PACKAGE LEAFLET
Patient Information Leaflet
MOVICOL 13.8g sachet, powder for oral solution
Please read all of this leaflet carefully before taking your 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 if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
If you need the information on this leaflet to be supplied in an alternative format such as large print or Braille, please ring from the UK 0800 198 5000.
In this leaflet:
- 1. What is MOVICOL and what is it used for?
- 2. Before you take MOVICOL
- 3. How to take MOVICOL
- 4. Possible side effects
- 5. Storing MOVICOL
- 6. Further information
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1. What is MOVICOL and what is it used for?
The name of this medicine is MOVICOL 13.8g sachet, powder for oral solution. It is a laxative for the treatment of constipation in adults, adolescents and elderly. It is not recommended for children below 12 years of age.
MOVICOL helps you to have a comfortable bowel movement even if you have been constipated for a long time. MOVICOL also works in very bad constipation called faecal impaction.
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2. Before you take MOVICOL
Do not take MOVICOL if your doctor has told you that you have:
- a blockage in your intestine (gut obstruction, ileus)
- a perforated gut wall
- severe inflammatory bowel disease like ulcerative colitis, Crohn’s disease or toxic megacolon
- an allergy to the active substances or any of the other ingredients of MOVICOL
Heart conditions
Follow the special instructions in section 3 if you are taking MOVICOL for faecal impaction
Pregnancy and breast feeding
If you are pregnant or breast feeding talk to your doctor before taking MOVICOL.
Driving and using machines
MOVICOL does not affect your ability to drive or use machines.
Taking other medicines
Please inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.
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3. How to take MOVICOL
This medicine can be taken at any time with or without food or drink
Constipation:
A dose of MOVICOL is 1 sachet.
Take this 1 –3 times a day according to the severity of your constipation.
Faecal impaction:
A dose is 8 sachets a day of MOVICOL is needed for the treatment of faecal impaction. The 8 sachets should be taken within 6 hours for up to 3 days if required. If you have a heart condition do not take more than 2 sachets in any one hour.
How to mix:
Open the sachet and pour the contents into a glass. Add about 125ml or a quarter pint of water to the glass. Stir well until all the powder has dissolved and the MOVICOL solution is clear or slightly hazy, then drink it. If you are taking MOVICOL for faecal impaction it may be easier to dissolve 8 sachets in 1 litre of water.
Duration of treatment:
Constipation:
Treatment with MOVICOL usually lasts for about 2 weeks. If you need to take MOVICOL for longer, please see your doctor. If your constipation is caused by an illness such as Parkinson’s disease or multiple sclerosis (MS), or if you take medicines that cause constipation your doctor may recommend that you take MOVICOL for longer than 2 weeks.
Usually for long term treatment that dose can be lowered to either 1 or 2 sachets a day.
Faecal impaction:
Treatment with MOVICOL can be for up to 3 days.
If you take more MOVICOL than you should:
You may develop diarrhoea. Stop taking MOVICOL until it clears, and then start again at a lower dose. If you are worried contact your doctor or pharmacist.
If you forget to take MOVICOL:
Take the dose as soon as you remember to take it.
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4. Possible side effects
Like all medicines, MOVICOL can have side effects.
If you feel weak, increasingly tired, breathless, very thirsty with a headache or get puffy ankles stop taking MOVICOL and tell your doctor immediately.
Sometimes people have stomach ache or rumbles, or an allergic reaction, or feel bloated or sick. You may have mild diarrhoea when starting to take MOVICOL.
If any of the above are troublesome or last more than a few days or if you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
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5. Storing MOVICOL
Keep all medicines out of the reach and sight of children
Do not use MOVICOL after the expiry date on the sachet.
Do not store above 25°C.
Once you have made up MOVICOL in water, if you cannot drink it straight away keep it covered and in the fridge (2 – 8°C). Throw away any solution not used within a 6 hour period.
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.
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6. Further Information
Each 13.8g sachet of MOVICOL contains the following:
- Macrogol 3350: 13.125 g
- Sodium Chloride: 0.3507 g
- Sodium Bicarbonate: 0.1785 g
- Potassium Chloride: 0.0466 g
MOVICOL also contains lime and lemon flavour, and acesulfame potassium as a sweetener. Lemon and lime flavour contains the following ingredients: acacia solids, maltodextrin, lime oil, lemon oil, citral, citric acid and water.
When it is made into a drink with 125 millilitres of water, each sachet gives the equivalent of:
- Sodium: 65 millimoles/litre
- Chloride: 53 millimoles/litre
- Potassium: 5.4 millimoles/litre
- Bicarbonate: 17 millimoles/litre
What MOVICOL looks like and contents of the pack
MOVICOL is available in boxes of 2, 6, 8, 10, 20, 30, 50, 60 or 100 sachets. Not all pack sizes may be marketed.
Marketing authorisation holder:
Norgine Ltd
Moorhall Rd
Harefield
Middx
UB9 6NS
U.K
Manufacturer:
Norgine Ltd
New Road
Hengoed
Mid Glamorgan
CF82 8SJ
U.K.
MOVICOL is approved throughout Europe. In Germany it is called MOVICOL V and in the Netherlands it is called MOVICOLON.
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This leaflet was last approved in April 2008.
PL 00322/0070