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Palexia Oral Solution 20 mg/ml

*
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-OS-20MG-[Left].jpeg

Updated on 04 September 2024

File name

ie-leaflet-2242-12-11-v18-clean.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 3 - duration of treatment
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Type II approval to remove the restrictions to a maximum treatment duration of 72-hour for the paediatric population.

Updated on 04 September 2024

File name

m1-3-1-spc-2242-12-11-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 6.6 - Special precautions for disposal and other handling
  • 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

Type II approval to remove the restrictions to a maximum treatment duration of 72-hour for the paediatric population.

Updated on 27 February 2023

File name

ie-leaflet-2242-12-11-v17-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 6 - date of revision
  • 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.

Updated on 27 February 2023

File name

m1-3-1-spc-2242-12-11-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-2242-12-11-v15-clean.pdf

Reasons for updating

  • Document format updated

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

Updated on 15 March 2022

File name

m1-3-1-leaflet-2242-12-11-v14-clean.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

RMS BfArM approval regarding composition change - addition of Sodium Benzoate as an excipient to the drug product. 

Updated on 15 March 2022

File name

m1-3-1-spc-2242-12-11-v15-clean.pdf

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 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

RMS - BfArM approval regarding compositon change - addition of Sodium Benzoate as an excipient to the drug product. 

Updated on 16 November 2021

File name

93032114_PIL_PALEXIA_OS_20MG_ML_EN_IRL.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-leaflet-2242-12-11-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-2242-12-11-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-spc-2242-12-11-v13-clean.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 05 March 2020

File name

m1-3-1-leaflet-2242-12-11-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

Information on sleep-related breathing disorders added

Updated on 31 October 2019

File name

m1-3-1-spc-2242-12-11-v12-clean.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-2242-12-11-v10-clean-ipha.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:

addition of Delirium as an adverse event of unknown frequency

Updated on 13 August 2019

File name

m1-3-1-spc-2242-12-11-v11-clean-v2.pdf

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

Correction to date of revision of text (section 10) of the update published on 23-Jul-2019

Updated on 23 July 2019

File name

m1-3-1-leaflet-2242-12-11-v9-ipha.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 3 - use in children/adolescents
  • Change to section 6 - date of revision

Updated on 23 July 2019

File name

m1-3-1-spc-2242-12-11-v11-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 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 4.1 (new text underlined, deleted text strike through)

PALEXIA is indicated for the relief of moderate to severe acute pain in children from 2 years of age with a body weight of more than 16 kg and in adults, which can be adequately managed only with opioid analgesics.

 

Section 4.2

For dosages of 20 mg or more (patients with a body weight of more than 16 kg) PALEXIA 20 mg/ml should be used, for dosages of less than 20 mg (patients with a body weight of 16 kg or less) PALEXIA 4 mg/ml is recommended.

PALEXIA 20 mg/ml is not recommended for children with a body weight of 16 kg or less due to the high concentration of tapentadol.

 

Section 4.4:

PALEXIA is not recommended in children with a body weight of 16 kg or less (see section 4.2)

 

Updated on 20 December 2018

File name

m1-3-1-leaflet-2242-12-11-v8-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-2242-12-11-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

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 05 November 2018

File name

m1-3-1-leaflet-2242-12-11-v7-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
  • Change to section 6 - date of revision

Updated on 05 November 2018

File name

m1-3-1-spc-2242-12-11-v9-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 20 August 2018

File name

m1-3-1-leaflet-2242-12-11-v6d2-ipha.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - excipient warnings
  • Change to section 3 - how to take/use
  • Change to section 3 - duration of treatment
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 20 August 2018

File name

m1-3-1-spc-2242-12-11-v8-ipha.pdf

Reasons for updating

  • 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 4.4 - 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 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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 2: Qualitative and quantitative composition

- propylene glycol and sodium added as excipients with known effect

 

Section 4.1: Therapeutic Indications

- indication extended to paediatric population. Approved indication is 'Palexia is indicated for the relief of moderate to severe acute pain in children from 2 years of age and in adults, which can be adequately managed only with opioid analgesics.'

 

Section 4.2: Posology and method of administration

- added 'The use of Palexia in children is restricted to hospital use where appropriate equipment to enable respiratory support is available'.

- dosing recommendations and dose by body weight is provided for the paediatric population.

- the oral syringe is referred to as the dosing pipette

- added ' Palexia may be administered through a nasogastric tube made of polyurethane, silicone, or polyvinyl chloride (these materials were tested and showed no interactions or degradation of tapentadol)'.

