KESTINE Coated tablet Ref.[51035] Active ingredients: Ebastine

Source: Web Search  Revision Year: 2007  Publisher: Laboratorios Almirall S.A., Rondo General Mire, 151, 08022 Barcelona, Spain

4.1. Therapeutic indications

Kestine is indicated for the symptomatic treatment of:

  • Allergic rhinitis (seasonal and perennial) whether or not associated with allergic conjunctivitis.
  • Idiopathic chronic urticaria.

4.2. Posology and method of administration

Allergic rhinitis

Kestine at a dose of 10 mg once-a-day is efficacious in the relief of the symptoms of allergic rhinitis; in patients with more severe symptoms including perennial allergic rhinitis, 20 mg once-a-day provides additional benefit.

Idiopathic chronic urticaria

The adult dose is one 10 mg tablet once daily.

Kestine may be taken with or without food.

Special populations

No dose adjustment is needed in patients with renal insufficiency, nor in patients with mild to moderate hepatic insufficiency. A dosage of 10 mg should not be exceeded in patients with severe hepatic insufficiency.

The safety and efficacy of Kestine in children less than 12 years has not been established.

4.9. Overdose

In studies conducted at a high dosage, no particular signs or symptoms were observed up to 100 mg. There is no specific antidote for Kestine. Gastric lavage, monitoring of vital functions including ECG and symptomatic treatment should be carried out.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Do not store above 30°C. Store in the original container.

6.5. Nature and contents of container

Boxes containing 1, 3 or 10 PVC aluminium blister cards.

Each blister card contains 10 tablets.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No specific instructions.

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