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 SACUBITRIL/VALSARTAN ALPHAPHARM?
SACUBITRIL/VALSARTAN ALPHAPHARM contains the active ingredients sacubitril and valsartan.
SACUBITRIL/VALSARTAN ALPHAPHARM is used to treat a type of heart failure. For more
information, see Section
1. Why am I using SACUBITRIL/VALSARTAN ALPHAPHARM? in the full CMI.
2. What should I know before I use SACUBITRIL/VALSARTAN ALPHAPHARM?
Do not use if you have ever had an allergic reaction to SACUBITRIL/VALSARTAN ALPHAPHARM
or any of the ingredients listed at the end of the CMI. Do not take SACUBITRIL/VALSARTAN
ALPHAPHARM if you are pregnant, taking medicines similar to SACUBITRIL/VALSARTAN ALPHAPHARM
or have severe liver problems. 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.
3. What if I am taking other medicines?
Some medicines may interfere with SACUBITRIL/VALSARTAN ALPHAPHARM and affect how it
works.
4. How do I use SACUBITRIL/VALSARTAN ALPHAPHARM?
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 SACUBITRIL/VALSARTAN ALPHAPHARM? in the full CMI.
5. What should I know while using SACUBITRIL/VALSARTAN ALPHAPHARM?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using SACUBITRIL/VALSARTAN
ALPHAPHARM.
Avoid becoming pregnant while using SACUBITRIL/VALSARTAN ALPHAPHARM.
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Things you should not do
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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.
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Driving or using machines
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SACUBITRIL/VALSARTAN ALPHAPHARM may cause dizziness or tiredness in some people.
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Drinking alcohol
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There are no known interactions between SACUBITRIL/VALSARTAN ALPHAPHARM and alcohol.
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Looking after your medicine
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Store it in a cool dry place away from moisture, heat or sunlight.
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6. Are there any side effects?
Common side effects include: dizziness, fainting, light-headedness, cough, headache,
diarrhoea, feeling sick, stomach pain, tiredness, weakness. Serious side effects include:
swelling of the face, lips, tongue and/or throat and difficulty breathing and/or swallowing.
For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
FILM-COATED TABLETS 24/26 mg, 49/51mg, 97/103 mg
Active ingredient(s):
(sacubitril/valsartan)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using SACUBITRIL/VALSARTAN ALPHAPHARM.
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 SACUBITRIL/VALSARTAN ALPHAPHARM.
Where to find information in this leaflet:
1. Why am I using SACUBITRIL/VALSARTAN ALPHAPHARM?
SACUBITRIL/VALSARTAN ALPHAPHARM is used to treat a type of heart failure in adults.
SACUBITRIL/VALSARTAN ALPHAPHARM has been shown to lower the risk of cardiovascular
related deaths and heart failure related hospitalisation.
SACUBITRIL/VALSARTAN ALPHAPHARM contains the active ingredients sacubitril and valsartan. It is an angiotensin receptor neprilysin inhibitor (ARNI), which contains two active
ingredients: sacubitril (a neprilysin inhibitor), and valsartan (angiotensin receptor
blocker or ARB). SACUBITRIL/VALSARTAN ALPHAPHARM works by blocking the changes caused
by the enzyme neprilysin, and angiotensin-II. As a result, blood vessels relax and
less water is kept by the body which is beneficial to treat heart failure.
2. What should I know before I use SACUBITRIL/VALSARTAN ALPHAPHARM?
Warnings
Do not use SACUBITRIL/VALSARTAN ALPHAPHARM if:
you are allergic to sacubitril or valsartan, or any of the ingredients listed at the
end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
you are taking another medicine for high blood pressure or heart failure from a class
known as angiotensin converting enzyme (ACE) inhibitor
you have taken another medicine containing an ACE inhibitor within the last 36 hours.
you or someone in your family, have had a reaction before that causes swelling of
the face, lips, tongue and/ or throat, with or without difficulties in breathing while
taking an ACE inhibitor or an ARB in the past.
you are taking a medicine called aliskiren and have Type 2 diabetes (high level of
sugar in the blood)
you have severe liver disease.
