Bilastina Combix 20 mg tablets EFG
SpainTable of Contents
Patient Information Leaflet
Introduction
Package Leaflet: Information for the Patient
Bilastina Combix 20 mg Tablets EFG
Read the entire leaflet carefully before you start taking this medicine, as 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 you should not give it to others, even if they have the same symptoms as you, because it may 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 Combix is and what it is used for
- What you need to know before taking Bilastina Combix
- How to take Bilastina Combix
- Possible adverse effects
- How to store Bilastina Combix
- Contents of the pack and other information
1. What Bilastina Combix is and what it is used for
Bilastina Combix contains bilastine as the active substance, which is an antihistamine.
Bilastine is used to relieve symptoms of allergic rhinoconjunctivitis (sneezing, itching nose, 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 Combix
Do not take Bilastina Combix:
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 using this medicine 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 prolongation on the electrocardiogram), which may occur in certain types of heart disease and especially if you are also taking other medicines (see "Other medicines and Bilastina Combix").
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 Combix
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 HIV)
- Rifampicin (an antibiotic)
Taking Bilastina Combix 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 juice, 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 responses to the medicine may vary. Therefore, check how this medicine affects you before driving or operating machinery.
Bilastina Combix contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; that is, essentially "sodium-free".
3. How to take Bilastina Combix
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.
- 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 Combix with food, drinks and alcohol”).
- Swallow the tablet with a glass of water.
- The break line is intended solely to divide the tablet if you have difficulty swallowing it whole.
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
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 Combix 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 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: 91 562 04 20 (indicating the medicine and the amount ingested).
If you forget to take Bilastina Combix
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 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 side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If you experience allergic reactions whose symptoms may include difficulty breathing, dizziness, collapse or loss of consciousness, swelling of the face, lips, tongue or throat, and/or skin swelling and redness, stop taking this medicine and seek immediate medical attention.
Other side 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)
- 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 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
Side 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 side effects
If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of Bilastina Combix
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is 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 medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of Bilastina Combix
- The active substance is bilastine. Each tablet contains 20 mg of bilastine.
- The other components are: microcrystalline cellulose, sodium carboxymethyl starch type A (from potato), colloidal anhydrous silica, and magnesium stearate.
Appearance of the product and contents of the pack
Bilastina Combix 20 mg are white to off-white, oval, biconvex tablets, scored, marked with a "2" on one side of the break line and "0" on the other side of the break line, smooth on the reverse side. The tablet dimensions are approximately 10.2 mm in length and 5.2 mm in width.
The tablets are presented in aluminium/aluminium blisters, in packs of 20 and 30 tablets.
Marketing Authorization Holder
Laboratorios Combix, S.L.U.
C/ Badajoz 2, Edificio 2
28223 Pozuelo de Alarcón (Madrid)
Spain
Manufacturer
Zydus France
ZAC Les Hautes Patures
Parc d'activités des Peupliers
25 Rue des Peupliers
92000 Nanterre
France
or
Netpharmalab Consulting Services S.L.
Polígono Vereda De Los Pobres
Carretera de Fuencarral 22,
Alcobendas,
28108 Madrid
Spain
or
Flavine Pharma France
3 Voie d’Allemagne
13127 Vitrolles
France
or
Centre Specialites Pharmaceutiques
Z.A.C. des Suzots
35 Rue de la Chapelle
63450 Saint Amant Tallende
France
or
Laboratori Fundació DAU
Calle Lletra C De La Zona França 12-14,
Polígono Industrial de la Zona Franca de Barcelona,
08040, Barcelona,
Spain
Date of the most recent revision of this leaflet: February 2025
Detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).