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
OxyNorm 5 mg.
Pharmaceutical Form |
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Capsule, hard. Each 5 mg capsule is a size 4, hard gelatin, orange/beige, opaque capsule printed with ONR and 5. |
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 | |
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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 |
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Cellulose, microcrystalline The capsules are printed with ink containing shellac, iron oxide (E172), propylene glycol and ammonium hydroxide 28%. |
PVdC coated PVC blister packs with aluminium backing foil.
Polypropylene container with polyethylene lid.
Pack sizes: 56 capsules.
Mundipharma Pharmaceuticals Ltd, 13 Othellos Str. Dhali Industrial Zone, Nicosia, Cyprus
Tel.: +357 22815656
Fax: +357 22487833
Email: info@mundipharma.com.cy
20304
Date of first authorisation: 27/03/2008
Renewal of the authorisation: 21/08/2018
Drug | Countries | |
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OXYNORM | Austria, Australia, Brazil, Cyprus, Spain, Finland, France, Hong Kong, Ireland, Netherlands, New Zealand, Poland, Singapore, Tunisia, United Kingdom, South Africa |
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