Bilastine Sandoz 20 mg tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Bilastina Sandoz 20 mg tablets EFG
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
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Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
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This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because 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 the leaflet
- What Bilastina Sandoz is and what it is used for
- What you need to know before taking Bilastina Sandoz
- How to take Bilastina Sandoz
- Possible side effects
5 Storage of Bilastina Sandoz
- Contents of the pack and other information
1. What Bilastina Sandoz is and what it is used for
Bilastina Sandoz contains the active substance bilastine, 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 can also be used to treat itchy skin rashes (hives or urticaria).
2. What you need to know before taking Bilastina Sandoz
Do not take Bilastina Sandoz
- 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 taking Bilastina Sandoz.
Talk to 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 Sandoz”).
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 Sandoz
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 chest pain or pressure—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 Sandoz with food, drinks, and alcohol
These tablets must 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 for 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 women, during breastfeeding, and 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 before taking this medicine.
Driving and using machines
It has been shown that bilastine 20 mg does not affect driving performance in adults. However, individual patient response to the medicine may vary. Therefore, check how this medicine affects you before driving or operating machinery.
3. How to take Bilastina Sandoz
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) daily.
- The tablet is for oral use.
- The tablet should be taken one hour before or two hours after eating food or fruit juice (see section 2, “Taking Bilastina Sandoz 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 how long you should take bilastine.
Use in children
There are other pharmaceutical forms more suitable for children aged 6 to 11 years.
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 Sandoz than you should
If you or anyone else has taken too much bilastine, inform your doctor immediately or go to the nearest hospital emergency department. Please remember to bring this medicine package or the 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 Sandoz
Do not take a double dose to make up for forgotten doses.
If you forget to take your dose, take it as soon as possible, and then continue with your regular dosing schedule.
If you stop taking Bilastina Sandoz
Generally, there are no consequences when treatment with bilastine is stopped.
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 lining),
- vertigo (a sensation of dizziness or instability),
- 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 heart rate),
- allergic reactions with symptoms that may include difficulty breathing, dizziness, fainting or loss of consciousness, swelling of the face, lips, tongue or throat, and/or skin redness and swelling. If you experience any of these serious adverse effects, stop taking the medicine and seek immediate medical attention,
- vomiting.
Adverse effects that may occur in children are:
Common: may affect up to 1 in 10 people
- rhinitis (nasal irritation),
- allergic conjunctivitis (allergic irritation of the eye conjunctiva),
- headache,
- stomach ache (abdominal pain up to 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 Sandoz
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/CAD. The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at 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 Sandoz
- The active substance is bilastine. Each tablet contains 20 mg of bilastine (as monohydrate).
- The other components are microcrystalline cellulose, crospovidone (type A), magnesium stearate, anhydrous colloidal silica.
Nature and content of the container
Bilastina Sandoz are white, round tablets.
Each pack contains 10, 20, 30, 40, 50 or 100 tablets.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Sandoz Farmacéutica, S.A.
Centro Empresarial Parque Norte
Edificio Roble
C/ Serrano Galvache, 56
28033 Madrid
Spain
Manufacturer
Noucor Health, S.A
Avda. Cami Reial, 51-57
08184 Palau Solita I Plegamans
Barcelona
Spain
or
Lek Pharmaceuticals d.d
Verovskova 57
1526 Ljubljana
Slovenia
This medicinal product is authorized in the European Economic Area member states under the following names:
Germany: Bilastin HEXAL 20 mg tablets
Estonia: Bilastine Sandoz
Spain: Bilastina Sandoz 20 mg tablets EFG
Italy: Bilastina Sandoz
Latvia: Bilastine Sandoz 20 mg tablets
Lithuania: Bilastine Sandoz 20 mg tablets
Poland: BILARGIN
Date of the most recent review of this leaflet: April 2025
Detailed and up-to-date 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/