AZITHROMYCIN VIR 500 mg FILM-COATED TABLETS

Introduction

Leaflet: information for the user

Azitromicina Vir 500 mg film-coated tablets EFG

Azithromycin dihydrate

Read the entire leaflet carefully before starting to take this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Azitromicina Vir is and what it is used for
2. What you need to know before taking Azitromicina Vir
3. How to take Azitromicina Vir
4. Possible side effects
5. Storage of Azitromicina Vir
6. Package contents and additional information.

1. What Azitromicina Vir is and what it is used for

Azithromycin belongs to a group of antibiotics called macrolide antibiotics. It is a broad-spectrum antibiotic, active against a wide variety of bacteria or "germs" that cause infections

It is used to treat the following infections:

• of the upper and lower respiratory tract, such as otitis media, sinusitis, pharyngitis, bronchitis, and pneumonia,
• of the skin and soft tissues,
• in sexually transmitted diseases.

2. What you need to know before taking Azitromicina Vir

Do not take Azitromicina Vir:

• If you are allergic (hypersensitive) to the active substance azithromycin, to erythromycin, to another macrolide or ketolide antibiotic, or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Azitromicina Vir:

• If you have a severe liver disease or severe kidney function impairment. In this case, inform your doctor.
• If during treatment with this medicine your skin and/or the whites of your eyes turn yellow, inform your doctor immediately, as it could be a symptom of severe liver disease (which can be fatal).
• If during treatment with this medicine or after finishing it, you experience diarrhea, abdominal pain, or fever, inform your doctor, as it is possible that, like with other antibiotics, during treatment with this medicine, a superinfection with resistant germs may occur, including fungi. If this is the case, inform your doctor.
• If you have a disease called myasthenia gravis or if during treatment with azithromycin, you experience muscle weakness and fatigue, inform your doctor, as this medicine may contribute to worsening the symptoms of this disease or triggering it.
• If you have heart rhythm disorders (arrhythmias) or if you have factors that predispose you to them (such as certain heart diseases, electrolyte imbalances in the blood, or certain medications), inform your doctor, as this medicine may contribute to worsening these disorders or triggering them.
• If during treatment with azithromycin, you experience an allergic reaction, characterized by symptoms such as itching, redness, skin rash, swelling, or difficulty breathing. If this happens, inform your doctor immediately.

Children

It should not be administered to children under 6 months.

Other medicines and Azitromicina Vir

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

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

• Ergotamine derivatives (such as ergotamine, used to treat migraines).
• Cyclosporin (a medicine used in transplant patients).
• Digoxin (a medicine used to treat heart arrhythmias).
• Colchicine (used for gout and familial Mediterranean fever)
• Antacids (medicines used for digestive problems). It is recommended to avoid simultaneous administration of both medicines at the same time of day.
• Oral 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).
• Rifabutin (a medicine for the treatment of pulmonary tuberculosis and non-pulmonary infections caused by mycobacteria).
• Amiodarone, Propafenone (medicines for the treatment of ventricular and supraventricular tachycardias).

Taking Azitromicina Vir with food and drinks

Azitromicina Vir tablets can be taken with or without food with a glass of water.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

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 is not recommended during pregnancy and breastfeeding unless, in the doctor's opinion, the benefit outweighs the risk to the child.

Driving and using machines

There is no evidence that azithromycin affects the ability to drive or operate machinery. However, since drowsiness and dizziness have been reported during treatment with azithromycin, the patient should be cautious when driving or operating machinery until it is established how azithromycin affects them individually.

Azitromicina Vir contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Azitromicina Vir

Follow the administration instructions of this medicine exactly as indicated by your doctor. In case of doubt, consult your doctor again.

The dose will be established by the doctor based on individual needs and the type of infection. As a general rule, the dose of medicine and the frequency of administration are as follows:

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

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

Use in children and adolescents

Children and adolescents: The dose of 500 mg 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 with a lower weight, other presentations are recommended.

If you think the effect of Azitromicina Vir is too strong or too weak, inform your doctor or pharmacist.

Azitromicina Vir is administered orally. The tablets should be swallowed whole with a sufficient amount of liquid - a glass of water.

