ENTRESTO 200 MG

Страна: Ізраїль

мова: англійська

Джерело: Ministry of Health

Активний інгредієнт:

SACUBITRIL/VALSARTAN AS SODIUM SALT COMPLEX

Доступна з:

NOVARTIS ISRAEL LTD

Код атс:

C09DX04

Фармацевтична форма:

FILM COATED TABLETS

Склад:

SACUBITRIL/VALSARTAN AS SODIUM SALT COMPLEX 97/103 MG

Адміністрація маршрут:

PER OS

Тип рецепту:

Required

Виробник:

NOVARTIS PHARMA AG.,SWITZERLAND

Терапевтична области:

VALSARTAN AND SACUBITRIL

Терапевтичні свідчення:

EntrestoTM is indicated for the treatment of heart failure (NYHA class II-IV) in patients with systolic dysfunction. EntrestoTM has been shown to reduce the rate of cardiovascular death and heart failure hospitalisation compared to angiotensin converting enzyme (ACE) inhibitor therapy

Дата Авторизація:

2020-11-30

інформаційний буклет

ENT APL JUL23 V3
EU PIL 05.2023
Patient leaflet in accordance with the Pharmacists' Regulations
(Preparations) - 1986
This medicine is dispensed with a doctor's prescription only
Entresto 50 mg
Entresto 100 mg
Entresto 200 mg
Film-coated tablets
Film-coated tablets
Film-coated tablets
Active ingredient:
Each film-coated tablet
contains:
24 mg sacubitril and 26 mg
valsartan as sodium salt
complex
Active ingredient:
Each film-coated tablet
contains:
49 mg sacubitril and 51 mg
valsartan as sodium salt
complex
Active ingredient:
Each film-coated tablet
contains:
97 mg sacubitril and 103 mg
valsartan as sodium salt
complex
Inactive ingredients and allergens in the medicine - see section 6
‘Additional information’.
Read the entire leaflet carefully before you start using this
medicine. This leaflet contains
concise information about this medicine. If you have any further
questions, consult your doctor or
pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm
them, even if it seems to you that their illness is similar to yours.
1. What is this medicine intended for?
Entresto is indicated for the treatment of heart failure (NYHA class
II-IV) in patients with systolic
dysfunction.
Entresto has been shown to reduce the rate of cardiovascular death and
heart failure
hospitalisation compared to angiotensin converting enzyme (ACE)
inhibitor therapy.
Therapeutic group:
Entresto belongs to a group of medicines that act on the
renin-angiotensin system; angiotensin II
receptor blockers (ARBs), different combinations.
Heart failure occurs when the heart is weak and cannot pump enough
blood to the lungs and the
rest of the body. The most common symptoms of heart failure are
breathlessness, tiredness and
ankle swelling
.
2. Before using this medicine
Do not use this medicine if:

you are sensitive (allergic) to the active ingredients sacubitril,
valsartan or to any of the other
ingredients in this medicine (listed in section 6).

you are taking another type of medicine

Характеристики продукта

ENT API JUL23 V3
1
EU SmPC 05.2023
1.
NAME OF THE MEDICINAL PRODUCT
Entresto
®
50 mg
Entresto
®
100 mg
Entresto
®
200 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Entresto
®
50 mg
Each 50 mg film-coated tablet contains 24 mg sacubitril and 26 mg
valsartan as sodium salt complex.
Entresto
®
100mg
Each 100 mg film-coated tablet contains 49 mg sacubitril and 51 mg
valsartan as sodium salt complex.
Entresto
®
200mg
Each 200 mg film-coated tablet contains 97 mg sacubitril and 103 mg
valsartan as sodium salt
complex.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Entresto
®
50 mg film-coated tablets: Violet white ovaloid biconvex film-coated
tablet with bevelled
edges, unscored, debossed with “NVR” on one side and “LZ” on
the other side. Approximate tablet
dimensions 13.1 mm x 5.2 mm.
Entresto
®
100 mg film-coated tablets: Pale yellow ovaloid biconvex film-coated
tablet with bevelled
edges, unscored, debossed with "NVR" on one side and "L1" on the other
side. Approximate tablet
dimensions 13.1 mm x 5.2 mm.
Entresto
®
200 mg film-coated tablets: Light pink ovaloid biconvex film-coated
tablet with bevelled
edges, unscored, debossed with "NVR" on one side and "L11" on the
other side. Approximate tablet
dimensions 15.1 mm x 6.0 mm.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Entresto
®
is indicated for the treatment of heart failure (NYHA class II-IV) in
patients with
systolic dysfunction.
Entresto
®
has been shown to reduce the rate of cardiovascular death and heart
failure
hospitalisation compared to angiotensin-converting enzyme (ACE)
inhibitor therapy.
4.2
Posology and method of administration
Posology
Entresto should not be co-administered with an
angiotensin-converting enzyme
(ACE) inhibitor or
an angiotensin II receptor blocker (ARB). Due to the potential risk of
angioedema when used
concomitantly with an ACE inhibitor, it must not be started for at
least 36 hours after discontinuing
ACE inhibitor therapy (see sections 4.3, 4.4 and 4.5).
ENT A