EBASTINE VIR 20 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ebastina Vir 20 mg film-coated tablets EFG

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Ebastina Vir is and what it is used for
2. What you need to know before you take Ebastina Vir
3. How to take Ebastina Vir
4. Possible side effects
5. Storage of Ebastina Vir
6. Contents of the pack and other information

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

Ebastina, the active substance of Ebastina Vir, belongs to a group of medicines called antihistamines.

This medicine 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, itching of the nose, itching of the eyes, tearing, sneezing), chronic urticaria and allergic dermatitis.

2. What you need to know before you take Ebastina Vir

Do not take Ebastina Vir

• if you are allergic to ebastina or any of the other ingredients of this medicine (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 medicine takes 1 to 3 hours to take effect.
• This medicine may interfere with the results of skin allergy tests, so it is recommended not to perform them until 5-7 days have passed since the treatment was discontinued.
• It may enhance the effects of other antihistamines.
• In patients with mild or moderate hepatic impairment, it is not necessary to adjust the dose. In patients with severe hepatic impairment, the dose of 10 mg/day of ebastina should not be exceeded, so it is recommended to use Ebastina 10 mg tablets.

Children

This medicine should not be given to children under 12 years of age.

Taking Ebastina Vir with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Ebastina may interact with erythromycin (an antibiotic) or ketoconazole (a medicine for the treatment of 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, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

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

Breastfeeding

It is not known whether the medicine passes into breast milk, so it is recommended to consult with a doctor before taking this medicine.

Driving and using machines

In humans, no effects on psychomotor function or the ability to drive or use machinery have been observed at the recommended therapeutic doses. However, observe your response to the medication because in some cases, drowsiness has occurred at usual doses. If this happens, avoid driving and handling hazardous machinery.

3. How to take Ebastina Vir

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

Your doctor will indicate the duration of your treatment with this medicine. Remember to take your medicine.

The normal recommended dose in adults and adolescents over 12 years is 10 mg of ebastina once a day, although some patients may require a dose of 20 mg (1 tablet of this medicine) once a day.

This medicine should not be given to children under 12 years of age.

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

If you think the action of this medicine is too strong or too weak, tell 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 Toxicology Information Service, phone 915 620 420, indicating the medicine and the amount ingested or go to the nearest hospital.

The treatment of intoxication with this medicine consists of gastric lavage and the administration of adequate medication. Carry this leaflet with you.

If you forget to take Ebastina Vir

In case of forgetting a dose, wait for the next one. Do not take a double dose to make up for the forgotten doses.

If you stop taking Ebastina Vir

Do not stop treatment before your doctor indicates, as your symptoms may worsen.

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

4. Possible side effects

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

The side effects described in adults and adolescents over 12 years are the following:

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

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

Frequency not known (cannot be estimated from the available data): weight gain, increased appetite

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ebastina Vir

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

No special storage conditions are required.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ebastina Vir 20 mg

• The active substance is ebastina. Each tablet contains 20 mg of ebastina.
• The other ingredients (excipients) are: microcrystalline cellulose, stearyl macrogolglycerides, sodium carboxymethylcellulose (type A) (from potato), magnesium stearate, purified water, white opadry.

Appearance of the product and contents of the pack

The tablets of Ebastina Vir are white and round.

The packs contain 20 tablets.

Marketing authorisation holder

Industria Química y Farmacéutica VIR, S.A.

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

28923 Alcorcón (Madrid)

Spain

Manufacturer

Generis Farmaceutica S.A.

Rua Joao de Deus, 19

2700-487 (Amadora)

Portugal

Date of last revision of this leaflet: March 2019

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