Package Insert: Information for the User

Azitromicina Tarbis 500 mg Powder for Oral Suspension in a Carton EFG

Azitromicina (dihidrato)

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Azitromicina 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, pharyngitis, bronchitis, and pneumonia.
• Skin and soft tissue infections.
• Sexually transmitted diseases.

Do not take Azitromicina 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 Azitromicina Tarbis:

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

Children

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

Use of Azitromicina Tarbis with other medications

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

Azitromicina 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 for migraine treatment).
• Ciclosporin (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). In case you are taking antacids and Azitromicina Tarbis, it is recommended to avoid simultaneous administration of both medications at the same time of day.
• Dicumarol anticoagulants (medications used to prevent blood clot formation).
• Nelfinavir, zidovudine (medications for HIV infection treatment).
• Terfenadine (a medication used for allergies and hay fever).
• Rifabutin (a medication for pulmonary tuberculosis and non-pulmonary infections caused by mycobacteria).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Azitromicina Tarbis is not recommended during pregnancy and breastfeeding unless, at the doctor's discretion, the benefits outweigh the risks for the child.

Driving and operating machinery

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

Azitromicina Tarbis contains saccharose

This medication contains saccharose. If your doctor has indicated 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 saccharose per 5 ml of reconstituted suspension.

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

Remember to take your medication.

Your doctor will indicate the duration of treatment with Azitromicina Tarbis. Do not discontinue treatment before completion, as there is a risk of disease relapse.

Azitromicina Tarbis is administered orally. Pour the contents of the packet into a glass and add a little water, mixing well. The resulting suspension must be ingested immediately.

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

The recommended dose and administration frequency are:

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

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

Children and adolescents: The 500 mg dose 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 weighing less, other presentations are recommended.

If you estimate that the action of Azitromicina Tarbis is too strong or too weak, inform 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Azitromicina Tarbis

Do not take a double dose to compensate for the missed doses.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

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

• Thrombocytopenia (decreased platelet count) and transient episodes of mild neutropenia (decreased white blood cell count).
• Aggression reactions, nervousness, agitation, anxiety, dizziness/dizziness, seizures, headache, somnolence, and hyperactivity.
• Auditory and, exceptionally, gustatory alterations.
• Cardiac alterations.
• 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.
• Liver and, rarely, kidney function alterations.
• Skin reactions such as itching, rash, photosensitivity, fluid accumulation, or urticaria (rash). Exceptionally, severe skin reactions have occurred. Rarely: a skin rash 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, paresthesia, 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 prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging and the container after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Azitromicina Tarbis 500 mg

• The active ingredient 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 aroma, vanilla aroma, and banana aroma.

Appearance of the product and contents of the packaging

Azitromicina Tarbis 500 mg is an oral suspension powder in sachets.

Each package contains 3 sachets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028-BARCELONA (Spain)

Responsible for manufacturing:

KERN PHARMA, S.L.

Polígono Ind. Colón II

Venus, 72

08228 Terrassa (Barcelona)

Last review date of this leaflet: May 2018

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/