PARIET 10 mg gastro-resistant tablets

  • Name:

    PARIET 10 mg gastro-resistant tablets

  • Company:
    info
  • Active Ingredients:

    Rabeprazole Sodium

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 09/05/19

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Summary of Product Characteristics last updated on medicines.ie: 8/5/2019

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Janssen Sciences Ireland

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1 - 0 of 55 items.Total: Infinity pages

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 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 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 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 PIL

Reasons for updating

  • New PIL for new product

Updated on 18 October 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 18 October 2017 SmPC

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

  • 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 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 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 SmPC

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

Revision date amended.

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

Revision date amended.

Updated on 11 October 2016 PIL

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

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 SmPC

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

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 19 November 2015 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

$04.8 Undesirable Effects$0$0$0$0$0The most commonly reported adverse drug reactions, during controlled clinical trials with rabeprazole were headache, diarrhoea, abdominal pain, asthenia, flatulence, rash and dry mouth.  The majority of adverse events experienced during clinical studies were mild or moderate in severity, and transient in nature.$0$0$0$0$0The following adverse events have been reported from clinical trial and post-marketed experience.  Frequencies are defined as: common (> 1/100, < 1/10), uncommon (> 1/1,000, < 1/100) and rare (>1/10,000, <1/1000) and very rare (<1/10,000) , not known (cannot be estimated from the available data).$0

Updated on 19 November 2015 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

$04.8 Undesirable Effects$0$0$0$0$0The most commonly reported adverse drug reactions, during controlled clinical trials with rabeprazole were headache, diarrhoea, abdominal pain, asthenia, flatulence, rash and dry mouth.  The majority of adverse events experienced during clinical studies were mild or moderate in severity, and transient in nature.$0$0$0$0$0The following adverse events have been reported from clinical trial and post-marketed experience.  Frequencies are defined as: common (> 1/100, < 1/10), uncommon (> 1/1,000, < 1/100) and rare (>1/10,000, <1/1000) and very rare (<1/10,000) , not known (cannot be estimated from the available data).$0

Updated on 14 September 2015 PIL

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • Change to section 4.4 - Special warnings and precautions for use

Free text change information supplied by the pharmaceutical company

Section 4.4

Addition of:

Subacute cutaneous lupus erythematosus (SCLE)
Proton pump inhibitors are associated with very infrequent cases of SCLE. If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping PARIET. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.


Section 4.8

Addtion of:

The following adverse events have been reported from clinical trial and post-marketed experience. Frequencies are defined as: common (> 1/100, < 1/10), uncommon (> 1/1,000, < 1/100) and rare (>1/10,000, <1/1000) and very rare (<1/10,000) , not known (cannot be estimated from the available data).

Inclusion of SCLE in table under not known frequency.

Section 10

09 September 2015

Updated on 14 September 2015 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • Change to section 4.4 - Special warnings and precautions for use

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:

Subacute cutaneous lupus erythematosus (SCLE)
Proton pump inhibitors are associated with very infrequent cases of SCLE. If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping PARIET. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.


Section 4.8

Addtion of:

The following adverse events have been reported from clinical trial and post-marketed experience. Frequencies are defined as: common (> 1/100, < 1/10), uncommon (> 1/1,000, < 1/100) and rare (>1/10,000, <1/1000) and very rare (<1/10,000) , not known (cannot be estimated from the available data).

Inclusion of SCLE in table under not known frequency.

Section 10

09 September 2015

Updated on 23 April 2015 PIL

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Section 4.4:

To
add a warning statement on the risk of reduced vitamin B12 absorption

Updated on 23 April 2015 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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:

To
add a warning statement on the risk of reduced vitamin B12 absorption

Updated on 24 February 2015 PIL

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 4.5 - 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 - how to report a side effect
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Section 4.2:

Editorial change: from elderly to older people

 

Section 4.4:

Addition of information on concomitant use of rabeprazole with methotrexate; editorial change: from elderly to older people


Section 4.5:

Addition of information on interaction with methotrexate

 

Section 4.6:

Editorial change: from lactation to breast-feeding


Section 4.8:

Addition of information on reporting of suspect adverse reactions

 

Section 5.2:

Editorial change: from elderly to older people

Updated on 24 February 2015 SmPC

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 4.5 - 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 - how to report a side effect
  • 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:

Editorial change: from elderly to older people

 

Section 4.4:

Addition of information on concomitant use of rabeprazole with methotrexate; editorial change: from elderly to older people


Section 4.5:

Addition of information on interaction with methotrexate

 

Section 4.6:

Editorial change: from lactation to breast-feeding


Section 4.8:

Addition of information on reporting of suspect adverse reactions

 

Section 5.2:

Editorial change: from elderly to older people

Updated on 13 May 2013 PIL

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

Free text change information supplied by the pharmaceutical company

Section 4.4:

Class labelling changes:

1. Implementation of warnings re the use of prescription only Proton Pump Inhibitors and increased risk of fracture. 

2. Class effects of Proton Pump Inhibitors on magnesium blood levels in long-term users.

 

Section 4.8:

Addition of hypomagnesaemia and fracture of the hip, wrist or spine.

