OxyNorm Capsules

  • Name:

    OxyNorm Capsules

  • Company:
    info
  • Active Ingredients:

    Oxycodone Hydrochloride

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 03/04/19

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Summary of Product Characteristics last updated on medicines.ie: 3/4/2019

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Mundipharma Pharmaceuticals Limited - Formerly Napp Laboratories

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Medicine Name Nyxoid 1.8 mg nasal spray Active Ingredients Naloxone Hydrochloride dihydrate
Medicine Name OxyContin prolonged release tablets Active Ingredients Oxycodone Hydrochloride
Medicine Name OxyNorm 10 mg/ml solution for Injection or Infusion Active Ingredients Oxycodone Hydrochloride
Medicine Name OxyNorm 50 mg/ml, solution for injection or infusion Active Ingredients Oxycodone Hydrochloride
Medicine Name OxyNorm Capsules Active Ingredients Oxycodone Hydrochloride
Medicine Name OxyNorm Concentrate Active Ingredients Oxycodone Hydrochloride
Medicine Name OxyNorm Dispersa 5, 10, 20 mg orodispersible tablets Active Ingredients Oxycodone Hydrochloride
Medicine Name OxyNorm liquid 1 mg/ml oral solution Active Ingredients Oxycodone Hydrochloride
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1 - 0 of 31 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 3 April 2019 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 3 April 2019 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update to section 4.5 of the SPC to include concomitant administration of oxycodone with serotonin agents.

Updated on 5 November 2018

Updated on 5 November 2018 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update to sections 4.4 and 4.5 to include information on the concomitant use of opiods with sedatives such as benzodiazepines:

Section 4.4:

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 oxycodone hydrochloride 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).

 

Section 4.5:

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). Drugs which affect the CNS include, but are not limited to: alcohol, other opioids, non-benzodiazepine sedatives, hypnotics, antidepressants, phenothiazines, anaesthetics, muscle relaxants, neuroleptic drugs, antihypertensives and SSRIs.  Oxycodone should be used with caution and the dosage may need to be reduced in patients using these medications.

Updated on 7 February 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 7 February 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 6 February 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 6 February 2018 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

$0Section 4.4$0$0Addition of ‘benzodiazepines,other CNS depressants (including alcohol) or ‘ $0$0Text regardingopioids has been added to section 4.4 – $0$0‘Opioids, such as oxycodone hydrochloride,may influence the hypothalamic-pituitary-adrenal or –gonadal axes. Some changesthat can be seen include an increase in serum prolactin, and decreases inplasma cortisol and testosterone. Clinical symptoms may manifest from thesehormonal changes.’ $0$0 $0$0Section 4.5$0$0The words inbold have been added to or have moved within this part of section 4.5.$0$0‘There can be an enhanced CNS depressanteffect, which can result in profoundsedation, respiratory depression, coma and death, during concomitanttherapy with benzodiazepines or otherdrugs which affect the CNS such as alcohol,other opioids, non-benzodiazepine sedatives, hypnotics, antidepressants, phenothiazines, anaesthetics, musclesrelaxants, neuroleptic drugs, antihypertensives and SSRIs.’ $0$0 $0$0Section 5.1$0$0The text below ‘EndocrineSystem’ has been replaced with ‘Seesection 4.4’ $0$0 $0$0Section 10$0$0The date of revision has been updated to read ‘November 2017’$0

Updated on 14 August 2015 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.2

The following headings has been deleted

Route of administration

Oral use

Adults under 20 years and children

Not recommended

The following headings have been added:

Adults under 20 years and paediatric population:
Not recommended

Method of administration
Oral Use
The capsules should be swallowed whole with water.

 

Section 4.4

Text in red and with strike through has been deleted:

Hyperalgesia that will not respond to a further dose increase of oxycodone may very rarely occur, particularly in high doses.  An oxycodone dose reduction or change to an alternative opioid may be required.

 

Section 4.5

Text in red with strike through has been deleted:

There can be an enhanced CNS depressant effect during concomitant therapy with drugs which affect the CNS such as phenothiazines, tricyclic antidepressants, anaesthetics, hypnotics, sedatives, muscle relaxants, other opioids, neuroleptic drugs, antihypertensives and SSRIs. 

