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MOVICAL POWDER FOR ORAL SOLUTION

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

PDF Transcript

PACKAGE LEAFLET:
INFORMATION FOR THE PATIENT

MOVICOL® Powder for Oral Solution
Your medicine is available using the name Movicol Powder for
Oral Solution but will be referred to as Movicol Powder
throughout the leaflet.

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.

What is in this leaflet:

1.
2.
3.
4.
5.
6.

What Movicol Powder is and what it is used for
What you need to know before you take Movicol Powder
How to take Movicol Powder
Possible side effects
How to store Movicol Powder
Contents of the pack and other information

1. What Movicol Powder is and what it is
used for
The name of this medicine is Movicol Powder. 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 Powder helps you to have a comfortable bowel
movement even if you have been constipated for a long time.
Movicol Powder also works in very bad constipation called
faecal impaction.

2. What you need to know before you take
Movicol Powder
Do not take Movicol Powder if your doctor has told
you that you have:






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 Powder (listed in section 6).

Warnings and precautions

When taking Movicol Powder you should continue to take
plenty of fluids. The fluid content of Movicol Powder should
not replace your regular liquid intake.

Heart conditions

Follow the special instructions in section 3 if you are taking
Movicol Powder for faecal impaction.

Other medicines and Movicol Powder

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 Powder.

Pregnancy and breast-feeding

Movicol Powder 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 Powder.

How to mix:

Open the sachet and pour the contents into a glass. Add
about 125ml or 1/4 pint of water to the glass. Stir well until
all the powder has dissolved and the Movicol Powder solution
is clear or slightly hazy, then drink it. If you are taking
Movicol Powder for faecal impaction it may be easier to
dissolve 8 sachets in 1 litre of water.

Duration of treatment:
Constipation:

Treatment with Movicol Powder usually lasts for about 2
weeks. If you need to take Movicol Powder 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 Powder for longer than 2
weeks. If you need to take Movicol Powder 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 Powder can be for up to 3 days.

If you take more Movicol Powder than you should:

Movicol Powder does not affect your ability to drive or use
machines.

You may develop excessive diarrhoea, which can lead to
dehydration. If this occurs, stop taking Movicol Powder and
drink plenty of fluids. If you are worried contact your doctor
or pharmacist.

3. How to take Movicol Powder

If you forget to take Movicol Powder:

This medicine can be taken at any time with or without food.
Dissolve the content of each sachet in 125ml (1/4 pint) of
water and drink.

4. Possible side effects

Driving and using machines

Constipation:

A dose of Movicol Powder is 1 sachet dissolved in 125 ml
(1/4 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 Powder is needed for the
treatment of faecal impaction. Each sachet dissolved in 125ml
(1/4 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.

a blockage in your intestine (gut obstruction, ileus)
a perforated gut wall

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Take the dose as soon as you remember to take it.

Like all medicines, this medicine can cause side effects,
although not everybody gets them.

Tell your doctor immediately and stop taking
Movicol Powder 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 Powder. These side effects generally get better if you
reduce the amount of Movicol Powder 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 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 Movicol Powder









Keep all medicines out of the sight and reach of children.
Sachet: do not store above 25°C.
Solution: store at 2-8°C (in a refrigerator and covered).
Discard any solution not used within 6 hours.
Do not use after the expiry date printed on the carton or
sachet.
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.
If your doctor tells you to stop taking the medicine,
please take them back to the pharmacist for safe
disposal. Only keep the medicine if your doctor tells you
to. If the powder becomes discoloured or shows signs of
deterioration, you should seek the advice of your
pharmacist.

Manufacturer

Manufactured by: Norgine Limited, New Road, Hengoed,
Mid Glamorgan, CF82 8SJ, UK.
Or
LABORATOIRES MACORS, Rue des Caillottes,
Z.I. Plaine des Isles, 89000 AUXERRE, France.
Or
SOPHARTEX, 21 Rue du Pressoir, 28500 VERNOUILLET,
France.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd.,
7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0147

P

If you wish to receive this leaflet in Braille, large font or audio
format please contact 01302 365000 and ask for the
Regulatory Department.
MOVICOL® is a registered trademark of Velinor AG.
Leaflet revision date: 07.04.16

6. Contents of the pack and other
information
What Movicol Powder contains
Each 13.8g sachet contains:





Macrogol 3350: 13.125g
Sodium Chloride: 0.3507g
Sodium Bicarbonate: 0.1785g
Potassium Chloride: 0.0466g

Movicol Powder also contains citrus flavour, and
acesulfame K (E950) as a sweetener.
Movicol Powder is a free flowing white, almost odourless
powder for oral solution which dissolves in water to give a
colourless solution with an odour of lemons.
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 Powder looks like and contents of the
pack
Movicol Powder is available in boxes of 20 sachets.
Each sachet contains 13.8 grams of Movicol Powder.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.