SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Normacol Plus

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

The active ingredients are 62% Sterculia and 8.0% Frangula Bark.

3    PHARMACEUTICAL FORM

Light brown to dark brown coated granules.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

The treatment of constipation, particularly hypertonic or slow transit constipation, resistant to bulk alone.

The initiation and maintenance of bowel action after rectal surgery and after haemorrhoidectomy.

4.2    Posology and method of administration

Posology

Adults (including older people ): 1 or 2 sachets or 1-2 heaped 5ml spoonfuls, once or twice daily after meals.

Paediatric population

Children (6 - 12 years): A reduced amount may be given at the discretion of the physician.

NORMACOL Plus ® is not recommended for children under 6 years of age.

Method of administration

The granules should be placed on the tongue and, without chewing or crushing, swallowed immediately with plenty of water or a cool drink. Prior to drinking they may also be sprinkled on and taken with soft food such as yoghurt.

Contraindications

Intestinal obstruction, faecal impaction and total atony of the colon.

Pregnancy and lactation (see section 4.6)

Known hypersensitivity to the active substances or any of the excipients listed in section 6.1

4.4 Special warnings and precautions for use

Caution should be exercised in the use of NORMACOL Plus in cases of ulcerative colitis.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.

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.

Patients should be advised to avoid Normacol Plus immediately before going to bed or in a recumbent position (especially if they are elderly) and to suspend treatment if bowel movements do not occur within four days.

Take with plenty of water to reduce the risk of oesophageal obstruction. Adequate fluid intake should be maintained.

4.5    Interaction with other medicinal products and other forms of interaction

None known

4.6    Fertility, pregnancy and lactation

Pregnancy:

There are no data from the use of sterculia and frangula in pregnant women. Frangula can cross the placenta and non-clinical studies have shown a potential genotoxic risk (see section 5.3). Therefore, NORMACOL Plus is contraindicated during pregnancy (see section 4.3).

Breastfeeding

There is no evidence that sterculia is excreted in human milk. It is unknown whether frangula or its metabolites are excreted in human milk, although it is reported that excretion of active metabolites from other anthranoids occurs in breast milk. A risk to the suckling child cannot be excluded. NORMACOL Plus is therefore contraindicated during breastfeeding (see section 4.3).

NORMACOL (Sterculia alone) is available if required in pregnancy and lactation (see section 4.3).

4.7 Effects on ability to drive and use machines

None known

4.8 Undesirable effects

System Organ Class	Adverse Drug Reaction
Immune system disorder	Allergic reactions
Gastrointestinal disorders	Oesophageal obstruction, intestinal obstruction or impaction, abdominal distension, flatulence, diarrhoea, nausea, abdominal pain, melanosis coli

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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard.

4.9 Overdose

Intestinal obstruction is possible in overdosage particularly in combination with inadequate fluid intake. Management is as for intestinal obstruction from other causes.

If there is profound diarrhoea, dehydration and electrolyte depletion may occur.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Sterculia acts in the colon by forming a soft bulky stool and inducing a laxative effect. Frangula acts as a mild peristaltic stimulant and aids the evacuation of the softened faecal mass.

5.2 Pharmacokinetic properties

Sterculia is not absorbed in the gastrointestinal tract; Frangula acts locally on the wall of the intestinal tract. The laxative action of Normacol Plus is normally effective within 12 hours of oral administration.

5.3 Preclinical safety data

Non-clinical safety data for frangula are not available. Although no teratogenic effects have been reported, non-clinical data suggest a possible genotoxic risk for several anthranoids related to frangula. There is also evidence to suggest that products of this class may cross the placenta and small amounts of metabolites may be excreted in milk.

There is no evidence that sterculia has a significant systemic toxicity potential based on repeated dose toxicity, reproductive toxicity and genotoxicity studies.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Sucrose

Talc

Sodium hydrogen carbonate Hard paraffin Peppermint flavouring Colourings: E110, E127 and E132

The sugar provides 7 - 14 calories per dose (1.7 to 3.4g carbohydrate per dose). The sodium content is 1.25 to 2.5mmol per does. Normacol Plus is gluten free.

6.2    Incompatibilities

None known

6.3    Shelf life

Sachet and lined carton: 2 years

6.4    Special precautions for storage

Store in a dry place below 25°C.

6.5    Nature and contents of container

Sachet containing 7g of granules in cartons of 2, 7, 10, 30 or 60 sachets.

Lined carton of 200g or 500g of granules.

6.6    Special precautions for disposal

None

7    MARKETING AUTHORISATION HOLDER

Norgine Limited Norgine House Widewater Place Moorhall Road Harefield Uxbridge Middlesex UB9 6NS United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

PL 00322/5011

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

01/05/1986

10 DATE OF REVISION OF THE TEXT

31/03/2016