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MACROGOL-RATIOPHARM 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.
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.
- You must contact a doctor if your symptoms worsen or do not improve after 14 days.
- If you get any of the 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.
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
salts help to maintain your body’s normal levels of sodium, potassium and water while you are being
treated for constipation
You must talk to a doctor if you do not feel better or if you feel worse after 14 days.
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 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 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.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
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, think you may be pregnant or are planning to have a baby, ask
your doctor for advice before taking this medicine
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 Macrogol-ratiopharm 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
Always take 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.
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. Stirr 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.
On your doctor's advice, you may need to take Compound macrogol powder for oral solution longer
than two weeks if you have ongoing constipation, or a disease that causes constipation (such as
Parkinson’s disease or multiple sclerosis), or if you are taking other regular medicines that can cause
constipation. In these cases, your doctor may advice you to reduce your dose to one sachet taken one
or two times daily.
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 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 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, reddening of the skin, shortness of breath or
difficulty in breathing, or swelling of the face, lips, tongue or throat.
- signs of a change in your body’s fluid or electrolyte levels, such as swelling (mainly in the
ankles), feeling weak, increasingly tired or increased thirst with headache.
The following side effects are also possible:
-

electrolyte disturbances, particularly high or low levels of potassium in the blood
headache
swelling of hands, feet or ankles
abdominal (stomach) pain
diarrhoea
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
indigestion
swelling of your abdomen (feeling bloated)
stomach rumbling
flatulence (wind)
soreness of the anus (bottom)

If you get any of the side effect,talk to your doctor or pharmacist. This includes any side effects not
listed in this leaflet.
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 solution can be covered and stored in the
refrigerator (2°C to 8°C), and should be used within six hours. After six 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
What Compound macrogol powder for oral solution contains
The active substances are:
Each sachet contains:
macrogol 3350 13.125 g
sodium chloride 0.3507 g
sodium hydrogen carbonate 0.1785 g
potassium chloride 0.0466 g
The other ingredients are silica colloidal anhydrous, saccharin sodium, orange flavour (Orange
flavour contains: flavouring preparations and substances, natural flavouring substances, maltodextrin,
acacia gum, α-tocopherol) and lemon lime flavour (Lemon lime flavour contains: natural lemon oil,
natural powder flavour lemon, powder flavour lime, mannitol, gluconolactone, sorbitol [E420], acacia
gum, silica colloidal anhydrous)
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
and 100 sachets.
Not all of these pack sizes are marketed.
Marketing Authorisation Holder
ratiopharm GmbH
Graf-Arco-Str. 3
89079 Ulm
Manufacturer
Merckle GmbH
Ludwig-Merckle-Str. 3
89143 Blaubeuren
This leaflet was last revised in February 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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