Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

Renal excretion is the main route of elimination of prucalopride (see section 5.2). A dose of 1 mg is recommended in subjects with severe renal impairment (see section 4.2).

Caution should be exercised when prescribing Resolor to patients with severe hepatic impairment (Child-Pugh class C) due to limited data in patients with severe hepatic impairment (see section 4.2).

There is limited information on the safety and efficacy of Resolor for use in patients with severe and clinically unstable concomitant disease (e.g. cardiovascular or lung disease, neurological or psychiatric disorders, cancer or AIDS and other endocrine disorders). Caution should be exercised when prescribing Resolor to patients with these conditions especially when used in patients with a history of arrhythmias or ischaemic cardiovascular disease.

In case of severe diarrhoea, the efficacy of oral contraceptives may be reduced and the use of an additional contraceptive method is recommended to prevent possible failure of oral contraception (see the prescribing information of the oral contraceptive).

Suicidal Ideation and Behaviour
In clinical trials, suicides, suicide attempts, and suicidal ideation have been reported (see Section 4.8). A causal association between treatment with RESOLOR and an increased risk of suicidal ideation and behaviour has not been established.
Monitor all patients treated with RESOLOR for persistent worsening of depression or the emergence of suicidal thoughts and behaviours. Counsel patients, their caregivers, and family members of patients to be aware of any unusual changes in mood or behaviour and alert the healthcare provider. Instruct patients to discontinue RESOLOR immediately and contact their healthcare provider if they experience any of these symptoms.


The tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine 

Effects on Driving

4.7   Effects on ability to drive and use machines
Resolor may have a minor influence on the ability to drive and use machines, since dizziness and fatigue have been observed in clinical studies, particularly during the first day of treatment (see section 4.8).