Palexia SR 100 mg prolonged-release tablets

  • Name:

    Palexia SR 100 mg prolonged-release 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 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 9 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 PIL

Reasons for updating

  • New PIL for new product

Updated on 5 June 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 5 June 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

Change to marketing authorisation holder and number

Updated on 15 January 2018 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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:
Correction made to state the below (highlighted text re-inserted to align with approved spc):
The table below lists adverse drug reactions that were identified from clinical trials performed with PALEXIA SR and from post-marketing environment.

Updated on 15 January 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 4 January 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 4 January 2018 PIL

Reasons for updating

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

Updated on 4 January 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 3 January 2018 SmPC

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 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 18 August 2016 SmPC

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

Updated on 18 November 2013 SmPC

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 7 November 2013 SmPC

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 08 October 2013

Updated on 4 November 2013 PIL

Reasons for updating

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

Updated on 31 October 2013 SmPC

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 PIL

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 13 August 2013 SmPC

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 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