 

The following text has been added:

Concomitant administration of oxycodone with anticholinergics or medicines with anticholinergic activity (e.g. tricyclic anti-depressants, antihistamines, antipsychotics, muscle relaxants, anti-Parkinson drugs) may result in increased anticholinergic adverse effects. Oxycodone should be used with caution and the dosage may need to be reduced in patients using these medications.

 

Section 4.6

 

Heading has been changed to

 

Fertility, pregnancy and lactation

 

 

Section 4.8

Frequency unknown has been changed to frequency not known.

Lethargy has been added to common side effects.

Hypogonadism has been added to uncommon side effects.

Fatigue has been added to common side effects.

Drug withdrawal syndrome neonatal has been added to frequency not known side effects.

 

The following has been added:

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important.  It allows continued monitoring of the benefit/risk balance of the medicinal product.  Healthcare professionals are asked to report any suspected adverse reactions  via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie

 

Section 4.9

Text in red has been added

Acute overdose with oxycodone can be manifested by respiratory depression, somnolence progressing to stupor or coma, hypotonia, miosis, bradycardia, hypotension, pulmonary oedema and death.

Section 5.1

Text in red has been added

Gastrointestinal System

Opioids may induce spasm of the sphincter of Oddi.

Updated on 12 August 2015 PIL

Reasons for updating

  • Change to side-effects
  • Change to dosage and administration

Updated on 30 July 2014 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.2       Posology and method of administration

 

Posology

 

Route of administration:

Oral use

 

Adults and elderly:

OxyNorm capsules should be taken at 4-6 hourly intervals.  The dosage is dependent on the severity of the pain and the patient’s previous history of analgesic requirements, the patient’s body weight, and sex (higher plasma concentrations are produced in females).

 

The usual starting dose for debilitated elderly patients, opioid naïve patients or patients presenting with severe pain uncontrolled with weaker opioids is 5 mg 4-6 hourly.  The dose should then be carefully titrated, every day if necessary, to achieve pain relief.  Increases should be made where possible in 25-50% increments.  The correct dosage for any individual patient is that which controls the pain and is well tolerated throughout the dosage interval.  The need for escape medication more than twice a day indicates that the dosage of OxyNorm capsules should be increased.

 

Conversion from oral morphine:

Patients receiving oral morphine before oxycodone therapy should have their daily dose based on the following ratio: 10 mg of oral oxycodone is equivalent to 20 mg of oral morphine.  It must be emphasised that this is a guide to the dose of OxyNorm capsules required.  Inter-patient variability requires that each patient is carefully titrated to the appropriate dose.

 

Elderly patients:

A dose adjustment is not usually necessary in elderly patients.

Controlled pharmacokinetic studies in elderly patients (aged over 65 years) have shown that compared with younger adults the clearance of oxycodone is only slightly reduced.  No untoward adverse drug reactions were seen based on age, therefore adult doses and dosage intervals are appropriate.

 

Non-malignant pain:

Treatment with oxycodone should be short and intermittent to minimise the risk of dependence.  The need for continued treatment should be assessed at regular intervals.  Patients should not usually require more than 160 mg per day. For the long-term treatment of severe pain prolonged release formulations of oxycodone are available.

 

Cancer-related pain:

Patients should be titrated up to a dose which achieves pain relief unless unmanageable adverse drug reactions prevent this.

 

Patients with renal or hepatic impairment:

Unlike morphine preparations, the administration of oxycodone does not result in significant levels of active metabolites.  However, the plasma concentration of oxycodone in this patient population may be increased compared with patients having normal renal or hepatic function.  Therefore dose initiation should follow a conservative approach in these patients i.e. one-third to one-half the usual dose with careful dose titrationThe recommended adult starting dose should be reduced by 50% (for example a total daily dose of 10 mg orally in opioid naïve patients), and There are no data in patients with severe renal and/or hepatic impairment.  A reduced dosage may be appropriate in these patients but each patient should be titrated to adequate pain control according to their clinical responsesituation.

 

Duration of treatment:

Oxycodone should not be used longer than necessary.

 

Discontinuation of treatment:

When a patient no longer requires therapy with oxycodone, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.

 

Adults under 20 years and children:

Not recommended.

4.3       Contraindications

Hypersensitivity to oxycodone or to any of the excipients listed in section 6.1.

