NORMACOL Granules
- Name:
NORMACOL Granules
- Company:
Norgine Limited
- Active Ingredients:
- Legal Category:
Supply through general sale
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 14/01/21
(Click to Download)XPIL
PACKAGE LEAFLET: INFORMATION FOR THE USER
PACKAGE LEAFLET: INFORMATION FOR THE USER
1. What NORMACOL is and what it is used for
1. What NORMACOL is and what it is used for
2. What you need to know before you take NORMACOL
2. What you need to know before you take NORMACOL
3. How to take NORMACOL
3. How to take NORMACOL
4. Possible side effects
4. Possible side effects
5. How to store NORMACOL
5. How to store NORMACOL
6. Contents of the pack and other information
6. Contents of the pack and other information
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Norgine Limited
Company Products
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 14 January 2021 SPC
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 PIL
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 SPC
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category: Supply through general sale
Updated on 10 January 2019 PIL
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 SPC
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 4 November 2015 SPC
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
Updated on 4 November 2015 SPC
Reasons for updating
- New SPC for new product
Legal category: Supply through general sale
Updated on 30 October 2015 SPC
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
- 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 PIL
Reasons for updating
- New PIL for new product
Updated on 22 October 2015 PIL
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 SPC
Reasons for updating
- Change to section 9 - Date of renewal of authorisation
Legal category: Supply through general sale
Updated on 22 April 2013 SPC
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
'with an odour of vanillin' was removed.
Section 10:
Revision date was updated for May 2011 to December 2012
Updated on 15 April 2013 PIL
Reasons for updating
- Change to date of revision
- Change to appearance of the medicine
Updated on 28 November 2012 PIL
Reasons for updating
- Change due to user-testing of patient information
Updated on 29 August 2012 SPC
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 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 SPC
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
Updated on 14 August 2006 PIL
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 SPC
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 PIL
Reasons for updating
- Improved electronic presentation
Updated on 21 September 2004 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 19 August 2003 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Supply through general sale
Updated on 15 August 2003 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Supply through general sale
Updated on 13 August 2003 SPC
Reasons for updating
- New SPC for new product
Legal category: Supply through general sale