VALTRESTO sacubitril/valsartan 97/103 mg film-coated tablet bottle pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sacubitril, Quantity: 97.2 mg; valsartan, Quantity: 102.8 mg

Available from:

Pharmacor Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

168's, 60's, 180's, 56's

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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

Product summary:

Visual Identification: 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.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2023-04-02

Patient Information leaflet

[medicine name]*
1
[VALTRESTO FILM-COATED TABLETS 24/26 MG,
49/51MG, 97/103 MG]*
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 VALTRESTO?
VALTRESTO 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.
For more information, see Section 1. Why am I using VALTRESTO? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE VALTRESTO?
Do not use if you have ever had an allergic reaction to VALTRESTO or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
VALTRESTO? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with VALTRESTO 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 VALTRESTO?
•
The usual recommended target dose of VALTRESTO is 97 mg/103 mg twice a
day (one tablet in the morning and one
tablet in the evening). You will usually start by taking 24 mg/26 mg
or 49 mg/51 mg twice a day
•
PHARMACOR SACUBITRIL VALSARTAN is for oral use (taken by mouth) only.
Swallow VALTRESTO tablets whole. The
coated tablet should not be broken or divided into parts.
More instructions can be found in Section 4. How do I use VALTRESTO?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING VALTRESTO?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
VALTRESTO
•
Tell your doctor if you are breastfeeding or plan to breast-feed.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly (if relevant).
•
Do not take this medicine if you have ever had an unusual or a

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
VALTRESTO
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
Valtresto film-coated tablets are available in 3 strengths:
Each Valtresto 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 Valtresto 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 Valtresto 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
Valtresto 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.
Valtresto 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.
Valtresto 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
Valtresto 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 MAY BE ADMINISTERED WITH OR WITHOUT
FOOD
_(SEE SECTION _
_5.2 _
2
_PHARMACOKINETIC PROPERTIES; ABSORPTION)_
.
Valtresto is usually administered in conjunction with other heart
failure therapies, in place of
a