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MOVICOL 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 / MACROGOL 3350 / POTASSIUM CHLORIDE / SODIUM BICARBONATE / SODIUM CHLORIDE

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10034407
1
CR1977
MOVICOL L&L
24/01/17
UK/Malta
PIL
Macors
NOR-LFT45-V1
175 x 230mm
(Code 128) 12853
10034407-12853
N/A

Black

Page 1 of 2

Frutiger LT Std-55 Roman
Frutiger LT Std-65 Bold
Frutiger LT Std-75 Black
Helvetica-Regular
Smallest point sized used:
9.0 pt
Average Text Size (Body Text):
9.0 pt

Barcodes
Type
Code 128

Number
12853

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.

557280A02

Fonts used:

Package Leaflet: Information for the patient

If you need the information on this
leaflet in an alternative format such as
large print , please ring from the UK
0800 198 5000.
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
breastfeeding. If you are pregnant, trying to become
pregnant or breastfeeding, 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 125 ml
(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.

10034407
1
CR1977
MOVICOL L&L
24/01/17
UK/Malta
PIL
Macors
NOR-LFT45-V1
175 x 230mm
(Code 128) 12853
10034407-12853
N/A

557280A02

Black

Page 2 of 2

Fonts used:
Frutiger LT Std-55 Roman
Frutiger LT Std-65 Bold
Frutiger LT Std-75 Black
Helvetica-Regular
Smallest point sized used:
9.0 pt
Average Text Size (Body Text):
9.0 pt

Barcodes
Type
Code 128

Number
12853

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 Movicol you take.
Reporting of side effects
UK: 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.
MT: 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
www.medicinesauthority.gov.mt/adrportal. By
reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Movicol
Keep this medicine out of the sight and reach of
children.
Do not use Movicol after the expiry date which is
stated on the sachet and carton.
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.
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 Movicol contains
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 a white powder.
Movicol is available in boxes of 2, 6, 8, 10, 20, 30, 50,
60 or 100 sachets. Not all pack sizes may be marketed.
UK and MT Marketing authorisation holder:
Norgine Limited
Norgine House
Widewater Place
Moorhall Road
Harefield
Uxbridge
Middlesex
UB9 6NS
United Kingdom
Manufacturer:
Laboratoires Macors, Rue des Caillottes, Zi De La
Plaine Des Isles 89000 Auxerre, France.
This medicinal product is authorised in the Member
States of the EEA under the following names:
Austria
MOVICOL®-Pulver
Belgium
MOVICOL®
Denmark
MOVICOL®
Germany
MOVICOL® V
Finland
MOVICOL®
MOVICOL®
France
Iceland
MOVICOL®
Ireland
MOVICOL®
Italy
MOVICOL® 13,8 g polvere per
soluzione orale
Luxembourg
MOVICOL®
Malta
MOVICOL®
Netherlands
MOVICOLON®
Norway
MOVICOL®
Portugal
MOVICOL®
Spain
MOVICOL®
Sweden
MOVICOL®
Switzerland
MOVICOL®
United Kingdom MOVICOL®
This leaflet was last revised in 01/2017

NORGINE and the sail logo are registered
trademarks of the Norgine group of companies.
10034407-12853

11628607
1
CR1977
MOVICOL L&L
23/01/17
UK/Malta
PIL
Hengoed
NOR-LFT4-V1
157 x 290mm
749
N/A
N/A

557125A02

Black

Package Leaflet: Information for the patient

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.

If you need the information on this
leaflet in an alternative format such
as large print , please ring from the
UK 0800 198 5000.

Fonts used:
Frutiger LT Std-55 Roman
Frutiger LT Std-56 Italic
Frutiger LT Std-65 Bold
Frutiger LT Std-75 Black
Helvetica-Regular
Smallest point sized used:
9.0 pt
Average Text Size (Body Text):
9.0 pt

Page 1 of 2

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 breastfeeding. If you are pregnant,
trying to become pregnant or breastfeeding,
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
125 ml (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.

11628607
1
CR1977
MOVICOL L&L
23/01/17
UK/Malta
PIL
Hengoed
NOR-LFT4-V1
157 x 290mm
749
N/A
N/A

557125A02

Black

Fonts used:
Frutiger LT Std-55 Roman
Frutiger LT Std-56 Italic
Frutiger LT Std-65 Bold
Frutiger LT Std-75 Black
Helvetica-Regular
Smallest point sized used:
9.0 pt
Average Text Size (Body Text):
9.0 pt

Page 2 of 2

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 Movicol
you take.
Reporting of side effects
UK: 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.
MT: 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
www.medicinesauthority.gov.mt/adrportal. By
reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Movicol
Keep this medicine out of the sight and reach
of children.
Do not use Movicol after the expiry date
which is stated on the sachet and carton.
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.
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 Movicol contains
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

UK and MT Marketing authorisation holder:
Norgine Limited
Norgine House
Widewater Place
Moorhall Road
Harefield
Uxbridge
Middlesex
UB9 6NS
United Kingdom
Manufacturer:
Norgine Limited, New Road, Tir-y-Berth
Hengoed, Mid Glamorgan, CF82 8SJ, U.K.
This medicinal product is authorised in
the Member States of the EEA under the
following names:
MOVICOL®-Pulver
Austria
Belgium
MOVICOL®
Denmark
MOVICOL®
Germany
MOVICOL® V
Finland
MOVICOL®
France
MOVICOL®
Iceland
MOVICOL®
Ireland
MOVICOL®
Italy MOVICOL® 13,8 g
polvere per soluzione
orale
Luxembourg
MOVICOL®
Malta
MOVICOL®
Netherlands
MOVICOLON®
Norway
MOVICOL®
Portugal
MOVICOL®
Spain
MOVICOL®
Sweden
MOVICOL®
Switzerland
MOVICOL®
United Kingdom
MOVICOL®
This leaflet was last revised in 01/2017

MOVICOL, NORGINE and the sail logo are
registered trademarks of the Norgine group of
companies.

What Movicol looks like and contents of
the pack
Movicol is a white powder.
Movicol is available in boxes of 2, 6, 8, 10, 20,
30, 50, 60 or 100 sachets. Not all pack sizes
may be marketed.
11628607

Expand Transcript

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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