TRACLEER Film-coated tablet Ref.[6576] Active ingredients: Bosentan

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340, Beerse, Belgium

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

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

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

Marketing authorization dates and numbers

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

Drugs

Drug Countries
TRACLEER Austria, Australia, Canada, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States

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