NORMACOL PLUS Granules *
General Sale: Non-prescription

  • Company:

    Norgine Limited
  • Status:

    No Recent Update
  • Legal Category:

    Supply through general sale
  • Active Ingredient(s):

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

Updated on 10 November 2021

File name

ie-smpc-nop-clean_1636543807.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

4.2 Posology and method of administration

Adolescents and Adults (including the elderly):

 

Adults (including the elderly) and children aged 12 years and over:

1 or 2 sachets or 1-2 heaped 5ml spoonfuls, once or twice daily after meals.

 

Sachets  

One sachet (equivalent to 7g of Normacol Plus) or two sachets (equivalent to 14g of Normacol Plus) per day, after meals.

 

Or

 

Granules

One heaped 5ml spoonful (equivalent to 3.5g of Normacol Plus) or two heaped 5ml spoonfuls (equivalent to 7g of Normacol Plus) to be taken once or twice a day, after meals.

 

The recommended dose of this herbal preparation is equivalent to 10 – 30 mg hydroxyanthracene derivatives, calculated as glucofrangulin A.

 

Paediatric Population

Normacol Plus is not recommended for use in children under 12 years of age (see section 4.3).

 

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.

 

10 DATE OF REVISION OF THE TEXT

03 November 2019 05 November 2021

 

Updated on 10 November 2021

File name

ie-pil-nop-clean_1636543573.pdf

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

3.            How to take Normacol Plus

Always take Normacol Plus exactly as described in this leaflet or as your doctor or pharmacist have told you. You should check with your doctor or pharmacist if you are not sure.

 

- The usual dose for adults, adolescents and the elderly is 1 to 2 sachets, or 1 to 2 heaped 5ml spoonfuls, taken once or twice a day after meals.

 

Adults (including the elderly) and children aged 12 years and over:

Sachets

One sachet (equivalent to 7g of Normacol Plus) or two sachets (equivalent to 14g of Normacol Plus) per day, after meals.

 

Or

 

Granules

One heaped 5ml spoonful (equivalent to 3.5g of Normacol Plus) or two heaped 5ml spoonfuls (equivalent to 7g of Normacol Plus) to be taken once or twice a day, after meals.

 

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-Dublin 2: Tel:+353 1 6764971: Fax: +353 1 6762517.  Website: www.hpra.ie; E-mail: medsafety@hpra.ie. By reporting side effects you can help provide more information on the safety of this medicine.

 

6.            Contents of the pack and other information

This leaflet was last approved in  09/2019 11/2021

 

 

Updated on 05 November 2019

File name

ie-spc-normacol-plus-rfi-clean-22753_1572958775.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 10 - Date of revision of the text

Legal category:Supply through general sale

Updated on 05 November 2019

File name

ie-pil-normacolplus-rfi-clean-22753_1572958698.pdf

Reasons for updating

  • Change to section 2 - excipient warnings

Updated on 12 April 2019

File name

ie-pil-normacolplus-Nov2018_1555066823.pdf

Reasons for updating

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

Updated on 12 April 2019

File name

ie-smpc-normacolplus-Nov2018_1555066858.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category:Supply through general sale

Updated on 25 October 2018

File name

ie-pil-normacolplus_1540464710.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 25 October 2018

File name

ie-smpc-normacolplus_1540464443.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 26 October 2015

File name

PIL_8993_692.pdf

Reasons for updating

  • New PIL for new product

Updated on 26 October 2015

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to date of revision
  • Change due to harmonisation of PIL
  • Addition of information on reporting a side effect.

Updated on 07 September 2015

Reasons for updating

  • New SPC for new product

Legal category:Supply through general sale

Updated on 07 September 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • 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

The following changes have been made.

 

Section 4.2      

Inclusion of subheadings according to QRD and that NORMACOL Plus is not recommended for children under the age of 6.

Rewording the method of administration.

 

Section 4.3      

excipients has been aligned with QRD wording.

 

Section 4.4      

Rewording of patient advice regarding oesophageal obstruction.

 

Section 4.6      

Aligned with QRD wording.

 

Section 4.8      

-Inclusion new ADR in system organ class ‘Gastrointestinal disorders: flatulence, diarrhoea, nausea, abdominal pain, melanosis coli

-Addition of information regarding adverse event reporting.

 

Section 10

Revision date

 

Updated on 30 October 2014

Reasons for updating

  • Change to section 5.3 - Preclinical safety data
  • 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 5.3 has been updated to:

 

No pre-clinical data are available for frangula. Although no teratogenic effects have been reported, pre-clinical data suggest a possible genotoxic risk for several anthranoids. There is also evidence to suggest that products of this class may cross the placenta and small amounts of metabolites may be excreted in breast milk.

There is no evidence that sterculia has a significant systemic toxicity potential, based on repeated dose toxicity, reproductive toxicity and genotoxicity studies. Pre-clinical carcinogenicity studies with sterculia are not available.

