Astin        Film Coated Tablets

Ebastine 10, 20mg

Usage and indications:

For the symptomatic treatment of seasonal and perennial allergic rhinitis, with or without allergic conjunctivitis.

To improve itching and to reduce new weal formation, in urticaria of unclear origin.

Dosage and administration:

The experience in children under the age of 12 years is limited.

Allergic rhinitis:

For children 12 years and above and adults: 1 film-coated tablet (10 mg ebastine) once daily.  

In cases of severe symptoms and for perennial allergic rhinitis the dose may be increased to 2 film-coated tablets (20 mg ebastine) once daily.

 Urticaria:

For adults above 18 years: 1 film-coated tablet (10 mg ebastine) once daily.

Special subject groups:

In patients with renal insufficiency, no dose adjustment is necessary for treatment up to 5 days. In patients with mild to moderate hepatic insufficiency, no dose adjustment is necessary for treatment up to 7 days. A dosage of 10 mg daily should not be exceeded in patients with severe hepatic insufficiency.

Duration of use:

The physician decides on the duration of use. For allergic rhinitis there is clinical experience of use for duration of up to 1 year and, for urticaria of unclear origin, for up to 3 months.                   

Undesirable effects:   

Cardiac disorders:  

Very rare: Tachycardia, Palpitations. 

Nervous system disorders:

Common: Somnolence, Headache.   

Very rare: Dysaesthesia.

Respiratory, thoracic and mediastinal disorders:

Uncommon: Epistaxis, Pharyngitis, Rhinitis.

Very rare: Sinusitis.

Gastrointestinal disorders:

Common: Dry mouth.

Uncommon: Nausea, Abdominal pain, Dyspepsia.

Very rare: Vomiting.

Skin and subcutaneous tissue disorders:

Very rare: Exanthema, Urticaria, Eczema, Rash, and Dermatitis.

General disorders:

Uncommon: Dizziness, Asthenia, Insomnia.

Very rare: Oedema.

 

Hepatobiliary disorders:

Very rare: Abnormal liver function test.

Reproductive system and breast disorders:

Very rare: Dysmenorrhoea, Menstrual disorders.

Psychiatric disorders:

Very rare: General nervousness.

Warnings and precautions:

As with other antihistamines, caution should be exercised when ebastine is administered to patients with known prolongation of the QTc interval on the ECG, hypokalaemia and in cases of concomitant use of medicinal products known to prolong the QTc interval or inhibit the hepatic CYP450 -2J2, -4F12 or -3A4 enzyme system, such as azole antifungal agents and macrolide antibiotics. Caution should be exercised in patients with severe hepatic insufficiency.

Pack: box of 10 tablets

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