Azitromicina viatris 200 mg/5 ml polvo para suspension oral efg

Label:information for the user

Azitromicina Viatris 200 mg/5 ml powder for oral suspension EFG

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

• Keep this label, 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 should not be given 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 not listed in this label. See section 4.

1. Contents of the package and additional information

Azitromicina belongs to a group of antibiotics called macrolide antibiotics.

It is used to treat bacterial infections caused by microorganisms such as bacteria,in adults and children with a weight of 45 kg or more.

It is used for the treatment of the following infections:

- Throat, tonsil, ear, or sinus infections.

- Bronchitis and pneumonia (mild to moderate in severity).

- Skin and soft tissue infections (mild to moderate in severity).

- Urethritis or cervicitis, see section 3.

- Sexually transmitted infections (chancroid), see section 3.

Do not take Azitromicina Viatris:

• If you are allergic to azithromycin, other macrolide or ketolide antibiotics, such as erythromycin or telithromycin, or any of the other ingredients in this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Azitromicina Viatris if:

• During treatment with azithromycin, you may experience allergic reactions (itching, redness, skin rash, swelling, or difficulty breathing, or an allergic reaction to the medication characterized by an increase in white blood cells in the blood and generalized symptoms) that could be severe. Inform your doctor, who may decide to interrupt treatment and start appropriate treatment.
• If you have liver problems or during treatmentyour skin and/or the white of your eyes turns yellow, report it to your doctor to confirm if you should interrupt treatment or if you need to undergo liver function tests.
• If you are being treated with ergotamine derivatives (used to treat migraines), inform your doctor as the combined treatment with azithromycin may cause a condition called ergotism.
• During treatment with this medication, there is a possibility of developing an overinfection by resistant germs, including fungi. In this case, inform your doctor.
• Duringor after treatment with azithromycin, you may experience symptoms that suggest antibiotic-associated colitis (diarrhea). If so, treatment should be suspended and your doctor will prescribe the most suitable treatment.
• If you have anysevere kidney function impairment,inform your doctor.
• If you have severe heart rhythm disturbances (arrhythmias) or factors that predispose you to them (certain heart diseases, alterations in the level ofelectrolytes in the blood, or certain medications), inform your doctor, as this medication may contribute to worsening or triggering these conditions.
• If you have a condition called myasthenia gravis or if you experience muscle weakness and fatigue during treatment, inform your doctor, as azithromycin may trigger or worsen symptoms of this disease.

If you experience severe and persistent diarrhea, especially with blood or mucus, during or after treatment, consult your doctor immediately.

If symptoms persist after completing treatment with azithromycin or if you notice any new and persistent symptoms, inform your doctor.

Children and adolescents

This medication is not indicated for children under 1 year of age.

Sinusitis: treatment is indicated for adults and adolescents over 16 years old.

Other medications and Azitromicina Viatris

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

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

• Antacids (medications used for digestive problems). It is recommended to avoid simultaneous administration of both medications at the samehour of the day.
• Ergotamine derivatives (such as ergotamine, usedfor migraine treatment), as simultaneous administration with azithromycin may cause ergotism (a potentially severe adverse effect with numbness or tingling in the extremities, muscle cramps, headaches, convulsions, or abdominal or chest pain).
• Digoxin (a medication used to treat heart arrhythmias) as azithromycin may increase digoxin levels in the blood and levels should be monitored.
• Colchicine (used for gout and familial Mediterranean fever).
• Ciclosporin (a medication used intransplant patients), as azithromycin may increase ciclosporin levels in the blood and levels should be monitored.
• Anticoagulant dicumarins (medications usedto prevent blood clotting), as azithromycin may potentiate the effect of these anticoagulants. Your doctor should control coagulation parameters (prothrombin time).
• Nelfinavir, zidovudine (medications for HIV infection treatment), as they may increase azithromycin levels in the blood.
• Fluconazole (medications for fungal infections), as they may increase azithromycin levels in the blood.
• Terfenadine (a medication usedfor allergies), as the combination of both may cause heart problems.
• Rifabutin (a medicationfor tuberculosis and non-pulmonary infections caused by mycobacteria), as it may cause a decrease in white blood cells in the blood.
• Medications with active substances that prolong the QT interval, such as antiarrhythmic class IA (quinidine and procainamide) and class III (dofetilide, amiodarone, and sotalol) medications, cisapride, antipsychotics (such as pimozide), antidepressants (such as citalopram), and antifungals (fluoroquinolones such as moxifloxacin or levofloxacin and chloroquine), as they may cause severe heart rhythm disturbances and even cardiac arrest.
• • Hydroxychloroquine (used for rheumatoid arthritis, lupus, and malaria prevention).

No interactions have been observed between azithromycin and cetirizine (for allergic reactions); didanosine, efavirenz, indinavir (for HIV infection); atorvastatin (for cholesterol and heart problems); carbamazepine (for epilepsy), cimetidine (an antacid); methylprednisolone (to suppress the immune system);theophylline (for respiratory problems);midazolam, triazolam (sedatives); sildenafil (for impotence) and trimethoprim/sulfamethoxazole (for treating infections).

