PRODUCT INFORMATION FOR THE USER

Ebastina TARBIS 20 mg Film-Coated Tablets

Ebastina

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

Ebastina belongs to a group of medicines called antihistamines.

Ebastina TARBIS is indicated for the symptomatic treatment of allergic processes such as seasonal or perennial allergic rhinitis associated or not with allergic conjunctivitis (such as runny nose, nasal itching, eye itching, tearing, urge to sneeze), chronic urticaria and allergic dermatitis.

Do not take Ebastina TARBIS 20 mg tablets:

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

Be especially careful with Ebastina TARBIS 20 mg tablets:

• if you present an acute allergic emergency, as ebastina takes 1 to 3 hours to take effect.
• Ebastina may interfere with the results of skin allergy tests, so it is recommended not to perform them until 5-7 days have passed since the treatment was interrupted.
• It may potentiate the effects of other antihistamines.
• In patients with mild or moderate liver insufficiency, no dose adjustment is necessary. In patients with severe liver insufficiency, the dose of ebastina should not exceed 10 mg/day, so the use of Ebastina TARBIS 20 mg tablets is recommended..

Use of other medications

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

Ebastina may interact with erythromycin (antibiotic medication) or ketoconazole (medication for fungal infections).

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

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

It is unknown if the medication passes into breast milk.

Driving and operating machinery

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, observe your response to the medication because in some cases drowsiness has been produced at usual doses. If this is the case, refrain from driving and operating hazardous machinery.

Follow exactly the administration instructions for Ebastina TARBIS 20 mg tablets as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts. In these cases, it is advisable to request written instructions from your doctor and ensure you understand them well.

Remember to take your medication.

Your doctor will indicate the duration of your treatment with Ebastina TARBIS 20 mg tablets. Do not discontinue treatment beforehand, as your symptoms may worsen.

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

Ebastina TARBIS tablets are for oral administration. The tablets should be swallowed whole, without chewing, with the help of a liquid, preferably water.

If you estimate that the action of Ebastina TARBIS is too strong or too weak, inform your doctor or pharmacist.

If you take more Ebastina TARBIS 20 mg tablets than you should

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

If you forgot to take Ebastina TARBIS 20 mg tablets

In case of forgotten dose, wait for the next one. However, do not take a double dose to compensate for the missed dose.

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

Like all medications, Ebastina TARBIS 20 mg tablets may produce adverse effects, although not all people will experience them.

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

The described adverse effects are as follows:

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

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

Unknown frequency (cannot be estimated from available data): weight gain, increased appetite.

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

Keep out of reach and sight of children.

No special storage conditions are required.

Do not use Ebastina TARBIS 20 mg tablets after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point at the pharmacy or any other medication waste collection system. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Ebastina TARBIS 20 mg tablets

• The active ingredient is ebastina. Each tablet contains 20 mg of ebastina.
• 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 content of the packaging

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

Other presentations

Ebastina TARBIS 10 mg film-coated tablets.

Holder of the marketing authorization

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028 (Barcelona) – Spain

Responsible for manufacturing:

Laboratorios Cinfa, S.A.

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

31620 Huarte - Pamplona (Navarra)-Spain

The last review of this leaflet was in May 2019

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/