PATIENT INFORMATION LEAFLET

Ebastina Vir 10 mg Film-Coated Tablets

Read this leaflet carefully before you start taking 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 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 leaflet. See section 4.

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

2. What you need to know before you start taking Ebastina Vir

3. How to take Ebastina Vir

4. Possible side effects

5. Storage of Ebastina Vir

6. Contents of the pack and additional information

Ebastina, the active component of Ebastina Vir, belongs to a group of drugs called antihistamines.

This medication is used in the treatment of allergic processes such as seasonal or perennial allergic rhinitis associated or not with allergic conjunctivitis (such as nasal discharge, nasal itching, eye itching, tearing, urge to sneeze), chronic urticaria and allergic dermatitis.

Do not take Ebastina Vir

• if you are allergic to ebastina or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor before starting to take Ebastina Vir:

• if you have an acute allergic emergency, as this medication takes 1 to 3 hours to take effect.
• This medication may interfere with skin allergy test results, so it is recommended not to perform them until 5-7 days after discontinuing treatment.
• This medication may potentiate the effects of other antihistamines.
• In patients with mild or moderate liver insufficiency, no dose adjustment is necessary. In patients with severe liver insufficiency, do not exceed a dose of 10 mg/day of ebastina.

Children

This medication should not be administered to children under 6 years old.

Taking Ebastina Vir with other medications

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

Ebastina may interact with erythromycin (antibiotic medication) or ketoconazole (medication for fungal infections).

Taking Ebastina Vir with food and drinks

The tablets can be taken with or without food.

Pregnancy and breastfeeding

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

Pregnancy

There is no experience in pregnant women, so it is recommended to consult a doctor before taking this medication.

Breastfeeding

The medication's passage into breast milk is unknown, so it is recommended to consult a doctor before taking this medication.

Driving and operating machinery

In men, no effects on psychomotor function or ability to drive or operate machinery have been observed at recommended therapeutic doses. However, observe your response to the medication because in some cases, drowsiness has been reported at usual doses. If this occurs, refrain from driving and operating hazardous machinery.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will inform you of the duration of your treatment with this medication.Remember to take your medication.

The recommended normal dose is:

- Adults and adolescents over 12 years old: 1 tablet (10 mg of ebastina) once a day.

- Children between 6 and 11 years old: half a tablet (5 mg of ebastina) once a day.The tablet can be divided into equal doses.

Ebastina Vir tablets are for oral administration. The tablets should be swallowed whole, without chewing, with the help of a liquid, preferably water.

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

If you take more Ebastina Vir than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, call the Toxicological Information Service, phone 915 620 420, indicating the medication and the amount ingested, and go to the nearest hospital.

The treatment of this medication overdose consists of gastric lavage and administration of the appropriate medication. Carry this leaflet with you.

If you forgot to take Ebastina Vir

In case of forgotten dose, wait for the next one. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Ebastina Vir

Do not discontinue treatment before the indicated time by your doctor, as your symptoms may worsen.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

The adverse effects described in adults and adolescents over 12 years old are as follows:

Frequent (may affect up to 1 in 10 people): headache, drowsiness, and dry mouth.

Rare (may affect up to 1 in 100 people): abdominal pain, digestive discomfort, nasal bleeding, rhinitis, sinusitis, nausea, and insomnia.

In children under 12 years old, the adverse events described are as follows:

Frequent (may affect up to 1 in 10 people): headache, dry mouth, and drowsiness.

Rare (may affect up to 1 in 100 people): increased appetite, diarrhea, skin eruptions, nervousness, affective imbalance, excessive mobility, taste alterations, and fatigue.

Unknown frequency (cannot be estimated from available data):weight gain, increased appetite

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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. 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.

Ebastina Composition Vir 10 mg

• The active ingredient is ebastina Each tablet contains 10 mg of ebastina.
• The other components (excipients) are: microcrystalline cellulose, stearoyl macrogolglycerides, carboxymethyl starch sodium (type A) (from potato), magnesium stearate, purified water, opadry white.

Product appearance and packaging contents

Ebastina Vir 10 mg tablets are oblong, biconvex, white in color, and have a groove.

The packaging contains 20 tablets.

Marketing Authorization Holder

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70. Polígono Industrial URTINSA II.

28923 Alcorcón (Madrid)

Spain

Responsible for manufacturing

Generis Farmaceutica S.A.

Rua Joao de Deus, 19

2700-487 (Amadora)

Portugal

Last review date of this leaflet: March 2019

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