OXYNORM Capsule, hard Ref.[27709] Active ingredients: Oxycodone

Source: Υπουργείο Υγείας (CY)  Revision Year: 2023  Publisher: Mundipharma Pharmaceuticals Ltd, 13 Othellos Str. Dhali Industrial Zone, Nicosia, Cyprus Tel.: +357 22815656 Fax: +357 22487833 Email: info@mundipharma.com.cy

Product name and form

OxyNorm 5 mg.

Pharmaceutical Form

Capsule, hard.

Each 5 mg capsule is a size 4, hard gelatin, orange/beige, opaque capsule printed with ONR and 5.

Qualitative and quantitative composition

Each capsule contains 4.5 mg of oxycodone as 5 mg of oxycodone hydrochloride.

Excipient with known effect: OxyNorm 5 mg capsule contains sunset yellow (E110). May cause allergic reactions.

For 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

Cellulose, microcrystalline
Magnesium stearate
Titanium dioxide (E171)
Iron oxide (E172)
Indigo carmine (E132)
Sunset yellow (E110)
Sodium laurylsulphate
Gelatin

The capsules are printed with ink containing shellac, iron oxide (E172), propylene glycol and ammonium hydroxide 28%.

Pack sizes and marketing

PVdC coated PVC blister packs with aluminium backing foil.

Polypropylene container with polyethylene lid.

Pack sizes: 56 capsules.

Marketing authorization holder

Mundipharma Pharmaceuticals Ltd, 13 Othellos Str. Dhali Industrial Zone, Nicosia, Cyprus
Tel.: +357 22815656
Fax: +357 22487833
Email: info@mundipharma.com.cy

Marketing authorization dates and numbers

20304

Date of first authorisation: 27/03/2008
Renewal of the authorisation: 21/08/2018

Drugs

Drug Countries
OXYNORM Austria, Australia, Brazil, Cyprus, Spain, Finland, France, Hong Kong, Ireland, Netherlands, New Zealand, Poland, Singapore, Tunisia, United Kingdom, South Africa

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.