ENTRESTO 49/51 sacubitril/valsartan (combined as a sodium salt hydrate complex) 48.6/51.4 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

valsartan, Quantity: 51.4 mg; sacubitril, Quantity: 48.6 mg

Available from:

Novartis Pharmaceuticals Australia Pty Ltd

INN (International Name):

sacubitril,Valsartan

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: purified talc; colloidal anhydrous silica; crospovidone; titanium dioxide; hypromellose; hyprolose; macrogol 4000; magnesium stearate; iron oxide red; microcrystalline cellulose; iron oxide yellow

Administration route:

Oral

Units in package:

60, 14 (sample), 56

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ENTRESTO is indicated in adult patients for the treatment of chronic heart failure (NYHA Class II-IV) with reduced ejection fraction.

Product summary:

Visual Identification: Pale yellow, ovaloid, biconvex, film-coated tablet with beveled edges, unscored, debossed with NVR on one side and L1 on the other side.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2016-01-20

Patient Information leaflet

ENTRESTO
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING ENTRESTO?
Entresto contains the active ingredients sacubitril and valsartan.
Entresto is used to treat a type of heart failure.
For more information, see Section 1. Why am I using Entresto? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ENTRESTO?
Do not use if you have ever had an allergic reaction to Entresto or
any of the ingredients listed at the end of the CMI. Do not take
Entresto if you are pregnant, taking medicines similar to Entresto or
have severe liver problems.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, PLAN TO BECOME PREGNANT OR ARE
BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Entresto? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Entresto and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE ENTRESTO?
•
Take one tablet in the morning and one tablet in the evening (your
doctor will tell you what strength) either with food or without
food.
More instructions can be found in Section 4. How do I use Entresto? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ENTRESTO?
THINGS YOU SHOULD
DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Entresto.
•
Avoid becoming pregnant while using Entresto.
THINGS YOU SHOULD
NOT DO
•
Do not stop using this medicine suddenly.
•
Do not take another medicine for high blood pressure or heart failure
from a class known as
angiotensin converting enzyme inhibitor.
DRIVING OR USING
MACHINES
•
Entresto may cause dizziness or tiredness in some people.
DRINKING ALCOHOL
•
There are no known interactions between Entresto and alcohol.
LOOKING AFTER YOUR
MEDICINE
•
Store it in a cool dry place away from moistu

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
ENTRESTO 24/26

ENTRESTO 49/51

ENTRESTO 97/103

(sacubitril/valsartan) film-coated tablets
1.
NAME OF THE MEDICINE
sacubitril and valsartan
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Entresto film-coated tablets are available in 3 strengths:
Each Entresto 24/26 film-coated tablet contains 24.3 mg sacubitril and
25.7 mg valsartan
(where both drug substances are combined as a sodium salt hydrate
complex). This has been
rounded to 24 mg/26 mg throughout the document.
Each Entresto 49/51 film-coated tablet contains 48.6 mg sacubitril and
51.4 mg valsartan
(where both drug substances are combined as a sodium salt hydrate
complex). This has been
rounded to 49 mg/51 mg throughout the document.
Each Entresto 97/103 film-coated tablet contains 97.3 mg sacubitril
and 102.8 mg valsartan
(where both drug substances are combined as a sodium salt hydrate
complex). This has been
rounded to 97 mg/103 mg throughout the document.
For the full list of excipients,
_see Section 6.1 List of excipients_
.
3.
PHARMACEUTICAL FORM
Entresto 24/26 (24.3 mg sacubitril/25.7 mg valsartan): Violet white,
ovaloid, biconvex, film-
coated tablet with beveled edges; unscored, debossed with “NVR” on
one side and “LZ” on
the other side.
Entresto 49/51 (48.6 mg sacubitril/51.4 mg valsartan): Pale yellow,
ovaloid, biconvex, film-
coated tablet with beveled edges; unscored, debossed with “NVR” on
one side and “L1” on
the other side.
Entresto 97/103 (97.3 mg sacubitril/102.8 mg valsartan): Light pink,
ovaloid, biconvex, film-
coated tablet with beveled edges; unscored, debossed with “NVR” on
one side and “L11” on
the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Entresto is indicated in adult patients for the treatment of chronic
heart failure (NYHA Class
II-IV)
_ _
with reduced ejection fraction.
4.2
DOSE AND METHOD OF ADMINISTRATION
For oral use. Entresto may be administered with or without food
_(see Section 5.2 _
2
_Pharmacokinetic properties; Absorption)_
.
Entrest