Catapres Ampoules

  • Name:

    Catapres Ampoules

  • Company:
    info
  • Active Ingredients:

    Clonidine hydrochloride

  • 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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Summary of Product Characteristics last updated on medicines.ie: 5/4/2019

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Boehringer Ingelheim Limited

Boehringer Ingelheim Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Actilyse Active Ingredients Alteplase
Medicine Name Actilyse Cathflo 2 mg Active Ingredients Alteplase
Medicine Name APTIVUS 100 mg/ml oral solution Active Ingredients Tipranavir
Medicine Name Aptivus 250 mg soft capsules Active Ingredients Tipranavir
Medicine Name Atrovent 250 UDVs, 250 micrograms/1ml Nebuliser Solution Active Ingredients ipratropium bromide monohydrate
Medicine Name Atrovent 500 UDVs, 500 micrograms/2ml Nebuliser Solution Active Ingredients ipratropium bromide monohydrate
Medicine Name Atrovent Inhaler CFC-Free Active Ingredients ipratropium bromide monohydrate
Medicine Name Catapres Ampoules Active Ingredients Clonidine hydrochloride
Medicine Name Catapres Tablets 100 micrograms Active Ingredients Clonidine hydrochloride
Medicine Name Giotrif 20 mg film-coated tablets Active Ingredients Afatinib dimaleate
Medicine Name Giotrif 30 mg film-coated tablets Active Ingredients Afatinib dimaleate
Medicine Name Giotrif 40 mg film-coated tablets Active Ingredients Afatinib dimaleate
Medicine Name Giotrif 50 mg film-coated tablets Active Ingredients Afatinib dimaleate
Medicine Name Glyxambi 10 mg/5 mg film-coated tablets Active Ingredients Empagliflozin, Linagliptin
Medicine Name Glyxambi 25 mg/5 mg film-coated tablets Active Ingredients Empagliflozin, Linagliptin
Medicine Name Jardiance 10 mg and 25 mg Film-Coated Tablets Active Ingredients Empagliflozin
Medicine Name Jentadueto 2.5 mg/850 mg film-coated tablets and Jentadueto 2.5 mg/1,000 mg film-coated tablets Active Ingredients Linagliptin, Metformin Hydrochloride
Medicine Name Metalyse 10,000 units Active Ingredients Tenecteplase
Medicine Name Metalyse 8,000 units Active Ingredients Tenecteplase
Medicine Name Micardis 20 mg Tablets Active Ingredients Telmisartan
Medicine Name Micardis 40 mg Tablets Active Ingredients Telmisartan
Medicine Name Micardis 80 mg Tablets Active Ingredients Telmisartan
Medicine Name MicardisPlus 40 mg/12.5 mg tablets Active Ingredients Hydrochlorothiazide, Telmisartan
Medicine Name MicardisPlus 80 mg/12.5 mg tablets Active Ingredients Hydrochlorothiazide, Telmisartan
Medicine Name MicardisPlus 80 mg/25 mg Active Ingredients Hydrochlorothiazide, Telmisartan
1 - 0 of 48 items.Total: Infinity pages

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 6.3 has been revised as a consequence.

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

Section 4.8

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

1. Addition of the following wording at the end of section 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: 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

4.2 Posology and method of administration

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

Catapres ampoules: Reason for change: section 2, 4.8, 6.3, 6.6, 9 and 10 updated.  All changes are minor.

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)