COMPOUND MACROGOL 13.8G POWDER FOR ORAL SOLUTION

Active substance: SODIUM HYDROGEN CARBONATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

SZ00000LT000

Compound Macrogol 13.8g Powder for Oral Solution
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to take Macrogol carefully
to get the best results from it.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact a doctor if your symptoms worsen or do not improve after 14 days.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

In this leaflet:
1. What Macrogol is and what it is used for
2. Before you take Macrogol
3. How to take Macrogol
4. Possible side effects
5. How to store Macrogol
6. Further information

1

Important information about some of the
ingredients of Macrogol
Compound Macrogol 13.8g Powder for Oral
Solution 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 Macrogol is and what it is
used for

Compound Macrogol 13.8g Powder for Oral
Solution is a laxative used for the treatment of
long time constipation. 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 bodyʼs
normal levels of sodium, potassium and water
while you are beeing treated for constipation.

2

Compound Macrogol 13.8g Powder for Oral
Solution contains 8.1 mmol (187 mg) of sodium
per sachet. This should be taken into consideration
if you are on a controlled sodium diet.

The lemon lime flavour in Compound Macrogol
13.8g Powder for Oral Solution 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.

Before you take Macrogol

3

Do not take Macrogol
• if you are allergic (hypersensitive) to macrogol
3350, sodium chloride, sodium hydrogen
carbonate, potassium chloride, or any of the
other ingredients in Compound Macrogol 13.8g
Powder for Oral Solution
• 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, Crohnʼs disease or
toxic megacolon

How to take Macrogol

Adults, children (aged 12 years and above)
and the elderly:
The usual dose for constipation is one sachet
taken one to three times daily.

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. Stirr well until the powder has
dissolved and then drink it.

If any of these applies to you, please talk to your
doctor or pharmacist for further advice.

Taking other medicines
Some medicines, e.g. anti-epileptics, may not
work as effectively during use with Macrogol.
Please tell your doctor or pharmacist if you are
taking, or have recently taken, any other
medicines, including medicines obtained without
a prescription.

Duration of treatment
This course of treatment for constipation should
not normally last longer than 2 weeks.

Taking Macrogol with food and drink
Macrogol can be taken at any time with or without
food or drink

Pregnancy and breast-feeding
If you are pregnant or breast-feeding talk to your
doctor before taking Macrogol.
Driving and using machines
Macrogol has no effect on the ability to drive or
use machinery.

If you take more Macrogol than you should
This can cause severe pain and swelling in your
abdomen (stomach), or vomiting (sickness) or
diarrhoea. If this happens, contact your doctor or
pharmacist.

If you forget to take Macrogol
If you forget to take a dose, take it as soon as
you remember and then continue on as before.
Do not take a double dose to make up for a
forgotten dose.

Continued on the next page >>

Artwork Proof Box
Ref: V016G: Resub of V014G Excipient amendment
Proof no.
005.1

Date prepared:
16/07/2014

Colours:
Black
Dimensions: 148 x 297 mm

Font size:
8pt
Fonts:
Helvetica

6

If you stop taking Macrogol
To get the most benefit from Macrogol, always
finish the course of treatment according to the
directions in this package leaflet. This will make
sure that your constipation is cleared, otherwise
the symptoms you are suffering from may persist.

What Macrogol contains
The active substances are:

You must contact a doctor if your symptoms
worsen or do not improve after 14 days.

Each sachet contains:
macrogol 3350
sodium chloride
sodium hydrogen carbonate
potassium chloride

If you have any further questions on the use of
this product, ask your doctor or pharmacist.

4

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, alpha-tocopherol and lemon lime flavour
(Lemon lime flavour contains: flavouring
preparations, maltodextrin, mannitol,
gluconolactone, sorbitol (E420), acacia gum,
colloidal anhydrous silica).

Possible side effects

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

If you experience any of the following side
effects, stop taking Macrogol and see your
doctor immediately:
• signs of an allergy, such as a rash, itching,
shortness of breath or difficulty in breathing.
• signs of a change in your bodyʼs fluid or
electrolyte levels (salts levels), such as
swelling (mainly in the ankles), feeling weak,
increasingly tired or increased thirst with
headache

What Macrogol looks like and contents of the
pack
Compound Macrogol 13.8g Powder for Oral
Solution contains 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.

The following side effects are also possible:

Marketing Authorisation Holder
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.

• abdominal (stomach) pain
• mild diarrhoea (when starting to take Macrogol,
this usually stops if you reduce the number of
sachets you take)
• nausea (feeling sick)
• vomiting
• swelling of your abdomen (feeling bloated)
• stomach rumbling
• flatulence (wind)
• soreness of the anus (bottom)

Manufacturer
Klocke Pharma-Service GmbH,
Strassburger Strasse 77,
77767 Appenweier,
Germany
or

If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

5

Further information

Salutas Pharma GmbH,
Otto-von-Guericke-Allee 1,
39179 Barleben,
Germany

How to store Macrogol

or

Keep out of the reach and sight of children.

Hermes Pharma Ges.m.b.H,
Allgäu 36, 9400 Wolfsberg,
Austria.

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

This leaflet was last revised in 07/2014.

Do not store above 25 °C.

Do not use Macrogol if you notice that any of the
sachets is damaged.

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.
Unused sachets of Macrogol should not be
disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of unused
sachets, which you no longer require. These
measures will help to protect the environment.

SZ00000LT000

Artwork Proof Box
Ref: V016G: Resub of V014G Excipient amendment
Proof no.
005.0

Date prepared:
30/04/2014

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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