EBASTEL Film-coated tablet Ref.[49512] Active ingredients: Ebastine

Source: Υπουργείο Υγείας (CY)  Revision Year: 2020  Publisher: Almirall , S.A., General Mitre, 151, 08022 Barcelona, Spain

4.1. Therapeutic indications

Ebastine is indicated in the symptomatic treatment of allergic rhinitis (seasonal and perennial) associated or otherwise with allergic conjunctivitis, idiopathic chronic urticaria and allergic dermatitis.

4.2. Posology and method of administration

The tablets and the solution may be taken with or without food.

Adults and children over 12 years of age

The usual dose is 1 tablet (10 mg) once daily.

Elderly patients

There is no need to adjust the dose.

Renal impairment

There is no need to adjust the dose in patients with mild, moderate or severe renal insufficiency.

Hepatic impairment

There is no need to adjust the dose in patients with mild to moderate hepatic impairment. There is no experience with doses over 10 mg in patients with severe hepatic insufficiency, therefore. The maximum recommended dose must not be exceeded in patients with severe hepatic insufficiency (10 mg/day).

Treatment may be prolonged until symptoms disappear.

4.9. Overdose

Studies carried out with high doses did not evidence clinically significant signs or symptoms at doses of up to 100 mg once daily. There is no specific antidote for ebastine. The following measures should be considered: stomach pump, monitoring of vital constants including ECG, and symptomatic treatment.

6.3. Shelf life

EBASTEL 10 mg Film-coated tablets: 3 years.

6.4. Special precautions for storage

EBASTEL 10 mg Film-coated tablets: Store below 30ºC.

6.5. Nature and contents of container

EBASTEL 10 mg Film-coated tablets: Package with 20 × 10 mg tablets.

6.6. Special precautions for disposal and other handling

EBASTEL 10 mg Film-coated tablets: None.

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