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.

For more information, see Section 2. What should I know before I use SACUBITRIL/VALSARTAN ALPHAPHARM? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with SACUBITRIL/VALSARTAN ALPHAPHARM 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 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?

For more information, see Section 5. What should I know while using SACUBITRIL/VALSARTAN ALPHAPHARM? in the full CMI.

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.

SACUBITRIL/VALSARTAN ALPHAPHARM

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 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

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

www.viatris.com.au

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.