Obila^®

Obila is a preparation of bilastine which is a non-sedating, long acting histamine antagonist with selective peripheral H₁ receptor antagonist affinity and no affinity for muscarinic receptors. Bilastine inhibits histamine induced skin reactions for 24 hours.

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Obila is indicated for the treatment of allergic rhino-conjunctivitis (seasonal and perennial) and urticaria. It is also indicated for relief of the symptoms of hayfever (sneezing, runny, blocked-up nose and red and watery eyes) and other forms of allergic rhinitis. It may also be used to treat itchy skin rashes.

Route of administration: Obila should be administered in oral route one hour before or two hours after intake of food. The recommended dose in adults, including the elderly and adolescents aged 12 years and over is one Obila 20 tablet once daily.

The recommended dose in children between 6 to 11 years of age with a body weight of at least 20 kg is 10 mg bilastine once daily (one Obila 10 ODT once daily or Obila syrup 4 mL once daily) limited to the period of exposure to allergens.

Pregnancy: There are no well controlled studies of pregnant women exposed to bilastine of a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.

Lactation: There is no information on the effects of bilastine on milk production. The developmental and health benefits should be considered along with the mother's clinical need for bilastine and any potential adverse effects on the breastfed child from bilastine or from the mother's underlying condition.

Use in children and adolescents
Safety and effectiveness in pediatric patients below 6 years of age with a body weight below 20 kg have not been established.

Caution should be taken in patients with moderate to severe renal impairment.

The most common side effects are headache, drowsiness, rhinitis, allergic conjunctivitis and abdominal pain.

It is contraindicated in patients with known hypersensitivity to bilastine or any other components of this product.

Drug interaction with medication: Caution should be taken in concomitant use with ketoconazole, erythromycin, diltiazem, cyclosporine, ritonavir and rifampicin.

Drug interaction with food and others: Fruit juice.

In the event of overdose, general supportive measures and proper monitoring should be initiated.

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Obila 20 tablet: Each tablet contains Bilastine INN 20 mg.
Obila 10 ODT: Each oral dispersible tablet contains Bilastine INN 10 mg.
Obila syrup: Each 5 mL contains Bilastine INN 12.5 mg.

Storage
Store below 30°C in a dry place, protected from light. Keep away from the reach of children.

Packing
Obila 20 tablet: Carton of 30 tablets in blister pack.
Obila 10 ODT: Carton of 30 tablets in blister pack.
Obila syrup: Bottle of 60 mL.