VIMOVO 500 mg/20 mg modified-release tablets
*Company:
Grunenthal Pharma Ltd.Status:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
![VIMOVO-[Left].jpeg](https://backend-prod.medicines.ie/uploads/files/VIMOVO-[Left]_1624023544.jpeg)
Updated on 05 December 2023
File name
uk-ie-pil-vimovo-v8-clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 20 July 2023
File name
ie-spc-vimovo-clean including approved Type IB cmdh_Type IA TIN change.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 20 July 2023
File name
ie-spc-vimovo-clean including approved Type IB cmdh_Type IA TIN change.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
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Re-uploading the approved SmPC changes for section 4.4, 4.6, 4.8 and 10.
Updated on 07 July 2023
File name
uk-ie-pil-vimovo-v7-clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 07 July 2023
File name
ie-spc-vimovo-clean.pdf
Reasons for updating
- 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 be renewed (B)
Updated on 27 April 2023
File name
uk-ie-pil-vimovo-v6-clean.pdf
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
Updated on 27 April 2023
File name
ie-spc-vimovo-clean.pdf
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 be renewed (B)
Updated on 31 January 2023
File name
ie-spc-vimovo-clean.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 31 May 2022
File name
uk-ie-pil-vimovo-v5-clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Type II Ireland approval: To include new adverse drug reactions terms of Acute Generalized Exanthematous Pustulosis (AGEP) and Drug Rash with Eosinophilia and Systemic Symptoms (DRESS). AGEP and DRESS will be included under the system organ class of “Skin and subcutaneous tissue disorders” with frequency of “Very rare” in Section 4.8 Undesirable effects under esomeprazole component. Section 4 of the PIL has been updated accordingly. Also, Section 4.4 “Special Warning and Precautions for Use” for naproxen component is to be amended to include a warning on DRESS as a class effect of NSAIDs.
Updated on 31 May 2022
File name
ie-spc-vimovo-clean.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
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Type II National Ireland Approval: To include new adverse drug reactions terms of Acute Generalized Exanthematous Pustulosis (AGEP) and Drug Rash with Eosinophilia and Systemic Symptoms (DRESS). AGEP and DRESS will be included under the system organ class of “Skin and subcutaneous tissue disorders” with frequency of “Very rare” in Section 4.8 Undesirable effects under esomeprazole component. Section 4 of the PIL has been updated accordingly. Also, Section 4.4 “Special Warning and Precautions for Use” for naproxen component is to be amended to include a warning on DRESS as a class effect of NSAIDs.
Updated on 30 November 2021
File name
uk_ie-mock-up-pil vimovo 93036312.pdf
Reasons for updating
- Individual PILs superseded by joint PIL
Free text change information supplied by the pharmaceutical company
Shared (joint) packs have been approved by UK - MHRA and HPRA. Please note. as agreed with HPRA the this joint PIL did not require any HPRA submission. The PIL mock up will be submitted at the next regulatory opportunity as confirmed by HPRA.
Updated on 08 October 2021
File name
ie-pl-vimovo-clean.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
Free text change information supplied by the pharmaceutical company
Addition of HDPE bottles
Updated on 08 October 2021
File name
ie-spc-vimovo-clean.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 06 April 2021
File name
ie-spc-vimovo.pdf
Reasons for updating
- Change to section 8 - Marketing authorisation number(s)
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
MA Number was incorrect on the SPC uploaded on 9th March 2021. This new upload contains the updated MA number which PA 2242/014/001.
Updated on 09 March 2021
File name
ie-pl-vimovo.pdf
Reasons for updating
- New PIL for medicines.ie
Free text change information supplied by the pharmaceutical company
Grunenthal Pharma Limited in Ireland is now the approved MA-Holder for this drug product.
Updated on 09 March 2021
File name
ie-spc-vimovo.pdf
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Grunenthal Pharma Limited in Ireland is officially the new MA-holder for this drug product.
