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Cystopurin 3g Granules for Oral Solution

  • Name:

    Cystopurin 3g Granules for Oral Solution

  • Company:
    info
  • Active Ingredients:

    Potassium Citrate

  • Legal Category:

    Supply through pharmacy only

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 16/02/15

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Summary of Product Characteristics last updated on medicines.ie: 17/2/2015
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Bayer Limited

Bayer Limited

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Medicine Name Cystopurin 3g Granules for Oral Solution Active Ingredients Potassium Citrate
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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 February 2015 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 17 February 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: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

 

4.8 Undesirable effects

…

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

August 2013February 2015

Updated on 16 February 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 16 February 2015 PIL

Reasons for updating

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

Updated on 30 August 2013 SmPC

Reasons for updating

  • 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

Date of revision of text has been changed from April 2013 to August 2013

Updated on 1 May 2013 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • 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

(Inserted text; Deleted text)

2        Qualitative and quantitative composition

Each sachet contains 3g of Potassium Citrate.

Excipients: contains aspartame (E951) 0.04g/sachet; sugar; soya lecithin (E322) and ethyl alcohol (ethanol).

For a full list of excipients, see section 6.1

 

4.4       Special warnings and precautions for use

This product is intended for short term treatment.  Patients should seek doctor's advice if symptoms persist after 48 hours treatment.

 

This product should only be used with caution in patients with cardiac disease.

 

This product contains a source of phenylalanine. May be harmful for people with phenylketonuria.

 

This medicinal product contains small amounts of ethanol (alcohol), less than 100mg per sachet.

 

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.

 

This medicinal product contains soya lecithin. If you are allergic to soya do not use this medicinal product.

 

 

6.1       List of Excipients

            Mannitol (E421)

            Citric Acid (Anhydrous) (E330)

            *  Flavour cranberry durarome

            **  Flavour cranberry juice

            Aspartame (E951)

Natural flavouring Cranberry type 14666: maltodextrin, natural flavouring substances, flavouring preparations, silicon dioxide (E551), carmine (E120), triacetin (E1518).

 

 

            *          Flavour cranberry durarome:

            (natural flavouring substances, flavouring preparations, maltodextrin, sugar, glycerol, triacetate, E322, ethyl alcohol, E 551).

            **        Flavour cranberry juice:

                        (flavourings derived from cranberry extract, maltodextrin).

 

 

10      Date of revision of the text

 

            January 2012 April 2013

Updated on 25 April 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to further information section
  • Change to date of revision

Updated on 16 August 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to further information section
  • Change due to user-testing of patient information

Updated on 26 January 2012 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • 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

 In section 4.2, the following sentence was added: Excipients: contains aspartame (E951) 0.04g/sachet; sugar; soya lecithin (E322) and ethyl alcohol (ethanol).

In section 4.4, the following information was added:
This product contains a source of phenylalanine. May be harmful for people with phenylketonuria.

This medicinal product contains small amounts of ethanol (alcohol), less than 100mg per sachet.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.

This medicinal product contains soya lecithin. If you are allergic to soya do not use this medicinal product.

Updated on 4 September 2009 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 29 May 2009 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: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 7:MA holder is now Bayer Ltd.

Section 8: MA number is now 1410/42/1

Updated on 30 June 2008 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 27 June 2008 SmPC

Reasons for updating

  • Change to section 5 - Pharmacological properties

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

 

Section 5 Updated so that 5.1 Pharmacodynamic properties, 5.2 Pharmacokinetic properties and 5.3 Preclinincal safety data are filled in:

 

Text added to Section 5.1 Pharmacodynamic properties:

Pharmacotherapeutic group: potassium                 ATC code: A12BA02

Potassium citrate, after absorption, is metabolised and acts to make the urine less acid. A mild diuresis usually follows treatment with potassium citrate.

 

Text added to Section 5.2 Pharmacokinetic parameters:

Potassium citrate is metabolised, after absorption, to bicarbonate. Bicarbonate ions are excreted in the urine, which is rendered alkaline, and there is an accompanying diuresis.

 

Text added Section 5.3 Preclinical safety data:

None available.

Updated on 25 July 2006 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 6.1 - List of excipients
  • 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: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

1.    3g Granules for Oral Solution  has been added
2.     PH.Eur. removed  and  For excipients, see 6.1  has been added
3.     White   changed to Pink-brown
4.5    ace changed to ACE
4.6    there is no epidemiological evidence - 'no' has been added
6.1     Ph.Eur have been replaced with E421, E330 and E951.  HSE has been removed
7.        MA holder changed from Roche Products Limited to Bayer plc
8.        MA number changed to 21/65/1
10.     Changed from July to November 2005
 
 

Updated on 11 August 2005 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5 - Pharmacological properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Updated on 27 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through pharmacy only