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NORMACOL Granules

*
General Sale: Non-prescription

  • Company:

    Norgine Limited

  • Status:

    No Recent Update

  • Legal Category:

    Supply through general sale

  • Active Ingredient(s):

    Sterculia

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

Updated on 19 June 2023

File name

ie-smpc-nor-en.pdf

Reasons for updating

  • Document format updated

Legal category:Supply through general sale

Updated on 14 January 2021

File name

ie-normacol-smpc-clean.pdf

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 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

2          QUALITATIVE AND QUANTITATIVE COMPOSITION

Each gram of NORMACOL Granules contains 0.62g of Sterculia BP (62% w/w).

Each sachet contains 4.34g of Sterculia BP.

Excipient(s) with know effect:

Contains sucrose 24.593% w/w and sodium hydrogen carbonate 1.5% w/w.

Contains 1.7g of sucrose and 28.7mg of sodium per 7g sachet

Contains 1.0g of sucrose and 16.8mg of sodium per 5ml spoonful

For a full list of excipients, see 6.1

4.4       Special warnings and precautions for use

This medicinal product contains 28.7 mg sodium per 7g sachet  or 16.8mg of sodium per 5ml spoonful, equivalent to 1.5 % or 0.9% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

 

4.6       Fertility, pregnancy and lactation

NORMACOL may be recommendedused during pregnancy or lactation.

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 – Dublin2; Tel:+353 1 6764971; Fax:+353 1 6762517. Website: www.hpra.ie.; Email: medsafety@hpra.ie.

5.1       Pharmacodynamic properties

NORMACOLNormacol is a laxative which contains sterculia. Sterculia is a bulking agent which stimulates the motility of the colon by increasing faecal volume, and reduces intraluminal recto-sigmoid pressure. Sterculia acts in the colon by forming a soft bulky stool and inducing a laxative effect.

10        DATE OF REVISION OF THE TEXT

March 2018

13 January 2021

 

 

 

Updated on 14 January 2021

File name

ie-normacol-pil-clean.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision
  • Change to other sources of information section

Free text change information supplied by the pharmaceutical company

Section 2. What you need to know before you take NORMACOL

 

Important information about some of the ingredients of NORMACOL

This medicinal product contains 28.7 mg sodium (main component of cooking /table salt ) per 7g sachet or 16.8mg of sodium per 5ml spoonful. This is equivalent to 1.5% or  0.9 % of the recommended maximum daily dietary intake of sodium for an adult.

This medicine contains 1.25-2.5 mmol sodium per dose. This should be taken into consideration by patients on a controlled sodium (low salt) diet.

 

 

Section 4. Possible Side Effects

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin2; Tel:+353 1 6764971; Fax:+353 1 6762517. Website: www.hpra.ie.; Email: medsafety@hpra.ie.

By reporting side effects you can help provide more information on the safety of this medicine.

 

Section 6. Contents of the pack and other information

 

Marketing Authorisation Number: PA 1336/007/001

 

This leaflet was last revised in 01/2021.

 

Other sources of information

If you need the information on this leaflet in an alternative format, such as large print, please ring 00 44 1895 826 606.

 

 

 

Updated on 12 March 2019

File name

ie-spc-normacol (7890 & 16121) - 11 March 2019.pdf

Reasons for updating

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

Legal category:Supply through general sale

Updated on 10 January 2019

File name

ie-pil-normacol (7890 & 16121)n.pdf

Reasons for updating

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

Updated on 10 January 2019

File name

ie-spc-normacol (7890 & 16121).pdf

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:Supply through general sale

Updated on 04 November 2015

Reasons for updating

  • New SPC for new product

Legal category:Supply through general sale

Updated on 04 November 2015

Reasons for updating

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

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

Section 10 Date of revision form March 2015 to October 2015

Updated on 30 October 2015

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 - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

In section 4.2 (Posology and method of administration)
- patient group 'elderly' has been replaced with 'older people'
- Normacol is not recommended for children under 6 years has been added

In section 4.3 (Contraindications)
- 'ingredients' has been replaced with 'active substance'
- QRD updates

In section 4.4 (Special warnings and precautions for use)
- This section has been reworded. No content has been added

In section 4.8 (Undesirable effects)
- advers events and system order class has been moved into a table
- reporting of suspected adverse reactions has been added

In section 4.9 (Overdose)
- If there is profound diarrhoea, dehydration and electrolyte depletion may occur has been added

In section 10 (Date of revision of the text)
October 2015

Updated on 22 October 2015

File name

PIL_8992_232.pdf

Reasons for updating

  • New PIL for new product

Updated on 22 October 2015

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to instructions about overdose
  • Change to side-effects
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 27 February 2014

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company


Section 9.

There was a typing error in the date for the Date of First Authorisation, which has now been rectified.



Updated on 22 April 2013

Reasons for updating

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

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

Section 3:
'with an odour of vanillin' was removed.

