RESOLOR FILM-COATED TABLET 2 MG

JANSSEN CILAG S.P.A. - ITALYSANICO NV (BELGIUM)🇸🇬 Health Sciences Authority

Approval Date: Feb 14, 2012
Approval ID: 9e15b9c27e200807
Company: JANSSEN CILAG S.P.A. - ITALYSANICO NV (BELGIUM)
Type: Therapeutic

Approval Details

Approval Id: 9e15b9c27e200807
Drug Name: RESOLOR FILM-COATED TABLET 2 MG
Product Name: RESOLOR FILM-COATED TABLET 2 MG
Approval Number: SIN14104P
Approval Date: 2012-02-14
Registrant: DCH AURIGA SINGAPORE
Licence Holder: DCH AURIGA SINGAPORE
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: TABLET, FILM COATED
Dosage: Dosage and Administration Dosage Adults 2 mg once daily Elderly (> 65 years) Start with 1 mg once daily (see Pharmacokinetic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information); if needed the dose can be increased to 2 mg once daily. Children and adolescents RESOLOR® is not recommended in children and adolescents younger than 18 years (see Pediatric Population and Clinical Studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Patients with renal impairment The dose for patients with severe renal impairment (GFR < 30 ml/min/1.73 m2) is 1 mg once daily (see Contraindications and Pharmacokinetic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). No dose adjustment is required for patients with mild to moderate renal impairment. Patients with hepatic impairment The dose for patients with severe hepatic impairment (Child-Pugh class C) is 1 mg once daily (see Warnings and Precautions and Pharmacokinetic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). No dose adjustment is required for patients with mild to moderate hepatic impairment. Due to the specific mode of action of prucalopride (stimulation of propulsive motility) exceeding the daily dose of 2mg is not expected to increase in efficacy. It has also been shown in clinical trials, a doubling of the daily dose to 4mg did not lead to an increase in efficacy. If the intake of once daily prucalopride is not effective after 4 weeks of treatment, the patient should be re-examined and the benefit of continuing treatment reconsidered. The efficacy of prucalopride has been established in double-blind placebo controlled studies for up to 3 months. If treatment is continued longer than 3 months, the benefit should be reassessed at regular intervals. Administration RESOLOR® film-coated tablets are for oral use and can be taken with or without food.
Route Of Administration: ORAL
Indication Info: Indications RESOLOR® is indicated for symptomatic treatment of chronic idiopathic constipation in adults in whom laxatives fail to provide adequate relief.
Contraindications: Contraindications <ul class="dash"> <li>Hypersensitivity to the active substance or to any of the excipients.</li> <li>Renal impairment requiring dialysis.</li> <li>Intestinal perforation or obstruction due to structural or functional disorder of the gut wall, obstructive ileus, severe inflammatory conditions of the intestinal tract, such as Crohn’s disease, ulcerative colitis and toxic megacolon/ megarectum.</li> </ul>
Atc Code: A03AE04
Atc Item Name: xa 03 ae 04
Pharma Manufacturer Name: DCH AURIGA SINGAPORE
Company Detail Path: /organization/dch-auriga-singapore

Active Ingredients

Prucalopride succinate 2.642mg eqv Prucalopride

2mg

PRUCALOPRIDE SUCCINATE 2.642 MG EQV PRUCALOPRIDE

2 MG

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Feb 14, 2012

Approval ID

9e15b9c27e200807

Type

Therapeutic

Back to HSA Approvals