OxyNorm Dispersa 5, 10, 20 mg orodispersible tablets

  • Name:

    OxyNorm Dispersa 5, 10, 20 mg orodispersible tablets

  • 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: 28/5/2019

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Mundipharma Pharmaceuticals Limited - Formerly Napp Laboratories

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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 28 May 2019 SmPC

Reasons for updating

  • 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 revision date following HPRA notificationn of approval 

Updated on 3 April 2019 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink

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 27 February 2019 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink

Updated on 27 February 2019 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 of the SPC to include information on concomitant use of benzodiazepines/benzodiazepine like products and opioids

Updated on 10 July 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 5.1 - 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

The text below was added to the first section of the paragraph:

benzodiazepines, other CNS depressants (including alcohol) or’

Opioids such as oxycodone hydrochloride, 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.’

 

Section 4.5

The text below which is in bold has been added to the first paragraph of the section:

‘There can be an enhanced CNS depressant effect which can result in profound sedation, respiratory depression, coma and death during concomitant therapy with benzodiazepines or other drugs which affect the CNS such as alcohol, phenothiazines, antidepressants, anaesthetics, hypnotics, non-benzodiazepines sedatives, 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.’

 

Section 5.1

The text below has been removed and replace with ‘See section 4.4.’

‘Opioids such as oxycodone hydrochloride, 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.’

 

Section 10

The date of revision has been updated to ’29 September 2017’

Updated on 10 July 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 25 July 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 25 July 2016 PIL

Reasons for updating

  • Change to marketing authorisation holder
  • Change to name of manufacturer

Updated on 5 August 2015 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 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

4.2       Posology and method of administration


The headings Route of administration, Oral use have been deleted. The following highlighted text has been added.

Conversion from oral morphine: 

 


Method of administration

OxyNorm Dispersa orodispersible tablets are for oral use.

 

The tablet is to be placed in the mouth where it should be allowed to disperse rapidly before being swallowed.

 

Missed dose:

If a patient forgets to take a dose, advise them to take a dose as soon as they remember, then go on as before.  They must not take two doses within 4 hours.  They must not take a double dose to make up for forgotten orodispersible tablets.

 

Duration of treatment:

Oxycodone should not be used longer than necessary. Oxycodone should not be used longer than necessary. If long- term treatment is necessary due to the type and severity of the illness, careful and regular monitoring is required to determine whether and to what extent treatment should be continued.

 

4.3.      Contraindications


Missed dose information and method of administration has been deleted from this section.

4.4.      Special warnings and precautions for use

Highlighted text 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.

4.5.      Interactions with other medicinal products and other forms of interaction

Highlighted text 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,

Anticholingerics (e.g. antisychotics, antihistamines, antiemetics, antiparkinson drugs) can enhance the antichlinergic undesirable effects of oxycodone (such as constipation, dry mouth or micturition disorders).

4.8.      Undesirable effects

Frequency category has been changed from unknown to not known.

Nervous system disorders
Lethargy has been added to common

Reproductive system and breast disorders
Hypogonadism has been added to uncommon

General disorders and administration site conditions

Fatigue has been added to Common

Drug withdrawl syndrome neonatal has been added to Not Known


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 has been added


4.9.      Overdose

Highlighted text 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.


 

5.1.      Pharmacodynamic properties


Highlighted text has been added

 

 

Gastrointestinal system

Opioids may induce spasm of the sphincter of Oddi.

 


Updated on 5 August 2015 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 8 June 2015 PIL

Reasons for updating

  • Change to instructions about overdose
  • Change to side-effects

Updated on 30 July 2014 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • 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 - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic 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

There have been extensive changes throughout the SPC - Section 2, Section 3, Section 4.1, Section 4.2, Section 4.3 Section 4.4, Section 4.5, Section 4.6, Section 4.8, Section 4.9, Section 5.2, Section 5.3, Section 6.1

Updated on 16 July 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to information about driving or using machinery
  • Change to date of revision

Updated on 10 June 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to information about drinking alcohol
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery

Updated on 30 August 2011 SmPC

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 23 August 2011 PIL

Reasons for updating

  • New PIL for new product