Active ingredients: Bosentan
Tracleer 62.5 mg film-coated tablets.
Tracleer 125 mg film-coated tablets.
Film-coated tablet (tablets).
Tracleer 62.5 mg film-coated tablets: Orange-white, round, biconvex, film-coated tablets, embossed with “62,5” on one side.
Tracleer 125 mg film-coated tablets: Orange-white, oval, biconvex, film-coated tablets, embossed with “125” on one side.
Tracleer 62.5 mg film-coated tablets: Each film-coated tablet contains 62.5 mg bosentan (as monohydrate).
Tracleer 125 mg film-coated tablets: Each film-coated tablet contains 125 mg bosentan (as monohydrate).
Excipient with known effect:
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium- free’.
For the full list of excipients, see section 6.1.
Bosentan is a dual endothelin receptor antagonist (ERA) with affinity for both endothelin A and B (ETA and ETB) receptors. Bosentan decreases both pulmonary and systemic vascular resistance resulting in increased cardiac output without increasing heart rate.
Tablet core:
Maize starch
Pregelatinised starch
Sodium starch glycolate (Type A)
Povidone
Glycerol dibehenate
Magnesium stearate
Film coat:
Hypromellose
Glycerol triacetate
Talc
Titanium dioxide (E171)
Iron oxide yellow (E172)
Iron oxide red (E172)
Ethylcellulose
Tracleer 62.5 mg film-coated tablets:
PVC/PE/PVDC/aluminium-blisters containing 14 film-coated tablets. Cartons contain 14, 56 or 112 film-coated tablets.
White high-density polyethylene bottles with a silica gel desiccant containing 56 film-coated tablets. Cartons contain 56 film-coated tablets.
Tracleer 125 mg film-coated tablets:
PVC/PE/PVDC/aluminium-blisters containing 14 film-coated tablets. Cartons contain 56 or 112 film-coated tablets.
White high-density polyethylene bottles with a silica gel desiccant containing 56 film-coated tablets. Cartons contain 56 film-coated tablets.
Not all pack sizes may be marketed.
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340, Beerse, Belgium
Tracleer 62.5 mg film-coated tablets:
EU/1/02/220/001
EU/1/02/220/002
EU/1/02/220/003
EU/1/02/220/007
Tracleer 125 mg film-coated tablets:
EU/1/02/220/004
EU/1/02/220/005
EU/1/02/220/008
Date of first authorisation: 15 May 2002
Date of latest renewal: 20 April 2012