ADEMPAS riociguat 1 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

riociguat, Quantity: 1 mg

Available from:

Bayer Australia Ltd

INN (International Name):

riociguat

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: hypromellose; crospovidone; lactose monohydrate; hyprolose; sodium lauryl sulfate; microcrystalline cellulose; magnesium stearate; propylene glycol; titanium dioxide; iron oxide yellow

Administration route:

Oral

Units in package:

42, 84, 21

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Pulmonary arterial hypertension:,Adempas, as monotherapy or in combination with approved PAH treatments (endothelin receptor antagonists or inhaled or subcutaneous prostanoids), is indicated for the treatment of:,? idiopathic pulmonary arterial hypertension,? heritable pulmonary arterial hypertension,? pulmonary arterial hypertension associated with connective tissue diseases or,? pulmonary arterial hypertension associated with congenital heart disease in adult patients with WHO functional Class II, lll or IV symptoms,Chronic thromboembolic pulmonary hypertension:,Adempas is indicated for the treatment of:,Persistent or recurrent chronic thromboembolic pulmonary hypertension (CTEPH) after surgical treatment or,inoperable CTEPH in adult patients with WHO functional Class II, lll or IV symptoms

Product summary:

Visual Identification: Pale yellow, round, biconvex tablets marked with the Bayer cross on one side and 1 and an 'R' on the other side.; Container Type: Blister Pack; Container Material: PP/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2014-04-14

Patient Information leaflet

Adempas
®
CMI VX2.0
1
ADEMPAS
®
(AH-DEM-PAS)
_RIOCIGUAT _
_ _
CONSUMER MEDICINE INFORMATION
ADEMPAS MAY CAUSE BIRTH DEFECTS AND MUST NOT BE TAKEN DURING
PREGNANCY.
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
Adempas. 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 taking
Adempas against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT ADEMPAS IS
USED FOR
Adempas is used to treat adults
with high blood pressure in the
lung vessels caused by:
•
blood clots in the lungs
(known as chronic
thromboembolic pulmonary
hypertension or CTEPH)
•
narrowing of the vessels that
carry blood from the heart to
the lungs (known as
pulmonary arterial
hypertension or PAH)
If the high blood pressure in the
lung vessels is caused by
CTEPH it can sometimes be
treated with surgery. Adempas
may be used if surgery is not
possible or if there is still high
blood pressure in the lung
vessels after surgery.
High blood pressure in the lung
vessels means that the heart
needs to work harder to pump
blood through the lungs. This
may cause you to feel tired,
dizzy and short of breath.
Adempas contains the active
substance riociguat. Riociguat
is a soluble guanylate cyclase
(sGC)-stimulator.
Adempas relaxes the lung
vessels making it easier for the
heart to pump blood through
them. This lowers the pressure
in these vessels, relieves the
symptoms, and can lead to an
improvement in the ability to
exercise and perform physical
tasks.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have
prescribed it for another reason.
This medicine is only available
with a doctor’s prescription.
BEFORE YOU TAKE
ADEMPAS
_WHEN YOU MUST NOT TAKE _
_IT _
DO NOT TAKE ADEMPA

Summary of Product characteristics

ADEMPAS PI XV2.0; CCDS 7
1
AUSTRALIAN PRODUCT INFORMATION
ADEMPAS (RIOCIGUAT)
ADEMPAS 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
Riociguat.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Adempas 0.5 mg: Each film-coated tablet for oral administration
contains 0.5 mg of riociguat.
Adempas 1 mg: Each film-coated tablet for oral administration contains
1 mg of riociguat.
Adempas 1.5 mg: Each film-coated tablet for oral administration
contains 1.5 mg of riociguat.
Adempas 2 mg: Each film-coated tablet for oral administration contains
2 mg of riociguat.
Adempas 2.5 mg: Each film-coated tablet for oral administration
contains 2.5 mg of riociguat.
Excipients with known effect: sugars as lactose
Each 0.5 mg film-coated tablet contains 39.8 mg lactose monohydrate.
Each 1 mg film-coated tablet contains 39.2 mg lactose monohydrate.
Each 1.5 mg film-coated tablet contains 38.7 mg lactose monohydrate.
Each 2 mg film-coated tablet contains 38.2 mg lactose monohydrate.
Each 2.5 mg film-coated tablet contains 37.7 mg lactose monohydrate.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Adempas is a film-coated tablet.
•
0.5 mg film-coated tablet: White, round, biconvex tablets marked with
the Bayer
cross on one side and 0.5 and an “R” on the other side.
•
1 mg film-coated tablet: Pale yellow, round, biconvex tablets marked
with the Bayer
cross on one side and 1 and an “R” on the other side.
•
1.5 mg film-coated tablet: Yellow orange, round, biconvex tablets
marked with the
Bayer cross on one side and 1.5 and an “R” on the other side.
•
2 mg film-coated tablet: Pale orange, round, biconvex tablets marked
with the Bayer
cross on one side and 2 and an “R” on the other side.
•
2.5 mg film-coated tablet: Red orange, round, biconvex tablets marked
with the
Bayer cross on one side and 2.5 and an “R” on the other side.
ADEMPAS PI XV2.0; CCDS 7