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COMPOUND MACROGOL VALE 13.8 G 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 patient
Compound Macrogol 13.8 g Powder for Oral Solution
macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium chloride
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 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.
What is in this leaflet
1.
What Compound Macrogol is and what it is used for
2.
What you need to know before you take Compound Macrogol
3.
How to take Compound Macrogol
4.
Possible side effects
5.
How to store Compound Macrogol
6.
Contents of the pack and other information

1.

What Compound Macrogol is and what it is used for

Compound Macrogol is a laxative (a medicine used to help you pass stools) for the treatment of longterm (chronic) constipation in adults, adolescents and elderly. It is not recommended for children
below 12 years of age.

2.

What you need to know before you take Compound Macrogol

Do not take Compound Macrogol:
-

if you are allergic to macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium
chloride or any of the other ingredients of this medicine (listed in section 6).
if you have a blockage in your intestine (gut obstruction, ileus)
if you have a perforated gut (bowel) wall
if you have severe inflammatory bowel disease such as ulcerative colitis, Crohn’s disease or
toxic megacolon

If any of these applies to you, please talk to your doctor or pharmacist for further advice.
Warnings and precautions
Talk to your doctor or pharmacist before taking Compound Macrogol.
During treatment
If you have possible signs of changes to electrolyte levels in the blood such as fluid retention in the
body, shortness of breath, tiredness, dehydration or heart problems, stop taking Compound Macrogol
and talk to your doctor immediately (see section 4 “Possible side effects”).

Children
Do not give this medicine to children below the age of 12 years.
Other medicines and Compound Macrogol
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including medicines obtained without a prescription.
Some medicines, e.g. medicines to treat epilepsy, may not work as effectively during use with
Compound Macrogol.
Pregnancy and breast-feeding
Compound Macrogol can be taken during pregnancy and whilst breast-feeding.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking this medicine.
Compound Macrogol contains potassium, sodium and sorbitol
This medicine contains 0.63 mmol (24 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.
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.
The lemon lime flavour in Compound Macrogol contains sorbitol. If you have been told by your
doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3.

How to take Compound Macrogol

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have
told you. Check with your doctor or pharmacist if you are not sure.
Adults, children (aged 12 years and above) and the elderly:
The recommended dose for constipation is one sachet taken one to three times daily.
This medicine can be taken at any time with or without food or drink
A dose of Compound Macrogol is 1 sachet.
Take this 1 –3 times a day according to the severity of your constipation.
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 Compound Macrogol solution is clear or slightly
hazy, then drink it.
Duration of treatment
Treatment with Compound Macrogol usually lasts for about 2 weeks.
If you need to take Compound Macrogol 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 Compound
Macrogol for longer than 2 weeks.
Usually for long term treatment, the dose can be lowered to either 1 or 2 sachets a day.
If you take more Compound Macrogol than you should
This can cause severe pain and swelling in your abdomen (stomach), vomiting (sickness) or diarrhoea.
If this happens, contact your doctor or pharmacist.
You may develop excessive diarrhoea, which can lead to dehydration. If this occurs, stop taking
Compound Macrogol and drink plenty of fluids. If you are worried contact your doctor or pharmacist.
If you forget to take Compound 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.
If you stop taking Compound Macrogol
To get the most benefit from Compound 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
your condition may persist.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any of the following side effects, stop taking this medicine and contact your doctor
immediately or go to the nearest hospital emergency department straight away:
Frequency not known (cannot be estimated from the available data)



serious allergic reaction which causes sudden signs of allergy such as shortness of breath,
difficulty in breathing, or swelling of the face, lips, tongue, throat or other parts of the body
(anaphylaxis, angioedema).
changes to electrolyte levels in the blood. You may experience tiredness, dehydration, shortness
of breath, swelling of the feet and legs due to fluid build up or heart problems

Other possible side effects
Frequency not known (cannot be estimated from the available data)









skin rash, itching, reddening of the skin or a nettle rash
swollen hands, feet or ankles
shortness of breath
headaches
high or low levels of potassium in the blood.
indigestion, stomach ache or rumbles, feeling bloated (swollen stomach), wind
feeling sick (nausea) or being sick (vomiting)
soreness of the rectum and anus (bottom)



diarrhoea. You may experience mild diarrhoea when taking Compound Macrogol. This side
effect generally get better if you reduce the amount Compound Macrogol you take.

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.

5.

How to store Compound Macrogol

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 carton and sachet. The expiry
date refers to the last day of that month.
Do not store above 25°C.
Do not use this medicine if you notice that any of the sachets is damaged.
Store the reconstituted solution in a refrigerator (2°C to 8°C), and use within 24 hours. After 24 hours,
any unused solution should be thrown away.
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.

6.

Contents of the pack and other information

What Compound Macrogol contains
The active substances in each 13.8 g sachet are:
Macrogol 3350
Sodium chloride
Sodium hydrogen carbonate
Potassium chloride

13.125 g
350.7 mg
178.5 mg
46.6 mg

When made into a drink with 125 ml of water, each sachet provides:
Sodium
Chloride
Hydrogen carbonate
Potassium

65 mmol/l
53 mmol/l
17 mmol/l
5 mmol/l

The other ingredients are colloidal anhydrous silica, saccharin sodium, orange flavour (orange flavour
contains: flavouring substances and flavouring preparations, maltodextrin, acacia gum, alphatocopherol) and lemon lime flavour (lemon lime flavour contains: flavouring preparations,
maltodextrin, mannitol, gluconolactone, sorbitol (see section 2, “Compound Macrogol contains
potassium, sodium and sorbitol”), acacia gum, colloidal anhydrous silica).
What Compound Macrogol looks like and contents of the pack
Compound Macrogol is a white powder.

Each sachet contains 13.8 g of powder and is packed in cartons containing 10, 20, 30 and 50 sachets.
Not all of these pack sizes are marketed.
Marketing Authorisation Holder
Generics [UK] Limited t/a Mylan
Station Close,
Potters Bar,
Hertfordshire, EN6 1TL,
United Kingdom
Manufacturer
Klocke Pharma-Service GmbH
Strassburger Strasse 77
77767 Appenweier
Germany
Hermes Pharma Ges.m.b.H.
Allgäu 36
9400 Wolfsberg
Austria
This medicinal product is authorised in the Member States of the EEA under the following
names:
Germany:
United Kingdom:

Macrogol Mylan 13,8 g Pulver zur Herstellung einer Lösung zum
Einnehmen
Compound Macrogol 13.8 g powder for oral solution

This leaflet was last revised in 09/2016

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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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