Section 10 has been updated to:

            Date revised: August 2014

Updated on 22 April 2013

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • 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:
Granules.
Brown irregular shaped granules with a slight odour and taste of peppermint. Irregular shaped brown granules.

Section 6.1:  
Paraffin wax Hard paraffin

Section 10:
November 2010 July 2012

Updated on 04 January 2013

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 4.1 - Therapeutic indications
  • 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 4.6 - Pregnancy and lactation
  • 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 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 7 - Marketing authorisation holder
  • 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 (Name of the medicinal product), 'Normacol Plus Granules' has been replaced with the following: 'Normacol Plus Granules, Sterculia 62% w/w, Frangula 8% w/w'.

In section 2 (Qualitative and quantitative composition), the following statement has been added: 'Excipients: contains sucrose 25% w/w, sodium hydrogen carbonate 1.5% w/w and sunset yellow FCF (E110).'
The following sentence: 'For excipients, see 6.1.' has been replaced with 'For a full list of excipients, see section 6.1.'

In section 4.1 (Therapeutic indications), '(...) and diverticulosis, particularly hypertonic or slow transit constipation, resistant to bulk alone.' has been added.

In section 4.2 (Posology and method of administration), the following statement: 'Adults (including the elderly): 1 or 2 sachets or 1-2 heaped 5ml spoonfuls, once or twice daily after meals.' has been replaced with '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 (Contraindications), the following '(...) and total atony of the colon' has been replaced with 'colonic atony'.
'Pregnancy and lactation.' has been added.
The following statement: ' Use in patients with a sensitivity to sterculia or frangula.' has been replaced with 'Known hypersensitivity to any of the ingredients.'

In section 4.4 (Special warnings and precautions for use), the following information:
'Caution should be exercised in the use of NORMACOL PLUS in cases of ulcerative colitis. Patients should be advised to maintain an adequate fluid intake, to avoid taking NORMACOL PLUS immediately before going to bed (especially if they are elderly), and to suspend treatment of bowel movements do not occur within four days.' has been updated with the following:
'Oesophageal obstruction is possible if the product is not adequately washed down with fluid. Caution should be exercised in the use of NORMACOL Plus in cases of ulcerative colitis.
Patients should be advised to:
• Take plenty of fluid and maintain an adequate fluid intake
• Avoid taking NORMACOL Plus 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.
Prolonged and excessive use of stimulant laxatives can cause dependence and loss of normal bowel function. Possible fluid and electrolyte depletion in association with diarrhoea.'

In section 4.6 (Fertility, pregnancy and lactation), the advise has changed, normacol is contraindicated in pregnancy and during breastfeeding.

In section 4.7 (Effects on ability to drive and use machines), 'None known' has been replaced with the following sentence: 'NORMACOL Plus has no known influence on the ability to drive or use machines.'

In section 4.8 (Undesirable effects), the following statement: 'Abdominal distension may occur. Oesophageal obstruction is possible if the product is not adequately washed down with fluid.'
has been replaced with the following: 'Immune system disorders: Allergic reactions.
Gastrointestinal disorders: Oesophageal obstruction, intestinal obstruction or impaction, abdominal cramp, abdominal distension.'

In section 4.9 (Overdose), the following statement has been added: 'Oesophageal obstruction is possible if the product is taken in overdosage. If there is profound diarrhoea, dehydration and electrolyte depletion may occur.'

In section 6.4 (Special precautions for storage), 'Store in original package in a dry place.' has been replaced with 'Store in the original package in order to protect from moisture.'
'Store in original package in a dry place. Keep the carton tightly closed.' has been replaced with 'Store in the original package. Keep the carton tightly closed in order to protect from moisture.'

In section 6.5 (Nature and contents of container), 10 and 30 sachets in a box have been added; 'Lined carton' has been replaced with 'Carton lining'.

In section 7 (Marketing Authorisation Holder), Chaplin House has been replaced with Norgine House due to the address change.

In section 9 (Date of first authorisation/renewal of the authorisation), Date of last renewal has been updated: 25 September 2009.

In section 10 (date of revision of the text), the date has been updated: November 2010

Updated on 03 July 2008

Reasons for updating

  • Correction of spelling/typing errors

Legal category:Supply through general sale

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
  • Change of active ingredient

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 6.6 - Special precautions for disposal and other handling
  • 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 Plus Granules contains 0.62g (62% w/w) of Sterculia and 0.08g (8% w/e) of Frangula.

 

                        Each sachet contains 4.34g of Sterculia and 0.56g of Frangula

 

                        For excipients, see 6.1

 

Section 3:       Brown irregular shaped granules with a slight odour and taste of peppermint.

 

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

 

Section 6.1: Sodium hydrogen carbonate

 

 

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.

 

                        Each sachet contains 7 g of brown granules in boxes of 2, 7, or 60 sachets.

 

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

 

                        Lined carton of 200 g or 500 g of brown granules.

 

                        Not all pack sizes may be marketed

 

Section 6.6:   No special requirements.

 

 

Section 10:    Date revised: August 2005

Updated on 25 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