Biltin | Tablet | 1 pcs

• Allergic Rhinitis: Bilastine is indicated for the symptomatic relief of nasal and non-nasal symptoms of allergic rhinitis.
• Allergic Rhinoconjunctivitis: Bilastine is indicated for the relief of symptoms associated with allergic rhinoconjunctivitis.
• Urticaria: Bilastine is indicated for the relief of symptoms associated with urticaria (e.g. pruritus and hives).

Non-sedating antihistamines

Bilastine is a non-sedative H1 receptor selective antagonist. Its principal effects are mediated via selective inhibition of peripheral H1-receptors. It shows moderate to high affinity for histamine H1-receptors and no affinity for muscarinic, serotonergic, dopaminergic and noradrenergic receptors.

Children between 6 to 11 years: 10 mg mouth dissolving tablet for the symptomatic relief of allergic rhinitis, allergic rhinoconjunctivitis and urticaria. The Mouth dissolving tablet is for oral use only. It should be placed in the mouth. It will disperse rapidly in saliva and can be easily swallowed. Alternatively, the mouth dissolving tablet can be dispersed in a tea spoon of water before being swallowed by the children. The maximum recommended daily dose for children in between 6 to 11 years is 10 mg Bilastine mouth dissolving tablet (1 tablet) and should not be exceeded. If a dose is missed, the next scheduled dose should be taken. An extra dose should not be taken.

Adults & adolescents (12 years of age and over): 20 mg tablet once daily for symptomatic relief of allergic rhinitis, urticaria and allergic rhinoconjunctivitis. The maximum recommended daily dose is 20 mg Bilastine (1 tablet) and should not be exceeded. If a dose is missed, the next scheduled dose should be taken. An extra dose should not be taken. 20 mg Bilastine tablet (1 tablet) once daily should be swallowed with water on an empty stomach to achieve optimal exposure to Bilastine

• Interaction with Ketoconazole or Erythromycin: Concomitant intake of Bilastine and Ketoconazole or Erythromycin increased Bilastine AUC 2-fold and Cmax 2-3 fold. These changes can be explained by interaction with intestinal efflux transporters, since Bilastine is substrate for P-gp and not metabolized. 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-gp, 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 increased 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 Bilastine was 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 did not potentiate the depressant CNS effects of Lorazepam.

Bilastine is contraindicated in patients with hypersensitivity to Bilastine or to any ingredient in the formulation or component of the Tablet.

The most common side effects of Bilastine include: headache, dizziness, and fatigue.

There are no adequate or limited amount of data for the use of Bilastine in pregnant women and during breast feeding and on the effects on fertility. In case of pregnancy or breast feeding, Bilastine should be avoided during pregnancy, unless advised otherwise by a physician.

Bilastine should be taken cautiously in case of moderate to severe renal impairment.

Use in patients with impaired hepatic & renal function: There is no clinical experience in patients with hepatic impairment. Since Bilastine is not metabolized and renal clearance is its major elimination route, hepatic impairment is not expected to increase the systemic exposure above the safety margin. Therefore, no dosage adjustment is required in patients with hepatic impairment. No dosage adjustment is required in patients with renal impairment.

Geriatrics (>65 years of age): No dosage adjustments are necessary in patients over 65 years.

Pediatrics (<6 years of age): The safety and efficacy of Bilastine in children under 6 years of age have not been established.

Information regarding acute overdose of Bilastine is retrieved from the experience of clinical trials conducted during the development and the post-marketing surveillance. In clinical trials, after administration of Bilastine at doses 10 to 11 times the therapeutic dose (220 mg as single dose; or 200 mg/day for 7 days) to healthy volunteers, the frequency of treatment emergent adverse events was two times higher than with placebo. The adverse reactions most frequently reported were dizziness, headache and nausea. No serious adverse events and no significant prolongation in the QTc interval were reported. The information collected in the post-marketing surveillance is consistent with that reported in clinical trials.

Keep below 30°C temperature, protected from light and moisture. Keep out of reach of children.