Senokot 7.5mg Tablets

  • Name:

    Senokot 7.5mg Tablets

  • Company:
    info
  • Active Ingredients:

    Sennoside

  • Legal Category:

    Supply through pharmacy only

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 15/01/20

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Summary of Product Characteristics last updated on medicines.ie: 13/4/2017
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Reckitt Benckiser Ireland Limited

Reckitt Benckiser Ireland Limited

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1 - 0 of 64 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 15 January 2020 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 5 September 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 13 April 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 13 April 2017 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.2:
Addition of paediatric posology (children over 12 years)

Section 4.3:
Addition of the following contraindications;
concomitant use with other laxatives
Children under 12 years of age

Section 4.4:
Addition of the following warnings / precautions;
Consult their doctor if senna is required daily
Additional information regarding prolonged & excessive use
Patients with kidney disorders should be aware of possible electrolyte imbalance

Section 4.5:
Addition of information regarding hypokalaemia

Section 4.6:
Addition of information regarding pregnancy, breast-feeding and fertility

Section 4.8
Addition of a MedDRA table by frequency & adverse events
Addition of HPRA details to report suspected adverse events

Section 4.9:
Addition of overdose & management information

Section 5.1:
Addition of pharmacotherapeutic group & ATC code
Addition of information regarding mechanism of action

Section 5.2:
Addition of information regarding systemic absorption







Updated on 16 January 2017 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 3. Pharmaceutical Form

Circular, biconvex, greenish brown tablets, with a diameter of 11/32 inch, one face imprinted with "S".

Changed to:

A greenish brown circular, biconvex, tablet with "S" imprinted on one side and plain on reverse side.

Section 10. Date of Revision of the text

November 2012

Changed to:

November 2016

Updated on 27 November 2012 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Updated section 2 to include the following:

Excipient: Contains Lactose Monohydrate 15.82mg

Updated section 4.3 to include the following:
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1

Updated section 4.4 to include the following:

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.


Updated on 3 March 2011 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 2:  Qualitative and Quantitative Compostion - revised.

Section 6.3
Amend shelf life of blisters from 2 to 3 years

Section 6.4
Amend storage conditions for blister to "store below 25degC"

Updated on 7 December 2009 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 6.3:  Extension of shelf life for the tablets packed in polypropylene containers with snap fit lids from 2 years to 5 years

Updated on 19 October 2009 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • SPC retired pending re-submission

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 1 - Strength added to name
Section 2 - Qualitative composition clarified to include both Alexandraina nd Tinnevelly Senna Pods
Section 9 -  Date of license renewal updated
Section 10 - Date of revision of text updated

Updated on 16 May 2007 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.4 - Special precautions for storage
  • Change to marketing authorisation holder address

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

SECTION 2.  Expansion of description of active ingredient to: "Each tablet contains standardised powdered senna pods..".
 
SECTION 4.4.  Additional warning added: "Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicine."
 
SECTION 5.1.  Pharmacodynamic properties expanded.
 
SECTION 6.4.  Removal of the word "dry" to read: "Store below 30oC. Store in the original package."
 
SECTION 7.  Change of address of marketing authorisation holder to: 7 Riverwalk, Citywest Business Campus, Dublin 24, Ireland.

Updated on 16 May 2005 SmPC

Reasons for updating

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

Legal category: Supply through pharmacy only

Updated on 10 August 2004 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Supply through pharmacy only

Updated on 16 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through pharmacy only