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

 

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

 

 

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

 

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

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

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

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

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