Each tablet contains 20 mg of bilastine.
Excipients/Inactive Ingredients: Cellulose microcrystalline, sodium starch glycolate, silica colloidal, magnesium stearate of vegetable origin.
Pharmacotherapeutic group: Antihistamines for systemic use, other antihistamines for systemic use. ATC Code: RO6AX.
Pharmacology: Bilastine is non-sedating, long-acting histamine antagonist, with selective peripheral H1 receptor antagonist affinity and no affinity for muscarinic receptors.
Symptomatic treatment of allergic rhino-conjunctivitis (seasonal and perennial) and urticaria.
Route of administration: Oral use.
The score line is for breaking the tablet and making swallowing easier, but not to divide it into equal doses.
These tablets should not be taken with food or with grapefruit juice or other fruit juices, as this would decrease the effect of bilastine. To prevent this the patient can: take the tablet and wait an hour before eating or drinking juices, or if the patient has eaten or drunk juice, he/she should wait for two hours before taking the tablet.
Adults, including the elderly and adolescents 12 years of age and over: One tablet once daily.
The tablet should be taken on an empty stomach.
Drink a glass of water to help swallow the tablet.
The score line is not for dividing the tablet into two equal doses. It can be used to break the tablet and make swallowing it easier.
Duration of treatment: With regard to the duration of treatment, the doctor will determine the type of illness the patient has and will tell how long the patient has to take BILAXTEN 20 mg tablets.
If the patient forgets to take BILAXTEN 20 mg tablets: Do not take a double dose to make up for a forgotten dose.
If the patient forgets to take the dose, he/she should take it as soon as possible, and then return to the normal dosage routine.
If the patient has any further questions on the use of this product, he/she should ask the doctor or pharmacist.
In the event of overdose or accidental ingestion, immediately consult the doctor or pharmacist.
Hypersensitivity to the active substance bilastine or to any of the excipients.
Alcohol intake: Bilastine, at the recommended dose (20 mg) does not increase drowsiness caused by alcohol.
Effects on ability to drive and use machines: A study performed to assess the effects of bilastine on the ability to drive demonstrated that treatment with 20 mg of bilastine did not affect the driving performance. However, patients should be informed that very rarely some people experience drowsiness, which may affect their ability to drive or use machines.
Use in Pregnancy & Lactation: Pregnancy: There are no or limited amount of data on the use of bilastine in pregnant women. As a precautionary measure, it is preferable to avoid the use of bilastine during pregnancy.
Breastfeeding: The use of BILAXTEN 20 mg tablets is not recommended during breastfeeding.
Please contact the doctor if the patient is pregnant, is likely to become pregnant or is breastfeeding.
Consult the doctor or pharmacist before taking any medicine.
The recommended dose should not be exceeded. Consult the doctor if the symptoms persist.
Efficacy and safety of bilastine in children under 12 years of age have not been established.
In patients with moderate or severe renal impairment concomitant intake of bilastine with P-glycoprotein inhibitors, such as e.g. ketoconazole, erythromycin, cyclosporine, ritonavir or diltiazem, may increase plasmatic levels of bilastine and therefore increase the risk of adverse effects of bilastine. Therefore, concomitant intake of bilastine and P-glycoprotein inhibitors should be avoided in patients with moderate or severe renal impairment.
Pregnancy: There are no or limited amount of data on the use of bilastine in pregnant women. As a precautionary measure, it is preferable to avoid the use of bilastine during pregnancy.
Breastfeeding: The use of BILAXTEN 20 mg tablets is not recommended during breastfeeding.
Please contact the doctor if the patient is pregnant, is likely to become pregnant or is breastfeeding.
Consult the doctor or pharmacist before taking any medicine.
Like all medicines, BILAXTEN 20 mg tablets can produce side effects, although not everybody gets them.
The side effects it may produce are: Common affects 1/10 users in 100: headache, drowsiness.
Uncommon affects 1/10 users in 1000: liver enzymes increased, blood creatinine increased, blood triglycerides increased, ECG abnormalities, irregular heartbeat, dizziness, tinnitus (ringing in the ears), vertigo (a feeling of dizziness or spinning), dyspnoea (difficulty in breathing), nasal dryness or nasal discomfort, stomach pain, nausea (the feeling of being sick), diarrhoea, dry mouth, indigestion, gastritis (inflammation of the stomach wall), pruritus, weight gain, abdominal pain, increased appetite, oral herpes, tiredness, thirst, fever, feeling of weakness, anxiety, difficulty in sleeping.
If any of the side effects get serious, or if the patient notices any side effects not listed in this monograph, please tell the doctor or pharmacist.
Please inform the doctor or pharmacist if the patient is taking or has recently taken any other medicines, including medicines obtained without a prescription.
Interaction with food: Food significantly reduces the oral bioavailability of bilastine by 30%.
Interaction with grapefruit juice: Concomitant intake of bilastine 20 mg and grapefruit juice decreases bilastine's bioavailability by 30%. This effect may also apply to other fruit juices. The degree of bioavailability decrease may vary between manufacturers and fruits. The mechanism responsible for this interaction is an inhibition of OATP1A2, an uptake transporter for which bilastine is a substrate. Medicinal products that are substrates or inhibitors of OATP1A2, such as ritonavir or rifampicin, may likewise have the potential to decrease plasma concentrations of bilastine.
Interaction with ketoconazole or erythromycin: Concomitant intake of bilastine 20 mg and ketoconazole or erythromycin increases bilastine AUC 2-fold and Cmax 2-3-fold. These changes can be explained by interaction with intestinal efflux transporters, since bilastine is a substrate for P-glycoprotein and is not metabolised. These changes do not appear to affect the safety profile of bilastine and ketoconazole or erythromycin, respectively. Other medicinal products that are substrates or inhibitors of P-glycoprotein, such as cyclosporine, may likewise have the potential to increase plasma concentrations of bilastine.
Interaction with diltiazem: Concomitant intake of bilastine 20 mg and diltiazem 60 mg increases the Cmax of bilastine by 50%. This effect can be explained by interaction with intestinal efflux transporters and does not appear to affect the safety profile of bilastine.
Interaction with alcohol: The psychomotor performance after concomitant intake of alcohol and 20 mg of bilastine is similar to that observed after intake of alcohol and placebo.
Interaction with lorazepam: Concomitant intake of bilastine 20 mg and lorazepam 3 mg for 8 days does not potentiate the depressant Central Nervous System effects of lorazepam.
Store below 30 °C.
Any unused product or waste material should be disposed of in accordance with local requirements.
R06AX29 - bilastine ; Belongs to the class of other antihistamines for systemic use.
Sign Out
