AZITHROMYCIN TARBIS 250 mg ORAL SUSPENSION POWDER FOR SOLUTION EFG

Introduction

Package Leaflet: Information for the User

Azitromicina Tarbis 250 mg Powder for Oral Suspension in Sachet EFG

Azitromicina (Dihydrate)

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Azitromicina Tarbis 250 mg is and what it is used for
2. What you need to know before you take Azitromicina Tarbis 250 mg
3. How to take Azitromicina Tarbis 250 mg
4. Possible side effects
5. Storage of Azitromicina Tarbis 250 mg
6. Contents of the pack and further information

1. What Azitromicina Tarbis 250 mg is and what it is used for

Azitromicina belongs to a group of antibiotics called macrolide antibiotics.

It is used to treat the following infections:

• Infections of the upper and lower respiratory tract, such as otitis media, sinusitis, pharyngitis, bronchitis, and pneumonia.
• Infections of the skin and soft tissues.
• Sexually transmitted diseases.

2. What you need to know before you take Azitromicina Tarbis 250 mg

Do not take Azitromicina Tarbis:

• if you are allergic (hypersensitive) to azitromicina, to another macrolide antibiotic, or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before taking Azitromicina Tarbis:

• If you have a severe liver disease. In this case, inform your doctor.
• If during treatment with this medicine or after completing it, you experience diarrhea, inform your doctor.
• It is possible that, as with other antibiotics, during treatment with this medicine, a fungal overinfection may occur. If this happens, inform your doctor.
• If during treatment with Azitromicina 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

Azitromicina Tarbis should not be administered to children under 6 months.

Using Azitromicina Tarbis with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Azitromicina may interact with other medicines. Tell your doctor or pharmacist if you are taking any of the following medicines:

• Ergot derivatives (such as ergotamine, used to treat migraines).
• Ciclosporin (a medicine used in transplant patients).
• Digoxin (a medicine used to treat heart arrhythmias).
• Colchicine (used for gout and familial Mediterranean fever)
• Antacids, cimetidine (medicines used for digestive problems). If you are taking antacids and Azitromicina Tarbis, it is recommended to avoid taking both medicines at the same time of day.
• Oral anticoagulants (medicines used to prevent blood clots).
• Nelfinavir, zidovudine (medicines for the treatment of infections caused by the human immunodeficiency virus).
• Terfenadine (a medicine used to treat allergies and hay fever).
• Rifabutin (a medicine 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Azitromicina Tarbis should not be used during pregnancy and breastfeeding unless, in the doctor's opinion, the benefit to the mother outweighs the risk to the baby.

Driving and using machines

There is no evidence that Azitromicina Tarbis affects the ability to drive or use machines.

Azitromicina Tarbis contains sucrose

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

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

3. How to take Azitromicina Tarbis 250 mg

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

Remember to take your medicine.

Your doctor will tell you the duration of treatment with Azitromicina Tarbis. Do not stop treatment before it is completed, as there is a risk of relapse of the disease.

Azitromicina Tarbis is administered orally. Pour the contents of the sachet into a glass, add a little water, and mix well. The resulting suspension should be taken immediately.

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 the dose and treatment duration.

The recommended dose and administration frequency are:

Adults (including elderly patients): 500 mg (2 sachets in a single dose) once a day for 3 consecutive days, with a total dose of 1500 mg (6 sachets). Alternatively, the same total dose can be administered over 5 days, with a dose of 500 mg (2 sachets) on the first day, followed by 250 mg (1 sachet) daily from day 2 to 5.

For the treatment of sexually transmitted diseases, the dose is 1000 mg (4 sachets) taken as a single oral dose.

Children and adolescents: The dose of 250 mg of this presentation is only suitable for children and adolescents over 45 kg in weight, for whom the same dose as for adults is recommended.

For those with a lower weight, it is recommended to use other presentations.

If you think the effect of Azitromicina Tarbis is too strong or too weak, talk to your doctor or pharmacist.

If you take more Azitromicina 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 medicine and the amount taken.

If you forget to take Azitromicina Tarbis

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Most side effects observed in clinical trials were mild to moderate, reversible after discontinuation of the drug, and mainly affected the digestive system, consisting mainly 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 Azitromicina Tarbis, any of the following side effects may appear, described for azitromicina when administered orally.

• Thrombocytopenia (decrease in platelet count) and transient episodes of mild neutropenia (decrease in white blood cell count).
• Aggression, nervousness, agitation, anxiety, dizziness/vertigo, convulsions, headache, somnolence, and hyperactivity.
• Hearing and, exceptionally, taste disorders.
• Cardiac disorders.
• 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. Rare: cutaneous eruption characterized by the rapid appearance of red skin areas dotted 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 of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Azitromicina Tarbis 250 mg

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

Do not use this medicine after the expiry date which is stated on the sachet and the carton after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Take the empty pack and any remaining medicine to a pharmacy for proper disposal. If you are unsure, ask your pharmacist how to dispose of the pack and any remaining medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Azitromicina Tarbis 250 mg

• The active substance is azitromicina. Each sachet contains 250 mg of azitromicina (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 contents of the pack

Azitromicina Tarbis 250 mg is a powder for oral suspension in sachet.

Each pack contains 3 sachets.

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 last revision of this package leaflet: May 2018

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