Taking Azitromicina Viatris with food

It can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctoror pharmacistbefore using this medication.

Your doctor will evaluate whether you should take this medication during pregnancy, if the benefits of treatment outweigh the potential risks.

Azitromicina is excreted in breast milk. Due to potential adverse reactions in the infant, it is not recommended to use azithromycin during breastfeeding. You can continue breastfeeding two days after completing treatment with azithromycin.

Driving and operating machinery

The influence of this medication on the ability to drive or operate machinery is negligible or insignificant.

Azitromicina Viatris contains saccharose and sodium:

This medication contains saccharose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.It contains 3.6mg of saccharoseper5 ml of reconstituted suspension, which should be taken into account in patients with diabetes mellitus.

This medication contains 18.17mg of sodium (main component of table salt/for cooking) per 5 ml of reconstituted suspension. This corresponds to 0.91% of the maximum daily sodium intake recommended for an adult.

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

This medication is administered orally. To facilitate administration, each bottle is accompanied by a dosing syringe.

Your doctor will establish the most suitable dose and treatment duration for you, according to your condition and response to treatment. As a general rule, the recommended dose of medication and administration frequency is as follows:

This medication is not indicated for children under 1 year of age, see sectionChildren and Adolescents.

Dose

Single-dose azithromycin suspension should be administered once a day, with or without food.

Shake the bottle vigorously before using the suspension.

Other presentations are available for different dosing regimens.

The usual dose is as follows:

Use in children and adolescents over 45 kg of weight, adults, and elderly people

The total dose of azithromycin is 37.5 ml (1,500 mg) administered over 3 days (12.5 ml (500 mg) once a day). Alternatively, the dose can be administered over 5 days (12.5 ml (500 mg) as a single dose on the first day and continue with 6.25 ml (250 mg) once a day).

For urethral or cervical inflammation caused byChlamydia, the dose is 25 ml (1,000 mg) as a single dose.

Only adults and adolescents over 16 years of age are indicated for sinusitis treatment.

Other presentations are available that are more suitable for patients with a weight greater than 45 kg.

Use in children and adolescents under 45 kg of weight

Azithromycin suspension treatment should be carefully measured, with the help of the dosing syringe provided, according to the child's weight, according to the following table:

For the treatment of pharyngitis/tonsillitis in children 2 years of age or older: the recommended dose of azithromycin is a single dose of 10 mg/kg or 20 mg/kg over 3 days, not exceeding a maximum daily dose of 500 mg.

Sinusitis

Available data in children under 16 years of age are limited for sinusitis treatment.

Patients with liver or kidney problems:

Inform your doctor if you have liver or kidney problems as you may need to modify the usual dose.

Administration form

Oral.

Preparation of the suspension

1. Invert the bottle and shake it gently until all the powder is freely moving.
2. Open the bottle and add the following amount of water according to the bottle size, using the dosing syringe provided:
   1. Bottle of 15 ml: add 10 ml of water
   2. Bottle of 30 ml: add 15 ml of water
3. Place the plastic stopper with a hole and press it until it is inserted into the bottle mouth.
4. Close the bottle with the metal cap.
5. Shake vigorously until a homogeneous suspension is obtained.
6. Do not forget to shake the suspension before each dose.

Each 5 ml of reconstituted suspension will contain 200 mg of azithromycin.

The reconstituted oral suspension can be stored at room temperature for a period of 10 days, after which the remaining solution should be discarded.

Administration of the prepared solution:

1. Open the safety metal cap. Insert the syringe into the plastic stopper with a hole.
2. Maintaining the syringe inserted, invert the bottle so that it remains in a vertical position.
3. Fill the syringe to the dose indicated by your doctor.
4. Return the bottle to its original position, extract the syringe, and proceed with administration.
5. Wash the syringe after each administration.

The dosing syringe is also graduated to allow administration according to the child's weight.

Once the syringe is prepared, administer immediately.

WARNING: ADMINISTER THE MEDICINE SLOWLY TO THE CHILD AND ENSURE IT IS INCORPORATED. THIS WILL PREVENT THE RISK OF ASPHYXIATION.

If you take more Azitromicina Viatris than you should

If you (or someone) take more azithromycin than you should, inform your doctor or pharmacist immediately. A overdose is likely to cause temporary hearing loss, intense nausea, vomiting, and diarrhea.

Information for the prescriber

In case of overdose, activated charcoal administration is indicated, and general symptomatic and supportive measures for vital functions should be applied.

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 Viatris

In case of forgotten dose, use the medication as soon as possible and continue treatment as prescribed. However, if the next dose is near, it is better not to take the forgotten dose and wait for the next one.Do not take a double dose to compensate for the forgotten doses.

