EBASTINE VIR 10 mg FILM-COATED TABLETS

Introduction

PATIENT INFORMATION LEAFLET

Ebastina Vir 10 mg film-coated tablets EFG

Read this leaflet carefully before starting to take this medicine, as 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, as it may harm them, even if they have the same symptoms as you.

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

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

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

This medicine is used to treat allergic processes such as seasonal or perennial allergic rhinitis, with or without 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 taking 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 after stopping treatment.
• It may enhance the effects of other antihistamines.
• In patients with mild or moderate hepatic impairment, no dose adjustment is necessary. In patients with severe hepatic impairment, the dose should not exceed 10 mg/day of ebastina.

Children

This medicine should not be given to children under 6 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 plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Pregnancy

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

Breastfeeding

It is not known whether the medicine passes into breast milk, so it is recommended to consult 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, as somnolence has occurred in some cases at usual doses. If this happens, avoid driving and operating 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 is:

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

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

The Ebastina Vir tablets 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 taken, or go to the nearest hospital.

Treatment of intoxication with this medicine consists of gastric lavage and administration of appropriate medication. Bring 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 it is indicated by your doctor, 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): headache, somnolence, and dry mouth.

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

In children under 12 years, the adverse events described are the following:

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

Uncommon (may affect up to 1 in 100 people): increased appetite, diarrhea, skin rash, nervousness, mood changes, excessive mobility, taste disorders, and fatigue.

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

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: 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 stated on the packaging after EXP. The expiry date is the last day of the month indicated.

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

6. Package contents and additional information

Composition of Ebastina Vir 10 mg

• The active ingredient is ebastina. Each tablet contains 10 mg of ebastina.
• The other ingredients (excipients) are: microcrystalline cellulose, stearyl macroglycerides, sodium carboxymethylcellulose (type A) (from potato), magnesium stearate, purified water, white opadry.

Appearance of the product and package contents

The Ebastina Vir 10 mg tablets are oblong, biconvex, white, and have a score line.

The packages contain 20 tablets.

Marketing authorization 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 the 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 Healthcare Products (AEMPS) http://www.aemps.gob.es