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STRIGOL PAEDIATRIC 6.86G POWDER FOR ORAL SOLUTION

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

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Package leaflet: Information for the patient

STRIGOL Paediatric 6.86 g
powder for oral solution
macrogol 3350, sodium chloride, sodium bicarbonate,
potassium chloride
Read all of this leaflet carefully before you give
this medicine to your child.
-- 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 your child.
Do not pass it on to others. It may harm them, even
if their signs of illness are the same as your child’s.
-- If your child gets any side effects, talk to your
doctor or pharmacist. This includes any possible
side effects not included in this leaflet. See section 4.

1. What STRIGOL Paediatric is and what it is
used for
The name of this medicine is STRIGOL Paediatric
6.86 g powder for oral solution.
It is a laxative for the treatment of chronic
constipation in children aged 2 to 11 years and for
the treatment of very bad constipation (called faecal
impaction) in children aged 5 to 11 years. STRIGOL
Paediatric also prevents re-impaction after successful
disimpaction in children 2 to 11 years of age.
STRIGOL Paediatric helps your child to have a
comfortable bowel movement even if they have been
constipated for a long time.
2. What do you need to know before you give
STRIGOL Paediatric
Do not give STRIGOL Paediatric if your doctor has
told you that your child has:
− a blockage in their intestine (gut obstruction, ileus)
− a perforated gut wall
− severe inflammatory bowel disease like ulcerative
colitis, Crohn’s disease or toxic megacolon
− an Allergy to macrogol, sodium chloride, sodium
bicarbonate, potassium chloride, or any of the other
ingredients in this medicine (listed in section 6).
If your child has a heart or kidney problem, an
impaired gag reflex or reflux oesophagitis (heart-burn
caused by back-flow of stomach contents into the
oesophagus), you should talk to your doctor before
giving STRIGOL Paediatric.
Warnings and precautions
When taking STRIGOL Paediatric you should
continue to take plenty of fluids. The fluid content
of STRIGOL Paediatric should not replace your
regular liquid intake.
STRIGOL Paediatric contains 0.3106 mmol (12.11
mg) of potassium per sachet. This should be taken
into consideration if the patient takes more than one
sachet daily and has reduced kidney function, or is
on a controlled potassium diet.

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Some medicines, e.g. anti-epileptics, may not work
as effectively during use with STRIGOL Paediatric.
When taking large volumes of STRIGOL Paediatric
(e.g. for faecal impaction), your child should not take
other medicines within one hour of taking STRIGOL
Paediatric.
STRIGOL Paediatric with food and drink
This medicine can be taken at any time with or
without food or drink
Pregnancy and breast-feeding
STRIGOL Paediatric can be given during pregnancy
and whilst breast feeding. If your child is pregnant
or breastfeeding, ask your doctor before giving this
medicine.
3. How to give STRIGOL Paediatric
Always give this medicine exactly as described in
this leaflet or as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you
are not sure.
This medicine can be given at any time with or
without food or drink.

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What is in this leaflet:
1. What STRIGOL Paediatric is and what it is
used for
2. What do you need to know before you give
STRIGOL Paediatric
3. How to give STRIGOL Paediatric
4. Possible side effects
5. How to store STRIGOL Paediatric
6. Contents of the pack and other information

Other medicines and STRIGOL Paediatric
Tell your doctor or pharmacist if your child is
taking, has recently taken or might take any other
medicines.

