OPSUMIT macitentan 10 mg film coated tablet blister pack

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

macitentan, Quantity: 10 mg

제공처:

Janssen-Cilag Pty Ltd

INN (국제 이름):

Macitentan

약제 형태:

Tablet, film coated

구성:

Excipient Ingredients: sodium starch glycollate type A; magnesium stearate; microcrystalline cellulose; polysorbate 80; povidone; lactose monohydrate; titanium dioxide; purified talc; xanthan gum; polyvinyl alcohol; lecithin

관리 경로:

Oral

패키지 단위:

6 film coated tablets, 3 film coated tablets, 9 film coated tablets, 30 film coated tablets

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

OPSUMIT, as monotherapy or in combination with approved PAH treatments (phosphodiesterase-5 inhibitors or inhaled prostanoids), is indicated for the treatment of: ?idiopathic pulmonary arterial hypertension ?heritable pulmonary arterial hypertension ?pulmonary arterial hypertension associated with connective tissue disease ?pulmonary arterial hypertension associated with congenital heart disease with repaired shunts in patients with WHO Functional class II, III or IV symptoms.

제품 요약:

Visual Identification: The drug product is supplied as a white to off white, biconvex, round, film-coated tablet debossed with 10 on both sides.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 60 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

승인 상태:

Licence status A

승인 날짜:

2014-02-05

환자 정보 전단

OPSUMIT(211007)ACMI
1
This leaflet was prepared in October 2021. Please check with your
pharmacist if an updated version of this leaflet has been
made available.
OPSUMIT
®
(OP-SUH-MIT)
_Macitentan (ma-SEE-ten-tan) 10 mg Tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about OPSUMIT.
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, SPEAK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT OPSUMIT IS
USED FOR
OPSUMIT tablets contain macitentan
which belongs to the class of
medicines called "endothelin receptor
antagonists".
OPSUMIT is used for the treatment
of pulmonary arterial hypertension
(PAH), it can be used on its own or
with other drugs to treat PAH. PAH
is high blood pressure in the blood
vessels (the pulmonary arteries) that
carry blood from the heart to the
lungs. In people with PAH, these
arteries get narrower, so the heart has
to work harder to pump blood
through them. This causes people to
feel tired, dizzy, and short of breath.
OPSUMIT widens the pulmonary
arteries, making it easier for the heart
to pump blood through them. This
lowers the blood pressure and
relieves the symptoms and improves
the course of the disease.
Your doctor however, may prescribe
OPSUMIT for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
BEFORE YOU TAKE
OPSUMIT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE OPSUMIT IF YOU
ARE PREGNANT OR IF YOU ARE PLANNING
TO BECOME PREGNANT, OR IF YOU
COULD BECOME PREGNANT BECAUSE
YOU ARE NOT USING RELIABLE BIRTH
CONTROL (CONTRACEPTION).
Talk to your doctor about what birth
control methods are reliable whilst
taking OPSUMIT.
DO NOT TAKE OPSUMIT IF YOU HAVE
EVER HAD

제품 특성 요약

CCDS 200915
OPSUMIT (211005)API
OPSUMIT
®
MACITENTAN
AUSTRALIAN PRODUCT INFORMATION
OPSUMIT
®
may cause birth defects and is contraindicated in pregnancy.
See section 4.3 CONTRAINDICATIONS and Section 4.6 FERTILITY, PREGNANCY
and
LACTATION.
1
NAME OF THE MEDICINE
OPSUMIT macitentan
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
OPSUMIT is available as a 10 mg film-coated tablet for once daily oral
administration.
Excipients with known effects: lactose monohydrate and soya lecithin.
For the full list of excipients,
see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white, round, biconvex film-coated tablet, debossed with
“10” on both sides.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
OPSUMIT, as monotherapy or in combination with approved PAH treatments
(phosphodiesterase-5
inhibitors or inhaled prostanoids), is indicated for the treatment of:
•
idiopathic pulmonary arterial hypertension
•
heritable pulmonary arterial hypertension
•
pulmonary arterial hypertension associated with connective tissue
disease
•
pulmonary arterial hypertension associated with congenital heart
disease with repaired
shunts
in patients with WHO Functional class II, III or IV symptoms.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Treatment with OPSUMIT should only be initiated and monitored by a
physician experienced in the
treatment of PAH.
CCDS 200915
2
OPSUMIT(211005)API
OPSUMIT is to be taken orally at a dose of 10 mg once daily, with or
without food. The film-coated
tablets are not breakable and are to be swallowed whole, with water.
Doses higher than 10 mg daily
have not been studied and are not recommended.
DOSAGE ADJUSTMENT IN ELDERLY PATIENTS
No dose adjustment is required in patients over the age of 65 years.
DOSAGE ADJUSTMENT IN PATIENTS WITH HEPATIC IMPAIRMENT
Based on pharmacokinetic data, no dose adjustment is required in
patients with mild or moderate
hepatic impairment. There is no clinical experience with the use of
OPSUMIT in PAH patients with
moderate or severe hepatic