Section 10:
Revision date was updated for May 2011 to December 2012

Updated on 15 April 2013

Reasons for updating

  • Change to date of revision
  • Change to appearance of the medicine

Updated on 28 November 2012

Reasons for updating

  • Change due to user-testing of patient information

Updated on 29 August 2012

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

In section 1: 'Normacol Granules' has been replaced with 'NORMACOL 62% w/w Granules'

In section 2: 'Each sachet contains 4.34g of sterculia' has been replaced with 'Each sachet contains 4.34g of Sterculia BP'; the following sentence has been removed: 'For excipients, see 6.1.' and the follwing statement added: 'Excipient: Contains sucrose 24.593% w/w and sodium hydrogen carbonate 1.5% w/w. For a full list of excipients, see 6.1.'

In section 4.2: the following statement has been removed: 'Adults (including the elderly): 1 or 2 sachets or 1-2 heaped 5ml spoonfuls, once or twice daily after meals.” and the following statement added: 'Adults: 1 or 2 sachets or 1-2 heaped 5ml spoonfuls, once or twice daily after meals. Elderly:As adult dose.'

In section 4.3: 'total atony of the colon' has been replaced with 'colonic atony'; 'Known hypersensitivity to any of the ingredients' has beeen added and 'Use in patients with a sensitivity to sterculia' removed

In section 4.4: the following has been replaced: 'Not to be taken immediately before retiring, especially in the elderly. Adequate fluid should be maintained. Caution should be exercised in cases of ulcerative colitis. Not to be taken for more than 4 days if there has been no movement of the bowels.'
with
'Oesophageal obstruction is possible if the product is not adequately washed down with fluid.

Caution should be exercised in cases of ulcerative colitis.

Patients should be advised to:

• take plenty of water and to maintain an adequate fluid intake.

• avoid taking NORMACOL immediately before going to bed or in a recumbent position (especially if they are elderly)

• suspend treatment if bowel movements do not occur within four days

It is not unusual for stools to appear paler in colour than normal as a result of local contact with sterculia. This does not indicate anything untoward.'

In section 4.7: 'None known' has been replaced with 'NORMACOL has no influence on the ability to drive or use machines'

In section 4.8: this section has been updated to the following: 'Immune system disorders: Allergic reactions.

 

Gastrointestinal disorders: Oesophageal obstruction, intestinal obstruction or impaction, occasional mild abdominal distension, flatulence.”

In section 4.9: the following statement has been added: 'Oesophageal obstruction is possible if the product is taken in overdosage.'

In section 5.1: the following statement has been added: 'NORMACOL is a laxative which contains sterculia. Sterculia is a bulking agent which stimulates the motility of the colon by increasing faecal volume, and reduces intraluminal recto-sigmoid pressure.'

In section 6.3: the word 'lined' has been removed

In section 6.5: the following statements: 'Lined carton: Laminate consisting of 4 layers of low density polyethylene; aluminium; low density polyethylene and paper. Lined box of 500 g of white granules' have been replaced with 'Carton lining: laminate consisting of 4 layers of low density polyethylene; aluminium; low density polyethylene and paper.

 

Lined carton of 500 g of white granules.'

In section 6.6: 'None.' has been replaced with 'No special requirements.'

In section 7: The MAH address has been updated

In section 9: dates have been updated: 'Date of first authorisation: 25 September 1984. Date of last renewal: 25 September 2009.'

In section 10: date of the revision of the text has been changed to May 2011

 

Updated on 13 August 2007

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

6.3.      Shelf Life

 

The shelf life of the sachet is 3 years and the lined carton 4 years.

Sachet and lined carton: 2 years.

10.   DATE OF REVISION OF THE TEXT

 

            Date revised: August 2005 September 2006

Updated on 14 August 2006

Reasons for updating

  • Change of inactive ingredient
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to storage instructions
  • Change to date of revision

Updated on 11 August 2006

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.3 - Contraindications
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

Section 2:       Each gram of Normacol Granules contains 0.62g of Sterculia (62% w/w).  Each sachet contains 4.34g of sterculia.

                        For excipients, see 6.1

 

 

Section 3:       White irregular shaped granules with an odour of vanillin.

 

Section 4.3: Addition of - Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.

 

Section 6.1:   Sodium hydrogen carbonate  

                        Titanium dioxide (E171)  

 

 

Section 6.4:  Sachet: Do not store above 25°C.  Store in original package in a dry place.

 

                        Carton: Do not store above 25°C.  Store in original package in a dry place.  Keep the carton tightly closed.

 

 

Section 6.5:  Sachet: Laminate consisting of 4 layers of low density polyethylene; aluminium; low density polyethylene and paper.

 

                        Sachet containing 7 g of white granules in boxes of 2, 7, or 60 sachets.  Not all pack sizes may be marketed

 

                        Lined carton: Laminate consisting of 4 layers of low density polyethylene; aluminium; low density polyethylene and paper.

 

Section 10:    Date revised: August 2005

Updated on 26 May 2005

Reasons for updating

  • Improved electronic presentation

Updated on 21 September 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 19 August 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Supply through general sale

Updated on 15 August 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Supply through general sale

Updated on 13 August 2003

Reasons for updating

  • New SPC for new product

Legal category:Supply through general sale