Norgalax
PACKAGE LEAFLET: INFORMATION FOR THE USER
NORGALAX rectal gel
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
• 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.
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.
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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.
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 at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.
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 harmacist how to dispose of medicines no longer required. These measures will elp 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 Essential Pharma Ltd., Crabtree Road, Egham, Surrey, TW20 8RB UK.
It is made by Purna Pharmaceuticals NV, Rijksweg 17, 2870 Puurs, Belgium.
UK Marketing Authorisation Number: PL 41871/0007
The leaflet was last revised: February 2016 Ep°°25°