TRACLEER TABLET 125 MG

Страна: Малайзія

мова: англійська

Джерело: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Активний інгредієнт:

BOSENTAN MONOHYDRATE

Доступна з:

JOHNSON & JOHNSON SDN BHD

ІПН (Міжнародна Ім'я):

BOSENTAN MONOHYDRATE

Одиниць в упаковці:

60 Tablets

Виробник:

Haupt Pharma Wuelfing GmbH

інформаційний буклет

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
TRACLEER
® TABLET
Bosentan monohydrate (62.5mg, 125mg)
1
WHAT IS IN THIS LEAFLET
1.
What Tracleer is used for
2.
How Tracleer works
3.
Before you use Tracleer
4.
How to use Tracleer
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Tracleer
8.
Product Description
9.
Manufacturer and Product
registration Holder
10.
Date of revision
WHAT TRACLEER IS USED FOR
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.
HOW TRACLEER WORKS
Tracleer widens the blood vessels
(pulmonary arteries), making it easier
for the heart to pump blood through
them. This lowers the blood pressure
and relieves the symptoms.
BEFORE YOU USE TRACLEER
-
_When you must not use it _
Do not take Tracleer:
-
if you are allergic to bosentan or
any of the other ingredients of this
medicine (listed in "Ingredients")
-
if you have liver problems (ask
your doctor)
-
if you are pregnant, or could get
pregnant because you are not
using reliable contraceptive
methods. Please read the
information under
"Contraceptives" and "Taking
other medicines"
-
If you are taking cyclosporine A
(a medicine used after a transplant
or to treat psoriasis)
If any of these apply to you, tell your
doctor.
-
_Before you start to use it _
Tests your doctor will do before
treatment
•
a blood test to check your liver
function
•
a blood test to check for anaemia
(low haemoglobin)
•
a pregnancy test if you are a
woman of childbearing potential
Some patients taking Tracleer have
been found to have abnormal liver
function tests and anaemia (low
haemoglobin).
-
_Taking other medicines _
Please tell your doctor or pharmacist if
you are taking or have recently taken
any medicines, in

Характеристики продукта

1
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) in patients of WHO
functional class II-IV.
CONSIDERATIONS FOR USE
Patients with WHO Class II symptoms showed reduction in the rate of
clinical deterioration and a
trend for improvement in walk distance. Physicians should consider
whether these benefits are
sufficient to offset the risk of liver injury in WHO Class II
patients, which may preclude future use as
their disease progresses.
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.
2
Patients should be advised not to swallow the desiccant found in the
white high-density polyethylene
bottles.
Posology
Pulmonary arterial hypertension
Treatment should only be initiated and monitored by a physician
experienced in the treatment of PAH.
_Adults_
In adult patients, Tracleer treatment should be initiated at a dose of
62.5 mg twice daily for 4 weeks
and then increased to the maintenance dose of 125 mg twice daily. The
same recommendations apply
to re-introduction of Tracleer after t