2.      QUALITATIVE AND QUANTITATIVE COMPOSITION

 Each prolonged‑release tablet contains 60 mg of oxycodone hydrochloride equivalent to 54 mg oxycodone and 30 mg naloxone hydrochloride as 32.7 mg of naloxone hydrochloride dihydrate, equivalent to 27 mg naloxone.

Excipient with known effect: Each prolonged‑release tablet contains 77.1 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

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 contains

The active substances are oxycodone hydrochloride and naloxone hydrochloride

 Targin 60 mg/30 mg

Each prolonged‑release tablet contains 60 mg of oxycodone hydrochloride equivalent to 54 mg oxycodone and 30 mg naloxone hydrochloride as 32.7 mg of naloxone hydrochloride dihydrate, equivalent to 27 mg naloxone.

  The other ingredients are:

 Targin 60 mg/30 mg

Tablet core:

Povidone K30, ethylcellulose, stearyl alcohol, lactose monohydrate, talc, magnesium stearate.

Tablet coat

Polyvinyl alcohol partially hydrolysed, titanium dioxide (E171), macrogol 3350, talc, iron oxide red (E172), iron oxide black (E172).

What Targin looks like and contents of the pack

Targin 60 mg/30 mg

Red, capsule shaped tablets, with a nominal length of 14 mm and with a film coating, embossed “OXN” on one side and “60” on the other.

 Targin is available in blisters of 10, 14, 20, 28, 30, 50, 56, 60, 98 and 100 prolonged-release tablets or child-resistant blisters of 10, 14, 20, 28, 30, 50, 56, 60, 98 and 100 prolonged-release tablets or in bottles with child-resistant closure containing 100 prolonged-release tablets or in multipacks comprising 2 cartons, each containing 50 tablets.

 Not all pack sizes may be marketed.

This leaflet was last revised in February 2025.

Section 2 - Update to warning on use of MAOIs to include 2 week period. Addition of warning regarding sleep apnoea. Addition of warning on increased sensitivity to pain.

Section 4 - Addition of sleep apnoea as a possible side effect.

Section 6 - Deletion of UK manufacturer following Brexit.

Section 4.4 - Reorganisation of warnings into bullet point format. Addition of warnings on respiratory depression and sleep-related breathing disorders. Addition of warning advising caution in use for patients taking MAOIs or who have received MAOIs within the previous two weeks. Addition of warning regarding hyperalgesia.

Section 4.5 - Clarification of warning advising caution in use for patients taking MAOIs or who have received MAOIs within the previous two weeks.

Section 4.8 - Addition of sleep apnoea as a potential undesirable effect. Correction of anaphylactic responses to anaphylactic reaction.

Addition of warnings in section 2 regarding concomitant use of serotonin agents and gabapentinoids with Targin

Addition of warnings in section 4.5 regarding concomitant use of serotonin agents and gabapentinoids with Targin

Section 4.4

The text in bold has been added to the section below:

‘Caution is advised in patients taking MAO inhibitors or CNS depressants.

Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs:

Concomitant use of opioids, including oxycodone hydrochloride and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing with these sedative medicines should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe Targin concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible.

The patients should be followed closely for signs and symptoms of respiratory depression and sedation. In this respect, it is strongly recommended to inform patients and their caregivers to be aware of these symptoms (see section 4.5).’

The text below has also been added to section 4.4:

‘Opioids such as oxycodone may influence the hypothalamic-pituitary-adrenal or –gonadal axes. Some changes that can be seen include an increase in serum prolactin, and decreases in plasma cortisol and testosterone. Clinical symptoms may manifest from these hormonal changes.’

‘total lactase deficiency’ has been added to replace ‘Lapp lactase deficiency’

Section 4.5

The text in bold has been added to the first paragraph of section 4.5 and text in strikethrough has been removed:

‘The concomitant use of opioids with sedative medicines such as benzodiazepines or related drugs increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect. The dose and duration of concomitant use should be limited (see section 4.4).

Substances having a Drugs which depress the CNS depressant effect include but are not limited to:(e.g. other opioids, anxiolytics, hypnotics and sedatives (including benzodiazepines), hypnotics, antidepressants, antipsychotics, antihistamines and antiemetics.) may enhance the CNS depressant effect (e.g. respiratory depression) of Targin.’

 Section 4.8

‘Rare:                    Drug dependence’ added underneath the subheading ‘Psychiatric disorders’

‘Aggression’ added to ‘Not known’ section beneath ‘Psychiatric disorders’

‘Drug dependence’ and ‘aggression’ removed from the ‘Psychiatric disorders’ subheading within the section ‘For the active substance oxycodone hydrochloride….’

Section 5.1

‘Opioids such as oxycodone may influence the hypothalamic-pituitary-adrenal or –gonadal axes. Some changes that can be seen include an increase in serum prolactin, and decreases in plasma cortisol and testosterone. Clinical symptoms may manifest from these hormonal changes.’

The text above has been replaced with this text: ‘For effects of opioids upon the endocrine system, see section 4.4’

Section 10

The date of revision was updated to ‘June 2018’