Bilastine Teva 20 mg tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the patient
Bilastina Teva 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, ask 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, as it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Bilastina Teva is and what it is used for
- What you need to know before taking Bilastina Teva
- How to take Bilastina Teva
- Possible side effects
- How to store Bilastina Teva
- Contents of the pack and other information
1. What Bilastina Teva is and what it is used for
Bilastina Teva contains the active substance bilastina, which is an antihistamine. Bilastina Teva is used to relieve the symptoms of allergic rhinoconjunctivitis (sneezing, nasal itching, runny nose, nasal congestion, and red, watery eyes) and other forms of allergic rhinitis. It may also be used to treat itchy skin rashes (hives or urticaria).
2. What you need to know before taking Bilastina Teva
Do not take Bilastina Teva
If you are allergic to bilastine or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before starting to use Bilastina Teva if you have moderate or severe renal impairment, low levels of potassium, magnesium, or calcium in your blood, 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 certain abnormal heart rhythm pattern (known as QTc interval prolongation on the electrocardiogram) that may occur in some forms of heart disease and are also taking other medicines (see “Other medicines and Bilastina Teva”).
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 Teva
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 pectoris)
- Cyclosporine (used 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 AIDS)
- Rifampicin (an antibiotic)
Taking Bilastina Teva with food, drinks, and alcohol
These tablets must not be taken with food or consumption of grapefruit 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 data are limited, on the use of bilastine in pregnant or breastfeeding women or on its effects on fertility.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.
Consult your doctor or pharmacist before using any medicine.
Driving and using machines
It has been shown that bilastine 20 mg does not affect driving performance in adults. However, individual patient responses to the medicine may vary. Therefore, check how this medicine affects you before driving or operating machinery.
Bilastina Teva 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 Teva
Follow exactly the instructions for use of this medicine as 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 and 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 food or fruit juice (see section 2, “Taking Bilastina Teva with food, drinks and alcohol”).
- Swallow the tablet with a glass of water.
Regarding the duration of treatment, your doctor will determine the type of illness you have and advise you on how long you should take bilastine.
Use in children
Other forms of this medicine—bilastine 10 mg orodispersible tablets or bilastine 2.5 mg/ml oral solution—may be more suitable for children aged 6 to 11 years with a minimum body weight of 20 kg. Consult your doctor or pharmacist.
Do not administer this medicine 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 Teva than you should
If you, or anyone else, exceed the prescribed dose of this medicine, inform your doctor immediately or go to the nearest hospital emergency department. Please remember to bring this medicine package or the package 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 Teva
Do not take a double dose to make up for a missed dose.
If you forget to take your dose on time, take it as soon as possible, and then return to your usual 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 may cause adverse effects, although not everyone experiences them.
If you experience symptoms of an allergic reaction, signs of which 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 immediately and seek medical help right away.
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)
- 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 ache (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 type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Bilastina Teva
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after CAD/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. Dispose of containers and unused medicines at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Bilastina Teva
- The active substance is bilastine. Each tablet contains 20 mg of bilastine.
- The other components are: mannitol (E421), microcrystalline cellulose, sodium glycolate starch carboxymethyl potato (type A), magnesium aluminometasilicate, magnesium stearate, anhydrous colloidal silica.
Appearance of the product and contents of the pack
Bilastina Teva tablets are round, white to off-white, biconvex, approximately 7 mm in diameter.
The tablets are packed in blisters containing 10, 20, 30, 50 or 100 tablets, or in unit-dose blisters of 10 x 1, 20 x 1, 30 x 1 tablets.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands
Manufacturer
Saneca Pharmaceuticals a.s.
Nitrianska 100
920 27 Hlohovec
Slovak Republic
Further information about this medicinal product can be requested by contacting the local representative of the Marketing Authorization Holder:
Teva Pharma, S.L.U.
C/ Anabel Segura, 11, Edificio Albatros B, 1st floor,
Alcobendas 28108, Madrid (Spain)
Date of the most recent review of this leaflet: March 2025
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es
You can access detailed and up-to-date information about this medicine by scanning the QR code included on the outer packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/85921/P_85921.html
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