Oxycodone must not be used in Aany situation where opioids are contraindicated: severe respiratory depression with hypoxia, elevated carbon dioxide levels in the blood (hypercarbia), head injury, paralytic ileus, acute abdomen, delayed gastric emptying, severe chronic obstructive airways lung disease, severe bronchial asthma, cor pulmonale, hypercarbia, known sensitivity to oxycodone, morphine or other opioids, hypersensitivity to any of the excipients, acute hepatic disease, concurrent administration of monoamine oxidase inhibitors or within 2 weeks of discontinuation of their use.


4.4       Special warnings and precautions for use

The major risk of opioid excess is respiratory depression.

 

Caution must be exercised when administering oxycodone to the debilitated elderly; patients with severely impaired pulmonary function, impaired hepatic or renal function; patients with myxoedema, hypothyroidism, Addison’s disease,  toxic psychosis, adrenocortical insufficiency, prostate hypertrophy, head injury (due to the risk of raised intracranial pressure), convulsive disorders, delirium tremens, disorders of consciousness, hypotension, hypovolaemia. Use with caution in opioid dependent patients, diseases of the biliary tract, biliary or ureteric colic, pancreatitis, obstructive and inflammatory bowel disorders, chronic obstructive airways disease, reduced respiratory reserve, alcoholism or patients taking MAO inhibitorsUse with caution in opioid dependent patients, in patients with toxic psychosis, raised intracranial pressure, convulsive disorders, delirium tremens, disorders of consciousness, hypotension, hypovolaemia, diseases of the biliary tract, biliary or ureteric colic, pancreatitis, obstructive and inflammatory bowel disorders, prostatic hypertrophy, adrenocortical insufficiency, hypothyroidism, chronic obstructive airways disease, severely impaired pulmonary function, reduced respiratory reserve, alcoholism, chronic renal and hepatic disease (see section 4.2), debilitated, elderly or infirm patients.  In patients in whom caution is required, a reduction in dosage may be advisable.

 

OxyNorm capsules should not be used where there is a possibility of paralytic ileus occurring.  Should paralytic ileus be suspected or occur during use, OxyNorm capsules should be discontinued immediately (see section 4.3).  Due to an increased perioperative risk of ileus and respiratory depression OxyNorm capsules should be used with caution pre-operatively and within the first 24 hours post-operatively.

 

OxyNorm should be used with caution pre-operatively and within the first 12-24 hours post-operatively.

 

As with all opioid preparations, patients about to undergo additional pain relieving procedures (e.g. surgery, plexus blockade) should not receive OxyNorm capsules for six hours prior to the intervention.  If further treatment with OxyNorm capsules is indicated then the dosage should be adjusted to the new post-operative requirement.

 

As with all opioid preparations, oxycodone products OxyNorm capsules should be used with caution following abdominal surgery as opioids are known to impair intestinal motility and should not be used until the physician is assured of normal bowel function.

 

The patient Patients may develop tolerance to the drug with chronic use and require progressively higher doses to maintain pain control.  There may also be cross-tolerance with other opioids.  Prolonged use of this product may lead to physical dependence and a withdrawal syndrome may occur upon abrupt cessation of therapy.  When a patient no longer requires therapy with oxycodone, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.  Withdrawal symptoms may include yawning, mydriasis, lacrimation, rhinorrhoea, tremor, hyperhidrosis, anxiety, agitation, convulsions and insomnia.

 

Hyperalgesia that will not respond to a further dose increase of oxycodone may very rarely occur, particularly in high doses.  An oxycodone dose reduction or change to an alternative opioid may be required.

 

Oxycodone has an abuse profile similar to other strong opioid agonists and may be sought and abused by people with latent or manifest addiction disorders.  There is potential for development of psychological dependence (addiction) to opioid analgesics, including oxycodone.  OxyNorm capsules should be used with particular caution care in patients with a history of alcohol or drug abuse.

 

The capsules should be swallowed whole, and not chewed or crushed.  Abuse of oral dosage forms by parenteral administration can be expected to result in serious adverse events, which may be fatal.

 

Concomitant use of alcohol and OxyNorm may increase the undesirable effects of OxyNorm; concomitant use should be avoided.

