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Takeda Products Ireland Ltd

First Floor, 3013 Lake Drive, Citywest Business Campus, Dublin 24, Ireland
Telephone: +353 1 642 0021
Fax: +353 1 642 0020
Medical Information Direct Line: 1800 937970
Medical Information e-mail: DSO-UK@takeda.com
Medical Information Facsimile: +44 (0)1628 526 617
Summary of Product Characteristics last updated on medicines.ie: 19/04/2017
SPC Protium 40mg iv

When a pharmaceutical company changes an SPC or PIL, 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 19/04/2017 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   24-Mar-2017
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

In section 4.8 (undesirable effects), Fundic gland polyps (benign) has been added under a new column 'common'
Updated on 03/11/2016 and displayed until 19/04/2017
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   30-Sep-2016
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



Section 4.4 following text deleted:
Pantoprazole, like all proton pump inhibitors (PPIs), might be expected to increase the counts of bacteria normally present in the upper gastrointestinal tract. Treatment with {Tradename} may lead to a slightly increased risk of gastrointestinal infections caused by bacteria such as Salmonella and Campylobacter.

Section 4.4 following text added:
Interference with Laboratory Tests
Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours. To avoid this interference, Protium 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.

Section 5.1 following text added:
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 28/09/2016 and displayed until 03/11/2016
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   02-Sep-2016
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Change to Section 7 - the MA holders address has changed.

Change to section 8 - The MA number has changed
Updated on 15/01/2016 and displayed until 28/09/2016
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   23-Dec-2015
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

The updated Protium SmPCs contain updated information in the following sections:

Change to section

Details of change

2. Qualitative and quantitative composition

The following line has been updated to (40mg iv only):

 

Each vial contains 40 mg of pantoprazole.

 

4.2       Posology and method of administration

The following section has been updated (40mg iv only)

 

Paediatric population

The safety and efficacy of Protium 40 mg powder for solution for injection in children aged under 18 years have not been established. Therefore, Protium 40 mg powder for solution for injection is not recommended for use in patients below 18 years of age.

 

Currently available data are described in section 5.2 but no recommendation on a posology can be made.

 

4.2       Posology and method of administration

 

Addition of heading:

 

Oral use

The tablets should not be chewed or crushed, and should be swallowed whole 1 hour before a meal with some water.

 

4.4       Special warnings and precautions for use

 

The following section previously entitled ‘In presence of alarm symptoms’ has been updated to:

 

Gastric malignancy

Symptomatic response to pantoprazole may mask the symptoms of gastric malignancy and may delay diagnosis. In the presence of any alarm symptom (e.g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis, anaemia or melaena) and when gastric ulcer is suspected or present, malignancy should be excluded.

 

Gastric malignancy

Symptomatic response to pantoprazole may mask the symptoms of gastric malignancy and may delay diagnosis. In the presence of any alarm symptom (e. g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis, anaemia or melaena) and when gastric ulcer is suspected or present, malignancy should be excluded.

 

4.4       Special warnings and precautions for use

 

The following section previously entitled ‘Co-administration with atazanavir’ had been updated to:

 

Co-administration with HIV protease inhibitors

Co-administration of pantoprazole is not recommended with HIV protease inhibitors for which absorption is dependent on acidic intragastric pH such as atazanavir, due to significant reduction in their bioavailability (see section 4.5).

 

Co-administration with HIV protease inhibitors

Co-administration of pantoprazole is not recommended with HIV protease inhibitors for which absorption is dependent on acidic intragastric pH such as atazanavir, due to significant reduction in their bioavailability (see section 4.5).

 

 

4.4       Special warnings and precautions for use

 

The following section has been updated to:

 

Gastrointestinal infections caused by bacteria

Treatment with Protium may lead to a slightly increased risk of gastrointestinal infections caused by bacteria such as Salmonella and Campylobacter or C. difficile.

 

Pantoprazole, like all proton pump inhibitors (PPIs), might be expected to increase the counts of bacteria normally present in the upper gastrointestinal tract. Treatment with Protium may lead to a slightly increased risk of gastrointestinal infections caused by bacteria such as Salmonella and Campylobacter.

 

 

4.4       Special warnings and precautions for use

 

The following new section has been added:

 

Sub-acute 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 healthcare professional should consider stopping Protium. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.

 

4.5       Interaction with other medicinal products and other forms of interaction

 

The following section has been updated, including updated subheadings as follows:

 

Medicinal products with pH-Dependent Absorption Pharmacokinetics

Because of profound and long lasting inhibition of gastric acid secretion, pantoprazole may interfere with the absorption of other medicinal products where gastric pH is an important determinant of oral availability, e.g. some azole antifungals such as ketoconazole, itraconazole, posaconazole and other medicines such as erlotinib.

 

HIV protease inhibitors)

Co-administration of pantoprazole is not recommended with HIV protease inhibitors for which absorption is dependent on acidic intragastric pH such as atazanavir due to significant reduction in their bioavailability (see section 4.4).

 

If the combination of HIV protease inhibitors with a proton pump inhibitor is judged unavoidable, close clinical monitoring (e.g. virus load) is recommended. A pantoprazole dose of 20 mg per day should not be exceeded. Dosage of the HIV protease inhibitor may need to be adjusted

 

Coumarin anticoagulants (phenprocoumon or warfarin)

Co-administration of pantoprazole with warfarin or phenprocoumon did not affect the pharmacokinetics of warfarin, phenprocoumon or INR. However, there have been reports of increased INR and prothrombin time in patients receiving PPIs and warfarin or phenprocoumon concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding, and even death. Patients treated with pantoprazole and warfarin or phenprocoumon may need to be monitored for increase in INR and prothrombin time.

