Targin 60 mg/30 mg prolonged-release tablets

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’