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.
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 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
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
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)
Frequent(may affect up to 1 in 10people)
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
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:
België/Belgique/Belgien Bayer SA-NV Tél/Tel: +32-(0)2-535 63 11 | Lietuva UAB Bayer Tel. +37 05 23 36 868 |
???????? ????? ???????? ???? T??.: +359 02 4247280 | Luxembourg/Luxemburg Bayer SA-NV Tél/Tel: +32-(0)2-535 63 11 |
Ceská republika Bayer s.r.o. Tel: +420 266 101 111 | Magyarország Bayer Hungária KFT Tel: +36 14 87-41 00 |
Danmark Bayer A/S Tlf: +45 45 23 50 00 | Malta Alfred Gera and Sons Ltd. Tel: +35 621 44 62 05 |
Deutschland Bayer Vital GmbH Tel: +49 (0)214-30 513 48 | Nederland Bayer B.V. Tel: +31-(0)297-28 06 66 |
Eesti Bayer OÜ Tel: +372 655 8565 | Norge Bayer AS Tlf:+47 23 13 05 00 |
Ελλ?δα Bayer Ελλ?ς ΑΒΕΕ Τηλ: +30-210-61 87 500 | Österreich Bayer Austria Ges.m.b.H. Tel: +43-(0)1-711 46-0 |
España Bayer Hispania S.L. Tel: +34-93-495 65 00 | Polska Bayer Sp. z o.o. Tel: +48 22 572 35 00 |
France Bayer HealthCare Tél (N° vert): +33-(0)800 87 54 54 | Portugal Bayer Portugal, Lda. Tel: +351 21 416 42 00 |
Hrvatska Bayer d.o.o. Tel: +385-(0)1-6599 900 | România SC Bayer SRL Tel: +40 21 529 59 00 |
Ireland Bayer Limited Tel: +353 1 216 3300 | Slovenija Bayer d. o. o. Tel: +386 (0)1 58 14 400 |
Ísland Icepharma hf. Sími:+354 540 8000 | Slovenská republika Bayer spol. s r.o. Tel. +421 2 59 21 31 11 |
Italia Bayer S.p.A. Tel: +39 02 397 8 1 | Suomi/Finland Bayer Oy Puh/Tel: +358- 20 785 21 |
Κ?προς NOVAGEM Limited Tηλ: +357 22 48 38 58 | Sverige Bayer AB Tel: +46 (0) 8 580 223 00 |
Latvija SIA Bayer Tel: +371 67 84 55 63 | United Kingdom (Northern Ireland) Bayer AG Tel: +44-(0)118 206 3000 |
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.
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