Verquvo

Posology Vericiguat is administered in conjunction with other heart failure therapies. 1). The recommended starting dose is 5 mg vericiguat once daily. The dose should be doubled after approximately 2 weeks to reach the target maintenance dose of 10 mg once daily, as tolerated by the patient.

5 mg vericiguat once daily. The dose should be doubled approximately every 2 weeks to reach the target maintenance dose of 10 mg once daily, as tolerated by the patient. 4). 4). Missed dose If a dose is missed, it should be taken as soon as the patient remembers on the same day of the missed dose.

Patients should not take two doses of vericiguat on the same day. 2). 73 m2 (without dialysis). 2). Hepatic impairment No dose adjustment is required in patients with mild or moderate hepatic impairment. 2). Paediatric population The safety and efficacy of vericiguat in children and adolescents aged below 18 years have not yet been established.

No clinical data are available. 3). 4 Method of administration For oral use. 2). 2).

4%). 1). 6 years. The adverse reactions reported with vericiguat obtained from clinical studies are listed in the table below by MedDRA system organ class and by frequency. Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), and very rare (<1/10,000).

Table 1:

Adverse reactions Description of selected adverse reactions Hypotension Over the course of the VICTORIA study, the mean reduction in systolic blood pressure was approximately 1 to 2 mmHg greater in patients who received vericiguat compared with placebo.

9% of placebo-treated patients. 0% of placebo-treated patients. 4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V. MedDRA system organ class Very common Common Blood and lymphatic system disorders Anaemia Nervous system disorders Dizziness Headache Vascular disorders Hypotension Gastrointestinal disorders Nausea Dyspepsia Vomiting Gastro-oesophageal reflux disease 8

4. Verquvo 5 mg film-coated tablets Each film-coated tablet contains 5 mg vericiguat. 4. Verquvo 10 mg film-coated tablets Each film-coated tablet contains 10 mg vericiguat. 4. 1. 3. 5” on one side and “VC” on the other side. Verquvo 5 mg film-coated tablets Round, biconvex, brown-red film-coated tablet with a diameter of 7 mm, marked with “5” on one side and “VC” on the other side.

Verquvo 10 mg film-coated tablets Round, biconvex, yellow-orange film-coated tablet with a diameter of 9 mm, marked with “10” on one side and “VC” on the other side. 3 4. 1). 2 Posology and method of administration Posology Vericiguat is administered in conjunction with other heart failure therapies.

1). The recommended starting dose is 5 mg vericiguat once daily. The dose should be doubled after approximately 2 weeks to reach the target maintenance dose of 10 mg once daily, as tolerated by the patient. 5 mg vericiguat once daily.

The dose should be doubled approximately every 2 weeks to reach the target maintenance dose of 10 mg once daily, as tolerated by the patient. 4). 4). Missed dose If a dose is missed, it should be taken as soon as the patient remembers on the same day of the missed dose.

Patients should not take two doses of vericiguat on the same day. 2). 73 m2 (without dialysis). 2). Hepatic impairment No dose adjustment is required in patients with mild or moderate hepatic impairment. 2). Paediatric population The safety and efficacy of vericiguat in children and adolescents aged below 18 years have not yet been established.

No clinical data are available. 3). 4 Method of administration For oral use. 2). 2). 1. 5). 8). Patients with SBP less than 100 mmHg or symptomatic hypotension at treatment initiation were not studied. 5). 2). 5). 2). 2). Excipients Lactose This medicinal product contains lactose.

Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-free”.

1. 5).