NORMACOL

• Some people may experience diarrhoea and stomach pains.
• Some people may feel sick.
Reporting of side effects
If you get any of the side effects, talk to your doctor or pharmacist.
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.
By reporting side effects you can help provide more information
on the safety of this medicine.
5. How to store Normacol
Keep this medicine out of the sight and reach of children.
Store in a dry place below 25oC.
Do not use Normacol after the expiry date which is stated on the
sachet/carton as month/year. The expiry date refers to the last day
of that month.
Do not throw away any 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. Contents of the pack and other information
What Normacol contains
The active substance is sterculia. The granules contain 62% w/w
sterculia.
The other ingredients are sodium hydrogen carbonate, sucrose,
talc, titanium dioxide, hard paraffin and vanillin.
What Normacol looks like and contents of the pack
Each carton contains 500 grams of white granules, or if it is a sachet
pack, 60 sachets each containing 7 grams of white granules.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is Norgine Ltd,
Moorhall Road, Harefield, Middlesex, UB9 6NS, UK.
It is made by Norgine Pharma: 29, rue Ethe Virton
– 28100 Dreux – France.

PACKAGE LEAFLET: INFORMATION FOR THE USER

NORMACOL Granules
®

62%w/w Sterculia

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects , talk to your doctor or pharmacist .
This includes any possible side effects not listed in this leaflet.
See section 4.
• You must talk to a doctor if you do not feel better or if you feel
worse after 4 days.
What is in this leaflet:
1. What Normacol is and what it is used for
2. What you need to know before you take Normacol
3. How to take Normacol
4. Possible side effects
5. How to store Normacol
6. Contents of the pack and other information
1. What Normacol is and what it is used for
Normacol granules contain 62% w/w sterculia, which is a
vegetable gum from the karaya tree. It is this natural dietary
fibre which helps to relieve constipation and help keep you
regular.
It is also used by people:
• with colostomies or ileostomies,
• who need a high fibre diet, for example in diverticular disease
of the colon,
• who have had rectal or anal surgery,
who have swallowed something sharp to reduce the chance of
damage to the intestine (gut).

NORMACOL, NORGINE and the sail logo are registered
trademarks of the Norgine group of companies.
The leaflet was last revised in March 2016
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.
10024505

2. What you need to know before you take Normacol
Do not take Normacol if your doctor has told you that
you have:
• A blockage in your intestine (gut)
• Total loss of muscle tone in the colon

• Faecal impaction
• Allergy to the active substance or any of the other ingredients
of this medicine (listed in section 6)
Talk to your doctor or pharmacist before taking Normacol
if you have ulcerative colitis (an inflammatory disease of the
bowel which can cause abdominal pain and bloody diarrhoea).
If you have been told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking this medicinal
product.
Normacol may cause diarrhoea which may result in loss of fluids
and a loss in certain salts in your body.
Plenty of water should be taken and maintained in order to
reduce the chance of developing oesophageal obstruction
( a blockage in the foodpipe/gullet ).
Children and adolescents
Normacol is not recommended in children under 6 years of age.
Other medicines and Normacol
Please tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines, including medicines
obtained without a prescription.
Normacol with food and drink
Normacol should be taken after meals and always drink plenty of
water or soft drinks.
Pregnancy, breast-feeding and fertility
Normacol can be taken if you are pregnant or breast-feeding.
Ask your doctor or pharmacist for advice before taking any
medicine.
Driving and using machines
Normacol should not affect your ability to drive or use machines.
Important information about some of the ingredients of
Normacol
This medicine contains 1.25-2.5mmol sodium per dose. This should
be taken into consideration by patients on a controlled sodium
(low salt) diet.
3. How to take Normacol
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.

• The usual dose for adults and the elderly is 1 to 2 sachets, or
1 to 2 heaped 5ml spoonfuls, taken once or twice a day after
meals. Do not take Normacol if you are lying down or just before
you go to bed.
Use in children
• The usual dose for children aged 6 to 12 years old is half the adult
dose (half to 1 sachet or half to 1 heaped 5ml spoonful).
If Normacol does not work after you have taken it for 4 days,
do not take anymore, and see your doctor or pharmacist.
• To take Normacol, put the dry granules on your tongue from
the sachet, spoon or your hand, or just take a few at a time if that
is easier.
• Alternatively you can sprinkle Normacol on to soft food such as
yoghurt.
• Swallow the granules with plenty of water or a cool drink, so that
the oesophagus (gullet) does not become blocked. Never chew
or crush the granules.
If you take more Normacol than you should and do not have
bowel movements, see your doctor.
You may develop severe diarrhoea and could become
dehydrated. If this happens to you, see your doctor or pharmacist
because it may reduce the levels of salts in your body.
If you forget to take Normacol, just take the next normal dose
at the usual time. Do not take a double dose to make up for a
forgotten dose.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.
4. Possible side effects
Like all medicines, Normacol can cause side effects, although not
everybody gets them:
• Occasionally Normacol causes a swollen stomach.
• Some people may suffer from wind.
• The bowel may become blocked.
• The oesophagus (gullet) can become blocked if Normacol is not
taken with enough fluid, or too much Normacol is taken.
• Some people may have an allergic reaction which may include an
itchy skin, rash or difficulty in breathing.
• It is not unusual for stool to appear paler in colour than normal
as a result of local contact with sterculia. This does not indicate
anything untoward.