Protium 20mg

  • Name:

    Protium 20mg

  • Company:
    info
  • Active Ingredients:

    Pantoprazole sodium sesquihydrate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 14/08/19

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Summary of Product Characteristics last updated on medicines.ie: 14/8/2019

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Takeda Products Ireland Ltd

Takeda Products Ireland Ltd

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Medicine Name Protium 20mg Active Ingredients Pantoprazole sodium sesquihydrate
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1 - 0 of 26 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 14 August 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 14 August 2019 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data
  • 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 (undesirable effects) addition of Microscopic colitis.

Section 5.3 (Preclinical safety data) addition of the following:

In a peri-postnatal rat reproduction study designed to assess bone development, signs of offspring toxicity (mortality, lower mean body weight, lower mean body weight gain and reduced bone growth) were observed at exposures (Cmax) approximately 2x the human clinical exposure. By the end of the recovery phase, bone parameters were similar across groups and body weights were also trending toward reversibility after a drug-free recovery period. The increased mortality has only been reported in pre-weaning rat pups (up to 21 days age) which is estimated to correspond to infants up to the age of 2 years old. The relevance of this finding to the paediatric population is unclear. A previous peri-postnatal study in rats at slightly lower doses found no adverse effects at 3 mg/kg compared with a low dose of 5 mg/kg in this study.

Date of revision: 31st July 2019

Updated on 29 March 2019 SmPC

Reasons for updating

  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.5 - Nature and contents of container
  • 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

The SmPCs for Protium in Ireland have been updated following a worksharing procedure to update section 5.3.

Updated on 16 November 2018 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • 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

  • In section 6.5, Nature and contents of container, the 168 tablet bottle has been deleted
  • In section 10, Date of revision has been updated to 26th October 2018

Updated on 19 February 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 19 February 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 19 February 2018 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)

Free text change information supplied by the pharmaceutical company



Change to section

Details of change

7.       MARKETING AUTHORISATION HOLDER

Takeda Products Ireland Ltd.

First Floor,

3013 Lake Drive,

Citywest Business Campus,

8.       MARKETING AUTHORISATION NUMBER(S)

 

PA 2229/010/001

10.     DATE OF REVISION OF THE TEXT

02/02/2018

Updated on 19 February 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 10 April 2017 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 7 April 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

In section 4.8 (undesirable effects), Fundic gland polyps (benign) has been added under a new column 'common'

Updated on 3 November 2016 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties

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 October 2016 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 6 October 2016 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 9 - Date of renewal of authorisation

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

Free text change information supplied by the pharmaceutical company

MA holder updated to:

Takeda UK Limited

Building 3,

Glory Park,

Glory Park Avenue,

Wooburn Green,

Bucks,

HP10 0DF

UK

MA number updated to: PA 1547/009/002
Date of revision updated to: 30Sep2016

Updated on 30 September 2016 PIL

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 15 January 2016 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to drug interactions
  • Change to information about driving or using machinery
  • Change to date of revision

Updated on 15 January 2016 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 4.7 - Effects on ability to drive and use machines
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

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

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 October 2014 PIL

Reasons for updating

  • Change to date of revision

Updated on 30 October 2014 SmPC

Reasons for 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

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

Protium is not recommended for use in children below 12 years of age because of limited data on safety and efficacy in the age group (see section 5.2).

 

 

 

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 12 April 2013 PIL

Reasons for updating

  • Change to storage instructions

Updated on 12 April 2013 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

 

Inclusion of: Shelf life for HDPE bottles after first opening: 120 days.


10. DATE OF REVISION OF THE TEXT

 

To: 02/01/2013

Updated on 18 December 2012 PIL

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 18 December 2012 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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

          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 3 October 2012 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

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 27 September 2012 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 2 March 2012 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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 29 February 2012 PIL

Reasons for updating

  • Change to side-effects

Updated on 18 April 2011 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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 to printing ink, resulting in removal of soya oil as an excipient and therefore removal of all soya related warnings.

Updated on 11 April 2011 PIL

Reasons for updating

  • Change of inactive ingredient

Updated on 6 September 2010 SmPC

Reasons for updating

  • Change to improve clarity and readability

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 for all pantoprazole products in the range.

Updated on 27 August 2010 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 12 March 2008 PIL

Reasons for updating

  • Change to marketing authorisation holder
  • Change to date of revision

Updated on 12 March 2008 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • 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 7: Update to name of MAH only
Section 8: Update to PA number
Section 10: Updated to reflect approval of above changes

Updated on 1 February 2008 PIL

Reasons for updating

  • Change to date of revision
  • Change due to harmonisation of patient information leaflet
  • Change due to user-testing of patient information
  • Changes to therapeutic indications

Updated on 4 January 2008 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 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

4.2 'Adults and adolescents 12 years of age and above: (new sub-heading)
        New sub-heading 'Adults' para 3
        New section 'Children below 12 years of age'....Protium is not recommended etc....in this age group'
 
4.4 Deletion of last para regarding no experience of treatment in children.
 
5.2   in last part of section inclusion of PK data from children.

 

Updated on 29 August 2007 SmPC

Reasons for 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

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

Free text change information supplied by the pharmaceutical company

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

 

Updated on 22 August 2007 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 9 August 2006 SmPC

Reasons for updating

  • Improved electronic presentation

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

Updated on 27 July 2006 SmPC

Reasons for 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

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

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 10 August 2005 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Correction of spelling/typing errors

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

Updated on 10 August 2004 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 9 August 2004 SmPC

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 9 August 2004 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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