LETIB® 62.5
Bosentan (as monohydrate) 62.5 mg

LETIB® 125
Bosentan (as monohydrate) 125 mg

Film-coated tablets

Argentine Industry - Rx only

Composition:

LETIB® 62.5
Each film-coated tablet contains bosentan (as monohydrate) 62.5 mg, pregelatinised corn starch, povidone, colloidal anhydrous silicon, sodium croscarmellose, microcrystalline cellulose, sodium stearyl fumarate, Opadry YS-1-7003, and quinoline yellow.

LETIB® 125
Each film-coated tablet contains bosentan (as monohydrate) 125 mg, pregelatinised corn starch, povidone, colloidal anhydrous silicon, sodium croscarmellose, microcrystalline cellulose, sodium stearyl fumarate, Opadry YS-1-7003, and ferric oxide yellow No. 10.

Therapeutic Action:

Pulmonary anti-hypertensive agent. Endothelin receptor antagonist. 

Indications:

LETIB® film-coated tablet for oral administration is indicated for the treatment of pulmonary arterial hypertension (PHA) to improve symptoms and exercise capacity in patients with WHO Functional Class III. Efficacy has been shown in:
•Primary pulmonary arterial hypertension (idiopathic or familial)
•Pulmonary arterial hypertension secondary to scleroderma without significant interstitial pulmonary disease
•Pulmonary arterial hypertension associated with congenital systemic-to-pulmonary shunts and Eisenmenger physiology.
Improvements have been also observed in patients with WHO Functional Class II pulmonary arterial hypertension.
LETIB
® is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis with active digital ulcer alteration.  

Storage:

Keep at temperature below 30 °C in its marketed packing.

Marketed presentations:

LETIB® 62.5
Cartons containing 10, 14, 30, 56, 60, and 112 film-coated tablets
Cartons containing 500 and 1000 film-coated tablets for use in hospitals

LETIB® 125
Cartons containing 10, 14, 30, 56, 60, and 112 film-coated tablets
Cartons containing 500 and 1000 film-coated tablets for use in hospitals

Medicinal speciality authorised by the Ministry of Health
Certificate No. 57251

Laboratorio DOSA S.A. 
Girardot 1369, (C1427AKC) City of Buenos Aires, Argentina.
Pharmaceutical Director: María C. Terzo, Pharmacist.