VERQUVO®

▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.

VERQUVO®(ver-KYU-voh)

Active ingredient(s): vericiguat

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Consumer Medicine Information (CMI)

This leaflet provides important information about using VERQUVO^®. 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 VERQUVO^®.

Where to find information in this leaflet:

1. Why am I using VERQUVO^®?
2. What should I know before I use VERQUVO^®?
3. What if I am taking other medicines?
4. How do I use VERQUVO^®?
5. What should I know while using VERQUVO^®?
6. Are there any side effects?
7. Product details

1. Why am I using VERQUVO^®?

VERQUVO^® contains the active ingredient vericiguat. It is a heart therapy medicine, called a soluble guanylate cyclase stimulator.

Your doctor would have prescribed this medicine because you may have had an increase or worsening of your heart failure symptoms recently.

Heart failure is when your heart is weak and can’t pump enough blood to your body. Common symptoms of heart failure may include difficulty breathing, swelling and fatigue.

VERQUVO^® works by widening the arteries to make it easier for the heart to get more blood and oxygen throughout the body. VERQUVO^® can lower your chances of having to go hospital for your heart failure.

VERQUVO^® is used along with other heart failure medicines.

2. What should I know before I use VERQUVO^®?

Warnings

Do not use VERQUVO^® if:

• you are taking another soluble guanylate cyclase stimulator, such as ADEMPAS^® (riociguat) used to treat high blood pressure in the lungs.
• you are allergic to vericiguat or any of the other ingredients in this medicine listed under Section 7 Product details.

If any of the above applies to you, talk to your doctor first and do not take VERQUVO^®.

Check with your doctor if you:

• have low blood pressure.
• have liver problems.
• have kidney problems or are on dialysis.
• take any medicines for any other condition.

During treatment, you may experience some side effects. It is important you understand what these may be and how to monitor for them. See additional information under Section 6. Are there any side effects?

VERQUVO^® contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking it.

Pregnancy and breastfeeding

VERQUVO^® is not recommended during pregnancy, as it is not known if it will harm your unborn baby. Use an effective contraception to prevent pregnancy while on VERQUVO^®. Talk to your doctor if you are pregnant or intend to become pregnant.

Breastfeeding is not recommended while taking VERQUVO^®. It is not known whether it passes into your breast milk and may harm your baby. Tell your doctor if you are breast-feeding or about to start breast-feeding before taking this medicine.

Children and adolescents

Do not give VERQUVO^® to children and adolescents under 18 years. VERQUVO^® has not been studied in this age group.

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.

Do not take VERQUVO^® if:

• you are taking another soluble guanylate cyclase stimulator, such as ADEMPAS^® (riociguat) used to treat high blood pressure in the lungs.
• you take medicine for erectile dysfunction (e.g. sildenafil, tadalafil, vardenafil).

Tell your doctor if you are taking medicines for angina (chest pain) called nitrates (e.g. glyceryl trinitrate, isosorbide mononitrate).

Know the medicines you take. Keep a list of them to show to your doctor or pharmacist when you get a new medicine.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect VERQUVO^®.

4. How do I use VERQUVO^®?

How much to take

Follow all directions given to you by your doctor and pharmacist carefully. They may be different to what is in this leaflet.

Take one (1) tablet of VERQUVO^® at the same time each day with food.

The usual recommended target dose of VERQUVO^® is 10mg once a day. You will usually start by taking 2.5mg tablet once a day for the first 2 weeks. Your doctor will gradually increase your dose every 2 weeks, depending on how you respond.

Follow the instructions provided and use VERQUVO^® until your doctor tells you to stop. Do not stop taking VERQUVO^® or change your dose without talking to your doctor.

If you are not able to swallow tablets, VERQUVO^® may be crushed and mixed with water immediately before taking.

When to take VERQUVO^®

Take VERQUVO^® at the same time each day with food.

If you forget to take VERQUVO^®

VERQUVO^® should be taken regularly at the same time each day. If you miss your dose at the usual time, take the missed dose as soon as you remember only on the same day of the missed dose. If you remember the next day, then skip the dose you missed and take your next dose when you are meant to.

Do not take two doses of VERQUVO^® on the same day.

If you are not sure how to take VERQUVO^®, call your doctor or pharmacist.

If you use too much VERQUVO^®

If you think that you have used too much VERQUVO^®, you may need urgent medical attention.

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 VERQUVO^®?

Things you should do

Take VERQUVO^® exactly as directed by your doctor.

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking VERQUVO^®.

Call your doctor straight away if you:

• feel dizzy or lightheaded.
• develop signs or symptoms of an allergic reaction, including: shortness of breath; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.
• notice any side effects that may be making you feel unwell.
• think that you have used too much VERQUVO^®.

Things you should not do

• Do not take VERQUVO^® to treat any other complaints unless your doctor tells you to.
• Do not stop taking your medicine or lower the dose without checking with your doctor.
• Do not give your medicine to anyone else, even if they have the same condition as you.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how VERQUVO^® affects you.

VERQUVO^® can cause dizziness. Do not drive or use machinery if you feel dizzy while using VERQUVO^®.

Drinking alcohol

Tell your doctor if you drink alcohol.

The effects of VERQUVO^® with alcohol are unknown.

Looking after your medicine

• Store below 30°C.

Follow the instructions on 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

Less serious side effects	What to do
Blood and lymphatic system disorders: Low number red blood cells (anemia) seen as pale skin, weakness or breathlessness. Gastrointestinal disorders: Feeling like you are going to throw up (nausea). Vomiting. Indigestion (dyspepsia). Heartburn (gastroesophageal reflux disease). Nervous system disorders: Dizziness. Headache.	Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects	What to do
Vascular disorders: Low blood pressure (hypotension).	Call your doctor if you become dizzy or lightheaded.

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.

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 VERQUVO^® contains

Active ingredient (main ingredient)	Vericiguat
Other ingredients (inactive ingredients)	Tablet core Microcrystalline cellulose Croscarmellose sodium Hypromellose 5 cP Lactose monohydrate Magnesium stearate Sodium lauryl sulfate Film-coat Hypromellose 5 cP Purified talc Titanium dioxide (E 171) Iron oxide red (E 172) (VERQUVO® 5 mg only) Iron oxide yellow (E 172) (VERQUVO® 10 mg only)

Do not take this medicine if you are allergic to any of these ingredients.

What VERQUVO^® looks like

VERQUVO^® 2.5 mg film-coated tablets are round, biconvex, white film-coated tablet with a diameter of 7 mm, debossed with “2.5” on one side and “VC” on the other side (AUST R 339992).

VERQUVO^® 5 mg film-coated tablets are round, biconvex, brown-red film-coated tablet with a diameter of 7 mm, debossed with “5” on one side and “VC” on the other side (AUST R 339994).

VERQUVO^® 10 mg film-coated tablets are round, biconvex, yellow-orange film-coated tablet with a diameter of 9 mm, debossed with “10” on one side and “VC” on the other side (AUST R 339993).

VERQUVO^® is available in:

• blisters in cartons of 14 or 28 film-coated tablets.
• perforated unit dose blisters in cartons of 100 x 1 film-coated tablets (for hospital dispensing only).

Who distributes VERQUVO^®

Bayer Australia Ltd
ABN 22 000 138 714
875 Pacific Highway
Pymble NSW 2073
www.bayer.com.au

This leaflet was prepared in November 2021.

See TGA website (www.ebs.tga.gov.au) for latest Australian Consumer Medicine Information.

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