Updated on 13 May 2013 SmPC

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:

Class labelling changes:

1. Implementation of warnings re the use of prescription only Proton Pump Inhibitors and increased risk of fracture. 

2. Class effects of Proton Pump Inhibitors on magnesium blood levels in long-term users.

 

Section 4.8:

Addition of hypomagnesaemia and fracture of the hip, wrist or spine.

Updated on 29 February 2012 PIL

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Free text change information supplied by the pharmaceutical company

Change to section 6.5: Addition of 112 pack size 

Updated on 29 February 2012 SmPC

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)

Free text change information supplied by the pharmaceutical company

Change to section 6.5: Addition of 112 pack size 

Updated on 10 February 2011 PIL

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

Free text change information supplied by the pharmaceutical company

Addition of class labelling text to SmpC sections 4.4 and 5.1 regarding treatment with proton pump inhibitors and possible increase in risk of GIT infections.

Updated on 10 February 2011 SmPC

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

Addition of class labelling text to SmpC sections 4.4 and 5.1 regarding treatment with proton pump inhibitors and possible increase in risk of GIT infections.

Updated on 21 April 2010 PIL

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

6.3

Shelf life

Increased from 2 years to 3 years

10

DATE OF REVISION OF THE TEXT

 

Changed to April 2010

 

 

Updated on 21 April 2010 SmPC

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 be renewed (B)

Free text change information supplied by the pharmaceutical company

6.3

Shelf life

Increased from 2 years to 3 years

10

DATE OF REVISION OF THE TEXT

 

Changed to April 2010

 

 

Updated on 2 December 2008 PIL

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 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

4.4

Special Warnings and Precautions for Use

Addition of information re post marketing reports of blood dyscrasias and hepatic enzyme abnormalties

4.5

Interaction with other medicinal products and other forms of interaction

Warning re co-administration with atazanvir

4.8

Undesirable effects

Reformatted table of ADRs and addition of column for ADR incidence Not Known

7.

MARKETING AUTHORISATION HOLDER

Change of  company address

9.

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Latest renewal date changed to 6th May 2008.

10.

DATE OF REVISION OF THE TEXT

 

Changed to November 2008

 

Updated on 2 December 2008 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 4.8 - Undesirable effects
  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of 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

4.4

Special Warnings and Precautions for Use

Addition of information re post marketing reports of blood dyscrasias and hepatic enzyme abnormalties

4.5

Interaction with other medicinal products and other forms of interaction

Warning re co-administration with atazanvir

4.8

Undesirable effects

Reformatted table of ADRs and addition of column for ADR incidence Not Known

7.

MARKETING AUTHORISATION HOLDER

Change of  company address

9.

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Latest renewal date changed to 6th May 2008.

10.

DATE OF REVISION OF THE TEXT

 

Changed to November 2008

 

Updated on 2 August 2007 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change

IPHA – Fragments submitted to IMB

Change to section 4.8 – Undesirable effects

Addition of info re gynaecomastia & peripheral oedema

Change to section 6.1 – List of Excipients

Replacement of printing ink

Updated on 2 August 2007 PIL

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients

Free text change information supplied by the pharmaceutical company

Change

IPHA – Fragments submitted to IMB

Change to section 4.8 – Undesirable effects

Addition of info re gynaecomastia & peripheral oedema

Change to section 6.1 – List of Excipients

Replacement of printing ink

Updated on 1 September 2006 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.8 - Introduction of Stevens Johnson Syndrome as a very rare side effect.
Section 10 - June 2004

Updated on 1 September 2006 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

Section 4.8 - Introduction of Stevens Johnson Syndrome as a very rare side effect.
Section 10 - June 2004

Updated on 25 August 2004 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • 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 25 August 2004 PIL

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Updated on 9 August 2004 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 be renewed (B)

Updated on 9 August 2004 PIL

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text

Updated on 5 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 5 June 2003 PIL

Reasons for updating

  • New SPC for medicines.ie