PARIET 20 mg gastro-resistant tablets

Type IAIN variation – C.I.3.a

Changes in the SmPC, Labelling or Package Leaflet of human medicinal products intended to implement the outcome of a procedure concerning PSUR – implementation of wording agreed by the competent authority

SE/H/1826/01-02/IA/116

Type IAIN variation – C.I.3.a

Changes in the SmPC, Labelling or Package Leaflet of human medicinal products intended to implement the outcome of a procedure concerning PSUR – implementation of wording agreed by the competent authority

SE/H/1826/01-02/IA/116

Manufacturer:

Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340, Beerse, Belgium

or

Eisai GmbH, Edmund-Rumpler-Straße 3, 60549, Frankfurt am Main, Germany

or

Lusomedicamenta – Sociedade, Estrada Consiglieri Pedroso 66, 69 B, Queluz de Baixo, 2730-055 Barcarena, Portugal

Sodium content

This medicine contains less than 1 mmol sodium (23 mg) per gastro-resistant tablet, that is to say essentially 'sodium-free'.

Sodium content

This medicine contains less than 1 mmol sodium (23 mg) per gastro-resistant tablet, that is to say essentially 'sodium-free'.

4.4     Special warnings and precautions for use

Sodium content

This medicine contains less than 1 mmol sodium (23 mg) per gastro-resistant tablet, that is to say essentially 'sodium-free'.

2. What you need to know before you take Pariet

Pariet contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per gastro-resistant tablet, that is to say essentially ‘sodium-free’.

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).

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).

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.

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.

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.

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.