ADEMPAS 1.5 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

RIOCIGUAT

Available from:

BAYER ISRAEL LTD

ATC code:

C02KX05

Pharmaceutical form:

FILM COATED TABLETS

Composition:

RIOCIGUAT 1.5 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

BAYER AG., GERMANY

Therapeutic area:

RIOCIGUAT

Therapeutic indications:

Chronic thromboembolic pulmonary hypertension (CTEPH) Adempas is indicated for the treatment of adult patients with WHO Functional Class (FC) II to III with • inoperable CTEPH, • persistent or recurrent CTEPH after surgical treatment, to improve exercise capacity. Pulmonary arterial hypertension (PAH)Adempas, as monotherapy or in combination with endothelin receptor antagonists, is indicated for the treatment of adult patients with pulmonary arterial hypertension (PAH) with WHO Functional Class (FC) II to III to improve exercise capacity.Efficacy has been shown in a PAH population including aetiologies of idiopathic or heritable PAH or PAH associated with connective tissue disease.

Authorization date:

2020-03-31

Patient Information leaflet

ناملأا تامولعم ةقاطب
ةجلاعتملل ساپم
ِ
دأ ،غلم 1 ساپم
ِ
دأ ،غلم 0.5 ساپم
ِ
دأ
غلم 2.5 ساپم
ِ
دأ ،غلم 2 ساپم
ِ
دأ ،غلم 1.5
יתוחיטב עדימ סיטרכ
תלפוטמל
ADEMPAS
® INITIAL TREATMENT
SUMMARY
Every two weeks (for a total of eight weeks) you will be assessed by
your PH healthcare professional. After eight weeks you and your
PH healthcare professional will have found the Adempas
®
dose
that is right for you
After checking your blood pressure, signs and symptoms
of low blood pressure (hypotension) and monitoring any
treatment-related side effects, your PH healthcare professional
will decide with you whether it’s best to increase, decrease or
maintain your dose
Remember, there is no right dose,
just the dose that is right for you
BP
ADEMPAS
® INITIAL TREATMENT
SUMMARY
Every two weeks (for a total of eight weeks) you will be assessed by
your PH healthcare professional. After eight weeks you and your
PH healthcare professional will have found the Adempas
®
dose
that is right for you
After checking your blood pressure, signs and symptoms
of low blood pressure (hypotension) and monitoring any
treatment-related side effects, your PH healthcare professional
will decide with you whether it’s best to increase, decrease or
maintain your dose
Remember, there is no right dose,
just the dose that is right for you
BP
,ג”מ 1 סאפמדא ,ג”מ 0.5 סאפמדא
,ג”מ 2 סאפמדא ,ג”מ 1.5 סאפמדא
ג”מ 2.5 סאפמדא
הלולע ןוירה ךלהמב סאפמדא תליטנ
.רבועל קיזהל
וא ןוירהב ךנה םא סאפמדא לוטיל ןיא
.ןוירהל סנכיהל תננכתמ תא םא
היושעה תוירופה ליגב השיא ךנה םא
תקידב עצבל ךממ שקבי ךאפור ,תורהל
,סאפמדאב לופיטה תליחת ינפל ןוירה
תליטנ ךלהמב שדוח לכ יתרגש ןפואב
.לופיטה םויס רחאל שדוח ןכו הפורתה
תקידב

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
Adempas 0.5 mg film-coated tablets
Adempas 1 mg film-coated tablets
Adempas 1.5 mg film-coated tablets
Adempas 2 mg film-coated tablets
Adempas 2.5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Adempas 0.5 mg film-coated tablets
Each film-coated tablet contains 0.5 mg of riociguat.
Adempas 1 mg film-coated tablets
Each film-coated tablet contains 1 mg of riociguat.
Adempas 1.5 mg film-coated tablets
Each film-coated tablet contains 1.5 mg of riociguat.
Adempas 2 mg film-coated tablets
Each film-coated tablet contains 2 mg of riociguat.
Adempas 2.5 mg film-coated tablets
Each film-coated tablet contains 2.5 mg of riociguat.
Excipients with known effect:
_Adempas 0.5 mg film-coated tablets_
Each 0.5 mg film-coated tablet contains 39.8 mg lactose monohydrate,
see section 4.4.
_ _
_Adempas 1 mg film-coated tablets_
Each 1 mg film-coated tablet contains 39.2 mg lactose monohydrate, see
section 4.4.
_ _
_Adempas 1.5 mg film-coated tablets_
Each 1.5 mg film-coated tablet contains 38.7 mg lactose monohydrate,
see section 4.4
_ _
_Adempas 2 mg film-coated tablets_
Each 2 mg film-coated tablet contains 38.2 mg lactose monohydrate, see
section 4.4..
_ _
_Adempas 2.5 mg film-coated tablets_
Each 2.5 mg film-coated tablet contains 37.7 mg lactose monohydrate,
see section 4.4.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Adempas 0.5 mg: White, round, biconvex tablets of 6 mm, marked with
the Bayer cross on one side and 0.5
and an “R” on the other side.
Adempas 1 mg: Pale yellow, round, biconvex tablets of 6 mm, marked
with the Bayer cross on one side and 1
and an “R” on the other side.
2
Adempas 1.5 mg: Yellow-orange, round, biconvex tablets of 6 mm, marked
with the Bayer cross on one side
and 1.5 and an “R” on the other side.
Adempas 2 mg: Pale orange, round, biconvex tablets of 6 mm, marked
with the Bayer cross on one side and 2
and an “R” on the other side.
Adempas 2.5 mg: Red-orange, round, bicon