Palexia 100 mg film-coated tablets

  • Name:

    Palexia 100 mg film-coated tablets

  • 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 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 15 June 2018

Updated on 30 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 product authorisation number

Updated on 18 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 9 December 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 9 December 2016 PIL

Reasons for updating

  • 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

  • New SmPC for new product

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

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 the marketing authorisation
  • In section 10, data of revision of text added

Updated on 16 December 2013 PIL

Reasons for updating

  • Product/presentation re-marketed

Updated on 16 December 2013 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 28 April 2011 PIL

Reasons for updating

  • New PIL for new product
  • PIL Submitted in error