PARMODIA FILM-COATED TABLETS 0.1 MG [SIN16492P]

Product Info

PARMODIA FILM-COATED TABLETS 0.1 MG

[SIN16492P]

4.1 Therapeutic indications

PARMODIA is indicated as adjunctive therapy to diet or other nonpharmacological treatment (e.g. exercise) to reduce TG and to increase HDL-C in patients with dyslipidemia characterised by high TG ≥150 mg/dL, particularly when there is evidence of associated risk such as hypertension and smoking.

4.2 Posology and method of administration

Patients should be on a lipid-lowering diet before the initiation of PARMODIA, and should continue dietary control during treatment. Serum lipid levels should be monitored periodically. If an adequate response has not been achieved, complementary or different therapeutic measures should be considered.

Posology
Adult
The usual adult dose is 0.1 mg twice daily. The dose may be individualized according to the patient’s age and symptoms. The maximum dose is 0.2 mg twice daily.

Elderly
No dose adjustment is necessary.

Since elderly patients often have reduced physiological function, PARMODIA should be carefully administered with close monitoring for signs of adverse reactions and clinical status of the patient.

Pediatric population
The safety of PARMODIA in low birth weight infants, newborns, infants, and children has not been established. No data are available.

Patients with renal impairment
PARMODIA should be used with caution in patients with renal impairment defined as estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m². A lower starting dose or prolonged dosing intervals should be considered. The maximum dose is 0.2 mg daily (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Patients with hepatic impairment
PARMODIA should be used with caution in patients with hepatic disorder (Child-Pugh grade A cirrhosis, etc.) or a history of hepatic disorder. Dose reduction should be considered as necessary (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

PARMODIA is contraindicated in patients with severe hepatic disorder, Child-Pugh grade B or C cirrhosis, or biliary obstruction (see section 4.3 and section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Method of administration
PARMODIA should be taken orally twice daily in the morning and evening. PARMODIA can be taken without regard to meals.

4.3 Contraindications

PARMODIA is contraindicated:

• in patients with known hypersensitivity to pemafibrate or to any of the excipients

• in patients with severe hepatic disorder, Child-Pugh grade B or C cirrhosis, or biliary obstruction

• in patients with cholelithiasis

• in pregnant or possibly pregnant women

• in patients receiving concomitant cyclosporine or rifampicin