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Palexia SR 50 mg prolonged-release tablets

*
Pharmacy Only: Prescription

  • Company:

    Grunenthal Pharma Ltd.

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Tapentadol Hydrochloride

    *Additional information is available within the SPC or upon request to the company

  • PALEXIA-SR-50MG-(28)-[Left].jpeg
  • PALEXIA-SR-50MG-[Left].jpeg

Updated on 26 June 2024

File name

ie_uk-common-leaflet-Palexia SR comb strengths-v7-clean.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

This type II approval was to extend the indication of Palexia prolonged-release tablets to children from 6 to 18 years for the relief of severe chronic pain. 

Updated on 26 June 2024

File name

m1-3-1-spc-2242-12-4-ie-v17-clean.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.6 - Special precautions for disposal and other handling

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

Free text change information supplied by the pharmaceutical company

This type II approval was to extend the indication of Palexia prolonged-release tablets to children from 6 to 18 years for the relief of severe chronic pain. 

Updated on 28 February 2023

File name

ie_uk-common-leaflet-Palexia SR comb strengths-v6-clean.pdf

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 2 - driving and using machines
  • Change to other sources of information section

Free text change information supplied by the pharmaceutical company

To update the PIL according to the position of CMDh (637158/2022) derived from PSUSA/00002849/202111 for tapentadol. This change also includes QRD updates and editorial changes. During assessment of this change, the RMS requested minor updates to the PIL. In preparation of the response to the PIL updates, the applicant, also updated the PIL texts for shared packs with Ireland to include the UK national drug driving warning into the PILs. Please note: At the request of the MHRA, the applicant submitted the above Drug Driving warning as Type IA variation on 12th December 2022.

Updated on 28 February 2023

File name

m1-3-1-spc-2242-12-4-ie-v16-clean.pdf

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 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

To update the SmPC according to the position of CMDh (637158/2022) derived from PSUSA/00002849/202111 for tapentadol. This change also includes QRD updates and editorial changes.

Updated on 31 January 2023

File name

m1-3-1-spc-2242-12-4-ie-v15-clean.pdf

Reasons for updating

  • Document format updated

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

Updated on 23 December 2021

File name

m1-3-1-spc-2242-12-4-ie-v15-clean.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition

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

Updated on 13 October 2021

File name

ie_uk-common-leaflet-Palexia SR combined strengths-approved v2-clean.pdf

Reasons for updating

  • Individual PILs superseded by joint PIL

Free text change information supplied by the pharmaceutical company

joint PIL for UK and Ireland - Approved. 

Updated on 08 June 2021

File name

m1-3-1-leaflet-pa-2242-12-4-8-v12-clean.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - how to report a side effect

Updated on 08 June 2021

File name

m1-3-1-spc-2242-12-4-ie-v14-clean.pdf

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

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

Updated on 05 March 2020

File name

m1-3-1-leaflet-pa-2242-12-4-8-v11-ipha.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Free text change information supplied by the pharmaceutical company

Addition of information on sleep-related breathing disorders

Updated on 05 March 2020

File name

m1-3-1-spc-2242-12-4-ie-v13-ipha.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

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

Free text change information supplied by the pharmaceutical company

Addition of information on sleep-related breathing disorders

Updated on 12 February 2020

File name

m1-3-1-leaflet-pa-2242-12-4-8-v10-ipha.pdf

Reasons for updating

  • Correction of spelling/typing errors

Updated on 31 October 2019

File name

m1-3-1-spc-2242-12-4-ie-v12-ipha.pdf

Reasons for updating

  • 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)

Free text change information supplied by the pharmaceutical company

Section 4.8:

Added Delirium** as an adverse event of unknown frequency

** Post marketing cases of delirium were observed in patients with additional risk factors such as cancer and advanced age.

Updated on 31 October 2019

File name

m1-3-1-leaflet-pa-2242-12-4-8-v10-clean.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Section 4: add 'Delirium' as an adverse event of unknown frequency

Updated on 20 December 2018

File name

m1-3-1-leaflet-pa-2242-12-4-8-v9-ipha.pdf

Reasons for updating

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

Updated on 19 December 2018

File name

m1-3-1-spc-2242-12-4-ie-v11-ipha.pdf

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

Section 4.4

Text added on Risk from concomitant use of sedating medicinal products such as benzodiazepines or related substances.

Section 4.5

Text updated in line with CMDh recommendation on ‘Sedative medicines such as benzodiazepines or related drugs’

Updated on 09 November 2018

File name

m1-3-1-leaflet-pa-2242-12-4-8-v8-ipha.pdf

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

Updated on 05 November 2018

File name

m1-3-1-spc-2242-12-4-ie-v10-ipha.pdf

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 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: Special warnings and precautions

Seizures: The following is included 'In addition, tapentadol may increase the  seizure risk in patients taking other medicinal products that lower the seizure threshold (see section 4.5)'

 Section 4.5: Interaction with other medicinal products and other forms of interaction

The following changes made:

​​PALEXIA can induce convulsions and increase the potential for selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, antipsychotics and other medicinal products that lower the seizure threshold to cause convulsions.

