MOXONIDINE Film-coated tablet Ref.[7003] Active ingredients: Moxonidine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Sandoz Limited, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom

Product name and form

Moxonidine 200 microgram film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Appearance: All tablets are round, approximately 6 mm in diameter.

The tablets are light pink.

Qualitative and quantitative composition

Each tablet contains 0.2 mg moxonidine.

Excipient: lactose monohydrate

For a full list of excipients, see section 6.1.

Active Ingredient Description
Moxonidine

Moxonidine has been shown to bind selectively to the I1-imidazoline receptors in the brain stem. These imidazoline-sensitive receptors are concentrated in the rostral ventrolateral medulla, an area which is of crucial importance for central control of the peripheral sympathetic nervous system. The result of this effect on the I1-imidazoline receptors has been apparent in reduced activity in the sympathetic nerves. (demonstrated for cardiac, splanchnic and renal sympathetic nerves).

List of Excipients

Tablet core:

Lactose monohydrate
Crospovidone
Povidone K25
Magnesium stearate

Film-coating:

Hypromellose
Titanium dioxide (E171)
Macrogol 400
Colouring agents ferric(III) oxide (E172)

Pack sizes and marketing

PVC/PVDC/Al blister pack with 10, 20, 28, 30, 50, 60, 98, 100, 400 (20 × 20, 10 × 40, as hospital pack sizes only) film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Sandoz Limited, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom

Marketing authorization dates and numbers

PL 04416/1287

05th August 2008

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