 

It should be emphasised that patients, once titrated to an effective dose of a certain opioid, should not be changed to other analgesic preparations without clinical assessment and careful retitration as necessary.  Otherwise, a continuous analgesic action is not ensured.

 

OxyNorm 5 mg capsules contain sunset yellow which may cause allergic reactions.

4.5       Interaction with other medicinal products and other forms of interaction

There can be an enhanced CNS depressant effect during concomitant therapy with drugs which affect the CNS such as phenothiazines, tricyclic antidepressants, anaesthetics, hypnotics, sedatives, alcohol, muscle relaxants, other opioids, neuroleptic drugs, antihypertensives and SSRIs.  Oxycodone should be used with caution and the dosage may need to be reduced in patients using these medications. 

 

Monoamine oxidase inhibitors are known to interact with narcotic analgesics, producing CNS excitation or depression associated with hypertensive- or hypotensive crisis (see section 4.4).  Oxycodone should be used with caution in patients administered MAO-inhibitors or who have received MAO-inhibitors during the last two weeks (see section 4.34).

 

Alcohol may enhance the pharmacodynamic effects of OxyNorm, concomitant use should be avoided.

 

Oxycodone is metabolised mainly by CYP3A4, with a contribution from CYP2D6.  The activities of these metabolic pathways may be inhibited or induced by various co-administered drugs or dietary elements.

 

CYP3A4 inhibitors, such as macrolide antibiotics (e.g. clarithromycin, erythromycin and telithromycin), azol-antifungals (e.g. ketoconazole, voriconazole, itraconazole, and posaconazole), protease inhibitors (e.g. boceprevir, ritonavir, indinavir, nelfinavir and saquinavir), cimetidine and grapefruit juice may cause a reduced clearance of oxycodone that could cause an increase of the plasma concentrations of oxycodone. Therefore the oxycodone dose may need to be adjusted accordingly.

 

Some specific examples are provided below:

 

·         Itraconazole, a potent CYP3A4 inhibitor, administered 200 mg orally for five days, increased the AUC of oral oxycodone.  On average, the AUC was approximately 2.4 times higher (range 1.5 - 3.4).

 

·         Voriconazole, a CYP3A4 inhibitor, administered 200 mg twice-daily for four days (400 mg given as first two doses), increased the AUC of oral oxycodone.  On average, the AUC was approximately 3.6 times higher (range 2.7 - 5.6).

 

·         Telithromycin, a CYP3A4 inhibitor, administered 800 mg orally for four days, increased the AUC of oral oxycodone.  On average, the AUC was approximately 1.8 times higher (range 1.3 – 2.3).

 

·         Grapefruit Juice, a CYP3A4 inhibitor, administered as 200 ml three times a day for five days, increased the AUC of oral oxycodone.  On average, the AUC was approximately 1.7 times higher (range 1.1 – 2.1).

 

CYP3A4 inducers, such as rifampicin, carbamazepin, phenytoin and St John´s Wort may induce the metabolism of oxycodone and cause an increased clearance of oxycodone that could cause a reduction of the plasma concentrations of oxycodone. The oxycodone dose may need to be adjusted accordingly.

 

Some specific examples are provided below:

 

·         St Johns Wort, a CYP3A4 inducer, administered as 300 mg three times a day for fifteen days, reduced the AUC of oral oxycodone.  On average, the AUC was approximately 50% lower (range 37-57%).

 

·         Rifampicin, a CYP3A4 inducer, administered as 600 mg once-daily for seven days, reduced the AUC of oral oxycodone.  On average, the AUC was approximately 86% lower.

 

Drugs that inhibit CYP2D6 activity, such as paroxetine and quinidine, may cause decreased clearance of oxycodone which could lead to an increase in oxycodone plasma concentrations.

Oxycodone is metabolised by the cytochrome P450 enzyme system (CYP2D6 and CYP3A4) but a full evaluation of interactions with other drugs metabolised by this route has not been undertaken.  Concurrent administration of quinidine, an inhibitor of cytochrome P450-2D6, resulted in an increase in oxycodone Cmax by 11%, AUC by 13% and t½ elim by 14%; also an increase in the metabolite noroxycodone level was observed.  The pharmacodynamic effects of oxycodone were not altered.  This interaction may be observed for other potent inhibitors of the cytochrome P450-2D6 enzyme such as paroxetine and fluoxetine.  Cimetidine and inhibitors or substrates of cytochrome P450-3A4 such as ketoconazole, voriconazole and erythromycin may inhibit the metabolism of oxycodone.

