OPSUMIT

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

MACITENTAN

متاح من:

J-C HEALTH CARE LTD

ATC رمز:

C02KX04

الشكل الصيدلاني:

FILM COATED TABLETS

تركيب:

MACITENTAN 10 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

ACTELION PHARMACEUTICALS LTD., SWITZERLAND

المجال العلاجي:

MACITENTAN

الخصائص العلاجية:

Opsumit ® is an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression. Disease progression included: death, initiation of intravenous (IV) or subcutaneous prostanoids or clinical worsening of PAH (decreased 6-minute walk distance, worsened PAH symptoms and need for additional PAH treatment). Opsumit also reduced hospitalization for PAH.

تاريخ الترخيص:

2019-09-30

نشرة المعلومات

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor's prescription only
OPSUMIT
® 10 MG
FILM-COATED TABLETS
ACTIVE INGREDIENT AND ITS QUANTITY
EACH FILM-COATED TABLET CONTAINS:
Macitentan 10 mg
For the list of inactive and allergenic ingredients in the
preparation, please see
section 6 "Further information" and subsection "Important information
about
some of the ingredients of this medicine" in section 2.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet
contains concise information about the medicine. If you have further
questions,
refer to your doctor or pharmacist.
This medicine has been prescribed for the treatment of your illness.
Do not pass
it on to others. It may harm them, even if you think that their
illness is similar.
Patient Safety Information Card
In addition to the leaflet, Opsumit also has a patient safety
information card.
This card contains important safety information that you should know,
before beginning and during treatment with Opsumit and act
accordingly.
Refer to the patient safety information card and patient leaflet
before using
the preparation. Keep the card and the leaflet for further reference
if
required.
Do not use Opsumit if you are pregnant, since use of this medicine may
cause harm to the fetus (see section 2 "Before you take the medicine"
subsections "Do not use the medicine if" and "Pregnancy, breastfeeding
and fertility").
If you are a woman of child-bearing age who could become pregnant, you
should take a pregnancy test before you start taking Opsumit and
regularly
every month while you are taking the medicine and a month after
termination of treatment. A negative result in each pregnancy test
must be
assured. You must use a reliable contraceptive method while taking
Opsumit and one additional month after termination of treatment (see
section 2 subsection "Pregnancy, breastfeeding and fertility").
1. WHAT IS THE MEDICINE INTENDED FOR?
•
The medicine is intended for

خصائص المنتج

1
Opsumit_PI_Clean_January-2023
OPSUMIT
PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Opsumit 10 mg film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg macitentan.
_U_
Excipients with known effect
_U_
:
Each film-coated tablet contains approximately 37 mg of lactose (as
monohydrate) and
approximately 0.06 mg of soya bean lecithin (E322).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
5.5 mm, round, biconvex, white to off-white film-coated tablets,
debossed with “10” on both
sides.
•
WARNING: EMBRYO-FETAL TOXICITY
Do not administer Opsumit to a pregnant female because it may cause
fetal
harm [see Contraindications (4.3) and Fertility, pregnancy and
lactation (4.6)].
Females of reproductive potential: Exclude pregnancy before the start
of
treatment, monthly during treatment, and 1 month after stopping
treatment.
Prevent pregnancy during treatment and for one month after stopping
treatment by using acceptable methods of contraception [see Fertility,
pregnancy and lactation (4.6)].
Each patient should receive a Patient alert card, emphasizing the
risks of
embryo fetal toxicity.
PATIENT SAFETY INFORMATION CARD
The marketing of Opsumit is subject to risk management plan (RMP)
including a 'Patient Safety
Information Card'. The patient safety information card, emphasizes
important safety information
that the patient should be aware of before and during the treatment.
The patient safety
information card is included in the pack.
Please explain to the patient the need to review the card before
starting treatment.
2
Opsumit_PI_EUPI update_January-2023
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
OPSUMIT
_P_
®
_P_
is an endothelin receptor antagonist (ERA) indicated for the treatment
of
pulmonary arterial hypertension (PAH, WHO Group I) to delay disease
progression. Disease
progression included: death, initiation of intravenous (IV) or
subcutaneous prostanoids, or
clinical worsening of PAH (decreased 6-mi