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Proctosedyl Ointment

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 30/11/17

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 4/12/2017
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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 4 December 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 4 December 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 4.6 - Pregnancy and lactation
  • 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)

Free text change information supplied by the pharmaceutical company

Section 4.3 added:-

bacterial, parasitic

Section 4.4 added:-

Before prescribing the product any potential malignancies should be excluded.

Section 4.6 added:-

In pregnant animals, administration of corticosteroids can cause abnormalities of foetal development.  The relevance of this finding to human beings has not been established.

Hydrocortisone may pass into human breast milk..

Section 4.6 removed:-

Animal studies have shown teratogenic effects.  To date similar effects have not been shown to occur in man. 

Section 4.8 added:-

contact dermatitis, rash.

adrenal suppression.

Updated on 30 November 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 30 November 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 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 28 November 2017 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 - date of revision

Updated on 20 June 2017 SmPC

Reasons for updating

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

Type IB.C.1.3.z - CMDh position on the conclusion of the PSUSA procedure for budesonide (PSUSA/000449/201604) which related to blurred vision and central serous chorioretinopathy and the decision to extend the warning to other corticosteroids for all routes of administration (Final minutes of the CMDh meeting of 23-25 January 2017).  SmPC & PL are updated to reflect change.

Updated on 15 March 2017 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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

Type IB.C.1.3.a  Change(s) in the Summary of Product Characteristics, Labelling or Package Leaflet of human medicinal products intended to implement the outcome of a procedure concerning PSUR or PASS, or the outcome of the assessment done by the competent authority under Articles 45 or 46 of Regulation (EC) No 1901/2006 Implementation of wording agreed by the competent authority

Updated on 27 January 2017 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink

Updated on 18 August 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: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

 

4.4  Special Warnings and Special Precautions for Use

 

  1. Continuous treatment for longer than three weeks should be avoided in patients under the age of three years because of the possibility of adrenocortical suppression and growth retardation.

 

  1. Continuous application without interruption will result in local atrophy of the skin, striae, and superficial vascular dilation.

 

  1. Prolonged use of an anti-infective may result in the development of super-infection due to organisms, including fungi, resistant to that anti-infective.

 

  1. May cause local skin reactions (e.g. contact dermatitis).

 

 

  1. Pheochromocytoma crisis, which can be fatal, has been reported after administration of corticosteroids.  Corticosteroids should only be administered to patients with suspected or identified pheochromocytoma after an appropriate risk/benefit evaluation (see section 4.8)




4.8       Undesirable Effects

 

Itching, pain or rash may develop around the back passage.

 

Skin and subcutaneous disorders:

Frequency not known: Urticaria

 

Endocrine disorders: 

Frequency not known: Pheochromocytoma crisis

 

 

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.

Updated on 17 August 2016 PIL

Reasons for updating

  • Change to date of revision

Updated on 27 August 2015 PIL

Reasons for updating

  • Addition of manufacturer
  • Addition of information on reporting a side effect.

Updated on 26 August 2015 PIL

Reasons for updating

  • Change to further information section
  • Addition of information on reporting a side effect.

Updated on 26 January 2015 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 24 September 2013 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 7 September 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 7 updated to include 'Sanofi' as a trading style

Updated on 4 September 2012 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 4 March 2011 PIL

Reasons for updating

  • Change to storage instructions

Updated on 4 March 2011 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

The following sections have been changed as a result of the renewal:
 
Section 2
Addition of an excipient warning
 
Section 6.3
Wording changes to reflect shelf life of Unopened and In use shelf life

Updated on 31 August 2009 SmPC

Reasons for updating

  • Change to improve clarity and readability

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

Free text change information supplied by the pharmaceutical company

Change to improve clarity and readability

Updated on 21 August 2009 PIL

Reasons for updating

  • Change of manufacturer

Updated on 22 February 2008 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 19 December 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 13 December 2006 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

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

Updated on 19 May 2005 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 4 February 2005 SmPC

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation

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

Updated on 19 August 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 31 May 2004 SmPC

Reasons for updating

  • 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 10 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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