Neparvis
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
08-12-2023
Produktets egenskaber
(SPC)
08-12-2023
Offentlige vurderingsrapport
(PAR)
22-06-2023
Aktiv bestanddel:
sacubitril, valsartan
Tilgængelig fra:
Novartis Europharm Limited
ATC-kode:
C09DX04
INN (International Name):
sacubitril, valsartan
Terapeutisk gruppe:
Agents acting on the renin-angiotensin system
Terapeutisk område:
Heart Failure
Terapeutiske indikationer:
Paediatric heart failureNeparvis is indicated in children and adolescents aged one year or older for treatment of symptomatic chronic heart failure with left ventricular systolic dysfunction (see section 5.1).Adult heart failureNeparvis is indicated in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction (see section 5.1).
Produkt oversigt:
Revision: 18
Autorisation status:
Authorised
Autorisation dato:
2016-05-26
Indlægsseddel
75
B. PACKAGE LEAFLET
76
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NEPARVIS 24 MG/26 MG FILM-COATED TABLETS
NEPARVIS 49 MG/51 MG FILM-COATED TABLETS
NEPARVIS 97 MG/103 MG FILM-COATED TABLETS
sacubitril/valsartan
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 Neparvis is and what it is used for
2.
What you need to know before you take Neparvis
3.
How to take Neparvis
4.
Possible side effects
5.
How to store Neparvis
6.
Contents of the pack and other information
1.
WHAT NEPARVIS IS AND WHAT IT IS USED FOR
Neparvis is a heart medicine containing an angiotensin receptor
neprilysin inhibitor. It delivers two
active substances, sacubitril and valsartan.
Neparvis is used to treat a type of long-term heart failure in adults,
children and adolescents (one year
and older).
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.
77
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
NEPARVIS
DO NOT TAKE NEPARVIS
•
if you are allergic to sacubitril, valsartan or any of the other
ingredients of this medicine (listed
in section 6).
•
if you are taking another type of medicine called an angiotensin
converting enzyme (ACE)
inhibitor (for example enalapril, lisinopril or ramipril), which is
used to treat high blood
pressure or heart failure. If you have been taking an ACE inhibitor,
wait for 36 hours after
taking the last dose before you sta
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Neparvis 24 mg/26 mg film-coated tablets
Neparvis 49 mg/51 mg film-coated tablets
Neparvis 97 mg/103 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Neparvis 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).
Neparvis 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).
Neparvis 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)
Neparvis 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.
Neparvis 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.
Neparvis 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.
3
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Adult heart failure
Neparvis is indicated in adult patients for treatment of symptomatic
chronic heart failure with reduced
ejection fraction (see section 5.1).
Paediatric heart failure
Neparvis is indicated in children and adolescents aged one year or
older for treatment of symptomatic
chronic heart failure with left ventricular systolic dysfunction (see
section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_General considerations
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