Verquvo 5 mg film-coated tablets

• 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.

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

• allergic to vericiguat or any of the other ingredients of this medicine (listed in section 6),
• taking any medicine that contains another soluble guanylate cyclase stimulator, e.g. riociguat used to treat high blood pressure in lungs.

If any of the above applies to you, talk to your doctor first and do not take this medicine.

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

• low blood pressure with symptoms like dizziness or light-headedness,
• severe kidney problems or are on dialysis,
• severe liver problems.

Do not give this medicine to children and adolescents aged under 18 years because it has not been studied yet in this age group.

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

• belong to the group of soluble guanylate cyclase stimulators (e.g. riociguat). Do not take Verquvo when taking 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). The use of these medicines is not recommended when taking Verquvo.
• treat heart disease including chest pain, called nitrates (e.g. isosorbide mononitrate).

If you are pregnant or breast-feeding, 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 harms the unborn baby. If there is a chance that you could become pregnant, talk to your doctor about reliable forms of contraception.

Breast-feeding

It is not known if Verquvo passes into your breast milk and could harm your baby. Your doctor will decide with you whether breast-feeding or Verquvo therapy should be stopped.

If you feel dizzy while taking this medicine, do not drive a vehicle, cycle or use any machines.

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

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

Contact your doctor immediately if you take more Verquvo than you should and you get any side effects listed in section 4. The most likely effect would be a lowering of your blood pressure which can make you feel dizzy and light-headed.

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 a forgotten tablet.

Do not stop taking this medicine without speaking with your doctor first. If you stop taking this medicine, your condition may worsen.

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 can cause pale skin, weakness or breathlessness
• dizziness
• headache
• nausea and vomiting
• indigestion (dyspepsia)
• heartburn (gastro-oesophageal reflux disease)

If you get 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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

• The active substance is vericiguat. Each film-coated tablet contains 2.5 mg, 5 mg or 10 mg vericiguat.
• The other ingredients are:
  Tablet core: Microcrystalline cellulose, croscarmellose sodium, hypromellose 2910, lactose monohydrate, magnesium stearate, sodium laurilsulfate (see section 2 “Verquvo contains lactose and sodium”).
  Film-coat: Hypromellose 2910, talc, titanium dioxide (E 171), iron oxide red (E 172) (Verquvo 5 mg only), iron oxide yellow (E 172) (Verquvo 10 mg only).

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 side.

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

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 side.

Verquvo is available

• in blisters in cartons of 14, 28 or 98 film-coated tablets
• in perforated unit dose blisters in cartons of 10 × 1 or 100 × 1 film-coated tablets
• in bottles of 100 film-coated tablets

Not all pack sizes may be marketed.