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NORGALAX RECTAL GEL

Active substance(s): DOCUSATE SODIUM / DOCUSATE SODIUM

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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 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.
• The name of this medicine is Norgalax® rectal gel but will be referred
to as Norgalax throughout the remainder of this leaflet.
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 breast-feeding 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.
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 out of the sight and reach of children.
• Store between 15 to 25oC in the original package.
• Do not use this medicine after the expiry date which is stated on the
label and carton. The expiry date refers to the last day of that month.
• If your medicine becomes discoloured or shows any signs of
deterioration, return it to your pharmacist.
• 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 10g micro enema
contains 0.12g docusate sodium.
Also contains glycerol, sodium carboxymethyl cellulose and purified
water.
What Norgalax looks like and contents of the pack
Norgalax comes in a tube containing 10g of an opalescent gel.
Each pack contains 6 tubes.
Manufactured by
Norgine Pharma, 29, Rue Ethé Virton, 28109 Dreux Cedex, France.
Procured from within the EU by the Product Licence Holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall, WS9 8ER.
Repackaged by MPT Pharma Ltd.
PL: 33532/0756
Leaflet dated 6th July 2017
Leaflet coded XXXXXXXXXXXX

P

Norgalax® is a registered trademark.

To request a copy of this leaflet in
Braille, large print or audio please
call 01922 745645 and ask for the
Regulatory Department.

Package Leaflet: Information for the User

Docusate sodium 0.12g/10g rectal gel
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.
• The name of this medicine is Docusate sodium 0.12g/10g rectal gel
but will be referred to as Docusate sodium throughout the remainder of
this leaflet.
In this leaflet:
1. What Docusate sodium is and what it is used for
2. Before you use Docusate sodium
3. How to use Docusate sodium
4. Possible side effects
5. How to store Docusate sodium
6. Further information
1. What Docusate sodium is and what it is used for
Docusate sodium 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 Docusate sodium
Do not use Docusate sodium 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 Docusate sodium.
Taking/using other medicines
Do not use other laxatives while you are using Docusate sodium 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 Docusate sodium before or after meals.
Pregnancy and breast-feeding
Do not take Docusate sodium if you are pregnant or breast-feeding
unless your doctor has told you to do so.
Driving and using machines
Using Docusate sodium will not affect your ability to drive or use
machinery.
3. How to use Docusate sodium
Always use Docusate sodium 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 Docusate sodium for more than a few days at a time.
To use Docusate sodium 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 Docusate sodium.
Docusate sodium is not recommended for use in children under 12
years old.

If you use more Docusate sodium 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, Docusate sodium 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
Docusate sodium.
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 Docusate sodium
• Keep out of the sight and reach of children.
• Store between 15 to 25oC in the original package.
• Do not use this medicine after the expiry date which is stated on the
label and carton. The expiry date refers to the last day of that month.
• If your medicine becomes discoloured or shows any signs of
deterioration, return it to your pharmacist.
• 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 Docusate sodium contains
The active substance is docusate sodium. Each 10g micro enema
contains 0.12g docusate sodium.
Also contains glycerol, sodium carboxymethyl cellulose and purified
water.
What Docusate sodium looks like and contents of the pack
Docusate sodium comes in a tube containing 10g of an opalescent gel.
Each pack contains 6 tubes.
Manufactured by
Norgine Pharma, 29, Rue Ethé Virton, 28109 Dreux Cedex, France.
Procured from within the EU by the Product Licence Holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall, WS9 8ER.
Repackaged by MPT Pharma Ltd.
PL: 33532/0756
Leaflet dated 6th July 2017
Leaflet coded XXXXXXXXXXXX

P

To request a copy of this leaflet in
Braille, large print or audio please
call 01922 745645 and ask for the
Regulatory Department.

Expand Transcript

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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