OXYACT Film-coated tablet Ref.[27781] Active ingredients: Oxycodone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: G.L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria

Product name and form

Oxyact 10 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Middle blue, vaulted, oblong film-coated tablets with break score on both sides.

The tablet can be divided into equal halves.

Diameter: 10.1 mm
Thickness: 3.2 mm
Width: 4.6 mm

Qualitative and quantitative composition

Each film-coated tablet contains 10 mg oxycodone hydrochloride equivalent to 8.97 mg oxycodone.

Excipients with known effect: Each film-coated tablet contains 64.48 mg lactose (as monohydrate) and 0.21 mg soya lecithin.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Oxycodone

Oxycodone is a full opioid agonist with no antagonist properties. It has an affinity for kappa, mu and delta opioid receptors in the brain and spinal cord. Oxycodone is similar to morphine in its action. The therapeutic effect is mainly analgesic, anxiolytic, antitussive and sedative.

List of Excipients

Tablet core:

Sodium starch glycolate type A
Lactose monohydrate
Cellulose, microcrystalline
Colloidal anhydrous silica
Magnesium stearate

Tablet coating:

Polyvinyl alcohol
Talc
Titanium dioxide (E171)
Macrogol 3350
Lecithin, soya (E322)
Indigo carmine, aluminium lake (E132)

Pack sizes and marketing

Child resistant PVC/PVdC/aluminium blisters containing 10, 20, 30, 56 and 60, film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

G.L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria

Marketing authorization dates and numbers

PL 21597/0042

11/10/2018

Drugs

Drug Countries
OXYACT United Kingdom

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