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COMPOUND MACROGOL 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
Compound Macrogol Powder for oral solution
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
This medicine is available without prescription. However, you still need to take Compound
Macrogol Powder for oral solution 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 you get any side effects talk to your doctor or pharmacist . This includes any possible
side effects not listed in this leaflet.
What is in this leaflet:
1.
What Compound Macrogol Powder for oral solution is and what it is used for
2.
What you need to know before you take Compound Macrogol Powder for oral solution
3.
How to take Compound Macrogol Powder for oral solution
4.
Possible side effects
5.
How to store Compound Macrogol Powder for oral solution
6.
Contents of the pack and other information

1. What Compound Macrogol Powder for oral solution is and what it is
used for
Compound Macrogol 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 body’s normal levels of sodium, potassium and water while you
are being treated for constipation.

2.What you need to know before you take Compound Macrogol Powder for
oral solution
Do not take Compound Macrogol Powder for oral solution
- if you are allergic (hypersensitive) to macrogol 3350, sodium chloride, sodium hydrogen
carbonate, potassium chloride, or any of the other ingredients in Compound Macrogol
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, Crohn’s disease
or toxic megacolon
If any of these applies to you, please talk to your doctor or pharmacist for further advice.

Other medicines and Compound Macrogol Powder for oral solution
Some medicines, e.g. anti-epileptics, may not work as effectively during use with Compound
Macrogol Powder for oral solution.
Please tell your doctor or pharmacist if you are taking, or have recently taken, any other
medicines, including medicines obtained without a prescription.
Compound Macrogol Powder for oral solution with food and drink
Compound Macrogol Powder for oral solution 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 Compound Macrogol
Powder for oral solution.
Driving and using machines
Compound Macrogol Powder for oral solution has no effect on the ability to drive or use
machinery.
Important information about some of the ingredients of Compound Macrogol Powder
for oral solution
Compound Macrogol 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.
Compound Macrogol 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 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.

3. How to take Compound Macrogol Powder for oral solution
Adults, children (aged 12 years and above) and the elderly:
The recommended 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. Stir well until the powder has dissolved and then drink it.
Duration of treatment
This course of treatment for constipation should not normally last longer than 2 weeks.

If you take more Compound Macrogol Powder for oral solution 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 Compound Macrogol Powder for oral solution
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 Powder for oral solution
To get the most benefit from Compound Macrogol Powder for oral solution, 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.
You must contact a doctor if your symptoms worsen or do not improve after 14 days.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Compound Macrogol Powder for oral solution can cause side effects,
although not everybody gets them.
If you experience any of the following side effects, stop taking Compound Macrogol
Powder for oral solution 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 body’s fluid or electrolyte levels (salts levels), such as swelling
(mainly in the ankles), feeling weak, increasingly tired or increased thirst with headache
The following side effects are also possible:
- abdominal (stomach) pain
- mild diarrhoea (when starting to take Compound Macrogol Powder for oral solution, 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)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 Powder for oral solution
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.
Reconstituted Compound Macrogol Powder for oral solution can be covered and stored in the
refrigerator (2°C to 8°C), and should be used within 24 hours. After 24 hours, any unused
solution should be discarded.
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.

6. Contents of the pack and other information
The active substances are:
Each sachet contains:
macrogol 3350
sodium chloride
sodium hydrogen carbonate
potassium chloride

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).

What Compound Macrogol Powder for oral solution looks like and contents of the pack
Compound Macrogol Powder for oral solution is a 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.

Marketing Authorisation Holder
Hermes Arzneimittel GmbH
Georg-Kalb-Strasse 5-8
82049 Grosshesselohe/München
Germany

Manufacturer
Klocke Pharma-Service GmbH
Strassburger Strasse 77
77767 Appenweier
Germany
Hermes Pharma Ges.m.b.H.
Allgäu 36
9400 Wolfsberg
Austria

This leaflet was last approved in {11/2014}

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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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