VERQUVO 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Verquvo 2.5mg film-coated tablets

Verquvo 5mg film-coated tablets

Verquvo 10mg film-coated tablets

vericiguat

This medicinal product is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Verquvo and what is it used for
2. What you need to know before you take Verquvo
3. How to take Verquvo
4. Possible side effects
5. Storage of Verquvo
6. Contents of the pack and other information

1. What is Verquvo and what is it used for

Verquvo contains the active substance vericiguat, which is a type of heart medicine called a soluble guanylate cyclase stimulator.

Verquvo is used to treat adults with long-term heart failure who have recently experienced an increase in symptoms of heart failure. You may have been hospitalized and/or received a medicine (diuretic) given into a vein to help you urinate more than usual.

Heart failure occurs when the heart is weak and cannot pump enough blood to the body. Some common symptoms of heart failure are difficulty breathing, tiredness, or swelling caused by fluid buildup.

2. What you need to know before you take Verquvo

Do not take Verquvo

• if you are allergicto vericiguat or any of the other ingredients of this medicine (listed in section 6),
• if you are taking any medicine that contains another soluble guanylate cyclase stimulator, for example, riociguat, which is used to treat high blood pressure in the lungs.

If any of these conditions apply to you, talk to your doctorbefore taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking Verquvo if you have

• low blood pressurewith symptoms such as dizziness or lightheadedness,
• severe kidney problemsor are on dialysis treatment,
• severe liver problems.

Children and adolescents

Do not give this medicine to children or adolescents under 18 years of age, as it has not been studied in this age group yet.

Other medicines and Verquvo

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, especially medicines that

• belong to the group of soluble guanylate cyclase stimulators (e.g., riociguat). Do not take Verquvo during treatment with these medicines. See "Do not take Verquvo".
• treat high blood pressure in the lungs, or medicines to achieve or maintain an erection, called PDE5 inhibitors (e.g., sildenafil, tadalafil, vardenafil). It is not recommended to use these medicines during treatment with Verquvo.
• treat heart diseases, including chest pain, called nitrates (e.g., isosorbide mononitrate).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Verquvo should not be used during pregnancy, as it is not known if it can harm the unborn baby. If you can become pregnant, ask your doctor about reliable methods of birth control.

Breastfeeding

It is not known if Verquvo passes into breast milk and if it can harm your baby. Your doctor will decide with you whether to stop breastfeeding or stop Verquvo treatment.

Driving and using machines

If you feel dizzy during treatment with this medicine, do not drive vehicles, ride bicycles, or use machines.

Verquvo contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, ask your doctor before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Verquvo

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

The recommended initial dose is 1tablet of 2.5mgonce a day. Your doctor will then adjust the dose based on how well you tolerate the treatment. Usually, your doctor will increase the dose after about 2 weeks to 1 tablet of 5 mg once a day and after about another 2 weeks to the maximum target dose of 1tablet of 10mgonce a day.

If you have low blood pressureduring treatment with Verquvo, this may make you feel dizzy and lightheaded, and your doctor may temporarily reduce your dose of Verquvo or stop your treatment with Verquvo.

Take one tablet at the same time every day with food. If you cannot swallow the tablet, you can crush Verquvo and mix it with water. Take this mixture immediately.

If you take more Verquvo than you should

Talk to your doctor immediately if you take more Verquvo than you should and experience any of the side effects listed in section 4. The most likely effect would be a drop in blood pressure, which can make you feel dizzy and lightheaded.

If you forget to take Verquvo

Take the missed tablet as soon as you remember on the same day as the missed dose. Do not take a double dose to make up for the missed tablet.

If you stop taking Verquvo

Do not stop taking this medicine without talking to your doctor first. If you stop taking this medicine, your condition may get worse.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Possible side effects are:

Very common(may affect more than 1 in 10 people)

• low blood pressure (hypotension)

Common(may affect up to 1 in 10 people)

• low red blood cell count (anemia), which can cause pale skin, weakness, or difficulty breathing
• dizziness
• headache
• nausea and vomiting
• indigestion (dyspepsia)
• heartburn (gastroesophageal reflux disease)

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Verquvo

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on each blister or bottle after "EXP". The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Verquvo

• The active substance is vericiguat. Each film-coated tablet contains 2.5 mg, 5 mg, or 10 mg of vericiguat.
• The other ingredients are: Tablet core: Microcrystalline cellulose, sodium croscarmellose, hypromellose 2910, lactose monohydrate, magnesium stearate, sodium lauryl sulfate (see section 2 "Verquvo contains lactose and sodium"). Film coating: Hypromellose 2910, talc, titanium dioxide (E171), red iron oxide (E172) (only Verquvo 5 mg), yellow iron oxide (E172) (only Verquvo 10 mg).

Appearance and packaging

Verquvo 2.5 mg film-coated tablets (tablets) are round, biconvex, and white with a diameter of 7 mm, marked with "2.5" on one side and "VC" on the other.

Verquvo 5 mg film-coated tablets (tablets) are round, biconvex, and reddish-brown with a diameter of 7 mm, marked with "5" on one side and "VC" on the other.

Verquvo 10 mg film-coated tablets (tablets) are round, biconvex, and yellow-orange with a diameter of 9 mm, marked with "10" on one side and "VC" on the other.

Verquvo is available

• in blisters in packs of 14, 28, or 98 film-coated tablets
• in unit-dose blisters in packs of 10 x 1 or 100 x 1 film-coated tablets
• in bottles of 100 film-coated tablets

Not all pack sizes may be marketed.

Marketing authorization holder

Bayer AG

51368 Leverkusen

Germany

Manufacturer

Bayer AG

Kaiser-Wilhelm-Allee

51368 Leverkusen

Germany

You can get more information about this medicine by contacting the local representative of the marketing authorization holder:

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.