CHOLIB Film-coated tablet Ref.[51306] Active ingredients: Fenofibrate Simvastatin Simvastatin and Fenofibrate

Source: European Medicines Agency (EU)  Revision Year: 2023  Publisher: Viatris Healthcare Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, Dublin, Ireland

Product name and form

Cholib 145 mg/20 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (tablet).

Oval, biconvex, tan coloured, film-coated tablet, with bevelled edges and 145/20 on one side. The diameter dimensions are 19.3 × 9.3 mm approximately and the tablet weight is about 734 mg.

Qualitative and quantitative composition

One film-coated tablet contains 145 mg of fenofibrate and 20 mg of simvastatin.

Excipient(s) with known effect: One film-coated tablet contains 160.1 mg of lactose (as monohydrate), 145 mg of sucrose, 0.7 mg of lecithin (derived from soya bean (E322)) and 0.17 mg of sunset yellow FCF (E110).

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.

Simvastatin

Simvastatin has a potent activity in inhibiting HMG-CoA reductase (3-hydroxy–3-ethylglutaryl-CoA-reductase). Simvastatin has been shown to reduce both normal and elevated LDL-C concentrations.

Simvastatin and Fenofibrate

The effects of simvastatin and fenofibrate are complementary. Simvastatin has a potent activity in inhibiting HMG-CoA reductase, an enzyme that catalyses the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in the biosynthesis of cholesterol. Fenofibrate is a fibric acid derivative whose lipid modifying effects reported in humans are mediated via activation of Peroxisome Proliferator Activated Receptor type alpha (PPARα). Through activation of PPARα, fenofibrate activates lipoprotein lipase production and reduces production of apoprotein CIII.

List of Excipients

Tablet core:

Butylhydroxyanisole (E320)
Lactose monohydrate
Sodium laurilsulfate
Starch, pregelatinised (maize)
Docusate sodium
Sucrose
Citric acid monohydrate (E330)
Hypromellose (E464)
Crospovidone (E1202)
Magnesium stearate (E572)
Silicified microcrystalline cellulose (comprised of cellulose, microcrystalline and silica, colloidal anhydrous)
Ascorbic acid (E300)

Film-coating:

Poly (vinyl alcohol), partially hydrolysed (E1203)
Titanium dioxide (E171)
Talc (E553b)
Lecithin (derived from soya bean (E322))
Xanthan gum (E415)
Iron oxide red (E172)
Iron oxide yellow (E172)
Sunset yellow FCF (E110)

Pack sizes and marketing

Alu/Alu blisters.

Pack sizes: 10, 30 and 90 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Viatris Healthcare Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, Dublin, Ireland

Marketing authorization dates and numbers

EU/1/13/866/001-002
EU/1/13/866/005

Date of first authorisation: 26 August 2013
Date of latest renewal: 16 May 2018

Drugs

Drug Countries
CHOLIB Austria, Cyprus, Estonia, Hong Kong, Croatia, Ireland, Lithuania, Poland, Singapore, United Kingdom

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