PARIET 20 mg gastro-resistant tablets
- Name:
PARIET 20 mg gastro-resistant tablets
- Company:
Janssen Sciences Ireland
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 16/07/20
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Janssen Sciences Ireland
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 16 July 2020 PIL
Reasons for updating
- Change to section 6 - manufacturer
- Change to date of revision
Updated on 9 May 2019 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 8 May 2019 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 be renewed (B)
Updated on 25 February 2019 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 18 October 2017 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Update to formatting and correction of typing errors throughout document.
4.8 Undesirable effects
Addition of Microscopic colitis as AE under System Organ Class ‘Gastrointestinal disorders’ with frequency ‘Not Known’
5.1 Pharmacodynamic properties
Paediatric population
The European Medicines Agency has deferred the obligation to submit the results of studies with PARIET in one or more subsets of the paediatric population in the treatment Gastro-Oesophageal Reflux Disease (see section 4.2 for information on paediatric use).
The European Medicines Agency has waived the obligation to submit the results of studies with PARIET in all subsets of the paediatric population in the treatment of Zollinger-Ellison syndrome, duodenal ulcer and gastric ulcer (see section 4.2 for information on paediatric use).
Updated on 18 October 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 18 October 2017 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 18 October 2017 PIL
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
Free text change information supplied by the pharmaceutical company
Update to formatting and correction of typing errors throughout document.
4.8 Undesirable effects
Addition of Microscopic colitis as AE under System Organ Class ‘Gastrointestinal disorders’ with frequency ‘Not Known’
5.1 Pharmacodynamic properties
Paediatric population
The European Medicines Agency has deferred the obligation to submit the results of studies with PARIET in one or more subsets of the paediatric population in the treatment Gastro-Oesophageal Reflux Disease (see section 4.2 for information on paediatric use).
The European Medicines Agency has waived the obligation to submit the results of studies with PARIET in all subsets of the paediatric population in the treatment of Zollinger-Ellison syndrome, duodenal ulcer and gastric ulcer (see section 4.2 for information on paediatric use).
Updated on 22 March 2017 PIL
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
4.8 Undesirable effects
Addition of Fundic gland polyps (benign) as an adverse event with common frequency under the System Organ Class of Gastrointestinal disorders.
Updated on 22 March 2017 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
4.8 Undesirable effects
Addition of Fundic gland polyps (benign) as an adverse event with common frequency under the System Organ Class of Gastrointestinal disorders.
Updated on 19 December 2016 SPC
Reasons for updating
- 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
Updated on 19 December 2016 PIL
Reasons for updating
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Updated on 11 October 2016 PIL
Reasons for updating
- New individual SPC (was previously included in combined SPC)
Free text change information supplied by the pharmaceutical company
Addition of the following:
4.4 Special warnings and precautions for use
Interference with laboratory tests
Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours. To avoid this interference, PARIET treatment should be stopped for at least 5 days before CgA measurements (see section 5.1). If CgA and gastrin levels have not returned to reference range after initial measurement, measurements should be repeated 14 days after cessation of proton pump inhibitor treatment.
5.1 Pharmacodynamic properties
During treatment with antisecretory medicinal products, serum gastrin increases in response to the decreased acid secretion. Also CgA increases due to decreased gastric acidity. The increased CgA level may interfere with investigations for neuroendocrine tumours.
Available published evidence suggests that proton pump inhibitors should be discontinued between 5 days and 2 weeks prior to CgA measurements. This is to allow CgA levels that might be spuriously elevated following PPI treatment to return to reference range.
Updated on 11 October 2016 SPC
Reasons for updating
- New individual SPC (was previously included in combined SPC)
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Addition of the following:
4.4 Special warnings and precautions for use
Interference with laboratory tests
Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours. To avoid this interference, PARIET treatment should be stopped for at least 5 days before CgA measurements (see section 5.1). If CgA and gastrin levels have not returned to reference range after initial measurement, measurements should be repeated 14 days after cessation of proton pump inhibitor treatment.
5.1 Pharmacodynamic properties
During treatment with antisecretory medicinal products, serum gastrin increases in response to the decreased acid secretion. Also CgA increases due to decreased gastric acidity. The increased CgA level may interfere with investigations for neuroendocrine tumours.
Available published evidence suggests that proton pump inhibitors should be discontinued between 5 days and 2 weeks prior to CgA measurements. This is to allow CgA levels that might be spuriously elevated following PPI treatment to return to reference range.