Pantoloc Control 20mg gastro-resistant tablets

  • Name:

    Pantoloc Control 20mg gastro-resistant tablets

  • Company:
    info
  • Active Ingredients:

    Pantoprazole sodium sesquihydrate

  • Legal Category:

    Supply through pharmacy only

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 06/06/17

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Summary of Product Characteristics last updated on medicines.ie: 13/4/2017
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GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

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1 - 0 of 52 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 6 June 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 6 June 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 13 April 2017 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

revised labelling to reflect the co-administration with HIV protease inhibitors is contraindicated (not only atazanavir), to include a warning about the reduction of the absorption of vitamin B12, and a warning about the increased risk of bone fractures and hypomagnesemia, to include drug interactions with HIV protease inhibitors in section 4.5 of the SmPC, to include that animal studies have shown excretion of pantaprazole in breast milk, and to include in section 4.8 undesirable effects ‘fracture of wrist, hip and spine with unknown frequency and fundic gland polyps (benign) with common frequency.

Updated on 13 April 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 9 January 2017 SmPC

Reasons for updating

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

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

4.4.Chromogranin A
5.1 Proton Pump

Updated on 19 December 2016 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 5 May 2016 SmPC

Reasons for updating

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

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In section 4.4 (special warnings and precautions), information concerning SCLE has been added.
In section 4.8 (undesirable effects), SCLE has been added.

Updated on 17 April 2014 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 4.6 - 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

SPC  Changes to Pantoloc Control 20 mg gastro-resistant tablets – 21 February 2014

Section 4.4

Added subheading “Gastrointestinal infections caused by bacteria”; information remains the same. Under same subheading after “Salmonella, Campylobacter, or” also added “Clostridium”

Section 4.5

Specific interactions between Pantoprazole and methotrexate have been added.

Addition of clarification on the interactions between Pantoprazole metabolised in the liver via P450 enzyme system and other substances by the same enzyme system.

Section 4.6

Under Pregnancy & Breast-feeding subheadings replaced “Pantoloc Control” with “Pantoprazole”

Section 4.7

“Adverse drug” replaced with “ However, adverse” & “operate” replaced with “use”

Section 4.8

Added subheading “Summary of the safety profile” and section slightly reworded.

Added subheading “Tabulated list of adverse reactions” and section slightly reworded.

Replaced “Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.” with “Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.”

The order of the tabulated adverse reactions frequenies has been amended. The information remains the same.

Information on reporting suspected adverse reactions added.

Section 4.9

Deleted: “There are no known symptoms of overdose in man.”

Section 5.1

After “Pharmacotherapeutic group” added: “Drugs for acid related disorders,”

Section 6.5

Deleted “Alu/Alu blisters containing 7 or 14 gastro-resistant tablets or”

After “Alu/Alu blisters with” added “or without”

Section 6.6

Heading renamed.

Deleted: “No special requirements for disposal.”

Section 7

Name “Nycomed” replaced with “Takeda”

Telephone number changed from: “+49-(0)7531-840” to “0800 825332 4”

Telefax number changed from: “+49-(0)7531-842474” to “0800 825332 9”

Section 9

Added: “Date of latest renewal: 12 June 2014”

Section 10

Change of date from 27 May 2013 to 21 February 2014

 

 

 

 

 

 

 

 

 

 

 

Updated on 10 July 2013 SmPC

Reasons for updating

  • 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 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section  4.5

Added information about concomitant use of PPIs with methotrexate

Section 4.6

Add  info on fertility

Section 4.7

Added “Pantoloc Control has no or negligible influence on the ability to drive and use machines.”

Section 5.2

Headings renamed

Section 5.3

Delete “Prec linical” add “Non-clinical”

Section 6.6

Add “for disposal.”

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.”

Updated on 10 February 2012 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • 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: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.1

Add : ‘PANTOLOC Control is indicated for ‘ before ‘short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.’

 

 

Section 4.2

Change of heading from ‘Paediatric use’ to ‘Paediatric population’.

 

 

Section 4.6

Heading changed from ‘Pregnancy and lactation’ to ‘Fertility, pregnancy and lactation’.

 

Pregnancy

Final sentence. Change ‘This medicinal product’ to ‘PANTOLOC Control’ before the words ‘should not be used during pregnancy’.

 

Heading changed from ‘Lactation’ to ‘Breastfeeding’.

Final sentence. Changed ‘This medicinal product’ to ‘PANTOLOC Control’ before the words  ‘should not be used during breast-feeding’.

 

 

Section 4.8

Second paragraph.

Wording changed from ‘Within the following table, undesirable effects are ranked under the following frequency classification:’ to ‘Within the following table, undesirable effects are ranked under the MedDRA frequency classification:’.

 

Changes in Table 1.

Against:

Blood and lymphatic system disorders –

Agranulocytosis added in rare column, Pancytopenia added in very rare column

 

Nervous system disorders –

Taste disorders added in rare column

 

Metabolish and nutrition disorders –

Hypomagnesaemia added in Not Known column

 

Addition of new line in table

Reproducdtive system and breast disorders –

Gynaecomastia added in Rare column

 

 

Section 5.3

First sentence. Change from   ‘ ..special hazard to humans...’ to ‘...special hazard for humans.....’.

 

 

Section 10

Date change from March 2011 to 7 December 2011

Updated on 15 August 2011 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 2:

Deletion of : Excipient: contains 1.06 microgram soya lecithin per gastro-resistant tablet.

 

Section 4.3

Change of wording from : Hypersensitivity to the active substance, to soya or to any of the other excipients

To: Hypersensitivity to the active substance or to any of the excipients

-

Section 6.1

Deletion of : Soya lecithin, Titanium dioxide (E171), Antifoam DC 1510

Addition of : Ammonia solution, concentrated

 

Section 10

Change of date from 12 June 2009 to March 2011.

Addition of words: Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/.

Updated on 11 May 2010 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

None provided