If you interrupt treatment with Azitromicina Viatris

Do not stop taking your medication without consulting your doctor, even if you feel better. It is very important that you continue taking azithromycin for the time your doctor has indicated, as the infection may recur if you stop treatment prematurely.

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 side effects reported during clinical trials and after marketing, classified by frequency, are:

Very common(may affect more than 1 in 10 people)

• Diarrhea.

Common(may affect up to 1 in 10 people)

• Headache.
• Vomiting, abdominal pain, nausea.
• Alteration in the number of some types of white blood cells (lymphocytes, eosinophils, basophils, monocytes, and neutrophils), decrease in bicarbonate).

Uncommon(may affect up to 1 in 100 people)

• Candida fungal infection in the mouth or generalized, vaginal infection, pneumonia, fungal or bacterial infection, pharyngitis, gastroenteritis, respiratory alteration, rhinitis.
• Decrease in the number of some types of white blood cells (leukocytes, neutrophils, and eosinophils).
• Allergic reaction, including a deep skin inflammatory process (angioedema).
• Alteration in eating behavior (anorexia).
• Nervousness, insomnia.
• Drowsiness, dizziness, alteration in taste, loss of tactile sensation.
• Visual alteration.
• Auditory alteration, vertigo.
• Palpitations.
• Hot flashes.
• Respiratory alteration, nasal hemorrhage.
• Constipation, flatulence, indigestion, gastritis, difficulty swallowing, abdominal distension, dry mouth, belching, mouth ulcers, increased salivation.
• Rash, pruritus, appearance of red, elevated papules, dermatitis, dry skin, excessive sweating, erythema.
• Joint inflammation, muscle pain, back pain, neck pain.
• Difficulty urinating, kidney pain.
• Vaginal hemorrhage, alteration in testicles.
• Generalized swelling, weakness, discomfort, fatigue, facial edema, chest pain, fever, pain and swelling of the extremities.
• Alteration in liver function tests (increase in liver enzymes GOT, GPT, and alkaline phosphatase) and increase in bilirubin, urea, creatinine, chloride, glucose, bicarbonate, and platelets in blood, alteration in sodium and potassium levels, decrease in hematocrit.
• Post-surgical complications

Rare(may affect up to 1 in 1,000 people)

• Agitation.
• Liver function alteration, yellow discoloration of the skin.
• Sensitivity to sunlight (photosensitivity), allergic reaction with increase in a type of white blood cell (eosinophilia) and generalized symptoms (multi-organ compromise) (DRESS syndrome).
• Characterized by the rapid appearance of red skin areas dotted with small white/yellow-filled blisters (small pustules).

Frequency not known(cannot be estimated from available data)

• Diarrhea caused by Clostridium difficile.
• Decrease in platelets in blood, anemia.
• Severe allergic reaction
• Aggressive behavior, anxiety, delirium, hallucinations.
• Loss of consciousness, convulsions, decreased sensitivity, hyperactivity, alteration and/or loss of smell, loss of taste, muscle weakness and fatigue (myasthenia gravis).
• Auditory alteration including deafness and tinnitus.
• Torsade de pointes cardiac rhythm alterations, prolongation of the QTc interval in the electrocardiogram.
• Decrease in blood pressure.
• Pancreatitis, change in tongue color.
• Severe liver damage and hepatic failure that rarely can be fatal, liver tissue death, fulminant hepatitis.
• Appearance of red, elevated papules, generalized rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), severe skin reactions such as erythema multiforme, toxic epidermal necrolysis.
• Joint pain.
• Acute renal failure and interstitial nephritis.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Sealed bottles: No special storage conditions are required. Store in the original packaging.

Reconstituted solution: 10 days, do not store at a temperature above 25°C. Note in the box and on the bottle label the day and month of the suspension reconstitution. Do not take the medication after 10 days of reconstitution; discard any remaining solution.

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 after CAD or EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and unused medicines at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and unused medicines. By doing so, you will help protect the environment.

Composition of Azitromicina Viatris:

The active ingredient is azithromycin (as dihydrate). Each 5 ml of reconstituted suspension contains 200 mg of azithromycin (as dihydrate).

The other components (excipients) are: sucrose, hydroxypropylcellulose (E-463), trisodium phosphate, xanthan gum (E-415), cherry aroma, vanilla aroma, and banana aroma, see section 2Azitromicina Viatris containssucrose and sodium.

Appearance of the product and contents of the packaging.

It is packaged in a topaz glass vial, closed with an aluminum capsule. The perforated stopper and the accompanying syringe are made of plastic.

Each package contains a vial of 15 ml or 30 ml.

The dosing syringe has three types of scales: in kg (from 10 to 40 kg) based on body weight; in ml (from 0.25 to 10 ml) based on the volume of suspension; and in mg (from 10 to 400 mg) based on the amount of active ingredient.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Responsible for manufacturing:

KERN PHARMA, S.L.

Polígono Ind. Colón II, C/ Venus, 72

08228 - Terrassa (Barcelona)

Spain

Date of the last review of this leaflet:September 2024

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