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Boehringer Ingelheim Limited

The Crescent Building, , Northwood, Santry, Dublin 9,
Telephone: +353 1 295 9620
Fax: : +353 1 816 3642
Medical Information e-mail: Medinfo@dbl.boehringer-ingelheim.com
Summary of Product Characteristics last updated on medicines.ie: 16/07/2015
SPC Dixarit

When a pharmaceutical company changes an SPC or PIL, 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 16/07/2015 and displayed until Current
Reasons for adding or updating:
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Jul-2015
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Adverse Event Reporting contact details updated from IMB to HPRA.

Date of revision amended to July 2015.
Updated on 03/06/2014 and displayed until 16/07/2015
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
Date of revision of text on the SPC:   21-May-2014
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Changes have been made to sections 6.3 (Shelf life) and 6.4 (Special precautions for storage):

• The shelf life has been reduced from 5 to 3 years

• The storage precautions have been amended from “Do not store above 25 degrees C” to “Store below 25 degrees C”
Updated on 20/05/2014 and displayed until 03/06/2014
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-May-2014
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

The following new wording (highlighted in red) has been added to the end of section 4.8 of the SPC:


4.8
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 preferably through the online reporting option accessible from
the IMB homepage. A downloadable report form is also accessible from the IMB
website, which may be completed manually and submitted to the IMB via
‘freepost’. Alternatively, the traditional post-paid ‘yellow card’ option may also
continue to be used.

FREEPOST
Pharmacovigilance Section
Irish Medicines Board
Kevin O’Malley House
Earlsfort Centre
Earlsfort Terrace
Dublin 2
Ireland
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.imb.ie
e-mail: imbpharmacovigilance@imb.ie


10. Date of revision
May 2014
Updated on 24/04/2013 and displayed until 20/05/2014
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • 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 10 - Date of revision of the text
Date of revision of text on the SPC:   28-Mar-2013
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Section 2 has been updated in line with an IMB request.

Section 4.2 a paragraph on Renal insufficiency has been added.

Section 4.4 Paragraph referring to patients with renal failure includes a reference to section 4.2; the amount of lactose per maximum daily dose has changed; also the deletion of any reference to Catapres Tablets 300 micrograms as this product has been discontinued and the licence cancelled.

Section 4.6 Statement added regarding limited amount of data from the use of clonidine in pregnant women. Section on Lactation and Fertility has been completely revised.

Section 4.7 Has been completely revised.

Section 5.2 Has been extensively updated.

Section 10 has been updated to March 2013
Updated on 13/10/2011 and displayed until 24/04/2013
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Aug-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Sections 4.2 and 5.1 have been updated to include paediatric information.
Section 10 has also consequently been updated.
Updated on 19/05/2009 and displayed until 13/10/2011
Reasons for adding or 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 4.9 - Overdose
Date of revision of text on the SPC:  
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


4.2 Including eldery patients.

4.3 In case of rare hereditary conditions that may be incompatible with an excipient of the product the use of the product is contraindicated.

4.4 Addition of polyneuropathy

4.8 Re-formatted to include frequencies of Adverse Events

4.9 Addition of somnolence and respiratory depression

Updated on 02/10/2007 and displayed until 19/05/2009
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • 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 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   03/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Addition to section 4.4 –Special Warnings and Special Precautions for Use

As this product contains lactose patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

 

As this product contains sucrose patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Updated on 03/06/2003 and displayed until 02/10/2007
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Clonidine hydrochloride