Source: Health Sciences Authority (SG) Revision Year: 2021 Publisher: SMB Technology S.A., Rue du Parc Industriel 39, B-6900 Marche en Famenne, Belgium
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.
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.
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.
Treatment initiation with Pravafen should be decided after renal function has been evaluated (see section 4.4 Renal and urinary disorders). Limited safety data on Pravafen is available in patients >75 years of age and care should be exercised.
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.)
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.).
There is no relevant use of Pravafen in the paediatric population in the indication of mixed dyslipidaemia (see section 4.3).
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).
In the event of an overdose, symptomatic and supportive measures should be employed.
Reported cases of overdose were asymptomatic and did not give rise to abnormal laboratory tests. No specific antidote is known. If overdose is suspected, treat symptomatically and institute appropriate supportive measures as required.
No specific antidote is known. If an overdose is suspected, treat symptomatically and institute appropriate supportive measures as required. Fenofibrate cannot be eliminated by haemodialysis.
3 years.
Store below 30°C.
Opaque white HDPE bottles containing 30 hard capsules.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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