What Bilastine is and what it is used for

Bilastine is an antihistamine that is used to relieve the symptoms of allergic rhinoconjunctivitis (sneezing, itchy nose, nasal secretion, nasal congestion and red, streaming eyes) and other forms of allergic rhinitis. It can also be used to treat itchy skin rashes (wheals or urticaria).

Warnings and precautions concerning bilastine

  • Before starting to use bilastine, talk to your pharmacist if you are suffering from moderate or severe kidney failure or if you are also taking other medicines.
  • You should not take bilastine if you are allergic to bilastine or to any other component of this medicine.
  • Do not exceed the recommended dose, and talk to your doctor if the symptoms persist.

Other medicines and bilastine tablets

If you are taking or have to take bilastine while taking other medicines (even if purchased without a prescription), tell your doctor or pharmacist so you can receive the appropriate advice.

In particular, do not hesitate to talk to your doctor if you are taking one of the following medicines:

  • Rifampicin (an antibiotic)
  • Ritonavir (to treat AIDS)
  • Diltiazem (to treat angina pectoris)
  • Ciclosporin (to reduce the activity of your immune system, to prevent transplant rejection or reduce the activity of autoimmune diseases and allergic disorders, such as psoriasis, atopic dermatitis or rheumatoid arthritis).
  • Erythromycin (an antibiotic)
  • Ketoconazole (an antifungal medication)

Consumption of bilastine with food, drinks and alcohol

This medicine should not be taken with food or fruit juice as the effect of bilastine will be reduced. Proceed as follows to prevent this from happening:

  • You can take the tablet, wait an hour, and then drink fruit juice or eat.
  • If you have drunk fruit juice or eaten something, wait two hours before taking this medicine.

Taking the recommended dose of bilastine (20 mg) does not increase the drowsiness caused by alcohol.

Pregnancy, breast-feeding and fertility

There is currently insufficient information concerning the use of bilastine in pregnant women or during breast-feeding, or the information available is insufficient. There is also no evidence concerning its effects on fertility.

You should talk to your doctor about using this medicine if you are pregnant or breast-feeding, even if you think you may be pregnant or are intending to become pregnant. You should also talk to your doctor or pharmacist before taking any other medicine.

Consumption of bilastine tablets and driving and using machines

Treatment with 20 mg bilastine does not affect driving performance, as shown by a study carried out for that purpose. However, there is a possibility that some people may rarely experience drowsiness and that this could affect the ability to drive or use machines.

How to take bilastine

As noted above, talk to your doctor or pharmacist before taking this medicine and follow the procedure for taking this medicine indicated by them exactly. If you have any further questions, ask your doctor or pharmacist again.

The recommended dose in adults is one table per day (20 mg), also taking into account elderly patients and adolescents aged 12 years or more.

The following indications must be followed:

  • The medicine (tablet) is taken orally.
  • It should be taken under fasting conditions. It may be taken before breakfast, and you should wait for one hour after taking the tablet before eating.
  • You should swallow the tablet with a glass of water.
  • If you find it difficult to swallow the tablet whole, split it using the score in the middle of the tablet. This should only be performed if you cannot swallow it whole.

Duration of treatment: Your doctor will determine the type of disease you are suffering from and therefore the time during which you should take bilastine.

Use in children This medicine should not be given to children younger than 12 years of age.

Bilastine overdose 

If you take more bilastine than you should or have taken the medicine accidentally, consult your doctor or pharmacist immediately or call the Toxicology Information Service on 91 562 04 20. In this case you should give the name of the medicine taken and how much you have taken.

What to do if you forget to take bilastine tablets

You should never take a double dose to make up for a forgotten dose. If you have forgotten to take this medicine, take it as soon as possible and then go back to your standard dosing routine.

As usual, if you have any questions regarding how to take bilastine tablets, talk to your doctor or pharmacist.

To whom should I report any side-effects?

If you get any side-effects, talk to your doctor or pharmacist. This includes any possible side-effects not listed in this leaflet.

You can also report side-effects directly via the Spanish Pharmacovigilance System for Medicinal Products for Human Use www.notificaRAM.es.

By reporting any side-effects you will help to provide more information regarding the safety of this medicine.

How to store bilastine

Bilastine should be kept 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 is the last day of that month.

No special storage conditions are required.

Do not throw away medicines via wastewater or household waste. Place the containers and medicines you no longer need in the SIGRE point at any pharmacy. If you have any questions, your pharmacist will advise you how to dispose of any medicines and packaging you no longer need correctly. This will help to protect the environment.

Composition

  • Each tablet contains 20 mg of active substance. The active substance is bilastine.
  • The other components are microcrystalline cellulose carboxymethyl starch sodium type A (potato derivative), anhydrous colloidal silica, magnesium stearate.

What the product looks like and contents of the pack 

Bilastine tablets are white, oval, biconvex and scored (length 10 mm, width 5 mm).

The tablets are supplied in blister packs containing 10, 20, 30, 40 or 50 tablets. Not all package sizes may be marketed.

