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NORMACOL PLUS GRANULES

Active substance: STERCULIA

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10024803

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Normacol Plus Granules
62%w/w Sterculia and 8% w/w Frangula Bark

Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription but you still need to take
NORMACOL Plus carefully to get the best results from it.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- You must contact a doctor if your symptoms worsen or do not improve after 4 days.
- 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 NORMACOL Plus is and what it is used for
2. Before you take NORMACOL Plus
3. How to take NORMACOL Plus
4. Possible side effects
5. How to store NORMACOL Plus
6. Further information

1. What NORMACOL Plus is and what it is used for
NORMACOL Plus granules contain 62% w/w sterculia and 8% w/w frangula bark.
Sterculia is a vegetable gum from the karaya tree and frangula bark comes from the
alder buckthorn plant. It is these natural products in NORMACOL Plus which help
to relieve constipation and help keep you regular.
NORMACOL Plus is also used by people who have recently had rectal surgery or
surgery to remove piles.

2. Before you take NORMACOL Plus
Do not take NORMACOL Plus if you know or your doctor has told you that you:
• Have a blockage in your intestine (gut).
• Have total loss of muscle tone in the colon.
• Have faecal impaction.
• Have allergy to any of the ingredients.
• Are pregnant or breast-feeding.
Talk to your doctor before taking NORMACOL Plus if:
• You have ulcerative colitis (an inflammatory disease of the bowel which can cause
abdominal pain and bloody diarrhoea)
As with all laxatives, Normacol Plus should not be taken every day for long periods.
If you need laxatives every day, you should see your doctor.
If you have been told by your doctor that you have an intolerance to some sugars,
contact your doctor before taking this medicinal product.
Taking 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 NORMACOL Plus with food and drink
NORMACOL Plus should be taken after meals, always drink plenty of water
or soft drinks.
Pregnancy and breast-feeding
Do not take NORMACOL Plus if you are pregnant, thinking about becoming
pregnant or breast-feeding.
Driving and using machines
NORMACOL Plus should not affect your ability to drive or use machines.
Important information about some of the ingredients of NORMACOL Plus
This medicine contains 1.25-2.5 mmol sodium per dose. This should be taken into
consideration by patients on a controlled sodium (low salt) diet.

3. How to take NORMACOL Plus
Always take NORMACOL Plus exactly as instructed. You should 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 Plus
just before you go to bed.
• NORMACOL Plus can be used in children aged between 6 to 12 years but only as
directed by a doctor.
If NORMACOL Plus does not work after you have taken it for 4 days, do not take
anymore, and see your doctor or pharmacist.
• To take NORMACOL Plus, 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 Plus onto 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 Plus than you should and do not have bowel
movements, see your doctor.
If you forget to take NORMACOL Plus, 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 Plus can cause side effects, although not everybody
gets them:
• The bowel may become blocked and some people may experience stomach cramps.
• Occasionally NORMACOL Plus causes a swollen stomach.
• The oesophagus (gullet) can become blocked if NORMACOL Plus is not taken
with enough fluid, or too much NORMACOL Plus is taken.
• Some people may have an allergic reaction which may include an itchy skin, rash,
or difficulty in breathing.
• Diarrhoea, which may cause a reduction in the level of salts in the blood.
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 NORMACOL Plus
Keep all medicines out of the reach and sight of children.
Store in a dry place below 25°C.
Do not use NORMACOL Plus after the expiry date which is stated on the
sachet/carton as month/year. The expiry date refers to the last day of the month.

6. Further information
What NORMACOL Plus contains
The active substances are sterculia and frangula bark. The granules contain 62% w/w
sterculia and 8% w/w frangula bark.
The other ingredients are sodium hydrogen carbonate, sucrose, talc, hard paraffin,
peppermint flavour and the colours E110, E127 and E132.
What NORMACOL Plus looks like and contents of the pack
Each carton contains 200 or 500 grams of light brown to dark brown granules, or if it
is a sachet pack, 60 sachets each containing 7 grams of 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 Ethé Virton - 28100 Dreux - France.
UK Marketing Authorisation Number: PL 00322/5011R
The leaflet was last approved in November 2012.
NORMACOL is a registered trademark.

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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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