4.6      

Use of this medicinal product should be avoided to the extent possible in patients who are pregnant or lactating.OxyNorm capsules should not be used in pregnancy or the breast feeding mother.

 

Pregnancy

There are limited data from the use of oxycodone in pregnant women. Infants born to mothers who have received opioids during the last 3 to 4 weeks before giving birth should be monitored for respiratory depression.  Withdrawal symptoms may be observed in the newborn of mothers undergoing treatment with oxycodone.

No clinical data on exposed pregnancies are available.

 

Studies in rats and rabbits with oral doses of oxycodone equivalent to 3 and 47 times an adult human dose of 160 mg/day respectively, did not reveal evidence of harm to the foetus due to oxycodone.

 

Oxycodone penetrates the placenta.  Oxycodone should not be used during pregnancy and labour due to impaired uterine contractility and the risk of neonatal respiratory depression.  Infants born to mothers who have received opioids during pregnancy should be monitored for respiratory depression.  Withdrawal symptoms may be observed in the newborn of mothers undergoing treatment with oxycodone.

 

Breast-feeding

Lactation

Oxycodone is may be secreted in breast milk and may cause respiratory depression in the newborn.  Oxycodone OxyNorm capsules should, therefore, not be used in breast-feeding mothers otherwise breast feeding has to be stopped.

4.7      

Oxycodone may impair the ability to drive and use machines.  Oxycodone may modify patients’ reactions to a varying extent depending on the dosage and individual susceptibility.  If affected, patients should not drive or operate machinery.

4.8      

The most commonly reported adverse reactions are nausea and constipation, both occurring in approximately 25 to 30 % of patients.  If nausea or vomiting are troublesome, oxycodone may be combined with an antiemetic.  Constipation should be anticipated as with any strong opioid, and treated appropriately with laxatives.  Should opioid related adverse events persist, they should be investigated for an alternative cause.

 

Adverse drug reactions are typical of full opioid agonists, and tend to reduce with time, with the exception of constipation.  Anticipation of adverse drug reactions and appropriate patient management can improve acceptability.

 

The most serious adverse reaction, as with other opioids, is respiratory depression (see Overdose section).  This is most likely to occur in elderly, debilitated or opioid-intolerant patients.

 

Adverse drug reactions seen during clinical trials and from spontaneous reports are listed below:

 

The following frequency categories form the basis for classification of the undesirable effects:

Term

Frequency

Very common

≥ 1/10

Common

≥ 1/100 to <1/10

Uncommon

≥ 1/1,000 to <1/100

Rare

Very rare

≥1/10,000 to <1/1,000

<1/10,000

Frequency unknown

Cannot be estimated from the available data

 

Immune system disorders:

Uncommon (≥1/1,000 to <1/100): hypersensitivity

Frequency unknown (cannot be estimated from the available data): anaphylactic responses.

 

Endocrine disorders:

Uncommon (≥1/1,000 to <1/100): syndrome of inappropriate antidiuretic hormone secretion (SIADH).

 

Metabolism and nutrition disorders:

Common (≥1/100 to <1/10): decreased appetiteanorexia

Uncommon (≥1/1,000 to <1/100): dehydration, thirst, weight fluctuation.

 

Psychiatric disorders:

Common (≥1/100 to <1/10): abnormal dreams, abnormal thinking, anxiety, confusional state, depression, insomnia, nervousness

Uncommon  (≥1/1,000 to <1/100): agitation, abnormal thinking, decreased libido, depersonalisation, affect lability, euphoric mood, hallucinations, drug dependence (see section 4.4)

Frequency unknown: aggression.

 

Nervous system disorders:

Very common (≥1/10): somnolence, dizziness, headache.

Common (≥1/100 to <1/10): tremor.

Uncommon (≥1/1,000 to <1/100): amnesia, convulsion, hyperkinesia, hypertonia, hypoaesthesia, hypotonia, involuntary muscle contractions, speech disorder, stupor, paraesthesia, dysgeusia, syncope.

Frequency unknown: hyperalgesia.

