Palexia 100 mg film-coated tablets
- Name:
Palexia 100 mg film-coated tablets
- Company:
Grunenthal Pharma Ltd.
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 14/07/20
(Click to Download)XPIL
Package leaflet: Information for the user
Package leaflet: Information for the user
1. What PALEXIA is and what it is used for
1. What PALEXIA is and what it is used for
2. What you need to know before you take PALEXIA
2. What you need to know before you take PALEXIA
3. How to take PALEXIA
3. How to take PALEXIA
4. Possible side effects
4. Possible side effects
5. How to store PALEXIA
5. How to store PALEXIA
6. Contents of the pack and other information
6. Contents of the pack and other information
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Grunenthal Pharma Ltd.
Company Products
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 14 July 2020 PIL
Reasons for updating
- Change to further information section
Free text change information supplied by the pharmaceutical company
Name change of product in Germany (Section 6 update)
Updated on 5 March 2020 PIL
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 added on sleep-related breathing disorders
Updated on 5 March 2020 SmPC
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
Information added on sleep-related breathing disorders
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
Updated on 28 April 2011 PIL
Reasons for updating
- New PIL for new product
- PIL Submitted in error