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NORGALAX

Active substance(s): DOCUSATE SODIUM

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NORGALAX rectal gel

0119171102

PACKAGE LEAFLET: INFORMATION FOR THE USER

Docusate Sodium
Read all of this leaflet carefully before you start taking this medicine
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may
harm them, even if their symptoms are the same as yours.
• If any of the side effects become serious, or you notice any side effects not listed
in this leaflet, please tell your doctor or pharmacist.
If you need the information on this leaflet in an alternative format,
such as large text, or Braille please ring from the UK: 0800 198 5000.
In this leaflet:
1. What NORGALAX is and what it is used for
2. Before you use NORGALAX
3. How to use NORGALAX
4. Possible side effects
5. How to store NORGALAX
6. Further information

1. WHAT NORGALAX IS AND WHAT IT IS USED 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. BEFORE YOU USE NORGALAX
Do not use NORGALAX if:
• You have haemorrhoids (piles) or bleeding from your rectum (back passage).
• You have a pain in your abdomen (tummy).
• You feel sick or are being sick.
• Your doctor has told you that you have:
– A blockage in your intestine (gut).
– Sores around your anus (bottom) called anal fissures.
– Inflammatory bowel disease such as ulcerative colitis or Crohn’s disease.
– Inflammation of the back passage called Rectocolitis.
– A bowel condition called “ileus” (loss of muscle tone in the bowel).
– An allergy to any of the ingredients in NORGALAX.
Taking/using other medicines
Do not use other laxatives while you are using NORGALAX as it may react with other
medicines. Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a prescription.
Taking/using with food and drink
It does not matter if you use NORGALAX before or after meals.
Pregnancy and breast-feeding
Do not take NORGALAX if you are pregnant or breastfeeding unless your doctor
has told you to do so.
Driving and using machines
Using NORGALAX will not affect your ability to drive or use machinery.

3. HOW TO USE NORGALAX
Always use NORGALAX exactly as your doctor has told you. You should check
with your doctor or pharmacist if you are not sure.
• The usual 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.
NORGALAX is not recommended for use in children under 12 years old.
If you use more NORGALAX than you should, contact your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, NORGALAX 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.
If any of the side effects become serious, or you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE NORGALAX
Keep all medicines out of the reach and sight of children.
Do not store above 25°C.
Do not use NORGALAX after the expiry date which is stated on the carton/tube as
month/year. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will
help to protect the environment.

6. FURTHER INFORMATION
What NORGALAX contains
The active substance is docusate sodium. Each tube contains 0.12g of docusate sodium.
The other ingredients are glycerol, sodium carboxymethyl cellulose and water.
What NORGALAX looks like and contents of the pack
NORGALAX comes in a tube containing 10g of gel. Each pack contains either 6 or
100 tubes.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is Norgine Ltd., Harefield, Middlesex, UB9
6NS UK. It is made by Norgine Pharma, 28102 Dreux, France.
UK Marketing Authorisation Number: PL 00322/0065
The leaflet was last approved: 20/05/2009

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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