 

Section 4.4: Special precautions for use

- Added details of quantities of propylene glycol and sodium

- precautions in relation to paediatric dosing is added

 

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

- added ' Due to the major elimination pathway being glucuronide conjugation the potential for interactions in adults is low. additionally, in vitro, tapentadol was found not to induce or inhibit any of the main CYP enzymes, including CYP 3A4.'

- For the paediatric population, added 'Due to the major elimination pathway being glucuronide conjugation the potential for interactions in children aged more than 5 months is low (see section 4.2).

 

Section 4.6: Fertility, pregnancy and lactation

- the title 'Lactation' is changed to 'Breast-feeding'

 

Section 4.8: Undesirable effects

- added 'The most severe adverse drug reactions are sedation, respiratory depression and allergic reactions'

- adverse event information relevant to the paediatric population is added

 

Section 5.1: Pharmacodynamic properties

- the summary for paediatric population is updated.

 

Section 5.2 Pharmacokinetic properties

- pharmacokinetic information relevant to the paediatric population is added

 

Section 5.3: Preclinical safety data

- preclinical data in juvenile animals is included

 

Section 6.1 List of excipients

- E number for propylene glycol is added (E 1520)

 

Section 6.5 Nature and contents of container

- description of the oral syringe is changed from 'Each bottle of the oral solution is provided with an oral syringe and an adapter. The syringe is scaled in 0.25 millilitre increments with a minimum volume of 0.25ml and a maximum volume of 5 ml' to ' Each bottle of the oral solution is provided with a dosing pipette and an adapter attached to the dosing pipette. The scale of the 5mL dosing pipette is subdivided in 0.1ml intervals. Additionally, the right scale shows the single doses for adults' 

 

Section 6.6 Special precautions for use and other handing.

- cross reference added to section 4.2

 

Section 10: Date of the revision of the text

- July 2018

Updated on 06 August 2018

File name

m1-3-1-spc-2242-12-11-v7-ipha.pdf

Reasons for updating

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

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

Updated on 06 August 2018

File name

m1-3-1-spc-2242-12-11-v8-ipha.pdf

Reasons for updating

  • 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 4.4 - 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 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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 2: Excipients with known effect added - propylene glycol and sodium

Section 4.1: Indication extended to paediatric population - Palexia is indicated for the relief of moderate to severe acute pain in children from 2 years of age and in adults, which can be adequately managed only with opioid analgesics.

Section 4.2: Use in children is restricted to hospital use. Information on paediatric dosing and use is included. Section on method of administration is updated in relation to administration through nasogastric tubes.

Section 4.4: Details on excipient propylene glycol and sodium added. Warning and precautions in relation to the paediatric population added.

Section 4.5: Added ' due to the major elimination pathwas being conjugation the potential for interactions in adults in low. Additionally, in vitro, tapentadol was found not to induce or inhibit any of the main CYP enzymes, including CYP 3A4'. Added information on potential for iteraction in paediatric population.

Section 4.6: title ' Lactation' changed to 'Breast-feeding'

Section 4.8: added details on adverse reaction in children.

Section 5.1: section on paediatric population is updated

Section 5.2: Details on paediatric population included

Section 5.3: preclinical data in juvenile animal included

Section 6.1: E 1520 added for propylene glycol

Section 6.5: Details of the dosing pipette is updated.

Section 6.6: title amended to ' Special precautions for disposal and other handling'. Reference made to section 4.2

Section 10: Date updated - July 2018

 

 

File name

m1-3-1-leaflet-2242-12-11-v5-ipha.pdf

Updated on 29 May 2018

File name

m1-3-1-spc-2242-12-11-v7-clean-no-header.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

update to marketing authorisation holder and number

File name

m1-3-1-leaflet-2242-12-11-v5-ipha.pdf

Updated on 21 May 2018

File name

m1-3-1-leaflet-2242-12-11-v5-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 29 August 2017

Reasons for updating

  • New SPC for new product

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

Updated on 29 August 2017

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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 6.3: Shelf life
extended from 3 years to 5 years

Section 10: Date of revision of the text
June 2017

Updated on 09 December 2016

File name

PIL_15973_564.pdf

Reasons for updating

  • New PIL for new product

Updated on 09 December 2016

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 07 September 2016

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 SPC following renewal of marketing authorisation

·         In section 10, date of revision of text changed

Updated on 11 April 2014

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 10 April 2014

Reasons for updating

  • New PIL for new product