Gastrografin

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 17/04/20

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Summary of Product Characteristics last updated on medicines.ie: 22/11/2019

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Bayer Limited

Bayer Limited

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1 - 0 of 69 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 17 April 2020 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 22 November 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals
  • Change to warnings or special precautions for use

Updated on 22 November 2019 SmPC

Reasons for 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

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 27 March 2019 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 12 March 2019 PIL

Reasons for updating

  • Change to section 6 - what the product contains

Updated on 12 March 2019 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 12 March 2019 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 20 April 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 20 April 2017 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 18 February 2015 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 13 January 2015 SmPC

Reasons for updating

  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.8 was updated to include HPRA adverse effect reporting text

Updated on 13 January 2015 PIL

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 13 January 2015 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 11 April 2012 PIL

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer

Updated on 3 March 2011 PIL

Reasons for updating

  • Change to date of revision
  • Change to improve clarity and readability
  • Change due to user-testing of patient information

Updated on 26 November 2009 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to further information section
  • Change to date of revision
  • Change to dosage and administration
  • Changes to therapeutic indications
  • Change to improve clarity and readability
  • Change to product name
  • Improved electronic presentation

Updated on 25 November 2009 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.2 - Incompatibilities
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Individual sections updated.

Updated on 24 June 2009 SmPC

Reasons for updating

  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
  • Change to section 9 - Date of renewal of authorisation

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company



  • In section 1 ( Name Of  Medicinal Product), product name is updated to include reference to active concentrations: " Gastrografin, 660mg/ml and 100mg/ml Oral and Rectal Solution"
  • In section 2 ( Qualitative and Quantative  Composition),  the wording is restructured to read   "Each ml of solution contains Amidotrizoic acid (dihydrate) equivalent to 597.30mg Amidotrizoic acid (anhydrous), 159.24 mg meglumine and 6.29 mg sodium hydroxide equivalent to 100 mg of sodium amidotrizoate and 660 mg of meglumine amidotrizoate (and containing the equivalent of 370 mg of iodine in combined form per ml). The following statement is also added, Excipients: Each ml also contains 3.76mg of sodium or 0.16mmol.
  • In section 4.8 ( Undesirable effects ), the text format of the table is changed to Italics. The following sub sections are underlined; Anaphylactoid reactions/hypersensitivity, Gastrointestinal, Respiratory and Skin.
  • In Section 6.2 ( Incompatibilities) the following statement is removed;" None known so far " and replaced with "This medicinal product must not be mixed with other medicinal products except those mentioned in section 4.2"
  • In section 6.3 ( Shelf Life) , the following statement is added; " Opened: Solution not used within one day after openinig the bottle must be discarded"
  • In section 6.5 ( Nature and Contents of container), the following statement is added; " Pilferproof closure:high density polyethylene, PE-HD, coloured, with sealing disk, low density polyethylene, PE-LD, natural."
  • In section 6.6 ( Special precautions for disposal and other handling), the title of this section is deleted and  replaced with " Special precautions for disposal of a used medicinal product or waste material derived from such medicinal product and other handling of the product "
  • In section 9 ( Date of First Authorisation/ Renewal of the Authorisation), the following is added; " Date of last renewal: 01 April 2008"
  • In section 10 ( Date of Revision of the text), August 2007 is deleted and replaced with Jan 2009.

 

Updated on 22 April 2009 PIL

Reasons for updating

  • Change to storage instructions
  • Change to date of revision

Updated on 5 November 2007 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 7: MA transferred to Bayer Limited.
 
Section 8: New MA number is 1410/4/1
 
 

Updated on 5 November 2007 PIL

Reasons for updating

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

Updated on 29 August 2007 PIL

Reasons for updating

  • Change of trade or active ingredient name
  • Change to date of revision

Updated on 29 August 2007 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 2. Qualitative and Quantitative Composition

This section was changed from:

“Each ml of solution contains 597.30 mg Amidotrizoic Acid (anhydrous), 159.24 mg Meglumine and 6.29 mg Sodium Hydroxide equivalent to 100 mg of Sodium Amidotrizoate and 660 mg of Meglumine Amidotrizoate (and containing the equivalent of 370 mg of Iodine in combined form per ml).

For excipients, see 6.1.”

to;

“Each ml of solution contains Amidotrizoic Acid (dihydrate) equivalent to Amidotrizoic acid (anhydrous) 597.30 mg, 159.24 mg Meglumine and 6.29 mg Sodium Hydroxide equivalent to 100 mg of Sodium Amidotrizoate and 660 mg of Meglumine Amidotrizoate (and containing the equivalent of 370 mg of Iodine in combined form per ml).

For excipients, see 6.1.”

Updated on 14 November 2006 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - 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
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Main Changes to the SPC include:

 

Section 4.1 Therapeutic Indications

Additional indications included:

Treatment of meconium ileus

Computerised tomography (CT) in the abdominal region

Section 4.2 Posology and method of administration

Addition of general information regarding use of the product including dietary suggestions, advice on hydration and use in children, infants and newborns.

Increased level of detail regarding the recommended dosage for oral use (in adults, children and CT).

Addition of information regarding the taking of exposures of the gastrointestinal tract.

Section 4.3 Contraindications

Deletion of the following contraindications:

Use in patients with thyrotoxicosis

Use in patients with hypersensitivity to iodine

Section 4.4 Special warnings and precautions for use

Inclusion of information regarding Hypersensitivity.

Information also supplied regarding use in the presence of Thyroid dysfunction, Severe cardiovascular disease and Very poor state of health

Section 4.5 Interaction with other medicinal products and other forms of interaction

Revised/additional text:

- use in patients taking beta-blockers

- interference with diagnostic tests

Section 4.6 Pregnancy and lactation

Use during pregnancy:

Inclusion of data from reproduction-toxicological studies.

Use during lactation:

Inclusion of additional information regarding risk to breast-feeding infant.

Section 4.8 Undesirable effects

Undesirable effects have been listed according to the frequency of occurrence and system affected.

In addition, the following undesirable effects have been included: anaphylactoid/hypersensitivity reactions,

erosions and bowel necrosis in case of prolonged contact with the bowel mucosa.

Section 4.9 Overdose

Revised text: Disorders of water- and electrolyte imbalance caused by an overdose should be corrected parenterally.

Section 5.1 Pharmacodynamic properties

Addition of table showing the physico-chemical characteristics of Gastrografin.

Section 5.2 Pharmacokinetic properties

Addition of information regarding higher absorption in some patients even in the absence of perforation.

Updated on 14 November 2006 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to instructions about overdose
  • Change to side-effects
  • Change to drug interactions
  • Change to dosage and administration

Updated on 19 October 2006 PIL

Reasons for updating

  • Change to storage instructions

Updated on 18 October 2006 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Main changes to the SPC:

 

Section 6.3 Shelf Life

Extension of the shelf life of Gastrografin to 5 years.

 

Section 6.5 Special precautions for storage

Change of the storage conditions of Gastrografin to 'Do not store above 25°C’

 

 

Updated on 15 June 2006 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 15 June 2006 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 27 October 2005 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 27 October 2005 PIL

Reasons for updating

  • New PIL for medicines.ie