Summary of Product Characteristics (SmPC) - Norgalax
1. NAME OF THE MEDICINAL PRODUCT
Norgalax
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 g micro-enema contains 120 mg of docusate sodium.
Excipient with known effect
Each 10 g micro-enema contains 3 g of glycerol (E 422).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Rectal gel.
Opalescent liquid.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Symptomatic treatment of constipation.
Preparation of the colon and rectum for endoscopic examination.
4.2 Posology and method of administration
Posology
Adults and children 12 years and over
Use one micro-enema. If required, a second micro-enema may be used on the same or the next day.
Paediatric population
Norgalax should not be used in children under 12 years old.
Method of administration
For rectal use.
Remove the protective cap and insert the applicator into the rectum, squeezing gently until the tube is empty. A drop of the gel maybe used as a lubricant if required.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Haemorrhoids, anal fissures, rectocolitis, anal bleeding, abdominal pain, intestinal obstruction, nausea, vomiting, inflammatory bowel disease, and ileus.
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.
Norgalax contains glycerol (E 422). May have a mild laxative effect.
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.
Breastfeeding
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
Norgalax has no or negligible influence on the ability to drive and use machines.
4.8 Undesirable effects
Gastrointestinal disorders: anal burning, rectal pain, rectal bleeding, diarrhoea
Hepatobiliary disorders: cases of hepatotoxicity have been reported with oral intake of docusate taken together with other laxatives.
Skin and subcutaneous tissue disorders: urticaria
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 Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
Overdose will lead to excessive purgation which should be treated symptomatically.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Drugs for constipation, enemas, ATC code: A06AG10
Docusate sodium 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. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Glycerol (E 422)
Carmellose sodium
Purified water
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years
6.4 Special precautions for storage
Do not store above 25ºC.
6.5 Nature and contents of container
A LDPE tube with fixed LDPE applicator and a LDPE cap closure, containing 10 g of gel.
Pack sizes: 6 and 100 tubes.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Essential Pharma Limited
8a Crabtree Road, Egham,
Surrey, TW20 8RN,
UK.
8. MARKETING AUTHORISATION NUMBER(S)
PL 41871/0007
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
Date of first authorisation: 18 January 2005
10 DATE OF REVISION OF THE TEXT
19/09/2024