Package Insert: Information for the User

Azitromicina Tarbis 40 mg/ml Powder for Oral Suspension in EFG Bottle

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.

Azithromycin belongs to a group of antibiotics called macrolides.

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.

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.

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.
• Dicumarinic anticoagulants (medications used to prevent blood clot formation).
• Nelfinavir, zidovudine (medications used for HIV treatment).
• Terfenadine (a medication used for allergies and hay fever).
• Rifabutin (a medication used 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 of this medication 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 beforehand, as there is a risk of relapse of the disease.

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 faithfully regarding the dose and duration of treatment.

The recommended dose is:

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

The recommended dose is 500 mg/day, taken once a day, 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 once a day for 3 consecutive days. Alternatively, the same total dose can be administered over 5 days, administering 10 mg/kg on the first day, followed by 5 mg/kg/day for the remaining 4 days. The dosing schedule based on weight is as follows:

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

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

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

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

More than 45 kg:The same adult dose (500 mg/day, once a day, 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 estimate that the action of Azitromicina Tarbis is too strong or too weak, inform your doctor or pharmacist.

Administration form

AzitromicinaTarbis 40 mg/ml powder fororal suspension in a bottleis administered orally. To facilitate administration, each bottle is accompanied by a dosing syringe.

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

suspension preparation:

• Invert the bottle and shake itgently until all the powder is freely moving.
• Open the bottle and add the following amount of water according to the size of the bottle, 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 stopper with a hole and press it until it is inserted into the mouth of the bottle.

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

Administration of the prepared product:

• Openthe safety metal cap. Insert the syringe into the plastic stopper with a hole.
• Maintaining the syringe inserted, invert the bottle so that it remains in a vertical position.
• Fill the syringe to the corresponding measure for the prescribed dose.
• Invert the bottle again, extract the syringe, and proceed with the administration.
• Wash the syringe after each administration.

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 may cause side effects, although not everyone will experience them.

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

Additionally, 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.
• Dermatological reactions such as itching, urticaria, photosensitivity, edema, or urticaria. 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 yeast 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 store the suspension once reconstituted at a temperature above25ºC.

Note, in the box provided for this purpose both on the box and on the bottle label, the day and month of the suspension reconstitution.

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

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

Medicines should not be thrown away through drains or inthe trash. Disposeof the packaging and medicines that you do not need at the SIGREcollection pointof the pharmacy. Incase of doubt, ask your pharmacist how to dispose of the packaging and medicines that you do not need. By doing so, you will help protect the environment.

Composition of Azitromicina Tarbis40mg/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 content of the container

Azitromicina Tarbis40 mg/ml is an oral suspension powder in a bottle.

Each container contains a 15 ml or 30 ml bottle.

Only some container sizes may be commercially available.

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.

Colón II Industrial Estate

Venus, 72

08228 Terrassa (Barcelona)

Last review date of this leaflet: May 2018

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