The score line is only for breaking the tablet if you find it difficult to swallow it whole.

If you take more Azitromicina Vir than you should

If you have taken more azithromycin than you should, consult your doctor, pharmacist, or call the Toxicology Information Service. Phone: 91 562 04 20, indicating the medicine and the amount taken. It is recommended to take the package and the leaflet of the medicine to the healthcare professional.

If you forget to take Azitromicina Vir

In case of forgetting a dose, use the medicine as soon as possible, continuing the treatment as prescribed. Do not take a double dose to make up for forgotten doses.

If you stop treatment with Azitromicina Vir

Do not stop treatment before completing it, as there is a risk of relapse of the disease.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects reported during clinical trials and after marketing have been classified by frequency:

The very common side effects (at least 1 in 10 patients) are:

? diarrhea, nausea, abdominal pain, and flatulence

The common side effects (at least 1 in 100 patients) are:

? fatigue

? alteration of eating habits (anorexia)

? dizziness, tingling sensation, alteration of taste, headache

? visual disturbance

? deafness

? vomiting, indigestion

? skin redness or inflammation, itching

? joint pain

? alteration of blood test results (alteration of the number of some types of white blood cells, decrease in bicarbonate)

The uncommon side effects (at least 1 in 1,000 patients) are:

? decrease in the number of some types of white blood cells

? allergic reaction, including an inflammatory process of the deep skin (angioedema)

? nervousness

? abnormal sleep sensation, insomnia, loss of tactile sensation

? stomach inflammation, constipation

? hearing disturbance, tinnitus

? sensitivity to sun exposure (photosensitivity), appearance of reddish rashes, generalized rash with blisters and peeling skin, which occurs especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome)

? palpitations

? Candida infection, vaginal infection

? liver inflammation

? chest pain, generalized swelling, discomfort, fatigue.

? alteration of liver function tests (increase in liver enzymes GOT and GPT and increase in bilirubin in blood), alteration of potassium levels in blood, increase in urea and creatinine in blood.

The rare side effects (at least 1 in 10,000 patients) are:

? vertigo

? agitation

? liver function alteration

? skin rash characterized by the rapid appearance of red skin areas with small blisters (small white/yellowish bumps).

The side effects of unknown frequency (cannot be estimated from the available data) are:

? heart rhythm disorders, torsades de pointes

? decrease in platelet count in blood, anemia.

? convulsions, hyperactivity, loss of consciousness, alteration and/or loss of smell, loss of taste, muscle weakness and fatigue (myasthenia gravis).

? pancreatitis, change in tongue color

? kidney inflammation and acute kidney failure

? severe skin reactions such as erythema multiforme, toxic epidermal necrolysis.

? diarrhea caused by Clostridium difficile

? decrease in blood pressure

? severe allergic reaction (rarely fatal)

? yellowing of the skin, severe liver damage that can occasionally be fatal

? aggressive reactions, anxiety

? prolongation of the QT interval

If you think any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

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 not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.aemps.gob.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Azitromicina Vir

This medicine does not require special storage conditions.

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

Do not use this medicine after the expiration date stated on the package after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packages and medicines you no longer need in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Azitromicina Vir

• The active substance is azithromycin. Each tablet contains 500 mg of azithromycin (equivalent to 524 mg of azithromycin dihydrate)
• The other components (excipients) are: pregelatinized corn starch, crospovidone, anhydrous calcium hydrogen sulfate, sodium lauryl sulfate, magnesium stearate, hypromellose, titanium dioxide (E171), lactose, and glycerol triacetate.

Appearance of the product and package contents

Azitromicina Vir is presented in the form of film-coated tablets, white in color, capsule-shaped, scored on one side and smooth on the other, in packages containing 3 and 150 tablets.

The score line is only for breaking the tablet and facilitating swallowing, but not for dividing into equal doses.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/ Laguna, 6-68-70. Polígono Industrial Urtinsa II.

28923 Alcorcón (Madrid)

Spain.

Date of last revision of this leaflet: May 2019

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) https://www.aemps.gob.es