PHARMACOR SACUBITRIL VALSARTAN sacubitril/valsartan 24/26 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sacubitril, Quantity: 24.3 mg; valsartan, Quantity: 25.7 mg

Available from:

Pharmacor Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: sodium starch glycollate type A; microcrystalline cellulose; magnesium stearate; purified talc; colloidal anhydrous silica; hyprolose; titanium dioxide; hypromellose; iron oxide yellow; iron oxide red; macrogol 4000; iron oxide black

Administration route:

Oral

Units in package:

28's, 60's, 14's, 56's

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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

Product summary:

Visual Identification: Off white to light pink, ovaloid biconvex, filmcoated tablets with bevelled edge unscored, debossed with 'SV5' on one side and plain on the other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2023-04-02

Patient Information leaflet

[medicine name]*
3
[
PHARMACOR SACUBITRIL/VALSARTAN FILM-COATED
TABLETS 24/26 MG, 49/51MG, 97/103 MG
]*
ACTIVE INGREDIENT(S): _(sacubitril/valsartan)_
CONSUMER MEDICINE INFORMATION (CMI)
This leaflet provides important information about using P
YOU SHOULD ALSO SPEAK TO YOUR DOCTOR OR PHARMACIST IF YOU
WOULD LIKE FURTHER INFORMATION OR IF YOU HAVE ANY
CONCERNS OR QUESTIONS ABOUT USING [MEDICINE NAME].
WHERE TO FIND INFORMATION IN THIS LEAFLET:
1.
Why am I using [medicine name]?
2.
What should I know before I use [medicine name]?
3.
What if I am taking other medicines?
4.
How do I use [medicine name]?
5.
What should I know while using [medicine name]?
6.
Are there any side effects?
7.
Product details
1.
WHY AM I USING PHARMACOR
SACUBITRIL/VALSARTAN?
PHARMACOR SACUBITRIL/VALSARTAN 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.
PHARMACOR
SACUBITRIL/VALSARTAN
is
an
angiotensin
receptor
neprilysin
inhibitor
(ARNI),
which
contains sacubitril (a neprilysin inhibitor), and valsartan (an
nerves so that seizures do not happen. angiotensin receptor
blocker
or
ARB).
PHARMACOR
SACUBITRIL/VALSARTAN
works
by
blocking
the
effects
of
neprilysin
via
sacubitril
and
angiotensin-II
receptor via valsartan. As a result, blood vessels relax and
less water is retained by the body which is beneficial to
treat heart failure.
ASK YOUR DOCTOR, NURSE PRACTITIONER OR PHARMACIST IF
YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it for another reason.
This medicine is only available with a doctor's prescription.
It is not addictive.
There
is
not
enough
information
to
recommend
this
medicine for use in children or adolescents under 18 years
old.
2.
WHAT SHOULD I KNOW BEFORE I USE
PHARMACOR SACUBITRIL/VALSARTAN?
WARNINGS
DO NOT USE PHARMACOR SACUBITRIL

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
PHARMACOR SACUBITRIL / VALSARTAN FILM-COATED TABLETS 24/26 MG,
49/51MG, 97/103 MG (SACUBITRIL/VALSARTAN)
1.
NAME OF THE MEDICINE
Sacubitril and Valsartan
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pharmacor Sacubitril / Valsartan film-coated tablets are available in
3 strengths:
Each Pharmacor Sacubitril / Valsartan 24/26 film-coated tablet
contains 24.3 mg sacubitril
and 25.7 mg valsartan (combined as a sodium salt amorphous mixture).
This has been
rounded to 24 mg/26 mg throughout the document.
Each Pharmacor Sacubitril / Valsartan 49/51 film-coated tablet
contains 48.6 mg sacubitril
and 51.4 mg valsartan (combined as a sodium salt amorphous mixture).
This has been
rounded to 49 mg/51 mg throughout the document.
Each Pharmacor Sacubitril / Valsartan 97/103 film-coated tablet
contains 97.3 mg sacubitril
and 102.8 mg valsartan (combined as a sodium salt amorphous mixture).
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
Pharmacor Sacubitril / Valsartan 24/26 (24.3 mg sacubitril/25.7 mg
valsartan): Off white to
light pink, ovaloid biconvex, film-coated tablets with bevelled edge
unscored, debossed with
'SV5' on one side and plain on the other side.
Pharmacor Sacubitril / Valsartan 49/51 (48.6 mg sacubitril/51.4 mg
valsartan): Pale yellow to
yellow, ovaloid biconvex, film-coated tablets with bevelled edge
unscored, debossed with
'SV1' on one side and plain on the other side.
Pharmacor Sacubitril / Valsartan 97/103 (97.2 mg sacubitril/102.8 mg
valsartan): Light pink
to pink, ovaloid biconvex, film-coated tablets with bevelled edge
unscored, debossed with
'SV2' on one side and plain on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Pharmacor Sacubitril / Valsartan 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. SACUBITRIL/VALSARTAN M