TRACLEER Film-coated tablet

Active ingredients: Bosentan

Product name and form

Tracleer 62.5 mg film-coated tablets.

Tracleer 125 mg film-coated tablets.

Pharmaceutical Form

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.

Qualitative and quantitative composition

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.

Active Ingredient
Description

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.

List of Excipients

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

Pack sizes and marketing

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.

Marketing Authorization Holder
Authorization Dates

Janssen-Cilag International NV, Turnhoutseweg 30, B-2340, Beerse, Belgium

Date of first authorisation: 15 May 2002
Date of latest renewal: 20 April 2012

Marketing authorization number:

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

Drugs

Drug
Countries
Austria, Australia, Canada, Spain, France, Hong Kong, Lithuania, Netherlands, Singapore, United Kingdom, United States