Bilastine Cinfa 20 mg tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Bilastina cinfa 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 effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Bilastina cinfa is and what it is used for
- What you need to know before taking Bilastina cinfa
- How to take Bilastina cinfa
- Possible side effects
- How to store Bilastina cinfa
- Contents of the pack and other information
1. What Bilastina cinfa is and what it is used for
Bilastina cinfa contains bilastine as the active substance, which is an antihistamine. Bilastina cinfa is used to relieve the symptoms of allergic rhinoconjunctivitis (sneezing, itching of the nose, 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 cinfa
Do not take Bilastina cinfa
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 take Bilastina cinfa.
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, 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 “Other medicines and Bilastina cinfa”).
Children
Do not give 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 cinfa
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 (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 cinfa 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
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.
There are no data or the data are limited regarding the use of bilastine in pregnant women, during breastfeeding, or on fertility.
Consult your doctor or pharmacist before using any medicine.
Driving and using machines
Bilastine has been shown not to affect performance during driving in adults. However, individual patient response to the medicine may vary. Therefore, assess how this medicine affects you before driving or operating machinery.
3. How to take Bilastina cinfa
Follow exactly the instructions for use of this medicine provided 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 any food or fruit juice (see section 2, “Taking Bilastina cinfa 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
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 cinfa 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 cinfa
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 experiences them.
Adverse effects that may occur in adults and adolescents are:
Frequent (may affect up to 1 in 10 people)
- headache
- somnolence
Uncommon (may affect up to 1 in 100 people)
- electrocardiogram abnormalities
- 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 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 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 and seek immediate medical attention
- vomiting
Adverse effects that may occur in children:
Frequent (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 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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Bilastina cinfa
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging 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 Collection Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Bilastina cinfa
- The active substance is bilastine. Each tablet contains 20 mg of bilastine (as monohydrate).
- The other excipients are: microcrystalline cellulose, crospovidone type A, magnesium stearate and colloidal anhydrous silica.
Nature of the product and pack size
The tablets are white and round, and are packaged in aluminium/aluminium blisters containing 20 or 30 tablets.
Only certain pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) - Spain
Manufacturer
Noucor Health, S.A.
Av. Cami Reial, 51-57;
08184 – Palau-solità i Plegamans,
Barcelona - Spain
Date of the most recent revision of this leaflet: February 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/
You can access detailed and updated information about this medicine by scanning the QR code included in the package leaflet and 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/86093/P_86093.html
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