Ixprim effervescent tablets
*Company:
Grunenthal Pharma Ltd.Status:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
![IXPRIM-EFFERVESCENT-[Left].jpeg](https://backend-prod.medicines.ie/uploads/files/IXPRIM-EFFERVESCENT-[Left]_1624022027.jpeg)
Updated on 22 December 2023
File name
m1-3-1-leaflet-pa2242-6-2-v21 ipha-clean.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 2 - excipient warnings
- Change to section 5 - how to store or dispose
- 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
- Change to other sources of information section
Free text change information supplied by the pharmaceutical company
- Deletion of immediate packaging container
- Addition of information on sulphite content
- Amendment according to QRD template version 10.2 (editorial)
- Correction of typographical error with sodium content (editorial)
Updated on 22 December 2023
File name
m1-3-1-spc-pa2242-6-2-v19 ipha-clean.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.1 - List of excipients
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- 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
- Deletion of immediate packaging container
- Addition of information on sulphite content
- Amendment according to QRD template version 10.2 (editorial)
- Correction of typographical error with sodium content (editorial)
Updated on 31 January 2023
File name
m1-3-1-spc-pa2242-6-2-v18 ipha-clean.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 24 November 2022
File name
m1-3-1-leaflet-pa2242-6-2-v20-ipha clean.pdf
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 4 - possible side effects
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
Updated on 24 November 2022
File name
m1-3-1-spc-pa2242-6-2-v18 ipha-clean.pdf
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 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)
Updated on 21 February 2022
File name
m1-3-1-spc-pa2242-6-2-v17 ipha-clean.pdf
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 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- 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
Approval of End of Procedure of two work-sharing procedures as outlined below;
- DE/H/XXXX/WS/964 - Grouped Type II and Type IB variations.
Change 1: Type II - to update product information following CCDS update with additions of 3 ADRs and working adaptation of section 5.3 (pre-clinical safety data) with impact on the wording in section 4.6 (fertility).
Change 2: Type IB unforseen - to implementation PSUSA/00003002/202005 outcome.
- DE/H/xxxx/WS/1000 – Type IB PRAC change - to implement the PRAC change recommendation on signals based on EMA/PRAC/2050777/2021; EPITT no 19635 (dated 31st May 2021) into the product information (SmPC and PIL).
Updated on 21 February 2022
File name
m1-3-1-leaflet-pa2242-6-2-v19-ipha clean.pdf
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 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Approval of End of Procedure of two work-sharing procedures as outlined below;
- DE/H/XXXX/WS/964 - Grouped Type II and Type IB variations.
Change 1: Type II - to update product information following CCDS update with additions of 3 ADRs and working adaptation of section 5.3 (pre-clinical safety data) with impact on the wording in section 4.6 (fertility).
Change 2: Type IB unforseen - to implementation PSUSA/00003002/202005 outcome.
- DE/H/xxxx/WS/1000 – Type IB PRAC change - to implement the PRAC change recommendation on signals based on EMA/PRAC/2050777/2021; EPITT no 19635 (dated 31st May 2021) into the product information (SmPC and PIL).
Updated on 21 February 2022
File name
m1-3-1-leaflet-pa2242-6-2-v19-ipha clean.pdf
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 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- 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
Approval of End of Procedure of two work-sharing procedures as outlined below;
- DE/H/XXXX/WS/964 - Grouped Type II and Type IB variations.
Change 1: Type II - to update product information following CCDS update with additions of 3 ADRs and working adaptation of section 5.3 (pre-clinical safety data) with impact on the wording in section 4.6 (fertility).
Change 2: Type IB unforseen - to implementation PSUSA/00003002/202005 outcome.
- DE/H/xxxx/WS/1000 – Type IB PRAC change - to implement the PRAC change recommendation on signals based on EMA/PRAC/2050777/2021; EPITT no 19635 (dated 31st May 2021) into the product information (SmPC and PIL).
