BEZAFIBRATE Film-coated tablet Ref.[6499] Active ingredients: Bezafibrate

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Generics [UK] Ltd t/a Mylan, Station Close, Potters Bar, Herts, EN6 1TL

Product name and form

Bezafibrate 200 mg Film-coated Tablets.

Pharmaceutical Form

Film-coated tablet.

Bezafibrate 200 mg Film-coated Tablets are 10mm, round normal convex white film-coated tablets, debossed “BZ/200” on one side and “G” on the other.

Qualitative and quantitative composition

Each tablet contains: 200 mg of bezafibrate.

Excipient with known effect: Each tablet contains 1.56 mg lactose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Bezafibrate

Bezafibrate lowers elevated blood lipids (triglycerides and cholesterol). Elevated VLDL and LDL are reduced by treatment with bezafibrate, whilst HDL-levels are increased. Furthermore, cholesterol biosynthesis is reduced by bezafibrate, which is accompanied by a stimulation of the LDL receptor-mediated lipoprotein catabolism.
List of Excipients

Bezafibrate 200 mg Film-coated Tablets contain the following excipients:

Tablet core excipients:

Silica, colloidal anhydrous
Magnesium stearate
Maize starch
Cellulose, microcrystalline
Povidone
Purified talc
Sodium starch glycolate

Film coat excipients:

Hypromellose
Lactose
Macrogol
Titanium dioxide (E171)

Pack sizes and marketing

Bezafibrate 200 mg Film-coated Tablets are available in either: -

  • cartoned PVC/PVdC/Aluminium foil blister packs along with patient leaflets as packs of 84 or 100 or
  • HDPP containers with tamper evident polyethylene caps (with optional polyethylene ullage filler) as packs of 84 or 100.
  • HDPP containers with tamper evident and child-resistant polyethylene caps (with optional polyethylene ullage filler) as packs of 84 or 100.

Not all pack sizes may be marketed.

Marketing authorization holder

Generics [UK] Ltd t/a Mylan, Station Close, Potters Bar, Herts, EN6 1TL

Marketing authorization dates and numbers

PL 04569/0390

26 October 1999 / 8 April 2005

 
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