Pharmacokinetic profile of Bilastine

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Pharmacodynamic profile of Bilastine

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The renal route is the main excretory route for BILASTINE reaching the plasma 1.

Clinical efficacy of Bilastine

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Safety and tolerability of Bilastine

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Summary of product characteristics

Use the following link to download the summary of product characteristics for bilastine. The study and careful evaluation of the technical datasheet for this product is essential to gain a better understanding thereof and ensure optimal care for your patients.

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Monograph

Use the following link to download the monograph for bilastine. The study and careful evaluation of the monograph for this product are essential to gain a better understanding thereof and ensure optimal care for your patients.

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1 – Bilaxten 20 mg tablets authorized technical sheet​.
2 – Bachert C, Kuna P, Zuberbier T. Bilastine in allergic rhinoconjunctivitis and urticaria. Allergy. 2010;65(Suppl. 93):1-13
3 – Kuna P, Bachert C, Nowacki Z, van Cauwenberge P, Agache I, Fouquert L, Roger A, Sologuren A, Valiente R; Bilastine International Working Group. Efficacy and safety of bilastine 20 mg compared with cetirizine 10 mg and placebo for the symptomatic treatment of seasonal allergic rhinitis: a randomized, double-blind, parallel-group study.Clin Exp Allergy. 2009;39(9):1338-47
4 – Bachert C, Kuna P, Sanquer F, Ivan P, Dimitrov V, Gorina MM, van de Heyning P, Loureiro A. Comparison of the efficacy and safety of bilastine 20 mg vs desloratadine 5 mg in seasonal allergic rhinitis patients. Allergy. 2009;64(1):158-65
5 – Horak F, Zieglmayer P, Zieglmayer R, Lemell P. The effects of bilastine compared with cetirizine, fexofenadine, and placebo on allergen-induced nasal and ocular symptoms in patients exposed to aeroallergen in the Vienna Challenge Chamber. Inflamm Res. 2010;59(5):391-8
6 – Zuberbier T, Oanta A, Bogacka E, Medina I, Wesel F, Uhl P, Antépara I, Jáuregui I, Valiente R; The Bilastine International Working Group*. Comparison of the efficacy and safety of bilastine 20 mg vs levocetirizine 5 mg for the treatment of chronic idiopathic urticaria: a multi-centre, double- blind, randomized, placebo-controlled study. Allergy. 2010;65(4):516-528
7 – Corcóstegui R, Labeaga L, Innerárity A, Berisa A, Orjales A. Preclinical pharmacology of bilastine, a new selective histamine H1 receptor antagonist: receptor selectivity and in vitro antihistaminic activity. Drugs R D. 2005;6(6):371-84
8 – Conen S, Theunissen EL, Van Oers AC, Valiente R, Ramaekers JG. Acute and subchronic effects of bilastine (20 and 40 mg) and hydroxyzine (50 mg) on actual driving performance in healthy volunteers. J Psychopharmacol. 2010 Sep 20 [Epub ahead of print]
9 – Corcóstegui R, Labeaga L, Innerárity A, Berisa A, Orjales A. In vivo pharmacological characterisation of bilastine, a potent and selective histamine H1 receptor antagonist.Drugs R D. 2006;7(4):219-31
10- Alvarez-Mon M, San Antonio E, Lucero M, Sanz E, Ledo F, De la Hera A. Bilastine a novel antihistamine that preferentially inhibits histamine and interleukin-4 release from human mast cells and granulocytes. XXVIII Congress of the European Academy of Allergology and Clinical Immunology. Warszawa (Poland) Jun. 6-10, 2009. Abstract 1454.Allergy. 2009;64(Suppl 90):555
11 – Morag N, Lucero ML, Orjales A. In vitro hepatic metabolism og [14C] bilastine. 8th International ISSX Meeting. Sendai (Japan) Oct. 9-12, 2007. Abstract 160. Drug Metab Rev. 2007;39(Suppl I):114
12 – Sologuren A, Lucero ML, Valiente R, Charles H, Mair SJ. Human mass balance with [14C]-Bilastine following oral administration to healthy volunteers. 9th Congress of the European Association for Clinical Pharmacology and Therapeutics. Edinburgh (UK) Jul. 12-15, 2009. Abstract TP85. Basic Clin Pharmacol Toxicol. 2009;105(Suppl 1):106-7
13 – Sologuren A, Valiente R, Allison M, Tyl B. A Lack of significant effect of bilastine on ventricular repolarization. A thorough QT/QTc study. XXVII Congress of the European Academy of Allergology and Clinical Immunology. Barcelona (Spain) Jun. 7-11, 2008. Abstract 189. Allergy. 2008;63(Suppl 88):85
14 – García-Gea C, Martínez-Colomer J, Antonijoan RM, Valiente R, Barbanoj MJ. Comparison of peripheral and central effects of single and repeated oral dose administrations of bilastine, a new H1 antihistamine: a dose-range study in healthy volunteers with hydroxyzine and placebo as control treatments. J Clin Psychopharmacol. 2008;28(6):675-85