AZITHROMYCIN TARBIS 500 mg FILM-COATED TABLETS

1. What Azithromycin Tarbis 500 mg is and what it is used for

Azithromycin belongs to a group of antibiotics called macrolide antibiotics.

It is used to treat the following infections:

• Upper and lower respiratory tract infections, such as otitis media, sinusitis, pharyngitis, bronchitis, and pneumonia.
• Skin and soft tissue infections.
• Sexually transmitted diseases.

2. What you need to know before taking Azithromycin Tarbis 500 mg

Do not take Azithromycin Tarbis:

• if you are allergic (hypersensitive) to azithromycin, to another macrolide antibiotic, or to 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 during treatment with this medication or after completion of treatment, you experience diarrhea, inform your doctor.
• It is possible that, as with other antibiotics, during treatment with this medication, a fungal overinfection may occur. If this is the case, inform your doctor.
• If during treatment with Azithromycin Tarbis, you experience an allergic reaction, 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 for 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 infections caused by the human immunodeficiency virus).
• 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, in the doctor's opinion, the benefit outweighs the risk to the child.

Driving and Using Machines

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

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 500 mg

Follow the instructions for administration of this medication 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 completion, as there is a risk of relapse of the disease.

Azithromycin Tarbis is administered orally. The tablets should be swallowed whole, with a sufficient amount of liquid (a glass of water).

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 dose and duration of treatment.

The recommended dose is:

Adults (including elderly patients): 500 mg (1 tablet) once a day for 3 consecutive days, with a total dose of 1500 mg (3 tablets).

For the treatment of sexually transmitted diseases, the dose is 1000 mg (2 tablets) taken as a single oral dose.

Children and adolescents: The dose of 500 mg of this formulation is only suitable for children and adolescents over 45 kg in weight, for whom the same dose as for adults is recommended. For those under 45 kg, other formulations are recommended.

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

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 further questions 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 changes in liver function accompanied by yellowing of the skin occurred rarely.

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

• Thrombocytopenia (decrease in platelet count) and transient episodes of mild neutropenia (decrease in white blood cell count).
• Aggressive reactions, nervousness, agitation, anxiety, dizziness/vertigo, convulsions, headache, somnolence, and hyperactivity.
• Hearing and taste disorders, and exceptionally, changes in taste.
• Cardiac disorders.
• Digestive disorders such as anorexia, nausea, vomiting/diarrhea (rarely causing dehydration), soft stools, abdominal discomfort (pain/cramps), constipation, gas, severe diarrhea, and rarely, tongue discoloration.
• Changes in liver and kidney function (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 package 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 500 mg

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

Do not use this medication after the expiration date shown on the blister pack and the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the Pharmacy 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

1.

• The active ingredient is azithromycin. Each tablet contains 500 mg of azithromycin (dihydrate).
• The other components (excipients) are: pregelatinized cornstarch, crospovidone, anhydrous calcium hydrogen phosphate, sodium lauryl sulfate, magnesium stearate, hypromellose (E-464), titanium dioxide (E-171), lactose, and glycerol triacetate.

Appearance of the Product and Package Contents

Azithromycin Tarbis 500 mg are film-coated tablets. Each package contains 3 tablets.

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)

Industria Quimica y Farmaceutica VIR, S.A.

C/ Laguna 66-68-70, Polígono Industrial Urtinsa II

28923 Alcorcón (Madrid)

Spain

Date of the last revision of this package leaflet: July 2022

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/