Check with your doctor if you:
are already taking any medicines that is an ACE inhibitor, ARB
have low blood pressure
are taking other medicines that lower your blood pressure
have ever experienced swelling of the face, lips, tongue and/or throat, with or without
difficulties in breathing
have kidney problems
have liver problems
are taking any medicines that increase the amount of potassium in your blood, or potassium
supplements, salt substitutes that contain potassium, potassium-sparing medicines,
or heparin
have any other medical condition.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Do not take this medicine if you are pregnant or plan to become pregnant. If you become pregnant or think you are pregnant, tell your doctor right away.
Check with your doctor if you want to become pregnant. Talk to your doctor if you
are breastfeeding or intend to breastfeed.
Contraception
To avoid becoming pregnant, you should use contraception while using SACUBITRIL/VALSARTAN
ALPHAPHARM and for 1 week after you stop using it.
Use in children
It is not known whether SACUBITRIL/VALSARTAN ALPHAPHARM is safe and effective in patients
below 18 years.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Medicines not to be taken with SACUBITRIL/VALSARTAN ALPHAPHARM include:
any medicine that is an angiotensin converting enzyme (ACE) inhibitor or angiotensin
receptor blocker (ARB)
Ask your doctor or pharmacist if you are unsure if you are being treated with these
other medicines. ACE inhibitors and ARBs are sold under many different brand names
in Australia.
Some medicines may interfere with SACUBITRIL/VALSARTAN ALPHAPHARM. These include:
statins, a medicine used to lower cholesterol levels e.g. atorvastatin
sildenafil, a medicine used to treat erectile dysfunction and certain types of high
blood pressure
medicines that increase the amount of potassium in the blood, including potassium
sparing diuretics, a medicine used to reduce excess fluid in your body, e.g. amiloride
medicines used to treat pain and arthritis, called nonsteroidal anti-inflammatory
drugs (NSAID) or selective cyclo-oxygenase-2 inhibitors ( COX-2 ) inhibitors, e.g.
ibuprofen
lithium, a medicine used to treat some types of depression
frusemide, a medicine used to reduce excess fluid in the body
metformin, a medicine used to control blood glucose for diabetes
some antibiotics, e.g. rifampicin, a medicine used to treat certain infections
ciclosporin, a medicine to treat certain problems with the immune system, or to help
prevent organ transplant rejection
ritonavir, a medicine used to treat HIV/AIDS infection.
Tell your doctor if you take potassium supplements or salt substitutes that contain
potassium.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect SACUBITRIL/VALSARTAN ALPHAPHARM.
4. How do I use SACUBITRIL/VALSARTAN ALPHAPHARM?
How much to take
Your doctor will decide how many tablets you should take
The usual starting dose is one 49 mg/51 mg (pale yellow) tablet taken twice a day
Some patients will start at a lower dose
Your doctor will adjust the dose based on how you respond to treatment after 2 to
4 weeks until the best dose for you is found
Follow the instructions provided and use SACUBITRIL/VALSARTAN ALPHAPHARM until your
doctor tells you to stop.
When to take SACUBITRIL/VALSARTAN ALPHAPHARM
Take one tablet in the morning and one tablet in the evening.
How to take SACUBITRIL/VALSARTAN ALPHAPHARM
Swallow SACUBITRIL/VALSARTAN ALPHAPHARM tablets whole.
Take SACUBITRIL/VALSARTAN ALPHAPHARM either with food or without food.
If you forget to take SACUBITRIL/VALSARTAN ALPHAPHARM
SACUBITRIL/VALSARTAN ALPHAPHARM should be used regularly at the same time each day.
