Azithromycin Tarbis 500 mg powder for oral suspension in sachet EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Azitromicina Tarbis 500 mg powder for oral suspension in sachet EFG

Azithromycin (dihydrate)

Read this entire leaflet carefully before you start taking this medicine, as 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; do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Azitromicina Tarbis 500 mg is and what it is used for
2. What you need to know before taking Azitromicina Tarbis 500 mg
3. How to take Azitromicina Tarbis 500 mg
4. Possible side effects
5. How to store Azitromicina Tarbis 500 mg
6. Contents of the pack and other information

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 for the treatment of the following infections:

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

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

Do not take Azithromycin Tarbis:

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

Warnings and precautions

Consult your doctor or pharmacist before taking Azithromycin Tarbis:

• If you have severe liver disease. In this case, inform your doctor.
• If you develop diarrhea during treatment or after treatment has ended, inform your doctor.
• As with other antibiotics, overgrowth of fungi (fungal superinfection) may occur during treatment with this medicine. If this happens, inform your doctor.
• If you experience any allergic reaction while taking Azithromycin Tarbis, characterized by symptoms such as itching, redness, skin rash, swelling, or difficulty breathing. If this occurs, inform your doctor immediately.

Children

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

Use of Azithromycin Tarbis with other medicines

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

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

• Ergot derivatives (such as ergotamine, used for migraine treatment).
• Cyclosporine (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 Azithromycin Tarbis, it is recommended to avoid administering both medicines at the same time of day.
• Dicoumarol 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Azithromycin Tarbis is not recommended during pregnancy and breastfeeding unless, in the physician's judgment, the benefit outweighs the risk to the child.

Driving and operating machinery

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

Azithromycin Tarbis contains sucrose

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

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

3. How to take Azithromycin Tarbis 500 mg

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

Remember to take your medicine.

Your doctor will tell you how long to take Azithromycin Tarbis. Do not stop treatment early, as there is a risk of the illness recurring.

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

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

The recommended dose and frequency of administration are:

Adults (including elderly patients): 500 mg (1 sachet) once daily for 3 consecutive days, for a total dose of 1500 mg (3 sachets).

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

Children and adolescents: The 500 mg dose of this formulation is only suitable for children and adolescents weighing more than 45 kg, for whom the same dose as adults is recommended.

For those weighing less, other formulations are recommended.

If you think that 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

Contact your doctor or pharmacist immediately.

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

If you forget to take Azithromycin Tarbis

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

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 produce adverse effects, although not everyone will experience them.

Most of the adverse effects observed in clinical trials were mild to moderate in severity, reversible upon discontinuation of the drug, and primarily affected the gastrointestinal system, consisting mainly of nausea, vomiting, diarrhea, or abdominal pain. Potentially serious adverse reactions such as laryngeal edema (due to allergic reaction) or disturbances in liver function accompanied by yellowing of the skin occurred rarely.

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

• Thrombocytopenia (reduced platelet count) and transient episodes of mild neutropenia (reduced white blood cell count).
• Reactions including aggression, nervousness, agitation, anxiety, dizziness/vertigo, seizures, headache, somnolence, and hyperactivity.
• Hearing disturbances and, very rarely, taste disturbances.
• Cardiac disorders.
• Gastrointestinal disorders such as anorexia, nausea, vomiting/diarrhea (rarely leading to dehydration), loose stools, abdominal discomfort (pain/cramps), constipation, flatulence, severe diarrhea, and very rarely, tongue discoloration.
• Liver function abnormalities (rarely severe) and kidney function disturbances.
• Skin reactions such as itching, rash, photosensitivity, fluid retention, or urticaria (rash). Very rarely, severe skin reactions have occurred. Rare: skin eruption characterized by the rapid appearance of red skin areas dotted with small pustules (small blisters filled with white/yellow fluid).
• Joint pain.
• Fungal vaginal infection (vaginitis).
• Fungal infections, fatigue, tingling sensation, and allergic-type reactions.

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 through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Azithromycin Tarbis 500 mg

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

Do not use this medicine after the expiry date stated on the blister and packaging following EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicine and its packaging at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicine and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Azithromycin Tarbis 500 mg

• The active substance is azithromycin. Each sachet contains 500 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 medicine and contents of the pack

Azithromycin Tarbis 500 mg is a powder for oral suspension in sachets.

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 the most recent revision of this leaflet: May 2018

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/