Label: Information for the User

Azitromicina Viatris 500 mg Film-Coated Tablets EFG

Read this label carefully before starting to take this medicine because 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.

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.

- Mild to moderate bronchitis and pneumonia.

- Mild to moderate skin and soft tissue infections.

- Urethritis or cervicitis, see section 3.

- Chancroid, see section 3.

Do not take Azitromicina Viatris:

Warnings and precautions

Consult your doctor or pharmacist before starting this medication:

• During treatment with azithromycin, 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) may occur, which could be severe. Inform your doctor, who may decide to discontinue treatment and initiate appropriate treatment.
• If you have liver problems or during treatment, if your skin and/or the white part of your eyes turns yellow, inform your doctor to confirm whether you should discontinue treatment or undergo liver function tests.
• If you are being treated with ergotamine derivatives (used to treat migraines), inform your doctor, as concurrent 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.
• During or after treatment with azithromycin, symptoms may appear that suggest antibiotic-associated colitis (diarrhea). If so, treatment should be discontinued, and your doctor will prescribe the most suitable treatment.
• If you have any kidney function alterations, inform your doctor.
• If you have arrhythmias or factors that predispose you to them (certain heart diseases, alterations in blood electrolyte levels, or certain medications), inform your doctor, as this medication may exacerbate or trigger these conditions.
• If you have myasthenia gravis or if muscle weakness and fatigue occur during treatment, inform your doctor, as azithromycin may trigger or worsen symptoms of this disease.

Children and adolescents

Children and adolescents weighing less than 45 kg.

Tablets are not indicated for this group of patients. Other forms of azithromycin may be used. Do not administer to children under 6 months.

Children and adolescents weighing more than 45 kg.

This medication is not suitable for children who are unable to swallow whole tablets. Other forms of azithromycin may be used.

Other medications and Azitromicina Viatris

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

Inform your doctor or pharmacist if you are being treated with any of the following medications:

No interactions have been observed between azithromycin and cetirizine (used to treat allergic reactions); didanosine, efavirenz, indinavir (used to treat HIV infections); atorvastatin (used to treat high cholesterol and heart problems); carbamazepine (used to treat epilepsy), cimetidine (used to treat excess stomach acid); methylprednisolone (used to suppress the immune system); theophylline (used to treat respiratory problems); midazolam, triazolam (used to induce sedation); sildenafil (used to treat impotence) and trimethoprim/sulfamethoxazole (used to treat infections).

Taking Azitromicina Viatris with food and drink

Tablets should be swallowed whole with water and may be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, inform your doctor or pharmacist before using this medication.

Your doctor will assess whether you should take this medication during pregnancy, whether the benefits of treatment outweigh the potential risks.Azithromycin is excreted in breast milk. Due to potential adverse reactions in the infant, it is not recommended to use azithromycin during breastfeeding, although breastfeeding may be continued two days after completing azithromycin treatment.

Driving and operating machinery

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

Azitromicina Viatris contains lactose and sodium

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free."

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

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:

Adults (including elderly patients) and children with a body weight of over 45 kg:

The usual dose is 1,500 mg divided over 3 or 5 days as follows:

In elderly patients, the same dose as for adults may be administered. However, in the case of patients with cardiac rhythm disorders, your doctor will closely monitor you.

Urethral or cervical infection (cervicitis):

The usual dose is 1,000 mg taken as a single dose, on a single day.

In the case of an infection caused by N.gonorrhoea, your doctor will administer the same dose in combination with another antibiotic (ceftriaxone, 250 mg).

Chancroid:

The usual dose is 1,000 mg taken as a single dose, on a single day.

Sinusitis:

Treatment is indicated for adults and adolescents over 16 years old

Children and adolescents under 45 kg of body weight:

The tablets are not recommended for these patients. Other pharmaceutical forms containing azithromycin (e.g. suspensions) may be used.

Use in patients with liver insufficiency

Inform your doctor if you have severe liver problems, as the normal dose may need to be modified.

Use in patients with renal insufficiency

Inform your doctor if you have kidney problems, as the normal dose may need to be modified.

Administration form

Oral route.

This medication should be administered as a single daily dose. Tablets should be taken whole with water and may be taken with or without food.

If you take more Azitromicina Viatris than you should

In case of overdose, you may experience reversible hearing loss, intense nausea, vomiting, and diarrhea.

Information for the prescriber

In case of overdose, administration of activated charcoal is indicated, and general symptomatic and supportive measures for vital function 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. Bring this leaflet, some of the remaining tablets, and the packaging to the hospital or to your doctor, so they know which tablets you have taken.

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 dose. Continue using azithromycin as indicated by your doctor.

If you interrupt treatment with Azitromicina Viatris

If you abandon treatment with azithromycin before the recommended time by your doctor, symptoms may worsen or reappear.

If you have any other doubts 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 of eating behavior (anorexia).
• Nervousness, insomnia.
• Drowsiness, dizziness, alteration of 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 of 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 of sodium and potassium levels, decrease in hematocrit.
• Post-surgical complications.

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

• Agitation.
• Alteration of liver function, yellow discoloration of the skin.
• Sensitivity to sunlight (photosensitivity), allergic reaction with increase of 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 alterations of heart rhythm, prolongation of QTc interval in electrocardiogram.
• Decrease in blood pressure.
• Pancreatitis, change in color of the tongue.
• 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 kidney 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.

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

No special storage conditions are required.

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.

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

Composition of Azitromicina Viatris

The active ingredient is azithromycin (as dihydrate). Each tablet contains 500 mg of azithromycin (as dihydrate).

The other components (excipients) are: pregelatinized cornstarch, crospovidone, anhydrous calcium hydrogen phosphate, sodium lauryl sulfate, magnesium stearate, hydroxypropylmethylcellulose, titanium dioxide (E171), lactose, and triacetin. See section 2Azitromicina Viatris contains lactose and sodium.

Appearance of the product and content of the container

Tabletscoated with a white film coating and capsule-shaped. They are packaged in blisters, in containers of 3 and 150 tablets (clinical container).

Only some sizes of containers may be commercially marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Manufacturer:

KERN PHARMA, S.L.

Polígono Ind. Colón II, C/ Venus, 72

08228 - Terrassa (Barcelona)

Spain

Last review date of this leaflet:April 2024

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