ADEMPAS FILM-COATED TABLET 2.0mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Riociguat micronized

Available from:

BAYER (SOUTH EAST ASIA) PTE LTD

ATC code:

C02KX05

Dosage:

2.00mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

Riociguat micronized 2.00mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Bayer AG, Leverkusen ( Mfg of bulk product,Pri&SecPackaging,QC & Stability Storage Testing)

Authorization status:

ACTIVE

Authorization date:

2014-11-24

Patient Information leaflet

Page: 1 of 27
Adempas_CCDS07_Jan 2022
1.
NAME OF THE MEDICINAL PRODUCT
Adempas 0.5 mg film-coated tablets
Adempas 1.0 mg film-coated tablets
Adempas 1.5 mg film-coated tablets
Adempas 2.0 mg film-coated tablets
Adempas 2.5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains either 0.5 mg, 1.0 mg,
1.5 mg, 2.0 mg or 2.5 mg
riociguat.
3.
PHARMACEUTICAL FORM
Adempas 0.5 mg film-coated tablets:
White tablets marked with the Bayer cross on one side and 0.5 and an
“R” on the other side.
Adempas 1.0 mg film-coated tablets:
Pale yellow tablets marked with the Bayer cross on one side and 1 and
an “R” on the other
side.
Adempas 1.5 mg film-coated tablets:
Yellow-orange tablets marked with the Bayer cross on one side and 1.5
and an “R” on the
other side.
Adempas 2.0 mg film-coated tablets:
Pale orange tablets marked with the Bayer cross on one side and 2 and
an “R” on the other
side.
Adempas 2.5 mg film-coated tablets:
Red-orange tablets marked with the Bayer cross on one side and 2.5 and
an “R” on the other
side.
Page: 2 of 27
Adempas_CCDS07_Jan 2022
4.
CLINICAL PARTICULARS
4.1
INDICATION(S)
Chronic thromboembolic pulmonary hypertension (CTEPH, WHO Group 4):
Adempas is indicated for the treatment of adult patients with WHO
functional Class II
to III symptoms
•
Inoperable CTEPH,
•
Persistent or recurrent CTEPH after surgical treatment
to improve exercise capacity ( see section 5.1.2).
Pulmonary arterial hypertension (PAH, WHO Group 1):
Adempas is indicated for the treatment of adult patients with WHO
functional class II to III
PAH to improve exercise capacity ( see section 5.1.2).
Efficacy was shown in patients on riociguat monotherapy or in
combination with endothelin
receptor antagonists or prostanoids.
Studies establishing effectiveness included predominately patients
with WHO functional
class II-III and etiologies of idiopathic or heritable PAH or PAH
associated with connective
tissue disease.
4.2
DOSAGE AND METHOD OF ADMINISTRATION
4.2.1
METHOD OF A

Summary of Product characteristics

Page: 1 of 27
Adempas_CCDS07_April 2021
1.
NAME OF THE MEDICINAL PRODUCT
Adempas 0.5 mg film-coated tablets
Adempas 1.0 mg film-coated tablets
Adempas 1.5 mg film-coated tablets
Adempas 2.0 mg film-coated tablets
Adempas 2.5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains either 0.5 mg, 1.0 mg,
1.5 mg, 2.0 mg or 2.5 mg
riociguat.
3.
PHARMACEUTICAL FORM
Adempas 0.5 mg film-coated tablets:
White tablets marked with the Bayer cross on one side and 0.5 and an
“R” on the other side.
Adempas 1.0 mg film-coated tablets:
Pale yellow tablets marked with the Bayer cross on one side and 1 and
an “R” on the other
side.
Adempas 1.5 mg film-coated tablets:
Yellow-orange tablets marked with the Bayer cross on one side and 1.5
and an “R” on the
other side.
Adempas 2.0 mg film-coated tablets:
Pale orange tablets marked with the Bayer cross on one side and 2 and
an “R” on the other
side.
Adempas 2.5 mg film-coated tablets:
Red-orange tablets marked with the Bayer cross on one side and 2.5 and
an “R” on the other
side.
Page: 2 of 27
Adempas_CCDS07_April 2021
4.
CLINICAL PARTICULARS
4.1
INDICATION(S)
Chronic thromboembolic pulmonary hypertension (CTEPH, WHO Group 4):
Adempas is indicated for the treatment of adult patients with WHO
functional Class II
to III symptoms
•
Inoperable CTEPH,
•
Persistent or recurrent CTEPH after surgical treatment
to improve exercise capacity ( see section 5.1.2).
Pulmonary arterial hypertension (PAH, WHO Group 1):
Adempas is indicated for the treatment of adult patients with WHO
functional class II to III
PAH to improve exercise capacity ( see section 5.1.2).
Efficacy was shown in patients on riociguat monotherapy or in
combination with endothelin
receptor antagonists or prostanoids.
Studies establishing effectiveness included predominately patients
with WHO functional
class II-III and etiologies of idiopathic or heritable PAH or PAH
associated with connective
tissue disease.
4.2
DOSAGE AND METHOD OF ADMINISTRATION
4.2.1
METHOD