PRAVAFEN HARD CAPSULES 40MG/160MG [SIN14508P]

Product Info

PRAVAFEN HARD CAPSULES 40MG/160MG

[SIN14508P]

4.1 Therapeutic indications

Pravafen is indicated as an adjunct to diet to reduce triglyceride (TG) and increase HDL-C in high coronary heart disease (CHD) -risk adult patients with mixed dyslipidemia whose LDL-C levels are adequately controlled while on a treatment with pravastatin 40 mg monotherapy.

No incremental benefit of Pravafen on cardiovascular morbidity and mortality has been established over and above that demonstrated for statin monotherapy.

4.2 Posology and method of administration

Prior to initiating Pravafen, secondary causes of combined dyslipidaemia should be excluded and patients should be placed on a standard cholesterol and triglycerides-lowering diet which should be continued during treatment.

Posology
The recommended dose is one capsule per day. Dietary restrictions instituted before therapy should be continued.

Response to therapy should be monitored by determination of serum lipid values. Treatment should be discontinued if an adequate response has not been achieved within three months.

Special populations
Elderly patients (≥ 65 years old)
Treatment initiation with Pravafen should be decided after renal function has been evaluated (see section 4.4 Renal and urinary disorders – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Limited safety data on Pravafen is available in patients >75 years of age and care should be exercised.

Renal impairment
No modification of posology should be necessary in patients with mild renal impairment.
Pravafen is contraindicated in patients with moderate to severe renal impairment (defined as a creatinine clearance < 60 ml/min) (See section 4.3).

Hepatic impairment
No posology adjustment is required in patients with mild hepatic impairment. Pravafen is not recommended in patients with moderate hepatic impairment and is contraindicated in patients with severe hepatic impairment (see section 4.3).

Paediatric population (< 18 years old)
There is no relevant use of Pravafen in the paediatric population in the indication of mixed dyslipidaemia (see section 4.3).

Method of administration
The recommended dose is one capsule taken daily during the evening meal. Since it is less well absorbed from an empty stomach, Pravafen should always be taken with food (see sections 4.5 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.3 Contraindications

• Hypersensitivity to the active substances or to any of the excipients.

• Severe hepatic impairment including biliary cirrhosis or active liver disease including unexplained persistent elevations in liver function tests (including serum transaminase elevation) exceeding 3 fold the upper limit of normal (ULN) (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Children and adolescents (age below 18 years).

• Moderate to severe renal impairment (defined as an estimated creatinine clearance < 60 ml/min).

• Known photo allergy or photo toxic reaction during treatment with fibrates or ketoprofen.

• Gallbladder disease (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridaemia (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Pregnancy and breast feeding (see section 4.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Personal history of myopathy and/or rhabdomyolysis with statins and/or fibrates or confirmed creatine phosphokinase (CK) elevation above 5 times the upper limit of normal (ULN) under previous statin treatment (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).