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to. Otherwise, take it as soon as you remember, and then take
the next tablet at the usual time.
Do not take a double dose to make up for the dose you missed.
This may increase the chance of you getting an unwanted side effect. If you are not
sure what to do, ask your doctor or pharmacist.
If you have trouble remembering when to take your medicine, ask your pharmacist for
some hints.
If you use too much SACUBITRIL/VALSARTAN ALPHAPHARM
If you think that you have taken too much SACUBITRIL/VALSARTAN ALPHAPHARM, you may
feel dizzy or lightheaded
You should immediately:
phone the Poisons Information Centre
(by calling 13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using SACUBITRIL/VALSARTAN ALPHAPHARM?
Things you should do
Call your doctor straight away if you:
show signs of swelling of the face, lips, tongue and/or throat, and difficulty in
breathing
become pregnant while taking SACUBITRIL/VALSARTAN ALPHAPHARM.
Remind any doctor, dentist or pharmacist you visit that you are using SACUBITRIL/VALSARTAN
ALPHAPHARM.
Keep all appointments with your doctor so your progress can be checked regularly. Your doctor may want to check your kidney function, blood cell counts, blood pressure,
sugar and potassium levels.
Things you should not do
Do not stop using this medicine suddenly.
Do not take ACE inhibitors at the same time as this medicine.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how SACUBITRIL/VALSARTAN
ALPHAPHARM affects you.
SACUBITRIL/VALSARTAN ALPHAPHARM may cause dizziness or tiredness in some people.
Drinking alcohol
Be careful drinking alcohol until you know how this medicine affects you.
Looking after your medicine
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
Serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Some side effects (for example problems with kidneys, low red blood cells, low sugar
levels in the blood, high or low levels of potassium in the blood, low blood pressure)
can only be found when your doctor does tests from time to time to check your progress.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What SACUBITRIL/VALSARTAN ALPHAPHARM contains
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Active ingredient
(main ingredient)
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sacubitril and valsartan
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Other ingredients
(inactive ingredients)
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microcrystalline cellulose
hydroxyl propyl cellulose
Sodium Starch Glycolate (Type A)
magnesium stearate
colloidal silicon dioxide
talc
The film-coating on the tablets contains:
Opadry 03F580070 White [ARTG Proprietary Ingredient No. 140202] (only for the 24 mg/26
mg tablets)
Opadry 03F520320 Yellow [ARTG Proprietary Ingredient No.140203] (only for the 49 mg/
51mg tablets)
Opadry 03F540210 Pink [ARTG Proprietary Ingredient No.140206] (only for the 97 mg/
103mg tablets)
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Potential allergens
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None
SACUBITRIL/VALSARTAN ALPHAPHARM does not contain lactose, gluten, tartrazine or any
other azo dyes.
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Do not take this medicine if you are allergic to any of these ingredients.
What SACUBITRIL/VALSARTAN ALPHAPHARM looks like
24 mg/26 mg: 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
49 mg/51 mg: 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.
97 mg/103 mg: 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.
Sponsor
Pharmacor Pty Ltd.
Suite 803, Level 8, Tower A,
The Zenith, 821 Pacific Highway,
Chatswood, NSW, 2067
Distributor
SACUBITRIL/VALSARTAN ALPHAPHARM is distributed in Australia by:
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
Australian Registration Numbers:
AUST R 475667 –
SACUBITRIL/VALSARTAN ALPHAPHARM sacubitril/valsartan (combined as sodium salts) 24/26
mg film-coated tablet blister pack
AUST R 475668 –
SACUBITRIL/VALSARTAN ALPHAPHARM sacubitril/valsartan (combined as sodium salts) 49/51
mg film-coated tablet blister pack
AUST R 475685 –
SACUBITRIL/VALSARTAN ALPHAPHARM sacubitril/valsartan (combined as sodium salts) 97/103
mg film-coated tablet blister pack
This leaflet was prepared in December 2024.