Eisai Ltd

Changes to the Pariet SmPC May 2009

Section 6.5 Nature and contents of container

Addition of 112 pack size.

This pack size will not be marketed in the UK

Section 7 MARKETING AUTHORISATION HOLDER

Updated the MA Holder address to:

Eisai Limited, European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom

Section 10 DATE OF REVISION OF THE TEXT

Date of revision of text updated to: May 2009

Changes and additions were made to the following sections:

Section 4.3 (change)

PARIET is contra-indicated in patients with known hypersensitivity to rabeprazole sodium, or to any excipient used in the formulation

Section 4.4 (change)

A risk of cross-hypersensitivity reactions with other proton pump inhibitor or substituted benzimidazoles cannot be excluded.

Section 4.4 (additions)

There have been post marketing reports of blood dyscrasias (thrombocytopenia and neutropenia). In the majority of cases where an alternative aetiology cannot be identified, the events were uncomplicated and resolved on discontinuation of rabeprazole.

Hepatic enzyme abnormalities have been seen in clinical trials and have also been reported since market authorisation. In the majority of cases where an

alternative aetiology cannot be identified, the events were uncomplicated and resolved on discontinuation of rabeprazole.

Co-administration of atazanavir with PARIET is not recommended

Section 4.5 (additions)

Co-administration of atazanavir 300mg/ritonavir 10mg with omeprazole (40 mg once daily) or atazanavir 400mg with lansoprazole (60mg once daily) to healthy volunteers resulted in a substantial reduction in atazanavir exposure. The absorption of atazanavir is pH dependent. Although not studied, similar results are expected with other proton pump inhibitors.  Therefore PPIs, including rabeprazole, should not be co-administered with atazanavir (see Section 4.4).

Section 4.8 (additions)

The following undesirable effects were added as not known: hyponatremia,confusion, peripheral oedema and gynaecomastia. 

Section 4.8 Undesirable effects

Change to text in first two paragraphs

Changes to table of undesirable effects

Changes include:

Acute systemic allergic reactions (for example facial swelling, hypotension and dyspnea) changed to Hypersensitivity¹

Addition of footnote 1¹ Includes facial swelling, hypotension and dyspnoea

Somnolence reclassified as a nervous system disorder

Fever changed to Pyrexia

Addition of text

There have been post marketing reports of gynaecomastia and peripheral oedema where a relationship to rabeprazole could not be excluded.  As these adverse events were reported outside of a clinical study the incidence is not known.

Section 5.1 Pharmacodynamic properties

Addition of text to first paragraph

Pharmacotherapeutic group: Alimentary tract and metabolism, Drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD), proton pump inhibitors,

Section 6.1 List of excipients

Changes to printing ink

Printing ink – Pariet 10mg: White Shellac, black iron oxide (E172), Dehydrated Ethyl Alcohol, 1-Butanol.

Printing ink – Pariet 20mg: White Shellac, Red Iron Oxide (E172), Carnauba wax, Glycerine fatty acid ester, Dehydrated Ethyl Alcohol, 1-Butanol.

Section 6.5 Nature and contents of container

Addition of pack sizes  5 and 98

Section 10 DATE OF REVISION OF THE TEXT   26 June 2007