Verquvo

Patient Information Leaflet

Verquvo 2.5 mg film-coated tablets, 5 mg film-coated tablets, 10 mg film-coated tablets

vericiguat
Please read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet. 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. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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, a type of heart medicine known as a
soluble guanylate cyclase stimulator.
Verquvo is used for the long-term treatment of adult patients with heart failure who have recently experienced worsening of symptoms. As a result, you may have been hospitalised and/or may have received an intravenous medicine (diuretic) to help you pass urine more than usual.
Heart failure occurs when the heart is weak and cannot pump enough blood around the body. Some common symptoms of heart failure include shortness of breath, fatigue, or swelling due to fluid retention.

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),
• you are taking any medicine containing another soluble guanylate cyclase stimulator, such as riociguat, used to treat high blood pressure in the lungs. If either of these applies to you, consult your doctor first and do not take this medicine.

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

• low blood pressure with symptoms such as dizziness or feeling lightheaded,
• severe kidney problems or are on dialysis,
• severe liver problems.

Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age, as it has not been studied in this age group.
Other medicines and Verquvo
Inform 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 at the same time as these medicines. See “Do not take Verquvo”.
• are used to treat high blood pressure in the lungs or medicines used to achieve or maintain erection, known as phosphodiesterase 5 (PDE5) inhibitors (e.g. sildenafil, tadalafil, vardenafil). The use of these medicines is not recommended while taking Verquvo.
• are used to treat heart conditions, including chest pain, known as nitrates (e.g. isosorbide mononitrate).

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Verquvo must not be used during pregnancy, as it is unknown whether it could harm the unborn baby. If there is a possibility you could become pregnant, discuss reliable methods of contraception with your doctor.
Breastfeeding
It is unknown whether Verquvo passes into breast milk and could harm the baby. Your doctor will decide together with you whether to stop breastfeeding or to stop treatment with Verquvo.

Driving and using machines
If you feel dizzy while taking this medicine, do not drive, ride a bicycle, or use any machinery.

Verquvo contains lactose and sodium
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, please consult them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially “sodium-free”.

3. How to take Verquvo

Take this medicine exactly as your doctor has told you. 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 according to your tolerance to the treatment. Usually, after about 2 weeks, your doctor will increase the dose up to the target maximum dose of 1 tablet of 10 mg once daily.
If you have had low blood pressure in the last 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. Usually, your doctor will increase the dose after about 2 weeks to 1 tablet of 5 mg once daily, and after another approximately 2 weeks to the maximum dose of 1 tablet of 10 mg once daily.
If you develop low blood pressure while taking Verquvo, you may experience dizziness or lightheadedness, and your doctor may temporarily reduce the dose of Verquvo or discontinue treatment with Verquvo.
Take one tablet every day at the same time with food. If you are unable to swallow the Verquvo tablet, you may crush it and mix it with a small amount of water. Take the resulting 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 side effects listed in section 4. The most likely side effect would be a drop in blood pressure, which may cause dizziness or lightheadedness.
If you forget to take Verquvo
Take the missed tablet as soon as you remember, on the same day that you missed the dose. Do not take a double dose to make up for the forgotten tablet.
If you stop taking Verquvo
Do not stop taking this medicine without first talking to your doctor. If you stop taking this medicine, your condition may worsen.
If you have any questions about how to use this medicine, speak to your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience 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 (anaemia) which may cause pale skin, weakness or breathlessness
• dizziness
• headache
• nausea and vomiting
• indigestion (dyspepsia)
• heartburn (gastro-oesophageal reflux disease)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly through the national reporting system detailed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 bottle after “Exp./EXP”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Verquvo contains

• 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, 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 (E 171), iron oxide red (E 172) (only in Verquvo 5 mg), iron oxide yellow (E 172) (only in Verquvo 10 mg).

Description of the appearance of Verquvo and contents of the pack
Verquvo 2.5 mg film-coated tablets (tablets) are round, biconvex, 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, 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, yellow-orange, 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
• Perforated unit-dose blister packs in boxes of 10 × 1 or 100 × 1 film-coated tablets
• Bottles containing 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
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
België/Belgique/Belgien Lietuva
Bayer SA-NV UAB Bayer
Tél/Tel: +32-(0)2-535 63 11 Tel: +37 05 23 36 868
България Luxembourg/Luxemburg
Байер България ЕООД Bayer SA-NV
Tел.: +359-(0)2-424 72 80 Tél/Tel: +32-(0)2-535 63 11
Česká republika Magyarország
Bayer s.r.o. Bayer Hungária KFT
Tel: +420 266 101 111 Tel.: +36 14 87-41 00
Danmark Malta
Bayer A/S Alfred Gera and Sons Ltd.
Tlf.: +45 45 23 50 00 Tel: +35 621 44 62 05
Deutschland Nederland
Bayer Vital GmbH Bayer B.V.
Tel: +49 (0)214-30 513 48 Tel: +31-(0)23-799 1000
Eesti Norge
Bayer OÜ Bayer AS
Tel: +372 655 8565 Tlf: +47 23 13 05 00
Ελλάδα Österreich
Bayer Ελλάς ΑΒΕΕ Bayer Austria Ges.m.b.H.
Τηλ: +30-210-61 87 500 Tel: +43-(0)1-711 46-0
España Polska
Bayer Hispania S.L. Bayer Sp. z o.o.
Tel: +34-93-495 65 00 Tel.: +48 22 572 35 00
France Portugal
Bayer HealthCare Bayer Portugal, Lda.
Tél (N° vert): +33-(0)800 87 54 54 Tel: +351 21 416 42 00
Hrvatska România
Bayer d.o.o. SC Bayer SRL
Tel: +385-(0)1-6599 900 Tel: +40 21 529 59 00
Ireland Slovenija
Bayer Limited Bayer d. o. o.
Tel: +353 1 216 3300 Tel: +386 (0)1 58 14 400
Ísland Slovenská republika
Icepharma hf. Bayer spol. s r.o.
Sími: +354 540 8000 Tel.: +421 2 59 21 31 11
Italia Suomi/Finland
Bayer S.p.A. Bayer Oy
Tel: +39 02 397 8 1 Puh/Tel: +358- 20 785 21
Κύπρος Sverige
NOVAGEM Limited Bayer AB
Tηλ: +357 22 48 38 58 Tel: +46 (0) 8 580 223 00
Latvija
SIA Bayer
Tel: +371 67 84 55 63
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu.