty breathing. If this happens, inform your doctor immediately.

Children

Azithromycin Tarbis should not be administered to children under 6 months of age.

Use of Azithromycin Tarbis with other medications

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Azithromycin may interact with other medications. Inform your doctor or pharmacist if you are taking any of the following medications:

• Ergotamine derivatives (such as ergotamine, used to treat migraines).
• Cyclosporine (a medication used in transplant patients).
• Digoxin (a medication used to treat heart arrhythmias).
• Colchicine (used to treat gout and familial Mediterranean fever).
• Antacids, cimetidine (medications used for digestive problems). If you are taking antacids and Azithromycin Tarbis, it is recommended to avoid simultaneous administration of both medications at the same time of day.
• Anticoagulant dicumarinics (medications used to prevent blood clots).
• Nelfinavir, zidovudine (medications for the treatment of HIV infections).
• Terfenadine (a medication used to treat allergies and hay fever).
• Rifabutin (a medication for the treatment of pulmonary tuberculosis and non-pulmonary infections caused by mycobacteria).

Pregnancy and breastfeeding

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.

Azithromycin Tarbis is not recommended during pregnancy and breastfeeding, unless the benefit outweighs the risk to the child, as determined by your doctor.

Driving and using machines

There is no evidence that Azithromycin Tarbis affects the ability to drive or operate machines.

Azithromycin Tarbis contains sucrose

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

Patients with diabetes mellitus should note that this medication contains 3.6 g of sucrose per 5 ml of reconstituted suspension.

3. How to take Azithromycin Tarbis 40 mg/ml

Follow the administration instructions for this medication exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Remember to take your medication.

Your doctor will indicate the duration of treatment with Azithromycin Tarbis. Do not stop treatment before completing it, as there is a risk of relapse of the disease.

The dose will be determined by your doctor based on your individual needs and the type of infection. To achieve optimal efficacy, follow your doctor's instructions regarding dosage and treatment duration.

The recommended dose is:

Adults (including elderly patients): To adjust the dose more easily, it is convenient to use other presentations.

The recommended dose is 500 mg/day, in a single dose, for 3 consecutive days, with a total dose of 1500 mg. Alternatively, the same total dose can be administered over 5 days, with a dose of 500 mg on the first day, followed by 250 mg daily from day 2 to 5.

For the treatment of sexually transmitted diseases, the dose is 1000 mg taken as a single oral dose.

Children and adolescents: In general, with the exception of the treatment of streptococcal pharyngitis, the recommended dose is 10 mg/kg/day, administered in a single dose for 3 consecutive days. Alternatively, the same total dose can be administered over 5 days, with 10 mg/kg on the first day, followed by 5 mg/kg/day for the remaining 4 days. The dosage schedule based on weight is as follows:

Less than 15 kg: 10 mg/kg/day (administered in a single dose) for 3 consecutive days; alternatively, 10 mg/kg on the first day, followed by 5 mg/kg/day for the next 4 days, administered in a single daily dose.

15-25 kg: 200 mg/day (administered in a single dose) for 3 consecutive days; alternatively, 200 mg on the first day, followed by 100 mg/day for the next 4 days, administered in a single daily dose.

26-35 kg: 300 mg/day (administered in a single dose) for 3 consecutive days; alternatively, 300 mg on the first day, followed by 150 mg/day for the next 4 days, administered in a single daily dose.

36-45 kg: 400 mg/day (administered in a single dose) for 3 consecutive days; alternatively, 400 mg on the first day, followed by 200 mg/day for the next 4 days, administered in a single daily dose.

More than 45 kg: The same dose as adults (500 mg/day, in a single dose, for 3 days).

For the treatment of streptococcal pharyngitis, a dose of 20 mg/kg/day should be administered for 3 consecutive days, without exceeding the maximum daily dose of 500 mg.

If you think the effect of Azithromycin Tarbis is too strong or too weak, inform your doctor or pharmacist.

Method of administration

Azithromycin Tarbis 40 mg/ml powder for oral suspension in bottle is administered orally. To facilitate administration, each bottle is accompanied by a dosing syringe.

