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Cystrin 5mg Tablets

  • Name:

    Cystrin 5mg Tablets

  • Company:
    info
  • Active Ingredients:

    Oxybutynin Hydrochloride

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 29/07/16

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Summary of Product Characteristics last updated on medicines.ie: 2/8/2016
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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 2 August 2016 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 2 August 2016 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

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

Free text change information supplied by the pharmaceutical company

 

4.4       Special Warnings and Special Precautions for Use

 

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

 

Oxybutynin should be used with caution in the frail elderly, patients with Parkinson’s disease and children who are at greater risk of occurrence of adverse reactions to the product and in patients with autonomic neuropathy, severe gastro-intestinal motility disorders, hepatic or renal impairment.


4.5         Interactions with other Medicaments and other forms of Interactions

 

            Care should be taken if other anticholinergic agents are used together with oxybutynin, as a potentiation of anticholinergic effects may occur.

 

The anticholinergic activity of oxybutynin is increased by concurrent use of other anticholinergics or medicinal products with anticholinergic activity, such as amantadine and other anticholinergic antiparkinsonian medicinal products (e.g. biperiden, levodopa), antihistamines, antipsychotics (e.g. phenothiazines, butyrophenones, clozapine), quinidine, digitalis, tricyclic antidepressants, atropine and related compounds like atropinic antispasmodics and dipyridamole.

 

By reducing gastric motility, oxybutynin may affect the absorption of other drugs.

 

Oxybutynin, as anticholinergic agent may antagonize the effect of prokinetic therapies.

 

Oxybutynin is metabolised by cytochrome P 450 isoenzyme CYP 3A4. Concomitant administration with a CYP3A4 inhibitor can inhibit oxybutynin metabolism and increase oxybutynin exposure.

Updated on 29 July 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 29 July 2016 PIL

Reasons for updating

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

Updated on 20 May 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

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

Free text change information supplied by the pharmaceutical company

Type II.C.I.3.b variation to align our SmPC with the Core Safety Profile for oxybutynin following the completion of PSUR Worksharing Procedure BE/H/PSUR/0014/0001 in November 2013. 

Updated on 13 May 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery

Updated on 9 October 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 9 October 2013 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

Type II.C.I.4 CCDS v2 variation to update Sections 4.4 and 4.8 of the SPC for the oxybutynin product range following an update to the Company Core Data Sheet version 2.

Updated on 31 May 2013 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

Type IB variation to update section 6.5 of the SPC following a change in the blister size in the current pack. 
At present the pack contains 84 tablets consisting of 4 x 21 tablet blisters.   Due to an ongoing harmonisation project at the site it is now proposed to change these packs of 84 tablets to consist of 3 x 28 tablet blisters. The pack size of 84 tablets remains same therefore no changes are made to the artwork text.

Updated on 30 May 2013 PIL

Reasons for updating

  • Change to packaging

Updated on 24 August 2012 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 21 March 2011 PIL

Reasons for updating

  • Change to dosage and administration
  • Changes to therapeutic indications

Updated on 21 March 2011 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration

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

Free text change information supplied by the pharmaceutical company

Sections affected / updated

                                    

Section 4.1: Therapeutic indications

Section 4.2: Posology and method of administration.

Updated on 31 August 2009 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

Correction of typing errors

Updated on 31 July 2008 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 23 August 2007 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 7 June 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Update
Section 7 - Change MAH to sanofi-aventis Ireland Ltd.
Section 8 - Change PA
Section 10 - Date of revision

Updated on 12 January 2007 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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

Update
section 2 - Addition of lactose
section 10 - date of revision

Updated on 4 September 2006 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

 
Section 2 updated to include the statement: "For a full list of excipients, see section 6.1"
Section 3 updated to include the statement: "The score line allows the tablet to be divided into equal halves."
Section 6.4 updated to include the statement: "Store in the original package."
Section 6.5 updated to include the statement: "Not all pack sizes may be marketed".

Updated on 28 July 2005 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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

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

Updated on 1 July 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 26 June 2003 SmPC

Reasons for updating

  • New SPC for new product

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