Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Laboratoires SMB s.a., Rue de la Pastorale, 26-28, B-1080 Brussels, Belgium Tel. +32 (2) 411 48 28 Fax. +32 (2) 411 28 28
Pravafenix is indicated as an adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight reduction) for the treatment of mixed hyperlipidaemia in adult patients at high cardiovascular risk to reduce triglycerides and increase HDL-C when LDL-C levels are adequately controlled while on a treatment with pravastatin 40 mg monotherapy.
Prior to initiating Pravafenix, 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. Rapid reduction of serum lipid levels usually follows Pravafenix treatment, but treatment should be discontinued if an adequate response has not been achieved within three months.
Treatment initiation with Pravafenix should be decided after renal function has been evaluated (see section 4.4 Renal and urinary disorders). Limited safety data on Pravafenix is available in patients >75 years of age and care should be exercised.
Pravafenix is contraindicated in patients with moderate to severe renal impairment (defined as a creatinine clearance <60 ml/min) (see section 4.3.).
No modification of posology should be necessary in patients with mild renal impairment.
Pravafenix is not recommended in patients with moderate hepatic impairment and is contraindicated in patients with severe hepatic impairment (see section 4.3.). No posology adjustment is required in patients with mild hepatic impairment.
There is no relevant use of Pravafenix in the paediatric population (<18 years old) for the indication of mixed dyslipidaemia (see section 4.3).
Oral use.
The recommended dose is one capsule taken daily during the evening meal. Since it is less well absorbed from an empty stomach, Pravafenix 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.
Polyamide-Aluminium-PVC/aluminium blister: 2 years.
HDPE bottle: 3 years.
This medicinal product does not require any special storage conditions.
Polyamide-Aluminium-PVC/aluminium blister packs containing 30, 60 and 90 hard capsules.
Opaque white HDPE bottles containing 14, 30, 60 and 90 hard capsules.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
