OXCARBAZEPINE MYLAN Film-coated tablet Ref.[7327] Active ingredients: Oxcarbazepine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Generics [UK] Ltd t/a Mylan, Station Close, Potters Bar, Herts. EN6 1TL, United Kingdom

Product name and form

Oxcarbazepine Mylan 150 mg Film-coated Tablets.

Pharmaceutical Form

Film-coated tablet.

Buff, oblong, normal convex film-coated tablet debossed “OX|150” on one side and “G|G” on the other side. The tablet has a score line to facilitate breaking for ease of swallowing and not to divide into equal doses.

Qualitative and quantitative composition

Each film-coated tablet contains 150 mg oxcarbazepine.

Excipient with known effect: Each 150 mg tablet contains 1.23 mg lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description

The pharmacological activity of oxcarbazepine is primarily exerted through the metabolite (MHD). The mechanism of action of oxcarbazepine and MHD is thought to be mainly based on the blockade of voltage-sensitive sodium channels.

List of Excipients

Tablet core:

Cellulose, microcrystalline
Silica, colloidal anhydrous
Magnesium stearate

Tablet coating:

Black iron oxide (E172)
Lactose monohydrate
Macrogol 4000
Red iron oxide (E172)
Titanium dioxide (E171)
Yellow Iron oxide (E172)

Pack sizes and marketing

Clear PVC-PVdC/aluminium blisters.

Pack sizes: 10, 20, 30, 50, 60, 100, 200 film-coated tablets.

Polypropylene tablet containers with tamper evident polyethylene caps and optional polyethylene ullage filler.

Pack sizes: 100, 200, 500 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 04569/0779


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