EBASTINE VIR 10 MG FILM-COATED TABLETS EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ebastina Vir 10 mg film-coated tablets EFG

Read the entire 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Ebastine, the active component of Ebastina Vir, belongs to a group of medicines known as antihistamines.

This medicine is used to treat allergic conditions such as seasonal or perennial allergic rhinitis with or without allergic conjunctivitis (such as nasal discharge, nasal itching, eye itching, tearing, and 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 ebastine or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor before starting Ebastina Vir:

• If you are experiencing an acute, urgent allergic reaction, as this medicine takes 1 to 3 hours to take effect.
• This medicine may interfere with the results of skin allergy tests; therefore, such tests should not be performed until 5–7 days after stopping treatment.
• It may enhance the effects of other antihistamines.
• In patients with mild or moderate hepatic impairment, dose adjustment is not necessary. In patients with severe hepatic impairment, the dose should not exceed 10 mg/day of ebastine.

Children

This medicine must not be given to children under 6 years of age.

Taking Ebastina Vir with other medicines

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

Ebastine may interact with erythromycin (an antibiotic) or ketoconazole (a medicine used to treat fungal infections).

Taking Ebastina Vir with food and drink

The tablets may be taken with or without food.

Pregnancy and breastfeeding

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

Pregnancy

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

Breastfeeding

It is unknown whether the medicine passes into breast milk; therefore, it is recommended to consult a doctor before taking this medicine.

Driving and using machines

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

3. How to take Ebastine Vir

Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will indicate how long you should take this medicine. Remember to take your medicine regularly.

The recommended normal dose is:

• Adults and adolescents over 12 years: 1 tablet (10 mg of ebastine) once daily.

• Children between 6 and 11 years: half a tablet (5 mg of ebastine) once daily. The tablet may be divided into equal doses.

Ebastine Vir tablets are for oral use. The tablets should be swallowed whole, without chewing, with a glass of liquid, preferably water.

If you think that the effect of this medicine is too strong or too weak, tell your doctor or pharmacist.

If you take more Ebastine Vir than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, call the Toxicology Information Service at telephone number 915 620 420, stating the medicine and the amount taken, or go to the nearest hospital.

Treatment of poisoning with this medicine consists of gastric lavage and administration of appropriate medication. Bring this leaflet with you.

If you forget to take Ebastina Vir

If you miss a dose, wait until the next scheduled dose. Do not take a double dose to make up for missed doses.

If you stop taking Ebastina Vir

Do not discontinue treatment earlier than indicated by your doctor, as your symptoms may worsen.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The adverse effects reported in adults and adolescents over 12 years of age are as follows:

Common (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 discomfort, nosebleed, rhinitis, sinusitis, nausea and insomnia.

In children under 12 years of age, the adverse events reported are as follows:

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

Uncommon (may affect up to 1 in 100 people): increased appetite, diarrhoea, skin rash, nervousness, emotional imbalance, excessive mobility, taste disturbances and fatigue.

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es.

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

5. Storage of Ebastine 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 must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of EbastinaVir 10 mg

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

Appearance of the product and contents of the pack

Ebastine Vir 10 mg tablets are oblong, biconvex, white, and scored.

The packs 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 Responsible

Generis Farmaceutica S.A.

Rua Joao de Deus, 19

2700-487 (Amadora)

Portugal

Date of the most recent review of this leaflet: March 2019

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es