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MOVIOL 13.8G SACHET POWDER FOR ORAL SOLUTION

Active substance(s): MACROGOL 3350 / POTASSIUM CHLORIDE / SODIUM BICARBONATE / SODIUM CHLORIDE / MACROGOL 3350 / POTASSIUM CHLORIDE / SODIUM BICARBONATE / SODIUM CHLORIDE

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Package Leaflet: Information for the User


MOVICOL 13.8g sachet, powder for oral solution
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, pharmacist or nurse 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, pharmacist or nurse.
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.
 The name of this medicine is Movicol® 13.8g sachet, powder for oral
solution but it will be referred to as Movicol throughout the remainder
of this leaflet.
What is in this leaflet:
1. What Movicol is and what it is used for
2. What you need to know before you take Movicol
3. How to take Movicol
4. Possible side effects
5. How to store Movicol
6. Contents of the pack and other information
1. What Movicol is and what it is 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.
2. What you need to know 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 (listed in section 6).
Warnings and precautions
When taking Movicol you should continue to take plenty of fluids. The
fluid content of Movicol should not replace your regular liquid intake.
Heart conditions
Follow the special instructions in section 3 if you are taking Movicol for
faecal impaction.
Other medicines and Movicol
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
Some medicines, e.g. anti-epileptics, may not work as effectively during
use with Movicol.
Pregnancy and breast feeding
Movicol can be taken during pregnancy and whilst breast feeding. If you
are pregnant, trying to become pregnant or breast feeding, ask your
pharmacist or doctor for advice before taking Movicol.
Driving and using machines
Movicol does not affect your ability to drive or use machines.

3. How to take Movicol
This medicine can be taken at any time with or without food.
Dissolve the content of each sachet in 125ml (¼ pint) of water and drink.
Constipation:
A dose of Movicol is 1 sachet dissolved in 125ml (¼ pint) of water.
Take this 1–3 times a day according to the severity of your constipation.
Faecal impaction:
Before you take Movicol for faecal impaction, it should be confirmed that
you have this condition.
A dose of 8 sachets a day of Movicol is needed for the treatment of
faecal impaction. Each sachet dissolved in 125ml (¼ pint) of water.
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
¼ 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. If you need to take Movicol for longer, please see
your doctor.
Usually for long term treatment the 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 excessive diarrhoea, which can lead to dehydration. If
this occurs, stop taking Movicol and drink plenty of fluids. 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.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Tell your doctor immediately and stop taking Movicol if you:
 Get a serious allergic reaction which causes difficulty in breathing or
swelling of the face, lips, tongue or throat.
Other side effects include:
Allergic reactions which may cause a skin rash, itching, reddening of the
skin or a nettle rash, swollen hands, feet or ankles, headaches and high
and low levels of potassium in the blood.
Sometimes you may have indigestion, stomach ache or rumbles.
You may also feel bloated, suffer from wind, feel sick or vomit, may also
experience soreness of the anus (bottom) and may have mild diarrhoea
when starting to take Movicol. These side effects generally get better if
you reduce the amount of Movicol you take.
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 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 Movicol









Keep out of the sight and reach of children.
Do not store above 25oC.
Sachets: store in the original package to protect from moisture.
Store the reconstituted solution at 2oC to 8oC (in a refrigerator and
keep covered).
Throw away any solution not used within a 6 hour period.
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 that are no
longer required. This will help to protect the environment.
6. Contents of the pack and other information

What Movicol contains
Each sachet contains:
macrogol 3350 - 13.125g
sodium chloride – 350.7mg
sodium bicarbonate – 178.5mg
potassium chloride – 46.6mg
On reconstitution in 125ml of water each sachet provides:
sodium 65milimoles/litre
chloride 53milimoles/litre
potassium 5.4milimoles/litre
bicarbonate 17milimoles/litre
Also contains acesulfame potassium and lemon flavour.
What Movicol looks like and contents of the pack
Movicol is a free flowing white powder.
Movicol is available in cartons containing 8, 20, 30 or 50 sachets.
Manufactured by
Laboratoires Macors, Rue des Caillottes, Z.I. Plaine des Isles,
89000 Auxerre, 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.
Leaflet dated 14th June 2017
Leaflet coded xxxxxxxxx
PL 33532/0728

P

MOVICOL is a registered trademark of the Norgine group of companies.

To request a copy of this leaflet in
Braille, large print or audio please
call 01922 745 645 and ask for the
Regulatory Department.

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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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