EBASTINE TARBIS 10 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ebastine TARBIS 10 mg film-coated tablets EFG

Ebastine

Read the package leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this package leaflet, as 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, even if they have the same symptoms of illness as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet.

Contents of the package leaflet:

1. What Ebastine TARBIS 10 mg film-coated tablets are and what they are used for
2. What you need to know before taking Ebastine TARBIS 10 mg film-coated tablets
3. How to take Ebastine TARBIS 10 mg film-coated tablets
4. Possible side effects
5. Storage of Ebastine TARBIS 10 mg film-coated tablets
6. Contents of the pack and further information

1. What Ebastine Tarbis 10 mg film-coated tablets are and what they are used for

Ebastine belongs to a group of medicines called antihistamines.

Ebastine TARBIS is indicated for the symptomatic treatment of 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 Ebastine Tarbis 10 mg film-coated tablets

Do not take Ebastine TARBIS 10 mg film-coated tablets:

• if you are allergic (hypersensitive) to ebastine or any of the other ingredients of Ebastine TARBIS 10 mg film-coated tablets.

Be cautious with Ebastine TARBIS 10 mg film-coated tablets:

• if you have an acute allergic emergency, as ebastine takes 1 to 3 hours to take effect.
• Ebastine 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 potentiate the effects of other antihistamines.
• In patients with mild or moderate hepatic insufficiency, it is not necessary to adjust the dose. In patients with severe hepatic insufficiency, the dose of ebastine should not exceed 10 mg/day.

Use of other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription, homeopathic medicines, herbal remedies, and other health-related products, as it may be necessary to interrupt treatment or adjust the dose of one of them.

Ebastine may interact with erythromycin (an antibiotic) or ketoconazole (a medicine for the treatment of fungal infections).

Pregnancy and lactation

Consult your doctor or pharmacist before using any medicine.

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

It is not known whether the medicine passes into breast milk.

Driving and using machines

In humans, no effects on psychomotor function or 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 at usual doses in some cases. If this happens, refrain from driving and operating hazardous machinery.

3. How to take Ebastine Tarbis 10 mg film-coated tablets

Follow the administration instructions of Ebastine TARBIS 10 mg film-coated tablets exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts. In these cases, it is advisable to ask the doctor for written instructions and make sure you have understood them well.

Remember to take your medicine.

Your doctor will indicate the duration of your treatment with Ebastine TARBIS 10 mg film-coated tablets. Do not stop treatment before, as your symptoms may worsen.

The recommended dose in adults and children over 12 years is 1 tablet (10 mg) once a day, regardless of food intake.

Ebastine TARBIS 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 effect of Ebastine TARBIS is too strong or too weak, tell your doctor or pharmacist.

If you take more Ebastine TARBIS 10 mg film-coated tablets than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Ebastine TARBIS 10 mg film-coated tablets

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

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

4. Possible side effects

Like all medicines, Ebastine TARBIS 10 mg film-coated tablets can cause side effects, although not everyone gets them.

The adverse reactions were mild or moderate, transient, and resolved spontaneously without specific treatment.

The side effects described are as follows:

Common (may affect 1 to 10 users in 100): headache, somnolence, dry mouth, pharyngitis, rhinitis, and fatigue.

Uncommon (may affect 1 to 10 users in 1,000): abdominal pain, digestive discomfort, nasal bleeding, sinusitis, nausea, and insomnia.

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

If you think any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this package leaflet, tell your doctor or pharmacist.

5. Storage of Ebastine Tarbis 10 mg film-coated tablets

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Ebastine TARBIS 10 mg film-coated tablets after the expiration date stated on the packaging after CAD. The expiration 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 pharmacy's SIGRE collection point or any other medication waste collection system. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Ebastine TARBIS 10 mg film-coated tablets

• The active ingredient is ebastine. Each tablet contains 10 mg of ebastine.
• The other ingredients are: anhydrous colloidal silica, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, hypromellose, titanium dioxide, and macrogol 400.

Appearance of the product and contents of the pack

Ebastine TARBIS 10 mg film-coated tablets are presented in the form of film-coated tablets for oral administration. Each pack contains 20 tablets of 10 mg.

Other presentations

Ebastine TARBIS 20 mg film-coated tablets.

Marketing authorization holder

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028 (Barcelona) – Spain

Manufacturer

Laboratorios Cinfa, S.A.

C/ Olaz-Chipi, 10 - Polígono Industrial Areta.

31620 Huarte - Pamplona (Navarra)-Spain

This package leaflet was last revised in: May 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/