TRACLEER TABLET 125 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

BOSENTAN MONOHYDRATE 129.082MG EQV BOSENTAN

Available from:

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

ATC code:

C02KX01

Dosage:

125 mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

BOSENTAN MONOHYDRATE 129.082MG EQV BOSENTAN 125 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

PATHEON INC

Authorization status:

ACTIVE

Authorization date:

2004-05-06

Patient Information leaflet

TRACLEER®  

_COMPOSITION  _
Active substance: Bosentan (as monohydrate) (62.5 mg
or 125 mg). 
Excipients: maize starch, pregelatinised maize
starch, sodium starch glycollate, 
povidone, glyceryl behenate, magnesium stearate, hypromellose, glycerol triacetate, 
talc, titanium dioxide, iron oxide yellow, iron oxide
red, ethylcellulose 

_PHARMACEUTICAL FORM AND WEIGHT OF ACTIVE SUBSTANCE
PER DOSAGE UNIT  _
Film-coated tablets  
62.5mg (orange white, round, biconvex, with «62.5» stamped on
one side) and 125 
mg (orange white, oval, biconvex, with «125» stamped on one
side)  
_ _
_INDICATIONS / AREAS OF USE _ 
Treatment of pulmonary arterial hypertension (PAH) in
patients with WHO functional 
class III or IV symptoms, to improve exercise ability and
decrease the rate of clinical 
worsening.  Some improvements have also been shown in
patients with PAH WHO 
functional class II 
Reduction in the number of new digital ulcers in patients with
systemic sclerosis with 
active digital ulcer disease.  

_POSOLOGY AND METHOD OF ADMINISTRATION  _
Treatment should only be initiated and monitored by a
doctor with experience in the 
treatment of pulmonary arterial hypertension and
systemic sclerosis. Tracleer should 
be taken in the morning and evening, with or without food. The
film-coated tablets 
are to be swallowed with water.  

_Pulmonary arterial hypertension (PAH)  _
Treatment with Tracleer should be started at a dosage
of twice daily 62.5 mg over a 
period of four weeks, followed by an increase to a maintenance
dose of twice daily 
125 mg.  

_Systemic sclerosis with active digital ulcer disease  _
Treatment with Tracleer should be started at a dosage of 62.5 mg
twice daily over a 
period of four weeks, followed by an increase to a
maintenance dose of 125 mg 
twice daily. Experience from controlled clinical trials in
this i

Summary of Product characteristics

1
TRACLEER
®
_COMPOSITION _
Active substance: Bosentan (as monohydrate) (62.5 mg or 125 mg).
Excipients: maize starch, pregelatinised maize starch, sodium starch
glycollate,
povidone, glyceryl behenate, magnesium stearate, hypromellose,
glycerol triacetate,
talc, titanium dioxide, iron oxide yellow, iron oxide red,
ethylcellulose
_PHARMACEUTICAL FORM AND WEIGHT OF ACTIVE SUBSTANCE PER DOSAGE UNIT _
Film-coated tablets
62.5mg (orange white, round, biconvex, with «62.5» stamped on one
side) and 125
mg (orange white, oval, biconvex, with «125» stamped on one side)
_ _
_INDICATIONS / AREAS OF USE _
Treatment of pulmonary arterial hypertension (PAH) in patients with
WHO functional
class III or IV symptoms, to improve exercise ability and decrease the
rate of clinical
worsening. Some improvements have also been shown in patients with PAH
WHO
functional class II.
Reduction in the number of new digital ulcers in patients with
systemic sclerosis with
active digital ulcer disease.
_POSOLOGY AND METHOD OF ADMINISTRATION _
Treatment should only be initiated and monitored by a doctor with
experience in the
treatment
of
pulmonary
arterial
hypertension
and
systemic
sclerosis.
Tracleer
®
should be taken orally in the morning and evening, with or without
food. The film-
coated tablets are to be swallowed with water. Patients must be urged
to refrain from
swallowing the desiccant in the white high density polyethylene
bottle.
_Pulmonary arterial hypertension (PAH) _
Treatment with Tracleer
®
should be started at a dosage of twice daily 62.5 mg over a
period of four weeks, followed by an increase to a maintenance dose of
twice daily
125 mg.
_Systemic sclerosis with active digital ulcer disease _
Treatment with Tracleer
®
should be started at a dosage of 62.5 mg twice daily over a
period of four weeks, followed by an increase to a maintenance dose of
125 mg
twice daily. Experience from controlled clinical trials in this
indication is limited to a
period of 6 months. Response to treatment and the necessity of
continuing treat