2.         What you need to know before you take Targin

Contact your doctor if you experience severe upper abdominal pain possibly radiating to the back, nausea, vomiting or fever as this could be symptoms associated with inflammation of the pancreas (pancreatitis) or the biliary tract system. 

Other medicines and Targin

·      muscle relaxants;

·      medicines to treat Parkinson’s disease.

4.      Possible side effects

Not known (frequency cannot be estimated from the available data)

•  a problem affecting a valve in the intestines that may cause severe upper abdominal pain (sphincter of Oddi dysfunction)

6.        Contents of the pack and other information

What Targin looks like and contents of the pack

These tablets are available in blister packs of 10, 14, 20, 28, 30, 50, 56, 60, 98 and 100 or in a hospital pack of 100 (10 x 10) or in a bottle with child-resistant closure containing 100 tablets.

This leaflet was last revised in July 2024.

2.      QUALITATIVE AND QUANTITATIVE COMPOSITION

Each prolonged‑release tablet contains 5 mg of oxycodone hydrochloride equivalent to 4.5 mg oxycodone and 2.5 mg naloxone hydrochloride as 2.73 mg of naloxone hydrochloride dihydrate equivalent to 2.25 mg naloxone.

Excipient with known effect: Each prolonged‑release tablet contains 71.8 mg lactose monohydrate

For the full list of excipients, see section 6.1.

4.      CLINICAL PARTICULARS

Below point has been added in Section 4.4

4.4    Special warnings and precautions for use

Hepatobiliary disorders

Oxycodone may cause dysfunction and spasm of the sphincter of Oddi, thus increasing the risk of biliary tract symptoms and pancreatitis. Therefore, oxycodone / naloxone has to be administered with caution in patients with pancreatitis and diseases of the biliary tract. 

Below point has been added in Section 4.5

4.5    Interaction with other medicinal products and other forms of interaction

Concomitant administration of oxycodone with anticholinergics or medications with anticholinergic activity (e.g. tri-cyclic antidepressants, antihistamines, anti-psychotics, muscle relaxants, anti-Parkinson drugs) may result in increased anticholinergic adverse effects. 

10.    DATE OF REVISION OF THE TEXT

IE MAH Address Change

IE MAH Address Change