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MOVICOL UNO 6.9 G POWDER FOR ORAL SOLUTION

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Patient Information Leaflet - Text
MOVICOL® Uno 6.9g, powder for oral solution

Read all of this leaflet carefully before you start using this medicine because it contains
important information for you.

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 only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet.
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 is MOVICOL Uno and what is it used for?
2. Before you take MOVICOL Uno
3. How to take MOVICOL Uno
4. Possible side effects
5. Storing MOVICOL Uno
6. Further Information

1. What is MOVICOL Uno and what is it used for?
It is a laxative for the treatment of chronic constipation in adults, the elderly, adolescents
(aged 12 years and above) and children (aged 8-11 years).
MOVICOL Uno helps you (or your child) to have a comfortable bowel movement even if you
have been constipated for a long time.

2. Before you take MOVICOL Uno
Do not take or give MOVICOL Uno if your doctor has told you that you (or your child)
have:
- a blockage in the intestine (gut obstruction, paralysis of the intestinal muscles)
- a perforated gut wall
- severe inflammatory bowel disease like ulcerative colitis, Crohn’s disease or toxic
megacolon
- an allergy to any of the ingredients
Take special care when taking MOVICOL Uno:
- If your child (aged 8 to 11 years) has a heart problem or a kidney problem you should talk
to your doctor before giving MOVICOL Uno.

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If you (or your child) have an impaired gag reflex, reflux oesophagitis (heart-burn caused
by back-flow of stomach contents into the oesophagus), you should talk to your doctor
before taking MOVICOL Uno.
Do not take MOVICOL Uno for longer periods of time unless you have been instructed to
do so by your doctor.

Taking other medicines
Please inform your doctor if you (or your child) are taking, or have recently taken, any other
medicines, including medicines obtained without a prescription.
Some medicines e.g., anti-epileptics, may not work as effectively during use with MOVICOL
Uno.
You should not take any other medicines by mouth for one hour before and for one hour after
taking MOVICOL Uno.
Pregnancy and breast feeding
If you (or your adolescent child) are pregnant or breast feeding talk to your doctor before
taking MOVICOL Uno.
Driving and using machines
MOVICOL Uno does not affect your ability to drive or use machines.

3. How to take MOVICOL Uno
You should check with your doctor if you are not sure how to take MOVICOL Uno.
This medicine can be taken or given, in water, at any time with or without food or drink.
Constipation:
In adults and adolescents (aged 12 years and above)
A dose of MOVICOL Uno is 2 sachets.
Take this 1 – 3 times a day according to the severity of your constipation.
In Children (8-11 years)
 Children aged 8 to 11 should be given 2 sachets once a day
 Your doctor may tell you to increase the number of sachets taken until your child has a
soft bowel movement. This does not normally need more than 4 sachets taken in one
day.
How to mix:
Open the sachet and pour the contents into a glass. For each sachet add about 62.5ml or ¼ of
a glass of water (for two sachets add 125ml). Stir well until all the powder has dissolved and
the MOVICOL Uno solution is clear or slightly hazy, then drink it
Duration of treatment:
Constipation in adults and adolescents (aged 12 years and above):

MOVICOL Uno should be used as recommended by your doctor. If your constipation is very
resistant, 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 Uno for a longer period of time.
Usually for long term treatment the dose can be adjusted to between 2 and 4 sachets a day.
Constipation in children (aged 8 to 11 years):
Treatment may need to be for a prolonged period of time, at least 6 – 12 months.
If you take more MOVICOL Uno than you should:
If you (or your child) take more MOVICOL Uno than advised you may develop excessive
diarrhoea, which can lead to dehydration. Stop taking MOVICOL Uno and take generous
amounts of fluid. If you are worried contact your doctor.
If you forget to take MOVICOL Uno (or forget to give it to your child):
Take or give the dose as soon as you remember.
Do not take a double dose to make up for a forgotten dose.

4. Possible side effects
Like all medicines, MOVICOL Uno can have side effects but not everyone suffers from them.
Tell your doctor immediately and stop taking (or giving) MOVICOL Uno if you (or your
child):
• Feels weak, increasingly tired, breathless, very thirsty with a headache or develops puffy
ankles
• Experience a serious allergic reaction which causes difficulty in breathing, dizziness or
swelling of the face, lips, tongue or throat.
Other side effects include:
In children
Very common side effects (i.e. occurring in more than 1 in 10 patients who received the
treatment) are: stomach ache, stomach rumbles
Common side effects (i.e. occurring in less than 1 in 10 but more than 1 in 100 patients who
received the treatment) are: mild diarrhoea, nausea (feeling sick), vomiting.
Uncommon side effects (i.e. occurring in less than 1 in 100 but more than 1 in 1,000 patients
who received the treatment) are: feeling bloated, suffering from wind (flatulence).
In adults
The frequency of these side effects cannot be estimated from the available data:
stomach ache, stomach rumbles, mild diarrhoea, nausea (feeling sick), vomiting, feeling
bloated, suffering from wind (flatulence).
In adults and children, these side effects generally get better if you reduce the amount of
MOVICOL Uno you take.
Other side effects where the frequency cannot be estimated from the available data are:
allergic reactions which may cause an itchy skin rash, reddening of the skin or a nettle rash.

Tiredness, swelling of hands, feet or ankles, headaches, high and low levels of potassium in
the blood, indigestion, soreness of the anus (bottom).
If any of the above become serious or last more than a few days or if you notice any side
effects not mentioned in this leaflet, please tell your doctor.

5. Storing MOVICOL Uno
Keep all medicines out of the reach and sight of children.
 Do not use MOVICOL Uno after the expiry date on the sachet and carton.
 The expiry date refers to the last day of that month.
 Do not store your MOVICOL Uno above 25°C.
 Once you have made up MOVICOL Uno in water, if you (or your child) cannot drink
it straight away keep it covered and in the fridge (2 – 8°C). Throw away any solution
not used within a 24 hour period.
Medicines should not be disposed of via wastewater or house hold waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help to
protect the environment.

6. Further information
Each 6.9g sachet of MOVICOL Uno contains the following:
Macrogol 3350
Sodium Chloride
Sodium Hydrogen Carbonate
Potassium Chloride

6.563 g
0.1754 g
0.0893 g
0.0233 g

MOVICOL Uno contains lemon and lime 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 ¼ glass (62.5ml) of water each sachet gives the equivalent
of:
Sodium
Chloride
Potassium
Bicarbonate

65 millimoles/litre
53 millimoles/litre
5.4 millimoles/litre
17 millimoles/litre

MOVICOL Uno is available in boxes of 6, 8, 10, 20, 30, 40, 50, 60 or 100 sachets. (Not all
pack sizes may be available).

Marketing authorisation holder:
To be completed nationally

Manufacturer:
Norgine Ltd, New Road, Hengoed, Mid Glamorgan, CF82 8SJ, U.K.
Marketing Authorisation Number:
To be completed nationally
The leaflet was last revised in: May 2013

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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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