Entresto 24mg26mg tablets

Ország: Egyesült Királyság

Nyelv: angol

Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktív összetevők:

Sacubitril; Valsartan

Beszerezhető a:

Novartis Pharmaceuticals UK Ltd

ATC-kód:

C09DX04

INN (nemzetközi neve):

Sacubitril; Valsartan

Adagolás:

24mg ; 26mg

Gyógyszerészeti forma:

Tablet

Az alkalmazás módja:

Oral

Osztály:

No Controlled Drug Status

Recept típusa:

Valid as a prescribable product

Termék összefoglaló:

BNF: 02050502; GTIN: 5010678912098

Betegtájékoztató

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ENTRESTO
® 24 MG/26 MG FILM-COATED TABLETS
ENTRESTO
® 49 MG/51 MG FILM-COATED TABLETS
ENTRESTO
® 97 MG/103 MG FILM-COATED TABLETS
sacubitril/valsartan
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Entresto is and what it is used for
2.
What you need to know before you take Entresto
3.
How to take Entresto
4.
Possible side effects
5.
How to store Entresto
6.
Contents of the pack and other information
1.
WHAT ENTRESTO IS AND WHAT IT IS USED FOR
Entresto is a medicine known as an angiotensin receptor neprilysin
inhibitor. It dissociates into two
active substances, sacubitril and valsartan.
Entresto is used to treat a type of long-term heart failure in adults.
This type of 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, fatigue,
tiredness and ankle swelling.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
ENTRESTO
DO NOT TAKE ENTRESTO:

if you are allergic to sacubitril, valsartan or any of the other
ingredients of this medicine (listed
in section 6). If you think you may be allergic to any component of
this medicine, talk to your
doctor before taking Entresto.

if you are taking another type of

Termékjellemzők

OBJECT 1
ENTRESTO 97 MG/103 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 16-May-2018 | Novartis
Pharmaceuticals UK Ltd
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1. Name of the medicinal product
Entresto
®
24 mg/26 mg film-coated tablets
Entresto
®
49 mg/51 mg film-coated tablets
Entresto
®
97 mg/103 mg film-coated tablets
2. Qualitative and quantitative composition
Entresto 24 mg/26 mg film-coated tablets
Each film-coated tablet contains 24.3 mg sacubitril and 25.7 mg
valsartan (as sacubitril valsartan sodium
salt complex).
Entresto 49 mg/51 mg film-coated tablets
Each film-coated tablet contains 48.6 mg sacubitril and 51.4 mg
valsartan (as sacubitril valsartan sodium
salt complex).
Entresto 97 mg/103 mg film-coated tablets
Each film-coated tablet contains 97.2 mg sacubitril and 102.8 mg
valsartan (as sacubitril valsartan sodium
salt complex).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet (tablet)
Entresto 24 mg/26 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 49 mg/51 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 97 mg/103 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 in adult patients for treatment of symptomatic
chronic heart failure w