 

Eye disorders:

Uncommon (≥1/1,000 to <1/100): abnormal vision, lacrimation disorder, miosis, visual impariment.

 

Ear and labyrinth disorders:

Uncommon (≥1/1,000 to <1/100): tinnitus, vertigo.

 

Cardiac disorders:

Uncommon (≥1/1,000  to <1/100): palpitations (in the context of withdrawal syndrome).

 

Vascular disorders:

Uncommon (≥1/1000 to <1/100): vasodilatation.

Rare (≥1/10,000 to <1/1000): hypotension, orthostatic hypotension.

 

Respiratory, thoracic and mediastinal disorders:

Common (≥1/100 to <1/10): dyspnoea, bronchospasm.

Uncommon (≥1/1,000 to <1/100): rhinitis, epistaxis, hiccup, voice alteration, respiratory depression.

 

Gastrointestinal disorders:

Very common (≥1/10): constipation, nausea, vomiting.

Common (≥1/100 to <1/10): abdominal pain, diarrhoea, dry mouth, dyspepsia.

Uncommon (≥1/1,000 to <1/100): dysphagia, flatulence, gastritis, mouth ulceration, eructation, ileus, stomatitis.

Frequency unknown (cannot be estimated from the available data): dental caries.

 

Hepato-biliary disorders:

Uncommon (≥1/1,000 to <1/100): hepatic enzymes increased.

Frequency unknown (cannot be estimated from the available data): biliary colic, cholestasis.

 

Skin and subcutaneous tissue disorders:

Very common (≥1/10): pruritus.

Common (≥1/100 to <1/10): rash, hyperhidrosis.

Uncommon (≥1/1,000 to <1/100): dry skin.

Rare (≥1/10,000 to <1/1,000): urticaria.

 

Renal and urinary disorders:

Common (≥1/100 to <1/10): urinary disorders.

Uncommon (≥1/1000 to <1/100): urinary retention.

 

Reproductive system and breast disorders:

Uncommon (≥1/1000 to <1/100): erectile dysfunction, decreased libido.

Frequency unknown (cannot be estimated from the available data): amenorrhoea.

 

General disorders and administration site conditions:

Common (≥1/100 to <1/10): asthenic conditions, fever.

Uncommon (≥1/1,000 to <1/100): chills, chest pain, drug withdrawal syndrome, gait disturbance, malaise, oedema, peripheral oedema, drug tolerance, thirst.

 

Tolerance may occur in patients treated with oxycodone, although this has not been a significant problem in the clinical trial programme.  Patients requiring marked dose escalation should have their pain control regimen carefully reviewed.

 

Abrupt withdrawal of OxyNorm capsules or administration of an opioid antagonist may result in a withdrawal syndrome characterised by anxiety, irritability, chills, hot flushes, piloerection, joint pain, rhinorrhea, diaphoresis, abdominal cramps and diarrhoea.  If the dose reduction regimen recommended in Section 4.4 results in a withdrawal syndrome, the dose should be slightly increased until the signs and symptoms disappear.  Dose reduction should then begin again with longer periods of time between each reduction.

4.9      

Acute overdosage with oxycodone can be manifested by respiratory depression, somnolence, progressing to stupor or, coma, hypotonia, misosisskeletal muscle flaccidity, miotic pupils, bradycardia, hypotension, and death.

 

Treatment of oxycodone overdosageA patent airway must be maintained.  The pure opioid antagonists such as naloxone are specific antidotes against symptoms from opioid overdose.  Other supportive measures should be employed as neededPrimary attention should be given to the establishment of a patent airway and institution of assisted or controlled ventilation.

 

In the case of massive overdosage, administer naloxone 0.8 mg intravenously. Repeat at 2-3 minute intervals as necessary, or by an infusion of 2 mg in 500 ml of normal saline or 5% dextrose (0.004 mg/ml).

 

The infusion should be run at a rate related to the previous bolus doses administered and should be in accordance with the patient’s response.  However, because the duration of action of naloxone is relatively short, the patient must be carefully monitored until spontaneous respiration is reliably re-established.

 

For less severe overdosage, administer naloxone 0.2 mg intravenously followed by increments of 0.1 mg every 2 minutes if required.

 

Naloxone should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to oxycodone overdosage.  Naloxone should be administered cautiously to persons who are known, or suspected, to be physically dependent on oxycodone.  In such cases, an abrupt or complete reversal of opioid effects may precipitate pain and an acute withdrawal syndrome.