Updated on 03 June 2021
File name
m1-3-1-spc-pa2242-6-2-v12d2-clean-ipha.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 03 June 2021
File name
m1-3-1-leaflet-pa2242-6-2-v14d2-clean-ipha.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - how to report a side effect
Updated on 09 March 2020
File name
m1-3-1-spc-pa2242-6-2-v11-ipha.pdf
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 disorder
Updated on 09 March 2020
File name
m1-3-1-leaflet-pa2242-6-2-v13-ipha.pdf
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 15 November 2019
File name
m1-3-1-leaflet-pa2242-6-2-v12d2-clean-emc.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - excipient warnings
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Details added on the risk from concomitant use of sedative medicines such as benzodiazepines or related drugs
Details added on the content of sodium
Updated on 15 November 2019
File name
m1-3-1-spc-pa2242-6-2-v10d2-clean-emc.pdf
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:
Details added on the risk from concomitant use of sedative medicines such as benzodiazepines or related drugs
Details added on the content of sodium
Section 4.5
Details added on the concomitant use of opioids with sedative medicines such as benzodiazepines or related drugs
Updated on 05 July 2019
File name
m1-3-1-spc-pa2242-6-2-v9-clean-noheader.pdf
Reasons for updating
- File format updated to PDF
Legal category:Product subject to medical prescription which may not be renewed (A)
File name
m1-3-1-leaflet-pa2242-6-2-v11-no-header.pdf
Updated on 30 May 2018
File name
m1-3-1-spc-pa2242-6-2-v9-clean-noheader.docx
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 product licence number
Updated on 18 May 2018
File name
m1-3-1-leaflet-pa2242-6-2-v11-no-header.pdf
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 20 November 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 November 2017
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
- Date of renewal has been corrected
Updated on 14 September 2017
File name
PIL_14395_874.pdf
Reasons for updating
- New PIL for new product
Updated on 14 September 2017
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- 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 reformatted. no new information.
Section 9: Date of first authorisation/renewal of authorisation
Date of renewal added as 19th July 2012
Section 10: Date of revision of the text
August 2017
Updated on 14 September 2017
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 25 July 2017
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
Pharmacotherapeutic group: changes from 'Tramadol, combinations' to 'Opioids in combination with non-opioid analgesics; tramadol and paracetamol'
ATC code: changes from 'N02 AX 52' to 'N02 AJ 13'
10: date of revision of the text
June 2017
Updated on 18 November 2016
Reasons for updating
- Change to information about pregnancy or lactation
Updated on 08 September 2016
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- 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 4.6 (Fertility, pregnancy and lactation), information on breastfeeding has been updated
- In Section 10, the date of revision of the text has been updated
Updated on 12 March 2015
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 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 2: alignment with QRD template
Section 4.1: formatting changes
Section 4.2: Editorial changes, information on dosing in Elderly patients, information on dosing in renal insufficiency/dialysis & hepatic impairment.
Section 4.3: alignment with QRD template
Section 4.4: Formatting changes. Deleted 'symptoms of withdrawal reactions, similar to those occurring during opiate withdrawal may occur'.
Section 4.5: sweating replaced by hyperhidrosis, updated information on concomitant use, details on serotonin syndrome added including symptoms.
Section 4.6: added under fertility ' Post marketing surveillance does not suggest an effect of tramadol on fertility.
Section 4.8: Adaptation to QRD template and adverse event terminology to MedDRA preferred terms. Addition of speech disorders, delirium, miosis, mydriasis as rare adverse events. Addition of AE reporting details to health authorities.
Section 4.9: formatting changes
section 5.1: formatting changes
Section 5.2: formatting changes
Section 5.3: added ' Male and female fertility was not affected'. Deleted ' no effect on fertility has been observed after oral administration of tramadol up to doses of 50mg/kg in the make rat and 75mg/kg in the female rat.'
Updated on 12 March 2015
Reasons for updating
- Change to side-effects
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to date of revision
- Change to dosage and administration
- Change to improve clarity and readability
- Addition of information on reporting a side effect.
Updated on 18 December 2014
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - 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 4.4: deleted 'Symptoms of withdrawal reactions, similar to those occurring during opiate withdrawal may occur (see section 4.8).'
section 4.8: added 'Very rare cases of serious skin reactions have been reported.'
Section 10: 07/2014
Updated on 18 December 2014
Reasons for updating
- Change to side-effects
Updated on 19 March 2014
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
4.8 Undesirable effects
Metabolism and nutrition disorders:
Unknown (cannot be estimated from available data): hypoglycaemia
Leaflet changes:
4. POSSIBLE SIDE EFFECTS
Unknown: cannot be estimated from the available data
· decrease in blood sugar level
Updated on 19 March 2014
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 26 July 2013
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
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 relating to tolerance and dependence added. Text on duration of treatment in patients with history of abuse added.
Section 4.8 – Syncope added as a rare undesirable effect
Updated on 25 July 2013
Reasons for updating
- Change to side-effects
Updated on 15 April 2010
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 10 - The revision date has been updated with the approval date.
Updated on 11 November 2009
Reasons for updating
- Change to packaging
Updated on 03 September 2009
Reasons for updating
- New PIL for new product
- New PIL for medicines.ie
Updated on 01 September 2009
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)