Catapres Tablets 100 micrograms

  • Name:

    Catapres Tablets 100 micrograms

  • Company:
    info
  • Active Ingredients:

    Clonidine hydrochloride

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 23/04/19

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Summary of Product Characteristics last updated on medicines.ie: 23/4/2019

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Boehringer Ingelheim Limited

Boehringer Ingelheim Limited

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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 23 April 2019 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 23 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Change the MA holder (MAH) from Boehringer Ingelheim Ltd, UK to Boehringer Ingelheim International GmbH, Germany. 

Updated on 29 May 2018 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains

Updated on 22 May 2018 SmPC

Reasons for updating

  • Change to section 6.1 - List of excipients
  • 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 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 6 August 2014 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 6 August 2014 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • 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


Adverse event reporting statements have been added to the end of section 4.8 (Undesirable effects) as follows:

 

4.8 Undesirable effects

 

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.

Section 10:
date of revision of the text updated to July 2014

Updated on 1 August 2014 PIL

Reasons for updating

  • New PIL for new product

Updated on 1 August 2014 PIL

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 16 January 2013 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 5.2 - Pharmacokinetic properties
  • 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

4.2 Posology and method of administration

The following section has been added to section 4.2

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

The following statement has been added into the fourth paragraph: (see Section 4.2 Posology and Method of Administration)

Monohydrate has been added to the last paragraph to state “lactose monohydrate per tablet”.


4.6 Fertility, pregnancy and lactation

Sub-headings pregnancy, lactation and fertility have been included with revised information.

4.7 Effects on ability to drive and use machines

Section has been re-written and updated.

5.2 Pharmacokinetic properties

Inclusion of sub-headings “absorption and distribution” and “metabolism and elimination”.
Information updated accordingly.

10. DATE OF REVISION OF THE TEXT

The date of revision of the text in section 10 has also been updated to December 2012.

Updated on 16 January 2013 PIL

Reasons for updating

  • Change to information about driving or using machinery
  • Change to date of revision

Updated on 1 March 2012 SmPC

Reasons for updating

  • Change to section 5.2 - Pharmacokinetic properties
  • 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

Section 5.2 Pharmacokinetic Properties
This section has been amended.

Section 10 Date of Revision of the Text
The date has been amended from August 2011 to February 2012.

Updated on 23 December 2011 PIL

Reasons for updating

  • Addition of separate PILs covering individual presentations

Updated on 17 October 2011 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 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 29 January 2010 PIL

Reasons for updating

  • Change to name of manufacturer

Updated on 12 October 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 4.9 - Overdose
  • 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)

Free text change information supplied by the pharmaceutical company

Details of Main Changes

Section 4.2

The following information has been added: Children: Not recommended. Please refer to section 4.4 Special Warnings and Precautions for Use.

 

Section 4.3

The following information has been added:

 

In case of rare hereditary conditions that may be incompatible with an excipient of the product (please refer to section 4.4 Special Warnings and Precautions for Use) the use of the product is contraindicated.

 

Section 4.4

Previous wording:

 

Cases of restlessness, palpitations, nervousness, tremor, headache and abdominal symptoms have also been reported.

 

Updated wording:

 

Cases of agitation, restlessness, palpitations, nervousness, tremor, headache and abdominal symptoms have also been reported.

 

The following information has been added:

 

 

Patients who wear contact lenses should be warned that treatment with Catapres may cause decreased lacrimation.

 

The following information has been added:

 

 

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.

 

The following information has been added:

 

 

This product contains 72.1 mg of lactose per tablet.

 

Section 4.8

Section has been re-formatted. Adverse Events are now ranked under headings of frequency using the following convention:

Very common > 1/10

Common > 1/100, <1/10

Uncommon >1/1000, <1/100

Rare >1/10000, <1/1000

Very rare <1/10000

Not known Cannot be estimated from the available data

Section 4.9

Previous wording:

 

Manifestations of intoxication are due to a generalised sympathetic depression and include pupillary constriction, lethargy, bradycardia, hypotension, hypothermia, coma and apnoea.

 

Updated wording:

 

Manifestations of intoxication are due to a generalised sympathetic depression and include pupillary constriction, lethargy, bradycardia, hypotension, hypothermia, somnolence including coma and respiratory depression including apnoea.

 

Updated on 7 July 2009 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • 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



Details of Main Changes

Section 6.3 - The shelf life has been changed from 5 years to 36 months

Section 6.5 - Packaging has been changed from clear to opaque blisters

Updated on 19 September 2008 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 17 October 2007 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 22 March 2007 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 7 July 2006 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

ection 4.4: Updated to include the following warning: "Patients with hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine."

Section 6.4: Updated to remove reference to polypropylene securitainers

Section 6.5: Updated to remove reference to polypropylene securitainers

Updated on 12 June 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 17 September 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 26 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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