Chronic constipation:
The dose of STRIGOL Paediatric depends on the
age of the child and their response to treatment.
-- As a starting dose, children aged 2 to 6 years
should be given 1 sachet each day.
-- Children aged 7 to 11 should be given 2 sachets
each day.
Your doctor may tell you to increase the number of
sachets taken until your child has a soft bowel
movement. If the dose does need increasing, this
should be done every other day. Normally, no more
than 4 sachets are required to be taken in one day.
It is not necessary to take all of the drink at one time,
if the child prefers it, half the drink can be taken in
the morning and half in the evening.
Faecal impaction:
Before your child takes STRIGOL Paediatric for
faecal impaction, it should be confirmed medically
that your child has this condition.
A course of treatment with STRIGOL Paediatric is
as follows:
Number of STRIGOL
Paediatric sachets
Age
(years)
5-11

Day Day Day Day Day Day Day
1
2
3
4
5
6
7
4

6

8

10

12

12

12

The daily number of sachets should be taken in
divided doses, all taken within 12 hours (e.g.
8am – 8pm). Treatment can be stopped when the
medicine has worked. This is shown by your child
passing large volumes of stool and/or watery diarrhoea.
Method of Administration
-- Open the sachet and pour the contents into a glass.
-- Add ¼ glass (about 62.5ml) of water.
-- Stir well until all the powder has dissolved and the
STRIGOL Paediatric solution is clear or slightly
hazy, then give it to your child to drink.

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Duration of treatment
Chronic constipation:
Treatment needs to be for a prolonged period of time,
at least 6 – 12 months.
Faecal impaction:
Treatment with STRIGOL Paediatric can be for up
to 7 days.
If your child takes more STRIGOL Paediatric
than they should:
Your child may develop excessive diarrhoea. If this
occurs, stop taking STRIGOL Paediatric and drink
plenty of fluids. If you are worried contact your
doctor or pharmacist.

5. How to store STRIGOL Paediatric
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date which
is stated on the sachet and carton. The expiry date
refers to the last day of that month.
Once you have made up STRIGOL Paediatric in
water, if 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.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away any medicines you no longer use. These
measures will help protect the environment.

If you forget to give STRIGOL Paediatric:
Give the dose as soon as you remember.

6. Contents of the pack and other information

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

Macrogol 3350

6.563 g

Sodium chloride

175.4 mg

Sodium bicarbonate

89.3 mg

Potassium chloride

23.30 mg

Tell your doctor immediately and stop giving
STRIGOL Paediatric if your child:
-- gets a serious allergic reaction which causes
difficulty in breathing or swelling of the face, lips,
tongue or throat.
Very common side effects (may affect more than 1
in 10 people)
-- stomach pains
-- stomach rumbles
Common side effects (may affect up to 1 in 10
people)
-- diarrhoea
-- vomiting (being sick)
-- nausea (feeling sick)
-- anal discomfort (uncomfortable sensation around
the bottom).
If your child is being treated for chronic constipation,
diarrhoea will usually improve when the dose is reduced.

Rare side effects (may affect up to 1 in 1,000
people)
-- allergic reactions, which may include,
breathlessness or difficulty in breathing.
Other side effects reported include:
Skin rash (hives), itching, reddening of the skin or a
nettle rash, swollen hands, feet or ankles, headaches,
indigestion, high or low levels of potassium in the
blood.
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 inform your doctor
or pharmacist.

The other ingredients are acesulfame potassium and
lemon flavor.
When it is made into a drink with ¼ glass (62.5ml) 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 STRIGOL Paediatric looks like and
contents of the pack
STRIGOL Paediatric is a white crystalline powder
which comes in single dose sachets. Boxes of 6, 8,
10, 20, 30, 40, 50, 60 or 100 sachets are available.
Not all pack sizes will be marketed.
Marketing Authorisation Holder and
Manufacturer:
Marketing Authorisation holder
Strides Arcolab International Ltd.
Unit 4, Metro Centre, Tolpits Lane, Watford,
Hertfordshire, WD18 9SS,
United Kingdom.

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Uncommon side effects (may affect up to 1 in 100
people)
-- swollen stomach
-- wind

What STRIGOL Paediatric contains:
Each 6.86g sachet of STRIGOL Paediatric contains
the following:

Manufacturer
Strides Pharma UK Ltd.
Unit 4, Metro Centre, Tolpits Lane, Watford,
Hertfordshire, WD18 9SS,
United Kingdom.
This leaflet was last revised in 03/2017

1xxxxxx

Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. 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.
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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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