Updated on 06 October 2020
File name
ie-spc-vimovo-cds-update-PAI 20 0002.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 - 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 be renewed (B)
Updated on 06 October 2020
File name
ie-pl-vimovo-cds-update-PAI 20 0001.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - excipient warnings
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 23 December 2019
File name
20191220-ie-smpc-vimovo-PAI 19 0003a.pdf
Reasons for updating
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Addition of a 10 pack size
Updated on 23 December 2019
File name
20191220-ie-pil-Vimovo-PAI 19 0002.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Addition of a 10 pack size
Updated on 30 October 2019
File name
20191016-pil-ie-Vimovo-PAI 19 0001.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 04 March 2019
File name
Package Leaflet-ie-VIMOVO tablets-Brexit MAH-PAI 18 0006.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 04 March 2019
File name
20190301_SPC_ie_VIMOVO_500_mg_20_mg_tablets_Brexit_MAH_PAI_18 0005.pdf
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 be renewed (B)
Updated on 16 May 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 16 May 2017
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 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.4 – Updated subheading from ‘older people’ to ‘elderly’ in line with QRD template.
Section 4.8 – Addition of ‘fundic gland polyps (benign)’ to ADR table for Esomeprazole under the Gastrointestinal SOC with frequency of ‘common’
Section 5.2 – Updated subheading from ‘older people’ to ‘elderly’ in line with QRD template.
Section 10 – Date of revision of text updated.
Updated on 15 May 2017
File name
PIL_14983_702.pdf
Reasons for updating
- New PIL for new product
Updated on 15 May 2017
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 22 March 2017
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- 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 - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.1 - List of excipients
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 1 – Removal of black triangle
Section 2 – Updated information relating to excipients with known effect
Section 3 – Updated information relating to pharmaceutical form
Section 4.2 – Updated information in line with QRD template
Section 4.4 – Updated spelling of esomeprazole and dyspepsia. Updated heading in line with QRD. Addition of information relating to the interaction between Chromogranin A with investigations for neuroendocrine tumours.
Section 4.8 – Minor formatting changes to ADR table, corrected spelling of erythematosus and pruritis and addition of reference to section 4.4. Update of HPRA contact details.
Section 5.1 – Updated information relating to the interaction between Chromogranin A with investigations for neuroendocrine tumours and minor formatting changes.
Section 6.1 – Updated list of excipients with additional information for hypromellose and methacrylic acid-ethyl acrylate copolymer.
Section 9 – Updated renewal date
Section 10 – Updated date of revision of text
Updated on 22 March 2017
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- 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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.1 - List of excipients
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 3 – Updated information relating to pharmaceutical form
Section 4.2 – Updated information in line with QRD template
Section 4.3 – Minor editorial changes and correct of spelling for Child Pugh C.
Section 4.4 – Updated spelling of esomeprazole and dyspepsia. Updated heading in line with QRD.
Section 4.8 – Minor formatting changes to ADR table, corrected spelling of erythematosus and pruritis and addition of reference to section 4.4. Update of HPRA contact details.
Section 5.1 –Minor formatting changes.
Section 6.1 – Updated list of excipients with additional information for hypromellose and methacrylic acid-ethyl acrylate copolymer.
Section 9 – Updated renewal date
Section 10 – Updated date of revision of text
Updated on 21 March 2017
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- 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 section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
Updated on 27 January 2017
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.4 – Updated with information relating to interaction between Chromogranin A level with investigations for neuroendocrine tumours.
Section 5.1 – Updated information on effects related to acid inhibition.
Section 10 – Updated date of revision of text.
Updated on 26 January 2017
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 01 February 2016
Reasons for updating
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.4: Addition of Dermatological effect for esomeprazole.
Section 4.8: Addition of new AE for Skin and subcutaneous tissue disorders.
Section 10: Date of revision.
Updated on 29 January 2016
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
- Change to improve clarity and readability
Updated on 04 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.8 addition of hypokalaemia to SE
Section 10 date of revision
Updated on 18 October 2013
Reasons for updating
- 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 4.8 – 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 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
· Section 2 - administrative changes
· Section 4.1 – administrative changes
· Section 4.2 – administrative changes and more detail on use in paediatric population
· Section 4.3 – administrative changes
· Section 4.4 - administrative changes and updated to align with the CDS wording with regards to combination use of Vimovo with non-aspirin NSAIDs. Information on angiotensin II receptor antagonists has been added in the subsection on renal effects. The subsection on impaired renal function has been updated to include angiotensin II receptor antagonists and ACE inhibitors. There has also been an update regarding interaction with clopidogrel.
