Verquvo 5 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Verquvo 2.5 mg film-coated tablets

Verquvo 5 mg film-coated tablets

Verquvo 10 mg film-coated tablets

vericiguat

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Verquvo is and what it is used for

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

Verquvo is used to treat adults with chronic heart failure who have recently experienced a worsening of heart failure symptoms. Therefore, you may have been hospitalized and/or received a medicine (a diuretic) given intravenously 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 include shortness of breath, fatigue, or swelling caused by fluid buildup.

2. What you need to know before taking Verquvo

Do not take Verquvo

• if you are allergic to vericiguat or to any of the other ingredients of this medicine (listed in section 6),
• if you are taking any medicine containing another soluble guanylate cyclase stimulator, for example, riociguat, which is used to treat pulmonary hypertension.

If either of these applies to you, talk to your doctor first and do not take this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Verquvo if you have

• low blood pressure with symptoms such as dizziness or lightheadedness,
• severe kidney problems or are undergoing dialysis,
• severe liver problems.

Children and adolescents

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

Other medicines and Verquvo

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

• belong to the group of soluble guanylate cyclase stimulators (for example, riociguat). Do not take Verquvo during treatment with these medicines. See “Do not take Verquvo”.
• treat high blood pressure in the lungs, or medicines used to achieve or maintain an erection, known as PDE5 inhibitors (for example, sildenafil, tadalafil, vardenafil). The use of these medicines is not recommended during treatment with Verquvo.
• treat heart conditions, including chest pain, known as nitrates (for example, isosorbide mononitrate).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Verquvo must not be used during pregnancy, as it is unknown whether it harms the unborn baby. If you could become pregnant, consult your doctor about reliable contraceptive methods.

Breastfeeding

It is unknown whether Verquvo passes into breast milk and could harm your baby. Your doctor will decide with you whether breastfeeding or treatment with Verquvo should be discontinued.

Driving and using machines

If you feel dizzy while being treated with this medicine, do not drive, ride a bicycle, or operate machinery.

Verquvo contains lactose and sodium

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

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; that is, essentially “sodium-free”.

3. How to take Verquvo

Follow exactly the instructions for administration of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist.

The recommended starting dose is 1 tablet of 5 mg once daily. Your doctor will then adjust the dose depending on how well you tolerate the treatment. Generally, your doctor will increase the dose after about 2 weeks to the maximum target dose of 1 tablet of 10 mg once daily.

If you have had low blood pressure in the past 4 weeks, the recommended starting dose is 1 tablet of 2.5 mg once daily. Your doctor will then adjust the dose depending on how well you tolerate the treatment. Generally, your doctor will increase the dose after about 2 weeks to 1 tablet of 5 mg once daily, and after approximately another 2 weeks to the maximum target dose of 1 tablet of 10 mg once daily.

If you have low blood pressure during treatment with Verquvo, this may cause you to feel dizzy and lightheaded, and your doctor may temporarily reduce your dose of Verquvo or interrupt your treatment with Verquvo.

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

If you take more Verquvo than you should

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

If you forget to take Verquvo

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

If you stop taking Verquvo

Do not stop treatment with this medicine without first talking to your doctor. If you stop treatment with this medicine, your condition may worsen.

If you have any further 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 number of red blood cells (anaemia), which may cause paleness of the skin, weakness, or difficulty breathing
• dizziness
• headache
• nausea and vomiting
• indigestion (dyspepsia)
• heartburn (gastro-oesophageal reflux disease)

Reporting of side effects

If you experience any type of side effect, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the national reporting system included 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 stated on the carton and on each blister or vial after “EXP”. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging when they are no longer needed. 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 components are:
  Tablet core: Microcrystalline cellulose, croscarmellose sodium, hypromellose 2 910, lactose monohydrate, magnesium stearate, sodium lauryl sulfate (see section 2 “Verquvo contains lactose and sodium”).
  Film coating: Hypromellose 2910, talc, titanium dioxide (E171), iron oxide red (E172) (only Verquvo 5 mg), iron oxide yellow (E172) (only Verquvo 10 mg).

Appearance of the product and contents of the container

Verquvo 2.5 mg film-coated tablets (tablets) are round, biconvex, white tablets 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, reddish-brown tablets 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, yellow-orange tablets with a diameter of 9 mm, marked with “10” on one side and “VC” on the other.

Verquvo is available:

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

Some pack sizes may not be marketed.

Marketing Authorization Holder

Bayer AG
51368 Leverkusen
Germany

Manufacturer

Bayer AG
Kaiser-Wilhelm-Allee
51368 Leverkusen
Germany

For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Other sources of information

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