Tracleer
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
13-02-2023
Produktets egenskaber
(SPC)
13-02-2023
Offentlige vurderingsrapport
(PAR)
03-12-2019
Aktiv bestanddel:
bosentan (as monohydrate)
Tilgængelig fra:
Janssen-Cilag International N.V.
ATC-kode:
C02KX01
INN (International Name):
bosentan
Terapeutisk gruppe:
Antihypertensives,
Terapeutisk område:
Scleroderma, Systemic; Hypertension, Pulmonary
Terapeutiske indikationer:
Treatment of pulmonary arterial hypertension (PAH) to improve exercise capacity and symptoms in patients with WHO functional class III.Efficacy has been shown in: , Primary (idiopathic and familial) PAH;, PAH secondary to scleroderma without significant interstitial pulmonary disease;, PAH associated with congenital systemic-to-pulmonary shunts and Eisenmenger's physiology. , Some improvements have also been shown in patients with PAH WHO functional class II. Tracleer is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease.,
Produkt oversigt:
Revision: 42
Autorisation status:
Authorised
Autorisation dato:
2002-05-14
Indlægsseddel
67
B. PACKAGE LEAFLET
68
PACKAGE LEAFLET: INFORMATION FOR THE USER
TRACLEER 62.5 MG FILM-COATED TABLETS
TRACLEER 125 MG FILM-COATED TABLETS
bosentan
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, please ask your doctor or
pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET
1.
What Tracleer is and what it is used for
2.
What you need to know before you take Tracleer
3.
How to take Tracleer
4.
Possible side effects
5.
How to store Tracleer
6.
Contents of the pack and other information
1.
WHAT TRACLEER IS AND WHAT IT IS USED FOR
Tracleer tablets contain bosentan, which blocks a naturally occurring
hormone called endothelin-1
(ET-1), which causes blood vessels to narrow. Tracleer therefore
causes blood vessels to expand and
belongs to the class of medicines called “endothelin receptor
antagonists”.
Tracleer is used to treat:
PULMONARY ARTERIAL HYPERTENSION (PAH): PAH is a disease of severe
narrowing of the blood
vessels in the lungs resulting in high blood pressure in the blood
vessels (the pulmonary
arteries) that carry blood from the heart to the lungs. This pressure
reduces the amount of
oxygen that can get into the blood in the lungs, making physical
activity more difficult. Tracleer
widens the pulmonary arteries, making it easier for the heart to pump
blood through them. This
lowers the blood pressure and relieves the symptoms.
Tracleer is used to treat patients with class III PAH to improve
exercise capacity (the ability to carry
out physical activity) and symptoms. The ‘class’ reflects the
seriousness of the disease: ‘class III’
involves marked limitation of physical
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Tracleer 62.5 mg film-coated tablets
Tracleer 125 mg film-coated tablets
2.
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.
3.
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.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of pulmonary arterial hypertension (PAH) to improve exercise
capacity and symptoms in
patients with WHO functional class III. Efficacy has been shown in:
Primary (idiopathic and heritable) pulmonary arterial hypertension
Pulmonary arterial hypertension secondary to scleroderma without
significant interstitial
pulmonary disease
Pulmonary arterial hypertension associated with congenital
systemic-to-pulmonary shunts and
Eisenmenger’s physiology
Some improvements have also been shown in patients with pulmonary
arterial hypertension WHO
functional class II (see section 5.1).
Tracleer is also indicated to reduce the number of new digital ulcers
in patients with systemic sclerosis
and ongoing digital ulcer disease (see section 5.1).
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration
Tablets are to be taken orally morning and evening, with or without
food. The film-coated tablets are
to be swallowed with water.
Patients should be advised not to swallow the desiccant found in the
white high-density polyethylene
bottles.
Posology
Pulmonary arterial
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