PRAVAFENIX Hard capsule Ref.[51225] Active ingredients: Fenofibrate Pravastatin Pravastatin and Fenofibrate

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

Product name and form

Pravafenix 40 mg/160 mg hard capsules.

Pharmaceutical Form

Hard capsule.

Hard capsule, with light green body and olive cap, containing a waxy white beige mass and a tablet.

Qualitative and quantitative composition

Each hard capsule contains 40 mg pravastatin sodium and 160 mg fenofibrate.

Excipient(s) with known effect: Each hard capsule contains 19 mg of lactose monohydrate and 33.3 mg of sodium.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Fenofibrate

Fenofibrate is a fibric acid derivative whose lipid modifying effects reported in humans are mediated via activation of Peroxisome Proliferator Activated Receptor type α (PPARα). Through activation of PPARα, fenofibrate increases lipolysis and elimination of atherogenic triglyceride rich particles from plasma by activating lipoprotein lipase and reducing production of Apoprotein C-III.

Pravastatin

Pravastatin is a competitive inhibitor of 3-hydroxy–3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme catalyzing the early rate limiting step in cholesterol biosynthesis, and produces its lipid lowering effect in two ways.

Pravastatin and Fenofibrate

Pravastatin and fenofibrate, which have different modes of action, show additive effects in terms of reduction of serum lipid. Pravastatin is more effective in reducing LDL-C and total cholesterol but presents only modest effects on TG and HDL-C while fenofibrate is very effective in decreasing TG and increasing HDL-C, but with few effects on LDL-C. Additionally, fibrates have the properties to modify the size and density of LDL-C particles to make them less atherogenic.

List of Excipients

Capsule content:

Lactose monohydrate
Cellulose microcrystalline
Ascorbyl palmitate
Povidone K29-32
Sodium starch glycolate
Magnesium stearate
Talc
Triacetin
Sodium hydrogen carbonate
Lauroyl macrogolglycerides Type 1500
Hydroxypropylcellulose
Macrogol 20 000

Capsule shell:

Gelatine
Indigo carmine
Black iron oxide
Titanium dioxide
Yellow iron oxide

Pack sizes and marketing

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.

Marketing authorization holder

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

Marketing authorization dates and numbers

EU/1/11/679/001-007

Date of first authorisation: 14 April 2011
Date of latest renewal: 14 January 2016

Drugs

Drug Countries
PRAVAFENIX Austria, Cyprus, Estonia, Spain, France, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland

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