IPOLIPID Hard gelatin capsule / Film-coated tablet Ref.[28138] Active ingredients: Gemfibrozil

Source: Υπουργείο Υγείας (CY)  Revision Year: 2015  Publisher: Medochemie Ltd, Constantinoupoleos 1-10, Limassol, Cyprus

Product name and form

Ipolipid 300mg capsules.

Ipolipid 600mg tablets.

Pharmaceutical Form

Hard gelatin capsules (300mg): Maroon – White, hard gelatin capsules, size “0” printed "Ipolipid"

Film coated tablets (600mg): White, capsule shaped, convex, scored, embossed “MC” with dimensions of nucleus 17.5 × 8 mm.

Qualitative and quantitative composition

Each capsule contains 300mg of gemfibrozil.

Each tablet contains 600mg of gemfibrozil.

Excipient with known effect: carmoisine (E122) (for the capsule).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Gemfibrozil

Gemfibrozil is a lipid regulating agent which regulates lipid fractions. Gemfibrozil stimulates the peripheral lipolysis of triglyceride rich lipoproteins such as VLDL and cholymicrons by stimulation of LPL. Gemfibrozil also inhibits synthesis of VLDL in the liver.

List of Excipients

Capsules: sodium starch glycollate, pregelatinised starch maize, colloidal silica hydrated and magnesium stearate.

Capsule shell: gelatin with colourants Brilliant blue FD&C Blue No 1 (E133), titanium dioxide (E171), erythrosine (E127) and carmoisine (E122).

Tablets: starch maize pregelatinised, colloidal anhydrous silica, microcrystalline cellulose, polysorbate 80, sodium starch glycollate and magnesium stearate.

Film coating: polyvinyl alcohol, titanium dioxide, purified talc, lecithin, xanthan gum.

Pack sizes and marketing

300mg capsules: PVC/aluminium foil blisters of 10 capsules, supplied in cartons of 50, 60, 100 and 500 capsules.

600mg tablets: PVC/aluminium foil blisters of 10 tablets, supplied in cartons of 20, 30, 50 and 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Medochemie Ltd, Constantinoupoleos 1-10, Limassol, Cyprus

Marketing authorization dates and numbers

Ipolipid 300mg: 10451
Ipolipid 600mg: 14035

Ipolipid 300mg capsules: 28.4.1986 / 06.11.2013
Ipolipid 600mg tablets: 26.11.1992 / 19.04.2010

Drugs

Drug Countries
IPOLIPID Cyprus, Hong Kong, Singapore

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