Ebastine Tarbis 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ebastine TARBIS 20 mg film-coated tablets EFG

Ebastine

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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet.

Leaflet contents:

1. What Ebastine TARBIS 20 mg tablets are and what they are used for
2. What you need to know before taking Ebastine TARBIS 20 mg tablets
3. How to take Ebastine TARBIS 20 mg tablets
4. Possible adverse effects
5. How to store Ebastine TARBIS 20 mg tablets
6. Contents of the pack and other information

1. What Ebastina Tarbis 20 mg Tablets Are and What They Are Used For

Ebastine belongs to a group of medicines known as antihistamines.

Ebastina TARBIS is indicated for the symptomatic treatment of 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 starting Ebastine Tarbis 20 mg tablets

Do not take Ebastine TARBIS 20 mg tablets:

• if you are allergic (hypersensitive) to ebastine or to any of the other components of Ebastine TARBIS 20 mg tablets.

Take special care with Ebastine TARBIS 20 mg tablets:

• if you are experiencing an acute, urgent allergic reaction, as ebastine takes 1 to 3 hours to take effect.
• Ebastine may interfere with the results of skin allergy tests; therefore, it is recommended not to perform such tests until 5–7 days after discontinuing 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 of ebastine should not exceed 10 mg/day; therefore, use of Ebastine TARBIS 20 mg tablets is not recommended.

Use of other medicines

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

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking any medicine.

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

It is unknown whether the medicine passes into breast milk.

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 response to the medication, as drowsiness has occurred in some cases at usual doses. If this occurs, refrain from driving or operating dangerous machinery.

3. How to take Ebastine Tarbis 20 mg tablets

Follow exactly the instructions for use of Ebastine TARBIS 20 mg tablets as given by your doctor. If you have any doubts, consult your doctor or pharmacist. In such cases, it is advisable to request written instructions from your doctor and make sure you have fully understood them.

Remember to take your medicine.

Your doctor will inform you of the duration of your treatment with Ebastine TARBIS 20 mg tablets. Do not stop treatment prematurely, as your symptoms may worsen.

The recommended dose for adults and children over 12 years of age is 1 tablet (20 mg) once daily, regardless of food intake.

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

If you feel that the effect of Ebastine TARBIS is too strong or too weak, inform your doctor or pharmacist.

If you have taken more Ebastine TARBIS 20 mg tablets than you should

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

If you forget to take Ebastine TARBIS 20 mg tablets

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

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

4. Possible adverse effects

Like all medicines, Ebastina TARBIS 20 mg tablets can cause adverse effects, although not everyone will experience them.

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

The adverse effects reported are as follows:

Common (may affect between 1 and 100 out of every 100 patients): headache, somnolence, dry mouth, pharyngitis, rhinitis, and fatigue.

Uncommon (may affect between 1 and 10 out of every 1,000 patients): abdominal pain, gastrointestinal discomfort, epistaxis (nosebleed), sinusitis, nausea, and insomnia.

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

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not mentioned in this leaflet, inform your doctor or pharmacist.

5. Storage of Ebastine Tarbis 20 mg Tablets

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Ebastine Tarbis 20 mg tablets after the expiry date which is 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. Dispose of unused medicines and their packaging at the SIGRE Point at your pharmacy or any other medicine waste collection system. If in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ebastina TARBIS 20 mg tablets

• The active substance is ebastine. Each tablet contains 20 mg of ebastine.
• The other components (excipients) 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

Ebastina TARBIS 20 mg tablets are film-coated tablets for oral administration. Each pack contains 20 tablets of 20 mg.

Other presentations

Ebastina TARBIS 10 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

The most recent revision of this leaflet was in May 2019

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