 

4.5       Interaction with other medicinal products and other forms of interaction

 

The following sentence has been added:

 

An interaction of pantoprazole with other medicinal products or compounds, which are metabolized using the same enzyme system, cannot be excluded.

 

4.5       Interaction with other medicinal products and other forms of interaction

 

The following section has been added:

 

Medicinal products that inhibit or induce CYP2C19:

 

Inhibitors of CYP2C19 such as fluvoxamine could increase the systemic exposure of pantoprazole. A dose reduction may be considered for patients treated long-term with high doses of pantoprazole, or those with hepatic impairment.

 

Enzyme inducers affecting CYP2C19 and CYP3A4 such as rifampicin and St John´s wort (Hypericum perforatum) may reduce the plasma concentrations of PPIs that are metabolized through these enzyme systems.

 

4.6 Fertility, pregnancy and lactation

The following sections have been updated:

 

Pregnancy

A moderate amount of data on pregnant women (between 300-1000 pregnancy outcomes) indicate no malformative or feto/ neonatal toxicity of Protium.

Animal studies have shown reproductive toxicity (see section 5.3).

As a precautionary measure, it is preferable to avoid the use of Protium during pregnancy.

 

Breast-feeding

Animal studies have shown excretion of pantoprazole in breast milk. There is insufficient information on the excretion of pantoprazole in human milk but excretion into human milk has been reported. A risk to the newborns/infants cannot be excluded. Therefore, a decision on whether to discontinue breast-feeding or to discontinue/abstain from Protium therapy should take into account the benefit of breast-feeding for the child, and the benefit of Protium therapy for the woman.

 

Fertility

There was no evidence of impaired fertility following the administration of pantoprazole in animal studies (see section 5.3).

 

4.7. Effects on ability to drive and use machines

The following information has been added:

 

Pantoprazole has no or negligible influence on the ability to drive and use machines.

 

4.8 Undesirable effects

The following adverse reaction has been added to Table 1 under skin and subcutaneous tissue disorders:

 

Sub-acute cutaneous lupus erythematosus (see section 4.4)

10. Date of revision of the text

Updated to:

 

23/12/2015

Updated on 30/10/2014 and displayed until 15/01/2016
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   13-Oct-2014
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



 

CHANGE TO SECTION

DETAILS OF CHANGE

4.2      POSOLOGY AND METHOD OF ADMINISTRATION

Moved:

Paediatric population

The experience in children is limited. Therefore, Protium 40 mg powder for solution for injection is not recommended for use in patients below 18 years of age until further data become available.

 

4.8.   UNDESIRABLE EFFECTS     

    

Added:

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

 

10.      DATE OF REVISION OF THE TEXT

Changed to:

13th October 2014

 

Updated on 19/12/2012 and displayed until 30/10/2014
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   30-Nov-2012
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

In section 7 the Marketing Authorisation Holder has changed to

Takeda GmbH


In section 10 Date of revision of the text is 30/11/2012

Updated on 03/10/2012 and displayed until 19/12/2012
Reasons for adding or 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
Date of revision of text on the SPC:   20-Sep-2012
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



SPC update to include Bone Fracture and Hypomagnesaemia Safety Warnings in Section 4.4 and 4.8

Updated on 01/03/2012 and displayed until 03/10/2012
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   11-Jan-2012
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Addition of a number of new adverse events to section 4.8 including agranulocytsis, pancytopenia and hypomagesaemia.
Updated on 06/09/2010 and displayed until 01/03/2012
Reasons for adding or updating:
  • Change to improve clarity and readability
Date of revision of text on the SPC:   31-Aug-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



Change in the Summary of Product Characteristics following a procedure in accordance with Article 30 of Directive 2001/83/EC (referral procedure) to harmonise the product information of all pantoprazole products in the range.

Updated on 30/10/2008 and displayed until 06/09/2010
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   10/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Marketing Authorisation Holder name changed from ALTANA Pharma AG to Nycomed GmbH following merger.  No change in address or any other details.
Updated on 21/08/2007 and displayed until 30/10/2008
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • 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 6.3 - Shelf life
Date of revision of text on the SPC:   06/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 4.3 - Section 4.3 - The addition of the co-administration of pantoprazole with atazanavir as a contraindication

Section 4.5 - The addition of a possible interaction with the co-administration of pantoprazole with atazanavir

Section 4.8 - The addition of depression, hallucination, disorientation and confusion as rare side effects

Section 6.3 – Shelf life changed to 2 years

 

Updated on 09/08/2006 and displayed until 21/08/2007
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 27/07/2006 and displayed until 09/08/2006
Reasons for adding or updating:
  • 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 10 - Date of revision of the text
Date of revision of text on the SPC:   12/2005
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction, Change to section 4.8 - Undesirable Effects, Change to section 10 (date of (partial) revision of the text
Change details:
4.5            Interactions with other Medicaments and other forms of Interaction
The following statement has been added: The response to anticoagulants such as warfarin, phenprocoumon or acenocoumarol may be affected by any concomitant medication
 
 
4.8            Undesirable Effects
 
The following have been added to this section: Leukopenia: Thrombocytopenia, Dry mouth, Arthralgia, Vomiting
Updated on 12/08/2005 and displayed until 27/07/2006
Reasons for adding or updating:
  • 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 6.1 - List of excipients
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors
Updated on 10/08/2004 and displayed until 12/08/2005
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 09/08/2004 and displayed until 10/08/2004
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 23/07/2004 and displayed until 09/08/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Pantoprazole sodium sesquihydrate