Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

Symptomatic hypotension

Vericiguat may cause symptomatic hypotension (see section 4.8). Patients with SBP less than 100 mmHg or symptomatic hypotension at treatment initiation were not studied.
The potential for symptomatic hypotension should be considered in patients with hypovolaemia, severe left ventricular outflow obstruction, resting hypotension, autonomic dysfunction, history of hypotension, or concomitant treatment with antihypertensives or organic nitrates (see section 4.5). If patients experience tolerability issues (symptomatic hypotension or SBP less than 90 mmHg), temporary down-titration or discontinuation of vericiguat is recommended (see section 4.2).
Concomitant use of vericiguat and PDE5 inhibitors, such as sildenafil, has not been studied in patients with heart failure and is therefore not recommended due to the potential increased risk for symptomatic hypotension (see section 4.5).

Renal impairment

Patients with eGFR <15 mL/min/1.73 m2 at treatment initiation or on dialysis have not been studied, therefore treatment with vericiguat is not recommended in these patients (see sections 4.2 and 5.2).

Hepatic impairment

Patients with severe hepatic impairment have not been studied, therefore treatment with vericiguat is not recommended in these patients (see sections 4.2 and 5.2).

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”.



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Effects on Driving

4.7   Effects on ability to drive and use machines

Vericiguat has minor influence on the ability to drive or use machines. When driving vehicles or operating machines it should be taken into account that dizziness may occur occasionally.