Palexia Oral Solution 20 mg/ml

  • Name:

    Palexia Oral Solution 20 mg/ml

  • Company:
    info
  • Active Ingredients:

    Tapentadol 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: 31/10/19

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 31/10/2019

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Grunenthal Pharma Ltd.

Grunenthal Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name Ixprim effervescent tablets Active Ingredients Paracetamol, Tramadol Hydrochloride
Medicine Name Ixprim film coated tablets Active Ingredients Paracetamol, Tramadol Hydrochloride
Medicine Name Palexia 100 mg film-coated tablets Active Ingredients Tapentadol hydrochloride
Medicine Name Palexia 50 mg film-coated tablets Active Ingredients Tapentadol hydrochloride
Medicine Name Palexia 75 mg film-coated tablets Active Ingredients Tapentadol hydrochloride
Medicine Name Palexia Oral Solution 20 mg/ml Active Ingredients Tapentadol hydrochloride
Medicine Name Palexia SR 100 mg prolonged-release tablets Active Ingredients Tapentadol hydrochloride
Medicine Name Palexia SR 150 mg prolonged-release tablets Active Ingredients Tapentadol hydrochloride
Medicine Name Palexia SR 200 mg prolonged-release tablets Active Ingredients Tapentadol hydrochloride
Medicine Name Palexia SR 250 mg prolonged-release tablets Active Ingredients Tapentadol hydrochloride
Medicine Name Palexia SR 50 mg prolonged-release tablets Active Ingredients Tapentadol hydrochloride
Medicine Name Qutenza 179mg Cutaneous Patch Active Ingredients Capsaicin
Medicine Name Versatis 700 mg medicated plaster Active Ingredients Lidocaine
Medicine Name Zomig 2.5mg Tablets Active Ingredients Zolmitriptan
Medicine Name Zomig Rapimelt 2.5mg Active Ingredients Zolmitriptan
Medicine Name Zydol 100mg Solution for Injection Active Ingredients Tramadol Hydrochloride
Medicine Name Zydol 50mg caps Active Ingredients Tramadol Hydrochloride
Medicine Name Zydol SR 100mg Active Ingredients Tramadol Hydrochloride
Medicine Name Zydol SR 100mg, 150mg, 200mg Tablets Active Ingredients Tramadol Hydrochloride
Medicine Name Zydol SR 150mg Active Ingredients Tramadol Hydrochloride
Medicine Name Zydol SR 200mg Prolonged Release Tablets Active Ingredients Tramadol Hydrochloride
Medicine Name Zydol SR 50mg Active Ingredients Tramadol Hydrochloride
1 - 0 of 22 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 31 October 2019 SmPC

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 PIL

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 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

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

Updated on 23 July 2019 PIL

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 SmPC

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 PIL

Reasons for updating

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

Updated on 19 December 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

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 5 November 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 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
  • 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 PIL

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 SmPC

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 6 August 2018 SmPC

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 6 August 2018 SmPC

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

 

 

Updated on 15 June 2018

Updated on 29 May 2018 SmPC

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

Updated on 29 May 2018

Updated on 21 May 2018 PIL

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 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 29 August 2017 SmPC

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 9 December 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 9 December 2016 PIL

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 7 September 2016 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 SPC following renewal of marketing authorisation

·         In section 10, date of revision of text changed

Updated on 11 April 2014 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 10 April 2014 PIL

Reasons for updating

  • New PIL for new product