In isolated cases there have been reports of serotonin syndrome in a temporal connection with the therapeutic use of tapentadol in combination with serotinergic medicinal products such as selective serotonin re-uptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs) and tricyclic antidepressants. Signs of serotonin syndrome may be for example confusion, agitation, fever, sweating, ataxia, hyperreflexia, myoclonus and diarrhea. Serotonin syndrome is likely when one of the following is observed:

  • Spontaneous clonus
  • Inducible or ocular clonus with agitation or diaphoresis
  • Tremor and hyperreflexia
  • Hypertonia and body temperature > 38oC and inducible ocular clonus

Updated on 15 June 2018

File name

m1-3-1-leaflet-pa-2242-12-4-8-v7-ipha.pdf

Reasons for updating

  • New PIL for new product

Updated on 05 June 2018

File name

m1-3-1-leaflet-pa-2242-12-4-8-v7-ipha.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 05 June 2018

File name

m1-3-1-spc-2242-12-4-ie-v9-ipha.docx

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • 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

Change to marketing authorisation holder and number.

Updated on 04 January 2018

File name

PIL_14970_678.pdf

Reasons for updating

  • New PIL for new product

Updated on 04 January 2018

File name

PIL_14970_678.pdf

Reasons for updating

  • New PIL for new product

Updated on 04 January 2018

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Updated on 03 January 2018

Reasons for updating

  • New SPC for new product

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

Updated on 03 January 2018

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 4.2: update to state that the tablet shell may be present in faeces however has no clinical relevance. 

Updated on 09 December 2016

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 18 August 2016

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
  • Section 5.1: updated in light of new clinical data
  • Section 10: date of revision of text

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

Free text change information supplied by the pharmaceutical company

  • Section 5.1: updated in light of new clinical data
  • Section 10: date of revision of text

Updated on 18 November 2013

Reasons for updating

  • 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 5.1: Pharmacodynamic properties

Tapentadol demonstrated efficacy in preclinical models of nociceptive, neuropathic, visceral and inflammatory pain; efficacy has been verified in clinical trials with tapentadol prolonged-release tablets in non-malignant nociceptive and neuropathic chronic pain conditions as well as chronic tumour-related pain. The trials in pain due to osteoarthritis and chronic low back pain showed similar analgesic efficacy of tapentadol to a strong opioid used as a comparator. In the trial in painful diabetic peripheral neuropathy tapentadol separated from placebo which was used as comparator.

For the treatment of cancer pain currently only limited data are available. Therefore, for the time being, there is not enough data to give any recommendations in this regard.

 

Updated on 07 November 2013

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 4.8 (undesirable effects):

-          The following statement is added in relation to Drug hypersensitivity - Post-marketing rare events of angioedema, anaphylaxis and anaphylactic shock have been reported.

 

- Details on how to report side effects to the Irish medicines board is provided

 

Section 10 (revision date):
- As October 2013

 

 

 

 

Updated on 04 November 2013

Reasons for updating

  • Change to side-effects
  • Addition of information on reporting a side effect.

Updated on 31 October 2013

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • 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
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • 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)

Free text change information supplied by the pharmaceutical company

In section 1: capitalisation of PALEXIA

In section 2: updated to current QRD template

In Section 4.1: capitalisation of PALEXIA

In section 4.2: capitalisation of PALEXIA

In section 4.3: capitalisation of PALEXIA and update to current QRD template

In section 4.4: capitalisation of PALEXIA, under 'seizures' wording change to state PALEXIA is not recommended in patients with a history of seizure ....', deletion of wording on concomitant treatment with monoamine oxidase inhibitors, wording added on the concomitant use with mixed opioid agonists/antagonists.

In section 4.5: Re-wording of text on mixed opioid agonists/antagonists, deletion of text on interaction studies.

In Section 4.6: text added shown in italics - delayed development and embryotoxicity were observed at doses resulting in exaggerated pharmacology (mu-opioid-related CNS effects related to dosing above the therapeutic range).

In section 4.7: editorial changes

In section 4.8: update of drug hypersinsitivity to drug hypersensitivity including angioedema as an uncommon ADR. Palpitations added as a uncommon ADR.

In section 4.9: editorial changes

In section 5.1: capitalisation of PALEXIA

In section 5.2: steady state serum concentration of tapentadol are reached on the second day of the treatment regimen has been added. The combined section on metabolism and elimination has been separated into two sections.

In section 5.3: mu-opioid related CNS effects related to dosing above the therapeutic range added in relation to delayed development and embryo toxicity observed after administration of doses resulting in exaggerated pharmacology.

In section 10: revision date added as October 2013

Updated on 24 October 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to information about drinking alcohol
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Change to dosage and administration

Updated on 15 August 2013

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

Addition of two pack sizes (24 and 54)

Updated on 28 April 2011

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 28 April 2011

Reasons for updating

  • New PIL for new product