Verquvo 10 mg comprimidos recubiertos con pelicula

Product Information for the Patient

Verquvo 2.5 mg Film-Coated Tablets

Verquvo 5 mg Film-Coated Tablets

Verquvo 10 mg Film-Coated Tablets

vericiguat

This product is subject to additional monitoring, which will expedite the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this entire product information carefully before starting to take this medicine, as it contains important information for you.

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

1.What is Verquvo and for what it is used

2.What you need to know before starting to take Verquvo

3.How to take Verquvo

4.Possible adverse effects

5.Storage of Verquvo

6.Contents of the package and additional information

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

Verquvo is used to treat adults with long-term heart failure who have recently experienced an increase in heart failure symptoms. Therefore, you may have been hospitalized and/or received a medication (diuretic) administered through a vein to help you urinate more frequently.

There is heart failure when the heart is weak and cannot pump enough blood to the body. Common symptoms of heart failure include difficulty breathing, fatigue, or swelling caused by fluid accumulation.

Do not take Verquvo

• if you areallergicto vericiguat or any of the other components of this medication (listed in section6),
• if you are taking any medication that contains anothersoluble guanylate cyclase stimulator, for example, riociguat, which is used to treat high blood pressure in the lungs.

If you apply to any of these circumstances,talk to your doctor firstand do not take this medication.

Warnings and precautions

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

• low blood pressurewith symptoms such as dizziness or lightheadedness,
• serious kidney problemsor are undergoingtreatment with dialysis,
• serious liver problems.

Children and adolescents

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

Other medications and Verquvo

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication, in particular medications that

• pertain to the group of soluble guanylate cyclase stimulators (for example, riociguat). Do not take Verquvo during treatment with these medications. See “Do not take Verquvo”.
• are used to treat high blood pressure in the lungs, or medications to achieve or maintain an erection, known as PDE5 inhibitors (for example, sildenafilo, tadalafilo, vardenafilo). It is not recommended to use these medications during treatment with Verquvo.
• are used to treat heart disease, including chest pain, known as nitrates (for example, isosorbide mononitrate).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Verquvo should not be used during pregnancy, as it is not known if it harms the fetus. If there is a possibility that you may become pregnant, consult your doctor about reliable contraceptive methods.

Breastfeeding

It is unknown if Verquvo passes into breast milk and if it could harm your baby. Your doctor will decide with you whether to interrupt breastfeeding or the treatment with Verquvo.

Driving and operating machinery

If you feel dizzy during treatment with this medication, do not drive vehicles, ride a bicycle, or use machines.

Verquvo contains lactose and sodium

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication.

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

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

If you havelow blood pressureduring treatment with Verquvo, this may cause you to feel dizzy and disoriented, and your doctor may temporarily reduce your Verquvo dose or interrupt your Verquvo treatment.

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

Consult your doctor immediately if you take more Verquvo than you should and experience any of the adverse effects listed in section4. The most likely effect would be a drop in blood pressure that may cause you to feel dizzy and disoriented.

If you forget to take Verquvo

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

If you interrupt treatment with Verquvo

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

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The possible adverse effects are:

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

• low blood pressure (hypotension)

Frequent(may affect up to 1 in 10people)

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly throughthe national notification system included in theAppendixV. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the box and on each blister or bottle after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of Verquvo

-The active ingredient is vericiguat. Each film-coated tablet contains 2.5mg, 5mg or 10mg of vericiguat.

-The other components are:
Core tablet:Microcrystalline cellulose, sodium croscarmellose, hypromellose 2910, lactose monohydrate, magnesium stearate, sodium lauryl sulfate (see section2 “Verquvo contains lactose and sodium”).
Film coating:Hypromellose 2910, talc, titanium dioxide (E171), iron oxide red (E172) (only Verquvo 5mg), iron oxide yellow (E172) (only Verquvo 10mg).

Appearance of the product and contents of the pack

Verquvo 2.5mg film-coated tablets are round, biconvex, white tablets with a diameter of 7mm, marked with “2.5” on one face and “VC” on the other.

Verquvo 5mg film-coated tablets are round, biconvex, brown-red tablets with a diameter of 7mm, marked with “5” on one face and “VC” on the other.

Verquvo 10mg film-coated tablets are round, biconvex, yellow-orange tablets with a diameter of 9mm, marked with “10” on one face and “VC” on the other.

Verquvo is available

• in blisters in boxes of 14, 28 or 98film-coated tablets
• in perforated unit dose blisters in boxes of 10x1 or 100x1 film-coated tablets
• in bottles of 100film-coated tablets

Only some pack sizes may be marketed.

Marketing authorisation holder

Bayer AG

51368 Leverkusen

Germany

Responsible for manufacturing

Bayer AG

Kaiser-Wilhelm-Allee

51368 Leverkusen

Germany

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Last update of the summary of product characteristics:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.