Bilastine Pensal 20 mg tablets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Bilastina pensa 20 mg tablets EFG
Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.
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Keep this leaflet. You may need to read it again.
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If you have any questions, ask your doctor or pharmacist.
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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. 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. See section 4.
Contents of this leaflet
- What Bilastina pensa is and what it is used for
- What you need to know before taking Bilastina pensa
- How to take Bilastina pensa
- Possible side effects
- How to store Bilastina pensa
- Contents of the pack and other information
1. What Bilastina pensa is and what it is used for
This medicine contains bilastine as the active substance, which is an antihistamine.
Bilastine is used to relieve 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 (hives or urticaria).
2. What you need to know before taking Bilastina pensa
Do not take Bilastina pensa
- 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, or if you have or have had a specific abnormal heart rhythm pattern (known as QTc interval prolongation on electrocardiogram), which may occur in certain types of heart disease and especially if you are also taking other medicines (see “Other medicines and Bilastina pensa”).
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 pensa
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 AIDS)
- Rifampicin (an antibiotic)
Taking Bilastina pensa 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 or drunk fruit juice, wait two hours before taking the tablet.
Bilastine, at the recommended dose (20 mg), does not increase 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 plan to become pregnant, consult your doctor before taking 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 impair driving performance in adults. However, individual patient responses to the medicine may vary. Therefore, assess how this medicine affects you before driving or operating machinery.
3. How to take Bilastina pensa
Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. If in doubt, please consult your doctor or pharmacist again.
The recommended dose for 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 eating any food or fruit juice (see section 2, “Taking Bilastina pensa 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 Bilastina pensa.
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 – bilastine 10 mg orodispersible tablets or bilastine 2.5 mg/ml oral solution. Please 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 pensa than you should
If you, or anyone else, take more than the prescribed dose of this medicine, inform your doctor or pharmacist immediately or go to the nearest hospital emergency department. Please remember to bring this medicine package or the patient information 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 pensa
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 continue with 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.
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 wall)
- vertigo (a sensation of dizziness or unsteadiness)
- feeling of weakness
- 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 reaction, the 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. If you experience any of these serious adverse effects, stop taking this medicine and seek immediate medical attention.
- 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, pharmacist or nurse, 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 pensa
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and on the 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. Dispose of containers and unused medicines at the SIGRE Point in your pharmacy. If you are unsure, 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 pensa
- The active substance is bilastine. Each tablet contains 20 mg of bilastine (as monohydrate).
- The other components are: microcrystalline cellulose grade 102, crospovidone type A, colloidal anhydrous silica, and magnesium stearate.
Appearance of the product and contents of the pack
Bilastina pensa tablets are round and white.
They are supplied in packs of 20 tablets.
Marketing Authorization Holder
Towa Pharmaceutical, S.A.
C/ de Sant Martí, 75-97
08107 Martorelles (Barcelona)
Spain
Manufacturer
Noucor Health, S.A.
Avda. Camí Reial, 51-57
08184 Palau-solità i Plegamans
Barcelona, Spain
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Spain: Bilastina pensa 20 mg tablets EFG
Portugal: Bilastina Tolife
Italy: Bilastina pensa
Date of the most recent review of this leaflet: February 2025
Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)