 

Gastric contents may need to be emptied as this can be useful in removing unabsorbed drug.

 

 

Updated on 28 May 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to further information section

Updated on 31 August 2011 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

            7.  MA holder is now

     

Mundipharma Pharmaceuticals Limited

Millbank House

Arkle Road

Sandyford

Dublin 18

8. 
Marketing Authorisation numbers are now

PA 1688/6/4-6

Updated on 25 August 2011 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 11 May 2011 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4

‘acute’ has been removed before the word alcoholism.

‘Due to an increased perioperative risk of ileus and respiratory depression OxyNorm concentrate should be used with caution pre-operatively and within the first 24 hours post-operatively.’ Has been added

Section 4.5

Words in bold have been added

‘Concurrent administration of quinidine, an inhibitor of cytochrome P450-2D6, resulted in an increase in oxycodone Cmax by 11%, AUC by 13% and t½ elim by 14%; also an increase in the metabolite noroxycodone level was observed.  The pharmacodynamic effects of oxycodone were not altered.  This interaction may be observed for other potent inhibitors of the cytochrome P450-2D6 enzyme such as paroxetine and fluoxetine.  Cimetidine and inhibitors or substrates of cytochrome P450-3A4 such as ketoconazole, voriconazole and erythromycin may inhibit the metabolism of oxycodone.

Section 4.8

(≥ 1/1,000 to <1/100) the word to has been added throughout the section.

 

Immune system disorders

Frequency unknown  symptoms of anaphylactic or analphylatctoid reaction has been changed to read ‘ anaphylactic responses.

Psychiatric disorders:

Uncommon: emotional lability has been changed to read ‘affect lability.  Mood altered has been removed.

Nervous system disorders

Common:  ‘faintness’ has been removed.

Uncommon:  ‘vertigo’ has been removed, dysgeusi, syncope has been added

Ear and labyrinth disorders

‘Vertigo’ has been added

Cardiac disorders

‘syncope’ has been deleted

Gastrointestinal disorders

Uncommon:  ‘taste perversion’ has been removed.

Skin and subcutaneous tissue disorders

Common:  sweating has been removed and ‘hyperhidrosis ‘ has been added

Reproductive system and breast disorders

Uncommon:  ‘impotence’ has been removed and replaced with ‘ erectile dysfunction

General disorders and administration site conditions

Common: asthenic has been replaced with ‘asthenic conditions’

Section 5.1

The therapeutic effect is mainly analgesic, anxiolytic, antitussive and sedative (antiussive has been added).

Updated on 4 May 2011 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 1 July 2010 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 2 " Excipients: Each 5 mg capsule contains 0.019 mg sunset yellow (E110)" has been added.
Section 4.3 "Any situation where opioids are contraindicated:" has been added.
"Chronic has been replaced with "severe"
"cor pulmonale" has been added
"hypersensitivity to any of the excipients" has been added.
Section 4.4
"The major risk of opioid excess is respiratory depression" has been added
"severely impaired pulmonary function" has been added
Paragraph 3 has been rewritten
Paragraph 5 onwards has been re-written.
Section 4.5
"
There can be an enhanced CNS depressant effect during concomitant therapy with drugs which affect the CNS such as" has been added.
other opioids, neuroleping drugs" has been added
"CYP2D6 and CYP3A4 have been added.
Section 4.6
"OxyNorm capsules should not be used in pregnancy or the breast feeding mother" has been added (changed from not recommended)
Section 4.8
 Has been re-written
Section 5.1 and 5.3 has been rewritten
Section 6
Sodium dodecylsulphate has been changed to Sodium laurilsulfate

Updated on 11 June 2010 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 31 July 2007 PIL

Reasons for updating

  • Change of inactive ingredient
  • Change to date of revision

Updated on 31 July 2007 SmPC

Reasons for updating

  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 6.1 capsule ink excipients updated
Section 10  revision date updated

Updated on 26 October 2005 SmPC

Reasons for updating

  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 26 October 2005 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 31 May 2005 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to date of revision

Updated on 23 May 2005 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to date of revision

Updated on 17 May 2005 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 26 August 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 3 March 2004 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 23 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)