The powder for suspension may exceed the marked level on the bottle. This is normal and due to the specific density of the preparation.

Preparation of the suspension:

• Invert the bottle and gently shake it until all the powder moves freely.
• Open the bottle and add the following amount of water, depending on the bottle size, using the dosing syringe provided:

Bottle of 15 ml: add 10 ml of water

Bottle of 30 ml: add 15 ml of water

Place the plastic perforated cap and press it until it is fully inserted into the bottle mouth.

• Close the bottle with the metal cap.
• Shake vigorously until a homogeneous suspension is achieved. The suspension level will be at the mark on the label.
• Do not forget to shake the suspension before each dose.

Administration of the preparation:

• Open the metal safety cap. Insert the syringe into the plastic perforated cap.
• Keeping the syringe inserted, invert the bottle so that it remains in a vertical position.
• Fill the syringe to the measure corresponding to the dose prescribed by your doctor.
• Invert the bottle again, remove the syringe, and proceed with administration.
• Wash the syringe after each administration.

If you take more Azithromycin Tarbis than you should

Consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Azithromycin Tarbis

Do not take a double dose to make up for forgotten doses.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Most side effects observed in clinical trials were mild to moderate, reversible after discontinuation of the medication, and mainly affected the digestive system, consisting primarily of nausea, vomiting, diarrhea, or abdominal pain. Potentially serious side effects, such as laryngeal edema (due to an allergic reaction) or liver function alterations accompanied by yellowing of the skin, occurred rarely.

In addition, during treatment with Azithromycin Tarbis, any of the following side effects may occur, which have been described for azithromycin when administered orally.

• Thrombocytopenia (decreased platelet count) and transient episodes of mild neutropenia (decreased white blood cell count).
• Aggressive behavior, nervousness, agitation, anxiety, dizziness/vertigo, convulsions, headache, somnolence, and hyperactivity.
• Hearing and taste alterations, and exceptionally, changes in taste.
• Cardiac alterations.
• Digestive disorders such as anorexia, nausea, vomiting/diarrhea (which can exceptionally cause dehydration), soft stools, abdominal discomfort (pain/cramps), constipation, gas, severe diarrhea, and rarely, tongue discoloration.
• Liver and kidney function alterations (rarely severe).
• Skin reactions such as itching, rash, photosensitivity, fluid accumulation, or urticaria (hives). Exceptionally, serious skin reactions have occurred. Rarely: a skin rash characterized by the rapid appearance of red skin areas with small pustules (small blisters filled with white/yellow liquid).
• Joint pain.
• Vaginal fungal infection (vaginitis).
• Fungal infections, fatigue, tingling sensation, and allergic reactions.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Azithromycin Tarbis 40 mg/ml

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

Do not store the reconstituted suspension at a temperature above 25°C.

Write the day and month of reconstitution of the suspension in the box provided on the carton and the label on the bottle.

Do not take the medication after 10 days of reconstitution; after this time, discard any remaining product.

Do not use this medication after the expiration date shown on the label and carton after EXP. The expiration date is the last day of the month indicated.

Medications should not be thrown away in drains or trash. Deposit the packaging and medications you no longer need in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Azithromycin Tarbis 40 mg/ml

• The active ingredient is azithromycin. Each ml of reconstituted suspension contains 40 mg of azithromycin (dihydrate).
• The other components (excipients) are: sucrose, hydroxypropylcellulose (E-463), anhydrous trisodium phosphate, xanthan gum (E-415), cherry flavor, vanilla flavor, and banana flavor.

Appearance of the product and package contents

Azithromycin Tarbis 40 mg/ml is a powder for oral suspension in a bottle.

Each package contains a 15 ml or 30 ml bottle.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028-BARCELONA (Spain)

Manufacturer:

KERN PHARMA, S.L.

Polígono Ind. Colón II

Venus, 72

08228 Terrassa (Barcelona)

Date of the last revision of this leaflet: May 2018

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