Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Docusate sodium may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for
Norgalax softens the faeces (stools) to make your bowel movements easier. It will help you when you are constipated or can be used to empty the large intestine (gut) if the doctor wants to examine inside it. 2.
e Norgalax
Do not use Norgalax if you are allergic to docusate sodium or any of the other ingredients of this medicine (listed in section 6). if you have haemorrhoids (piles) or bleeding from your rectum (back passage). if you have a pain in your abdomen (tummy). if you feel sick or are being sick. if you have a blockage in your intestine (gut). if you have sores around your anus (bottom) called anal fissures. if you have inflammatory bowel disease such as ulcerative colitis or Crohn's disease. if you have inflammation of the back passage called rectocolitis. if you have a bowel condition called "ileus" (loss of muscle tone in the bowel). Warnings and precautions Talk to your doctor or pharmacist before using Norgalax. Prolonged use can cause the gut to become lazy and not work properly. It can also lead to low levels of potassium in the blood (called 'hypokalaemia'). Children
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Norgalax should not be used in children under 12 years old. Other medicines and Norgalax Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. The liver may be affected (signs include yellowing of the skin and eyes, bruising or itching) especially if other laxatives are being used as well as Norgalax. Pregnancy and breast-feeding Do not use Norgalax if you are pregnant or breast-feeding unless your doctor has told you to do so. Norgalax contains glycerol Norgalax contains glycerol (E 422). May have a mild laxative effect. 3.
Norgalax
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Adults and children 12 years and over The recommended dose is one tube and this is usually all you need. You can use a second tube later in the day, or the next day if needed. Do not use Norgalax for more than a few days at a time. To use Norgalax: Pull the cap off the neck of the tube. Gently squeeze the tube and smear a drop around the neck of the tube to help it slide in. Push the neck of the tube all the way into your rectum (back passage). Squeeze the tube gently until it is empty. Stay near a toilet because you should need to use it about 5 to 20 minutes after using Norgalax. If you use more Norgalax than you should, contact your doctor. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Sometimes there is burning or pain around the anus (bottom). The wall of the rectum (back passage) may become reddish or it may bleed and you may suffer from diarrhoea but this soon goes. Some people may also experience an itchy skin rash. The liver may be affected (signs include yellowing of the skin and eyes, bruising or itching) especially if other laxatives are being used as well as Norgalax. 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 the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
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5.
Norgalax
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton after 'Exp' and the end of the tube as month/year. The expiry date refers to the last day of that month. Do not store above 25°C. Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6.
What Norgalax contains The active substance is docusate sodium. Each tube contains 0.12 g docusate sodium. The other ingredients are glycerol (E 422), carmellose sodium and purified water. See section 2 "Norgalax contains glycerol". What Norgalax looks like and contents of the pack Norgalax is a rectal gel. Norgalax is available in a tube with fixed applicator and a cap closure, containing 10 g of gel. Each pack contains either 6 or 100 tubes. Not all pack sizes may be marketed. Marketing Authorisation Holder Essential Pharma Ltd., Crabtree Road, Egham, Surrey, TW20 8RN UK. Manufacturer Purna Pharmaceuticals NV, Rijksweg 17, 2870 Puurs, Belgium. This leaflet was last revised in June 2024.
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The active substance in Norgalax is docusate sodium.
Medicines with the same active substance, strength and form include: Docusol Constipation Relief. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Norgalax, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Symptomatic treatment of constipation.
Preparation of the colon and rectum for endoscopic examination.
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.
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.
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.
Norgalax may increase the resorption of medicines and is not to be used in combination with hepatotoxic agents.
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.
Norgalax has no or negligible influence on the ability to drive and use machines.
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.
Overdose will lead to excessive purgation which should be treated symptomatically.
Ask anything about Norgalax. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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