EBASTINE TARBIS 20 mg FILM-COATED TABLETS

2. What you need to know before taking Ebastine Tarbis 20 mg film-coated tablets

Do not take Ebastine TARBIS 20 mg film-coated tablets:

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

Be cautious with Ebastine TARBIS 20 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 10 mg/day of ebastine should not be exceeded, so the use of Ebastine TARBIS 20 mg film-coated tablets is recommended.

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 with a doctor before taking ebastine.

It is unknown whether the medicine passes into breast milk.

Driving and using machines

In humans, no effects have been observed on psychomotor function or the ability to drive or use machinery at the recommended therapeutic doses. However, observe your response to the medication, as somnolence has occurred at usual doses in some cases. If so, refrain from driving and operating hazardous machinery.

3. How to take Ebastine Tarbis 20 mg film-coated tablets

Follow the administration instructions of Ebastine TARBIS 20 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 convenient 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 20 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 (20 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, inform your doctor or pharmacist.

If you take more Ebastine TARBIS 20 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, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Ebastine TARBIS 20 mg film-coated tablets

In case of forgetting a dose, wait for the next one. But 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 20 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 the following:

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

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

Frequency not known (cannot be estimated from the 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, inform your doctor or pharmacist.

5. Storage of Ebastine Tarbis 20 mg film-coated tablets

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Ebastine TARBIS 20 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 SIGRE collection point at the pharmacy or any other medication waste collection system. If in doubt, 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 20 mg film-coated tablets

• The active ingredient is ebastine. Each tablet contains 20 mg of ebastine.
• The other ingredients (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

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

Other presentations

Ebastine 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 last revision of this package leaflet was 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/