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HSA Approval

PARMODIA FILM-COATED TABLETS 0.1 MG

SIN16492P

PARMODIA FILM-COATED TABLETS 0.1 MG

PARMODIA FILM-COATED TABLETS 0.1 MG

May 18, 2022

DKSH SINGAPORE PTE. LTD.

DKSH SINGAPORE PTE. LTD.

Regulatory Information

DKSH SINGAPORE PTE. LTD.

DKSH SINGAPORE PTE. LTD.

Therapeutic

Prescription Only

Formulation Information

TABLET, FILM COATED

**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.

ORAL

Medical Information

**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.

**4.3 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

PENDING

xpending

Manufacturer Information

DKSH SINGAPORE PTE. LTD.

Kowa Company, Ltd., Nagoya Factory

Active Ingredients

Pemafibrate

0.1mg

Pemafibrate

Documents

Package Inserts

Parmodia Tablet PI.pdf

Approved: March 22, 2023

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PARMODIA FILM-COATED TABLETS 0.1 MG - HSA Approval | MedPath