Bilastine Tarbis 20 mg tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Bilastina Tarbis 20 mg 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, consult 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 could harm them.
- If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet contents
- What Bilastina Tarbis is and what it is used for
- What you need to know before taking Bilastina Tarbis
- How to take Bilastina Tarbis
- Possible side effects
- How to store Bilastina Tarbis
- Contents of the pack and other information
1. What Bilastina Tarbis is and what it is used for
Bilastina Tarbis contains the active substance bilastine, which is an antihistamine. Bilastine is used to relieve the symptoms of allergic rhinoconjunctivitis (sneezing, nasal itching, nasal discharge, nasal congestion, and red, watery eyes) and other forms of allergic rhinitis. It may also be used to treat itchy skin rashes (wheals or urticaria).
2. What you need to know before taking Bilastina Tarbis
Do not take Bilastina Tarbis
If you are allergic to bilastine or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before taking bilastine if you have moderate or severe renal impairment, low blood levels of potassium, magnesium, or calcium, if you have or have had heart rhythm problems or if your heart rate is very low, if you are taking medicines that may affect heart rhythm, if you have or have had a specific abnormal heart rhythm pattern (known as QTc interval prolongation on the electrocardiogram) that may occur in certain types of heart disease and you are also taking other medicines (see “Other medicines and Bilastina Tarbis”).
Children
Do not administer this medicine to children under 12 years of age.
Do not exceed the recommended dose. If symptoms persist, consult your doctor.
Other medicines and Bilastina Tarbis
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.
In particular, please discuss with your doctor if you are taking any of the following medicines:
- Ketoconazole (a medicine for fungal infections)
- Erythromycin (an antibiotic)
- Diltiazem (used to treat angina)
- Cyclosporine (to reduce the activity of your immune system, to prevent transplant rejection, or to reduce the activity of autoimmune diseases and allergic disorders such as psoriasis, atopic dermatitis, or rheumatoid arthritis)
- Ritonavir (used to treat HIV)
- Rifampicin (an antibiotic)
Taking Bilastina Tarbis with food, drinks, and alcohol
These tablets should not be taken with food or with grapefruit juice or other fruit juices, as this would reduce the effect of bilastine. To avoid this, you may:
- take the tablet and wait one hour before eating or drinking fruit juices, or
- if you have eaten food or drunk fruit juice, wait two hours before taking the tablet.
Bilastine, at the recommended dose (20 mg), does not increase the drowsiness caused by alcohol.
Pregnancy, breastfeeding, and fertility
There are no data or the data are limited on the use of bilastine in pregnant women, during breastfeeding, or on effects on fertility.
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.
Consult your doctor or pharmacist before using any medicine.
Driving and using machines
It has been demonstrated that bilastine 20 mg does not affect driving performance in adults. However, individual patient response to the medicine may vary. Therefore, assess how this medicine affects you before driving or operating machinery.
Bilastina Tarbis contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; hence, it is essentially “sodium-free”.
3. How to take Bilastina Tarbis
Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended dose in adults, including elderly patients and adolescents aged 12 years or older, is 1 tablet (20 mg) per day.
- The tablet is for oral use.
- The tablet should be taken one hour before or two hours after eating any food or fruit juice (see section 2, “Taking Bilastina Tarbis with food, drinks, and alcohol”).
- Swallow the tablet with a glass of water.
- The tablet’s score line is intended only for splitting the tablet if you have difficulty swallowing it whole.
Regarding the duration of treatment, your doctor will determine the type of illness you have and advise you on how long you should take Bilastina Tarbis.
Use in children
For children aged 6 to 11 years with a minimum body weight of 20 kg, other more suitable pharmaceutical forms are available—such as orodispersible tablets or oral solution. Please consult your doctor or pharmacist.
Do not administer bilastina to children under 6 years of age with a body weight below 20 kg, as sufficient data are not available.
If you take more Bilastina Tarbis than you should
If you, or anyone else, exceed the recommended dose of this medicine, inform your doctor immediately or go to the nearest hospital emergency department. Please remember to bring this medicine’s packaging or this leaflet with you.
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 medicine and the amount ingested).
If you forget to take Bilastina Tarbis
Do not take a double dose to make up for a missed dose.
If you forget to take your dose, take it as soon as possible, and then return to your regular dosing schedule.
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 will experience them.
If you experience allergic reactions whose symptoms may include difficulty breathing, dizziness, collapse or loss of consciousness, swelling of the face, lips, tongue or throat, and/or swelling and redness of the skin, stop taking this medicine and contact your doctor immediately.
Other adverse effects that may occur in adults and adolescents are:
Common: may affect up to 1 in 10 people
- headache
- drowsiness
Uncommon: may affect up to 1 in 100 people
- changes in electrocardiogram
- blood tests showing changes in liver function
- dizziness
- stomach pain
- fatigue
- increased appetite
- irregular heartbeat
- weight gain
- nausea (feeling sick)
- anxiety
- dry nose or nasal discomfort
- abdominal pain
- diarrhoea
- gastritis (inflammation of the stomach lining)
- vertigo (a sensation of dizziness or unsteadiness)
- feeling weak
- thirst
- dyspnoea (difficulty breathing)
- dry mouth
- indigestion
- itching
- cold sores
- fever
- tinnitus (ringing in the ears)
- difficulty sleeping
- blood tests showing changes in kidney function
- increased blood fats
Frequency not known: cannot be estimated from available data
- palpitations (awareness of heartbeats)
- tachycardia (rapid heartbeat)
- allergic reactions whose symptoms may include difficulty breathing, dizziness, collapse or loss of consciousness, swelling of the face, lips, tongue or throat, and/or swelling and redness of the skin. If you experience any of these serious adverse effects, stop taking this medicine and contact your doctor immediately.
- vomiting
Adverse effects that may occur in children:
Common: may affect up to 1 in 10 people
- rhinitis (nasal irritation)
- allergic conjunctivitis (eye irritation)
- headache
- stomach pain (abdominal pain/upper abdominal pain)
Uncommon: may affect up to 1 in 100 people
- eye irritation
- dizziness
- loss of consciousness
- diarrhoea
- nausea (feeling sick)
- swelling of the lips
- eczema
- urticaria (hives)
- fatigue
Reporting of adverse effects
If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 Bilastina Tarbis
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Instead, dispose of packaging and any unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused packaging and medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Bilastina Tarbis
The active substance is bilastine.
Each tablet contains 20 mg of bilastine.
Other components:
Anhydrous colloidal silica, microcrystalline cellulose, sodium starch glycolate from potato (type A), magnesium stearate.
Appearance of the product and contents of the pack
White to off-white tablets, 10.0 mm x 5.0 mm, oval-shaped, biconvex, with the inscription “B” and “H” engraved on either side of the break line on one side and “2” on the other.
The score line is intended only to facilitate tablet splitting if you have difficulty swallowing it, and is not intended to divide the tablet into equal doses.
Bilastina Tarbis is available in blisters containing 20 tablets.
Marketing Authorization Holder
Tarbis Farma S.L.
Gran Vía Carlos III, 94
08028 Barcelona
Spain
Manufacturer
Amarox Pharma B.V.
Rouboslaan 32
2252 TR Voorschoten
The Netherlands
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Germany: Bilastin Amarox 20 mg Tabletten
Spain: Bilastina Tarbis 20 mg comprimidos EFG
Italy: Bilastina Amarox 20 mg compresse
Date of the most recent review of this leaflet: March 2025
Detailed 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/