Catapres Ampoules
- Name:
Catapres Ampoules
- Company:
Boehringer Ingelheim Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 09/04/19
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Boehringer Ingelheim Limited
Company Products
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 9 April 2019 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 5 April 2019 SmPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
- 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
Marketing Authorisation transfer to change the Irish Marketing Authorisation Holder (MAH) from Boehringer Ingelheim Ltd, UK to Boehringer Ingelheim International GmbH, Germany. Marketing Authorisation numbers also changed. Section 10, date of revision, has been updated.
Updated on 25 September 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 25 September 2017 SmPC
Reasons for updating
- Change to section 6.3 - Shelf life
- 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 10, date of revision of the text has also been revised to align with the implementation date of the change which was 25 August 2017
Updated on 2 July 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
Contact details amended to reflect the change of name from IMB to HPRA.
Updated on 30 June 2015 PIL
Reasons for updating
- New PIL for new product
Updated on 30 June 2015 PIL
Reasons for updating
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 5 June 2014 PIL
Reasons for updating
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 20 May 2014 SmPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- 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
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: http://www.imb.ie/
e-mail: imbpharmacovigilance@imb.ie
2. Change in the spelling of ‘sulphate’ to ‘sulfate’ in section 4.9:
Treatment:
There is no specific antidote for clonidine overdose. Administration of activated charcoal should be performed where appropriate.
Supportive care may include atropine sulphate sulfate for symptomatic bradycardia, and intravenous fluids and/or inotropic sympathomimetic agents for hypotension. Severe persistent hypertension may require correction with alpha-adrenoceptor blocking drugs.
Naloxone may be a useful adjunct for the management of clonidine-induced respiratory depression.
Section 10
Date of revision changed to May 2014
Updated on 3 June 2013 PIL
Reasons for updating
- Change to date of revision
- Change to name of manufacturer
Updated on 24 October 2012 SmPC
Reasons for updating
- 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 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
The following paragraph has been added:
Renal insufficiency:
Dosage must be adjusted
- according to the individual antihypertensive response which can show high variability in patients with renal insufficiency
- according to the degree of renal impairment
4.4 Special warnings and precautions for use
Editorial change and update to include cross reference to section 4.2 regarding renal insufficiency
4.6 Fertility, pregnancy and lactation
Updated statements for pregnancy and lactation. New statement on fertility.
4.7 Effects on ability to drive and use machines
Section has been updated in its entirety and new information added.
10. DATE OF REVISION OF THE TEXT
Section has been updated from August to October 2012
Updated on 19 October 2012 PIL
Reasons for updating
- Change to information about driving or using machinery
Updated on 21 August 2012 SmPC
Reasons for 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
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.2 Posology and Method of Administration
The text:
Children:
Not recommended. Please refer to section 4.4 Special Warnings and Precautions for Use
has been deleted and replaced with a new final sub-heading paragraph and corresponding text entitled Paediatric Population.
Section 4.6 Fertility, Pregnancy and Lactation
This section’s header has had the word Fertility added to it.
Section 5.1 Pharmacodynamic Properties
Completely new second, third, fourth and fifth paragraphs have been added to this section.
Section 10 Date of Revision of the Text
The date has been amended to August 2012.
Updated on 15 August 2012 PIL
Reasons for updating
- Change of contraindications
- Change to dosage and administration
Updated on 23 December 2009 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 30 November 2009 SmPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.9 - Overdose
- 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 4.4 – Special warnings and precautions for use
Previous wording:
In particular, when clonidine is used off-label concomitantly with methylphenidate in children with ADHD, serious adverse reactions, including death, have been observed. Therefore clonidine in this combination is not recommended.
Updated wording:
Serious adverse events, including sudden death have been reported in concomitant use with methylphenidate. The safety of using methylphenidate in combination with clonidine has not been systematically evaluated.
Section 4.9 - Overdose
Previous wording:
Treatment:
In most cases all that is required are general supportive measures. Where bradycardia is severe atropine will increase the heart rate.
Updated wording:
Treatment:
There is no specific antidote for clonidine overdose. Administration of activated charcoal should be performed where appropriate.
Supportive care may include atropine sulphate for symptomatic bradycardia, and intravenous fluids and/or inotropic sympathomimetic agents for hypotension. Severe persistent hypertension may require correction with alpha-adrenoceptor blocking drugs.
Naloxone may be a useful adjunct for the management of clonidine-induced respiratory depression
Section 10 – Date of revision of the text
November 2009
Updated on 11 June 2009 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 9 - Date of renewal of authorisation
- 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 4.4 - The following information has been added:
Patients who wear contact lenses should be warned that treatment with Catapres may cause decreased lacrimation.
The use and the safety of clonidine in children and adolescents has little supporting evidence in randomized controlled trials and therefore cannot be recommended for use in this population.
In particular, when clonidine is used off-label concomitantly with methylphenidate in children with ADHD, serious adverse reactions, including death, have been observed. Therefore clonidine in this combination is not recommended.
Section 4.8 - This section has been completely rewritten and now includes frequencies of adverse events
Section 4.9 - coma and apnoea
now reads 'somnolence including coma and respiratory depression including apnoea'
Updated on 31 March 2009 SmPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.8 - Undesirable effects
- Change to section 6.3 - Shelf life
- 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
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 25 February 2009 PIL
Reasons for updating
- Change to date of revision
Updated on 23 December 2008 PIL
Reasons for updating
- Improved electronic presentation
Updated on 19 September 2008 PIL
Reasons for updating
- Improved electronic presentation
Updated on 2 August 2007 SmPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 6.3 - Shelf life
- 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
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Reason for update:
Change to Section 1 - Name of medical product
Change to section 4.5 - Interaction with other medical products and other forms of interaction
Change to section 6.3 -Shelf life
Change to section 6.4 - Special precautions for storage
Change to section 6.6 - Instructions for use and handling
Change to section 9 - Date of first authorisation/ renewal of authorisation
Change to section 10 - Date of revision of text.
All changes are minor.
Updated on 22 March 2007 PIL
Reasons for updating
- Improved electronic presentation
Updated on 31 August 2006 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 8 July 2003 SmPC
Reasons for updating
- Improved electronic presentation
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 3 June 2003 SmPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may not be renewed (A)