Summary of product characteristics
1. Name of the medicinal product
Norgalax
2. Qualitative and quantitative composition
Norgalax contains the active ingredient Docusate Sodium 0.12 gin each 10g micro-enema.
3. Pharmaceutical form
Rectal gel.
4.1. Therapeutic indications
For the symptomatic treatment of constipation whenever an enema is required and for the preparation of the colon and rectum for endoscopic examination.
4.2. Posology and method of administration
Adults: use one micro-enema. If required, a second micro-enema may be used on the same or the next day.
Children:
not recommended for children under 12 years old.
Norgalax is to be administered rectally. Remove the protective cap and insert the applicator in to the rectum, squeezing gently until the tube is empty. A drop of the gel maybe used as a lubricant if required.
4.3. Contraindications
Haemorrhoids, anal fissures, rectocolitis, anal bleeding, abdominal pain, intestinal obstruction, nausea, vomiting, inflammatory bowel disease, ileus and known hypersensitivity to any of the ingredients.
4.4. Special warnings and precautions for use
As with all laxatives, Norgalax should not be administered chronically. Prolonged use can precipitate the onset of an atonic non- functioning colon and hypokalaemia.
4.5. Interaction with other medicinal products and other forms of interaction
Norgalax may increase the resorption of medicines and is not to be used in combination with hepatotoxic agents.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no adequate data from the use of docusate enema or oral docusate in pregnant women. Animal studies with oral docusate are insufficient with respect to effects on pregnancy and embryonic foetal development.
The potential risk for humans is unknown. As minimal systemic absorption cannot be ruled out following rectal application, Norgalax should be used in pregnancy only if the benefits outweigh the risks.
Lactation
It is unknown whether docusate is excreted in human breast milk. Animal studies have shown excretion of docusate and its metabolites in breast milk when administered systemically. A decision on whether to continue/discontinue breast-feeding or continue/discontinue therapy with NORGALAX should be made taking into account the benefit of breast-feeding to the child and the benefit of NORGALAX therapy to the woman.
4.7. Effects on ability to drive and use machines
None known.
4.8. Undesirable effects
Gastrointestinal disorders: anal burning, rectal pain, rectal bleeding, diarrhoea
Skindisorders: urticaria
Hepaticdisorders: cases of hepatotoxicity have been reported with oral intake of docusate taken together with other laxatives.
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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9. Overdose
Overdose will lead to excessive purgation which should be treated symptomatically.
5.1. Pharmacodynamic properties
Docusatesodium is an anionic surfactant and used as a faecal softening agent. It is considered to ease constipation by increasing the penetration of fluid into the faeces thereby causing them to soften. Norgalax is usually effective in 5 to 20 minutes.
5.2. Pharmacokinetic properties
Norgalax has a local effect in the rectum. Minimal absorption cannot be ruled out even with a rectal application.
5.3. Preclinical safety data
Non-clinical data reveal no special hazard for humans based on studies of acute toxicity, repeated dose toxicity and in-vitro genotoxicity. Docusate sodium has been shown to exhibit developmental toxicity in rodents at oral doses that are maternally toxic and sufficiently in excess of the maximum human exposure indicating little relevance to clinical use. High oral doses given during lactation reduced pup weight and survival which was attributed to docusate and its metabolites present in the milk of the dams.
6.1. List of excipients
Glycerol
Sodium carboxymethylcellulose
Purified Water
6.2. Incompatibilities
None known
6.3. Shelf life
3 years
6.4. Special precautions for storage
Do not store above 25°C.
6.5. Nature and contents of container
A polyethylene tube with fixed applicator and a cap closure, containing 10g of gel in pack sizes of 6 and100 tubes.
6.6. Special precautions for disposal and other handling
None.
7. Marketing authorisation holder
Essential Pharma
7 Egham Business Village
Crabtree Road
Egham, Surrey
TW20 8RB
United Kingdom
8. Marketing authorisation number(s)
PL 41871/0007
9. Date of first authorisation/renewal of the authorisation
18/01/2005
10. Date of revision of the text
21/09/2015
4.1 Therapeutic indications
For the symptomatic treatment of constipation whenever an enema is required and for the preparation of the colon and rectum for endoscopic examination.
4.2 Posology and method of administration
Adults: use one micro-enema. If required, a second micro-enema may be used on the same or the next day.
Children:
not recommended for children under 12 years old.
Norgalax is to be administered rectally. Remove the protective cap and insert the applicator in to the rectum, squeezing gently until the tube is empty. A drop of the gel maybe used as a lubricant if required.
4.3 Contraindications
Haemorrhoids, anal fissures, rectocolitis, anal bleeding, abdominal pain, intestinal obstruction, nausea, vomiting, inflammatory bowel disease, ileus and known hypersensitivity to any of the ingredients.
4.4 Special warnings and precautions for use
As with all laxatives, Norgalax should not be administered chronically. Prolonged use can precipitate the onset of an atonic non- functioning colon and hypokalaemia.
4.5 Interaction with other medicinal products and other forms of interaction
Norgalax may increase the resorption of medicines and is not to be used in combination with hepatotoxic agents.
4.6 Fertility, pregnancy and lactation
Pregnancy
There are no adequate data from the use of docusate enema or oral docusate in pregnant women. Animal studies with oral docusate are insufficient with respect to effects on pregnancy and embryonic foetal development.
The potential risk for humans is unknown. As minimal systemic absorption cannot be ruled out following rectal application, Norgalax should be used in pregnancy only if the benefits outweigh the risks.
Lactation
It is unknown whether docusate is excreted in human breast milk. Animal studies have shown excretion of docusate and its metabolites in breast milk when administered systemically. A decision on whether to continue/discontinue breast-feeding or continue/discontinue therapy with NORGALAX should be made taking into account the benefit of breast-feeding to the child and the benefit of NORGALAX therapy to the woman.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
Gastrointestinal disorders: anal burning, rectal pain, rectal bleeding, diarrhoea
Skindisorders: urticaria
Hepaticdisorders: cases of hepatotoxicity have been reported with oral intake of docusate taken together with other laxatives.
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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
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Drug Licencing
Drugs appearing in this section are approved by UK Medicines & Healthcare Products Regulatory Agency (MHRA), & the European Medicines Agency (EMA).