Patient Information Leaflet

Azithromycin Vir 500 mg Film-Coated Tablets EFG

Azithromycin dihydrate

Read this leaflet carefully before you start 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms to 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 leaflet. See section 4.

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

It is used for the treatment of the following infections:

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

Do not take Azitromicina Vir:

• If you are allergic (hypersensitive) to the active ingredient azitromicina, to erythromycin, to another macrolide or ketolide antibiotic, or to 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 Vir:

• If you have a serious liver disease or severe kidney function impairment. Inform your doctor about this.
• If during treatment with this medication your skin and/or the white part of your eyes turns yellow, inform your doctor immediately, as it could be a sign of a serious liver disease (which can be fatal).
• If during treatment with this medication or after its completion you experience diarrhea, abdominal pain, or fever, inform your doctor, as it is possible that, like with other antibiotics, during treatment with this medication an overinfection by resistant germs, including fungi, may occur. If this is your case, inform your doctor.
• If you have a disease called myasthenia gravis or if during treatment with azitromicina you experience muscle weakness and fatigue, inform your doctor, as this medication may contribute to worsening the symptoms of this disease or triggering it.
• If you have heart rhythm alterations (arrhythmias) or if you have factors that predispose you to them (such as certain heart diseases, alterations in the level of electrolytes in the blood, or certain medications), inform your doctor, as this medication may contribute to worsening these alterations or triggering them.
• If during treatment with azitromicina, you experience an allergic reaction, characterized by symptoms such as itching, redness, skin rash, swelling, or difficulty breathing. If this occurs, inform your doctor immediately.

Children

Do not administer to children under 6 months.

Other medications and Azitromicina Vir

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:

• Ergotamine derivatives (such as ergotamine, used for migraine treatment).
• Ciclosporina (a medication used in transplant patients).
• Digoxina (a medication used to treat heart arrhythmias).
• Colchicina (used for gout and familial Mediterranean fever).
• Antacids (medications used for digestive problems). 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, zidovudina (medications for HIV infection treatment).
• Terfenadina (a medication used for allergy treatment).
• Rifabutina (a medication for pulmonary and non-pulmonary tuberculosis treatment).
• Amiodarona, Propafenona (medications for ventricular and supraventricular tachycardia treatment).

Taking Azitromicina Vir with food and beverages

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 medication.

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

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

Driving and operating machinery

There is no evidence that azitromicina affects the ability to drive or operate machinery. However, since during treatment with azitromicina cases of drowsiness and dizziness have been reported, the patient should exercise caution when driving or operating machinery until it is established how azitromicina may affect them individually.

Azitromicina Vir contains lactose

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

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

The dosage will be established by your doctor based on your individual needs and the type of infection. As a general rule, the medication dosage and administration frequency is as follows:

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

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

Use in children and adolescents

Children and adolescents: The 500 mg dosage of this presentation is only suitable for children and adolescents weighing more than 45 kg , for whom the same dosage as for adults is recommended. For those weighing less, other presentations are recommended.

If you estimate that the action of Azitromicina Vir is too strong or too weak, inform your doctor or pharmacist.

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

The groove is only for breaking the tablet if it is difficult to swallow whole.

If you take more Azitromicina Vir than you should

If you have taken more azitromycin than you should, consult your doctor, pharmacist, or call the Toxicological Information Service immediately. Telephone: 91 562 04 20 indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forget to take Azitromicina Vir

In case of forgotten dosage, use the medication as soon as possible and continue treatment as prescribed. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Azitromicina Vir

Do not discontinue treatment as there is a risk of disease recurrence.

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

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

Side effectsvery frequent (in at least 1 in 10 patients)are:

?diarrhea, nausea, abdominal pain, and flatulence

Side effectsfrequent (in at least 1 in 100 patients)are:

?fatigue

?alteration of eating behavior (anorexia)

?dizziness, tingling sensation, alteration of taste, headache

?vision alteration

?hearing loss

?vomiting, indigestion

?redness or inflammation of the skin, pruritus

?joint pain

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

Side effectsinfrequent (in at least 1 in 1,000 patients)are:

?decrease in some types of white blood cells

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

?nervousness

?abnormal sensation of sleep, insomnia, loss of tactile sensation

?inflammation of the stomach, constipation

?alteration of hearing, tinnitus

?sensitivity to sunlight (photosensitivity), appearance of red, elevated papules, generalized eruption with blisters and peeling skin, which occurs especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome)

?palpitations

?Candida infection, vaginal infection

?inflammation of the liver

?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

Side effectsrare (in at least 1 in 10,000 patients)are:

?dizziness

?agitation

?liver function alteration

?skin eruption characterized by the rapid appearance of red skin areas dotted with small pustules (small blisters filled with a white/yellow liquid).

Side effectsof unknown frequency(cannot be estimated from available data) are:

?alterations of heart rhythm, 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 color of the tongue

?kidney inflammation and acute kidney failure

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

?diarrhea caused byClostridium difficile

?decrease in blood pressure

?severe allergic reaction (exceptionally fatal)

?yellow discoloration of the skin, severe liver damage that in some cases can be fatal

?aggressive behavior, anxiety

?prolongation of the QT interval

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this prospectus, 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 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.otificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

This medication does not require special storage conditions.

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. 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 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 packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofAzitromicina Vir

• The active ingredient is azithromycin. Each tablet contains 500 mg of azithromycin (equivalent to 524 mg of azithromycin dihydrate)
• The other components (excipients) are: pregelatinized cornstarch, crospovidone, anhydrous calcium hydrogen sulfate, sodium laurylsulfate, magnesium stearate, hydroxypropylmethylcellulose, titanium dioxide (E171), lactose, and triacetin.

Appearance of the product and content of the packaging

Azitromicina Vir is presented in the form of film-coated tablets with a white color, capsule shape, scored on one side and smooth on the other in packaging with 3 and 150 tablets.

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

Only some packaging sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

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

28923 Alcorcón (Madrid)

Spain.

Last review date of this leaflet: May 2019

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