NORMACOL Granules Ref.[49824] Active ingredients:

Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: Norgine B.V., Antonio Vivaldistraat 150, 1083 HP Amsterdam, Netherlands

4.3. Contraindications

Intestinal obstruction, faecal impaction, and colonic atony.

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

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

4.4. Special warnings and precautions for use

Adequate fluid intake should be maintained.

Caution should be exercised in cases of ulcerative colitis.

Patients should be advised:

of possible fluid and electrolyte depletion in association with diarrhoea.
to take with plenty of water to reduce the risk of oesophageal obstruction.
to take plenty of water and to maintain an adequate fluid intake.
to avoid taking NORMACOL immediately before going to bed or in a recumbent position (especially if they are elderly).
to 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.

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.

4.5. Interaction with other medicinal products and other forms of interaction

None known.

4.6. Pregnancy and lactation

NORMACOL may be used during pregnancy or lactation.

4.7. Effects on ability to drive and use machines

NORMACOL has no influence on the ability to drive or use machines.

4.8. Undesirable effects

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

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 Website: www.hpra.ie.

6.2. Incompatibilities

None known.

< Previous: Usage

Next: Pharmacology >

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.