TRICOR TABLET 160 MG [SIN17013P]

Product Info

TRICOR TABLET 160 MG

[SIN17013P]

4.1 Therapeutic indications
Hypercholesterolaemia and hypertriglyceridaemia alone or combined (types IIa, IIb, IV dyslipidaemias, as well as types III and V dyslipidaemias) in patients unresponsive to dietary and other non-drug therapeutic measures (e.g. weight reduction or increased physical activity), particularly when there is evidence of associated risk such as hypertension and smoking.

The treatment of secondary hyperlipoproteinaemias is indicated if the hyperlipoproteinaemia persists despite effective treatment of the underlying disease (e.g. dyslipidaemia in diabetes mellitus).

Appropriate dietary measures initiated before therapy should be continued.

4.2 Posology and method of administration
Response to therapy should be monitored by determination of serum lipid values (total cholesterol, LDL-Cholesterol, triglycerides), if an adequate response has not been achieved after several months (e.g. 3 months) complementary or different therapeutic measures should be considered.

Posology:
Adults: The recommended dose of TRICOR TABLET 160 mg tablets is one tablet taken once daily. Patients currently taking one 160mg tablet can be changed to one 145mg fenofibrate tablet without further dose adjustment.

Special populations
Geriatric population:
In elderly patients, without renal impairment, the usual adult dose is recommended in elderly patients.

Renal impairment: Dosage reduction is required in patients with renal impairment.

In moderate chronic kidney disease (creatinine clearance 30 to 59 mL/min), and if a low dose is available, start with one capsule of 100 mg standard or 67 mg micronized once daily.

If no low dose is available, then fenofibrate is not recommended.
In patients with chronic kidney disease (creatinine clearance < 30ml/min), fenofibrate is contraindicated.

Hepatic impairment: TRICOR TABLET 160 is not recommended for use in patients with hepatic impairment due to lack of data.

Paediatric population: The safety and efficacy of fenofibrate in children and adolescents younger than 18 years has not been established. No data are available. Therefore the use of fenofibrate is not recommended in paediatric subjects under 18 years.

Method of administration: Tablets should be swallowed whole during a meal.

4.3 Contraindications

• Hepatic insufficiency (including biliary cirrhosis and unexplained persistent liver function abnormality),

• Known gallbladder disease

• Severe chronic kidney disease,

• Chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridemia,

• Known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen,

• Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

TRICOR TABLET 160 mg should not be taken in patients allergic to peanut or arachis oil or soya lecithin or related products due to the risk of hypersensitivity reactions.