BOSENTAN DR.REDDY'S bosentan (as monohydrate) 62.5 mg tablet blister pack

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

bosentan monohydrate, Quantity: 64.541 mg

Beschikbaar vanaf:

Dr Reddys Laboratories Australia Pty Ltd

INN (Algemene Internationale Benaming):

bosentan monohydrate

farmaceutische vorm:

Tablet, film coated

Samenstelling:

Excipient Ingredients: maize starch; pregelatinised maize starch; sodium starch glycollate type A; povidone; glycerol dibehenate; magnesium stearate; hypromellose; titanium dioxide; triacetin; purified talc; iron oxide yellow; iron oxide red; ethylcellulose; cetyl alcohol; sodium lauryl sulfate

Toedieningsweg:

Oral

Eenheden in pakket:

60

Prescription-type:

(S4) Prescription Only Medicine

therapeutische indicaties:

For the treatment of ? idiopathic pulmonary arterial hypertension ? familial pulmonary arterial hypertension ? pulmonary arterial hypertension associated with scleroderma or ? pulmonary arterial hypertension associated with congenital systemic to pulmonary shunts including Eisenmenger?s physiology,in patients with WHO functional Class II, III or IV symptoms

Product samenvatting:

Visual Identification: Light orange, film-coated, round biconvex tablet debossed with '62.5' on one side and plain on the other side; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorisatie-status:

Licence status A

Autorisatie datum:

2016-12-21

Bijsluiter

Bosentan Dr.Reddy’s CMI
Page 1 of 3
BOSENTAN
DR.REDDY’S
_Bosentan (BOZ-en-tan) 62.5 mg/125 _
_mg film- coated tablets_
CONSUMER MEDICINE
INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Bosentan
Dr.Reddy’s.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this
medicine against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT BOSENTAN
DR.REDDY’S IS USED FOR
Bosentan Dr.Reddy’s is used for
the treatment of high blood
pressure in the blood vessels
between the heart and the lungs.
This condition is called
pulmonary arterial hypertension.
This medicine acts to reduce
abnormally high blood pressure by
widening these blood vessels. It
belongs to the class of medicines
known as endothelin receptor
antagonists.
Your doctor however, may prescribe
Bosentan Dr.Reddy’s for another
purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS WHY IT HAS BEEN
PRESCRIBED FOR YOU.
This medicine is only available with a
doctor’s prescription.
BEFORE YOU TAKE BOSENTAN
DR.REDDY’S
_WHEN YOU MUST NOT TAKE BOSENTAN _
_DR.REDDY’S_
_ _
DO NOT TAKE THIS MEDICINE IF YOU ARE:

PREGNANT OR INTEND TO BECOME
PREGNANT.
YOU MUST STOP TAKING
THE MEDICINE AT LEAST 3 MONTHS
BEFORE TRYING TO BECOME
PREGNANT. I
t
is known that this
medicine causes harm to the
developing baby if you take it
during pregnancy and in the three
months before
b
ecoming
pregnant.
•
BREASTFEEDING: Tell your doctor
immediately if you are
breastfeeding. You are advised to
stop breastfeeding if this medicine
is prescribed for you because it is
not known if this drug passes into
the milk in women who are taking
this medicine.
•
B
eing treated with cyclosporine A
(a medicine used after a transplant
or to treat psoriasis)

B

Productkenmerken

1
AUSTRALIAN PRODUCT INFORMATION – BOSENTAN DR.REDDY’S
(BOSENTAN AS MONOHYDRATE) TABLETS
1
NAME OF THE MEDICINE
Bosentan
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Bosentan monohydrate, a white to off-white powder, is practically
insoluble at low pH
(0.1 mg/100 mL at pH 1.1 and 4.0; 0.2 mg/100 mL at pH 5.0). Solubility
increases at higher pH
values (43 mg/100 mL at pH 7.5). In the solid state, bosentan
monohydrate is very stable, is not
hygroscopic and shows no light sensitivity.
Refer to Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
62.5 mg film-coated, round, biconvex, light-orange tablets, debossed
with
identification marking
“62.5” on one side and plain on the other side.
125 mg film-coated, oval, biconvex, light-orange tablets, debossed
with identification marking “125”
on one side and plain on the other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
BOSENTAN DR.REDDY’S
is indicated for the treatment of

idiopathic pulmonary arterial hypertension

familial pulmonary arterial hypertension

pulmonary arterial hypertension associated with scleroderma or

pulmonary arterial hypertension associated with congenital systemic to
pulmonary
shunts including Eisenmenger’s physiology
in patients with WHO functional Class II, III or IV symptoms.
WARNING: Causes birth defects and is contraindicated in pregnancy.
See Section 4.3 CONTRAINDICATIONS and Section 4.4 SPECIAL WARNINGS AND
PRECAUTIONS FOR USE.
Rare cases of hepatic cirrhosis and hepatic failure have been reported
in patients
using bosentan. See Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR
USE
2
4.2
D
OSE AND METHOD OF ADMINISTRATION
GENERAL
BOSENTAN DR.REDDY’S should be administered under the supervision of
a physician experienced in
the management of pulmonary arterial hypertension. BOSENTAN
DR.REDDY’S treatment should be
initiated at a dose of 62.5 mg twice daily for 4 weeks. Efficacy was
demonstrated in clinical trial
subjects who increased to
a maintenance dose of 125 mg twice daily. Doses above 125 mg tw