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COMPOUND MACROGOL 13.8G POWDER FOR ORAL SOLUTION

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

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PACKAGE LEAFLET: INFORMATION FOR THE USER

SZ00000LT000

Compound Macrogol 13.8g Powder for Oral Solution
macrogol 3350/ sodium chloride / sodium hydrogen carbonate / potassium chloride
Read all of this leaflet carefully to get the best results from it 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 or pharmacist 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 or pharmacist. 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 after 14 days for chronic
constipation.

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

1

work as effectively during use with Macrogol.
Therefore, other medicines should not be taken
orally for one hour before and for one hour after
taking this medicine.

What Macrogol is and what it is
used for

Pregnancy and breast-feeding
Macrogol can be taken during pregnancy and
whilst breast-feeding. If you are pregnant or
breast-feeding, ask your doctor or pharmacist for
advice before taking this medicine.

Compound Macrogol 13.8g Powder for Oral
Solution is a laxative used for the treatment of
constipation, (especially if constipation lasts a
long time) in adults, adolescents and the elderly.
It is not recommended for children below 12
years of age. Macrogol 3350 makes your faeces
softer and easier to pass, giving you relief from
constipation. The electrolytes (salts) help to
maintain your body’s normal levels of sodium,
potassium and water while you are beeing
treated for constipation.

2

Driving and using machines
This medicine does not affect your ability to drive
or use machines.
Macrogol contains potassium, sodium and
sorbitol
This medicine contains 0.63 mmol (25 mg) of
potassium per sachet. This should be taken into
consideration if you take more than one sachet
daily and you have reduced kidney function, or if
you are on a controlled potassium diet.

What you need to know before you
take Macrogol

This medicine contains 8.1 mmol (187 mg) of
sodium per sachet. This should be taken into
consideration if you are on a controlled sodium
diet.

Do not take Macrogol
• if you are allergic to macrogol 3350, sodium
chloride, sodium hydrogen carbonate,
potassium chloride, or any of the other
ingredients in this medicine (listed in section 6)
• if you have a perforated gut (bowel) wall
• if you have a blockage in your intestine (gut
obstruction, ileus)
• if you have severe inflammatory bowel disease
such as ulcerative colitis, Crohn’s disease or
toxic megacolon

The lemon lime flavour in this medicine contains
sorbitol (E420). If you have been told by your
doctor that you have an intolerance to some
sugars, contact your doctor before taking this
medicinal product.

3

Talk to your doctor or pharmacist before taking
this medicine.
Warnings and precautions
If you feel weak, breathless, very thirsty with a
headache, have difficulty breathing when lying
down or get swollen ankles stop taking this
medicine and tell your doctor immediately.

How to take Macrogol

Always take this medicine exactly as your doctor
or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
Constipation
A dose of Macrogol 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.
Treatment with this medicine usually lasts for
about 2 weeks. If you need to take this medicine
for longer, please see your doctor.

Children
Do not give this medicine to children below 12
years of age.
Other medicines and Macrogol
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

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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

5

Keep this medicine out of the sight and reach of
children.

your doctor may recommend that you take this
medicine for longer than 2 weeks. If you need to
take this medicine for longer, please see your
doctor. Usually for long term treatment the dose
can be lowered to either 1 or 2 sachets a day.

Do not use this medicine after the expiry date
which is stated on the carton and sachet. The
expiry date refers to the last day of that month.

How to mix
Open the sachet and pour the contents into a glass.
Add about 125 ml or a quarter pint of water to the
glass. Stir well until all the powder has dissolved
and the solution is clear or slightly hazy, then
drink it.

Do not store above 25 °C.
Reconstituted Macrogol solution can be covered
and stored in the refrigerator (2°C to 8°C), and
should be used within twenty-four hours. After
twenty-four hours, any unused solution should be
discarded.

This medicine should be taken orally.

Do not use this medicine if you notice that any of
the sachets are damaged.

Children
Do not give this medicine to children below 12
years of age.

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.

If you take more Macrogol than you should
This can cause severe pain and bloated
stomach, vomiting (sickness) or diarrhoea.
Excessive diarrhoea can lead to dehydration. If
this occurs, stop taking this medicine and drink
plenty of fluids. If you are worried contact your
doctor or pharmacist.

6

If you forget to take Macrogol
Take the dose as soon as you remember to take it.

4

How to store Macrogol

Contents of the pack and other
information

What Macrogol contains
The active substances are:
Each sachet contains:
macrogol 3350
sodium chloride
sodium hydrogen carbonate
potassium chloride

Possible side effects

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

13.125 g
0.3507 g
0.1785 g
0.0466 g

The other ingredients are colloidal anhydrous
silica, saccharin sodium, orange flavour (Orange
flavour contains: flavouring substances and
flavouring preparations, maltodextrin, acacia gum
(E414), alpha-tocopherol (E307)) and lemon lime
flavour (Lemon lime flavour contains: natural
lemon oil, natural powder lemon flavour, powder
lime flavour, maltodextrin, mannitol (E421),
gluconolactone (E575), sorbitol (E420), acacia
gum (E414), colloidal anhydrous silica (E551)).

If you experience any of the following side
effects, stop taking Macrogol and see your
doctor immediately:
• If you get signs of an allergy, such as a rash,
itching, reddening of the skin, shortness of
breath, difficulty in breathing, or swelling of the
face, lips, tongue or throat.
• If you get signs of a change in your body’s fluid
or electrolyte levels (salts levels), such as
swelling (mainly in the ankles), feeling weak,
dehydration, increasingly tired or increased
thirst with headache. These symptoms may be
a sign that the potassium levels in your blood
are higher or lower than normal.

What Macrogol looks like and contents of the
pack
Macrogol is a free flowing white powder.
Each sachet contains 13.8 g of powder and is
packed in cartons containing 2, 6, 8, 10, 20, 30,
50, 60 (2x30) and 100 (2x50) sachets.
Not all of these pack sizes are marketed.

Other side effects include:
• swollen hands, feet or ankles
• headaches
• indigestion, stomach ache or rumbles
• feel bloated, suffer from wind, feel sick or vomit
• soreness of the anus (bottom)
• diarrhoea (when starting to take this medicine)
These side effects generally get better if you
reduce the amount of Macrogol you take.
The frequencies of these side effects are not
known (cannot be estimated from the available
data).

Marketing Authorisation Holder
Sandoz Ltd, Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
Manufacturer
Klocke Pharma-Service GmbH, Strassburger
Strasse 77, 77767 Appenweier, Germany or
Salutas Pharma GmbH, Otto-von-Guericke-Allee
1, 39179 Barleben, Germany or Hermes Pharma
Ges.m.b.H, Allgäu 36, 9400 Wolfsberg,Austria.

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: www.mhra.gov.uk/yellowcard. By
reporting side effects you can help provide more
information on the safety of this medicine.

This leaflet was last revised in 10/2015.

SZ00000LT000

Artwork Proof Box
Ref: V022: Update in line with reference product
Proof no.
007.0

Date prepared:
09/10/2015

Colours:
Black
Dimensions: 148 x 297 mm

Font size:
8pt
Fonts:
Helvetica

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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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