Bilastine Normon 20 mg tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Bilastina Normon 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 must not give it to other people, even if they have the same symptoms as you, since it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Bilastina Normon is and what it is used for
- What you need to know before taking Bilastina Normon
- How to take Bilastina Normon
- Possible side effects
- How to store Bilastina Normon
Pack contents and additional information
1. What Bilastina Normon is and what it is used for
Bilastina Normon contains the active substance bilastine, which is an antihistamine.
Bilastina Normon 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 (hives or urticaria).
2. What you need to know before taking Bilastina Normon
Do not take Bilastina Normon:
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 starting to use Bilastina Normon 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 the electrocardiogram) that may occur in certain types of heart disease and are also taking other medicines (see “Use of Bilastina Normon with other medicines”).
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free”.
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 Normon
Inform your doctor or pharmacist if you are using, have recently used, or might need to use 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 Normon 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 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 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, check how this medicine affects you before driving or operating machinery.
3. How to take Bilastina Normon
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) once daily.
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The tablet is for oral use.
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The tablet should be taken one hour before or two hours after food or fruit juice (see section 2, "Taking Bilastina Normon with food, drinks and alcohol").
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Swallow the tablet with a glass of water.
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The score line is only intended for dividing the tablet if you have difficulty swallowing it whole.
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Regarding treatment duration, your doctor will determine the type of illness you have and advise you on how long you should take Bilastina Normon 20 mg tablets.
Use in children
For children aged 6 to 11 years with a minimum body weight of 20 kg, there are more suitable pharmaceutical forms 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 Normon than you should
If you, or anyone else, take more of this medicine than recommended, 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 Normon
Do not take a double dose to make up for the missed dose.
If you miss a dose, take it as soon as possible, 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 may 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 lipids
Frequency not known: cannot be estimated from available data
- palpitations (awareness of heartbeats)
- tachycardia (rapid heartbeats)
- allergic reactions, the symptoms of which may include difficulty breathing, dizziness, collapse or loss of consciousness, swelling of the face, lips, tongue or throat, and/or skin swelling and redness. If you experience any of these serious adverse effects, stop taking this medicine immediately and seek medical help without delay.
- 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, 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 Normon
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated after EXP on the packaging and on the blister. 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 unused containers and medicines at the Sigre Point located at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.
6. Contents of the pack and other information
Composition of Bilastina Normon 20 mg tablets EFG:
The active substance is bilastine. Each tablet contains 20 mg of bilastine.
The other components are microcrystalline cellulose, sodium carboxymethylstarch type A (derived from potato), colloidal anhydrous silica, magnesium stearate.
Appearance of the product and contents of the pack:
Bilastina Normon 20 mg tablets EFG are white or almost white, elongated, biconvex, scored tablets with printing.
The tablets are available in packs of 20 and 30 tablets.
Marketing Authorization Holder and Manufacturer
Laboratorios Normon, S.A.
Ronda de Valdecarrizo, 6
28760 – Tres Cantos
Madrid (Spain)
Date of the most recent revision of this leaflet: September 2025
Other sources of information
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/)
You can access detailed information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/85226/P_85226.html