Palexia SR 250 mg prolonged-release tablets
- Name:
Palexia SR 250 mg prolonged-release 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: 05/03/20
(Click to Download)XPIL
Package leaflet: Information for the user
Package leaflet: Information for the user
1. What PALEXIA SR is and what it is used for
1. What PALEXIA SR is and what it is used for
2. What you need to know before you take PALEXIA SR
2. What you need to know before you take PALEXIA SR
3. How to take PALEXIA SR
3. How to take PALEXIA SR
4. Possible side effects
4. Possible side effects
5. How to store PALEXIA SR
5. How to store PALEXIA SR
6. Contents of the pack and other information
6. Contents of the pack and other information
Click on this link to Download PDF directly
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 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
Addition of information on sleep-related breathing disorders
Updated on 5 March 2020 SPC
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 12 February 2020 PIL
Reasons for updating
- Correction of spelling/typing errors
Updated on 31 October 2019 SPC
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:
add 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 SPC
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
Updated on 5 November 2018 SPC
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 SPC
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 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 SPC
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
Updated on 3 January 2018 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
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 SPC
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
- Section 5.1: updated in light of new clinical data
- Section 10: date of revision of 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 10: date of revision of text
Updated on 18 November 2013 SPC
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 SPC
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 SPC
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 15 August 2013 SPC
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 SPC
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