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Senokot 7.5mg Tablets

*
Pharmacy Only: Non-prescription

  • Company:

    Reckitt Benckiser Ireland Limited

  • Status:

    No Recent Update

  • Legal Category:

    Supply through pharmacy only

  • Active Ingredient(s):

    Sennoside

    *Additional information is available within the SPC or upon request to the company

Updated on 20 September 2024

File name

PIL Senokot 7.5mg Tabs 20,60,100- Aug 2022.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 20 September 2024

File name

IE SPC Senokot 7.5mg tabs Aug22.pdf

Reasons for updating

  • Correction of spelling/typing errors

Legal category:Supply through pharmacy only

Updated on 20 September 2024

File name

PIL Senokot 7.5mg Tabs 20,60,100- Aug 2022.pdf

Reasons for updating

  • Correction of spelling/typing errors

Updated on 20 February 2023

File name

SPC Senokot 7.5mg tabs Aug22 CRN00CY2S.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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

Legal category:Supply through pharmacy only

Updated on 20 February 2023

File name

Senokot 7.5mg Tabs 20,60,100- CRN00CY2S- Aug 2022.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - use in children/adolescents
  • Change to section 4 - possible side effects

Updated on 15 January 2020

File name

Senokot 7.5mg Tablets.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 05 September 2017

File name

PIL_17278_590.pdf

Reasons for updating

  • New PIL for new product

Updated on 13 April 2017

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 13 April 2017

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

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

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 03 March 2011

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 07 December 2009

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

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

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

Reasons for updating

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

Legal category:Supply through pharmacy only

Updated on 10 August 2004

Reasons for updating

  • Improved electronic presentation

Legal category:Supply through pharmacy only

Updated on 16 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Supply through pharmacy only