· Section 4.5 - updated with regards to potential interaction with tacrolimus and information on tacrolimus and cyclosporin has been split into separate subsections. There has been an update with regards to information on the combination of NSAIDs and angiotensin II receptor antagonists and ACEinhibitors. The text concerning potential interaction with methotrexate has been updated and there is an update to the information on interaction with clopidogrel.
· Section 4.6 - updated with regards to female infertility and spontaneous abortion.
· Section 4.7 – Administrative changes
· Section 4.8 - updated to include hypocalcaemia in connection with severe hypomagnesaemia. Microscopic colitis has also been added. Addition of AE wording.
· Section 4.9 - administrative change
· Section 5.1 - updated with information on Chromogranin A and ECL cell hyperplasia. Text regarding clostridium difficile in hospitalised patients has also been added
· Section 5.2 – Addition of linearity/non-linearity information and administrative changes.
· Section 6.5 - updated with an administrative change for clarity of use to explain that the sachet containing the desiccant in the packaging is not to be eaten
· Section 10 – date of revision
Updated on 16 October 2013
Reasons for updating
- Change to warnings or special precautions for use
- Change to drug interactions
- Change to further information section
- Change to date of revision
- Addition of information on reporting a side effect.
- Improved electronic presentation
Updated on 09 January 2013
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 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.2
Update around non-fixed combination products.
Section 4.4
Update on overtreatment and non-fixed combination products.
Addition of information on hypomagnesaemia and bone fracture.
Section 4.8
Add fracture of hip, wrist and spine as a side effect.
Change frequency of hypomagnesaemia side effect.
Section 5.1
Administrative changes.
Section 5.2
Update on Naproxen absorption.
Section10
Date of revision amended to 12th December 2012.
Updated on 08 January 2013
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to further information section
- Change to dosage and administration
Updated on 02 October 2012
Reasons for updating
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.4
Addition of Hypomagnesaemia and Bone Fracture.
Section 4.8
Addition of bone fracture to side effects for esomeprazole and change frequency of hypomagnesaemia side effect.
Section 10
Date of revision amended to 2nd September 2012
Updated on 26 September 2012
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 01 November 2011
Reasons for updating
- 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 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Following text deleted:
because these patients should not receive more than 20 mg esomeprazole per day
Section 4.3
Active peptic ulceration text amended.
Section 4.4
Paragraph 18 text replaced with:
Treatment with proton pump inhibitors may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter (see section 5.1).
Use in patients with impaired renal function
Not recommended replaced with contraindicated
New paragraph inserted after Hepatic effects:
Hepatorenal syndrome
The use of NSAIDs may be associated with acute renal failure in patients with severe hepato-cirrhosis. These patients frequently also have concomitant coagulopathy related to inadequate synthesis of clotting factors. Antiplatelet effects associated with naproxen could further increase risk of severe bleeding in these patients.
Section 4.5
Amendments to text and percentages in the Clopidogrel paragraph.
Amendments to text and percentages in the Drugs with gastric pH-dependent absorption
Other Information Concerning Drug Interactions
Paragraph 7 and 8 insertion of new text:
Drugs known to induce CYP2C19 or CYP3A4 or both (such as rifampicin and St. John’s Wort) may lead to decreased esomeprazole serum levels by increasing the esomeprazole metabolism.
Omeprazole as well as esomeprazole act as inhibitors of CYP2C19. Omeprazole, given in doses of 40 mg to healthy subjects in a cross-over study, increased Cmax and AUC for cilostazol by 18% and 26% respectively, and one of its active metabolites by 29% and 69% respectively.
Section 5.1
Insertion of text under Other effects related to acid inhibition:
Also chromogranin A (CgA) increases due to decreased gastric acidity.
Decreased gastric acidity due to any means including proton pump inhibitors, increases gastric counts of bacteria normally present in the gastrointestinal tract. Treatment with proton pump inhibitors may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter.
Clinical efficiency and safety
Paragraph updated – text inserted.
Section 5.2
Text change under Special Populations:
Not recommended replaced with contraindicated
Esomeprazole: Text removed:
Therefore, a maximum of 20 mg daily should not be exceeded in patients with severe hepatic impairment.
Section 10
Date amended to 30th September 2011.
Updated on 27 October 2011
Reasons for updating
- Change to drug interactions
- Change to date of revision
Updated on 09 May 2011
Reasons for updating
- New PIL for new product
Updated on 06 May 2011
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)