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MACROGOL-RATIOPHARM POWDER FOR ORAL SOLUTION

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

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Package leaflet:Information for the user
Macrogol-ratiopharm 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.
- 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.
What is in this leaflet
1. What Macrogol-ratiopharm powder for oral solution is and what it is used for
2. What you need to know before you take Macrogol-ratiopharm powder for oral solution
3. How to take Macrogol-ratiopharm powder for oral solution
4. Possible side effects
5. How to store Macrogol-ratiopharm powder for oral solution
6. Contents of the pack and other information
1. What Macrogol-ratiopharm powder for oral solution is and what it is used for
The name of this medicine is Macrogol-ratiopharm, powder for oral solution. It is a laxative for the
treatment of chronic constipation in adolescents, adults and the elderly. It is not recommended for
children below 12 years of age.
Macrogol-ratiopharm powder helps you to have a comfortable bowel movement even if you have
been constipated for a long time.
You must talk to a doctor if you do not feel better or if you feel worse.
2. What you need to know before you take Macrogol-ratiopharm powder for oral solution
Do not take Macrogol-ratiopharm 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
Warnings and precautions
When taking Macrogol-ratiopharm powder you should continue to take plenty of fluids. The fluid
content of Macrogol-ratiopharm powder should not replace your regular liquid intake.
Other medicines and Macrogol-ratiopharm powder
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Some medicines, e.g. anti-epileptics (medicines for epilepsy), may not work as effectively during use
with Macrogol-ratiopharm powder.

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 or pharmacist for advice before taking this medicine
Macrogol-ratiopharm powder can be taken during pregnancy and whilst breast-feeding.
Driving and using machines
Macrogol-ratiopharm powder for oral solution does not affect your ability to drive or use machines.
Macrogol-ratiopharm powder for oral solution contains potassium, sodium and sorbitol
Important information about some of the ingredients of Macrogol-ratiopharm powder for oral
solution
Macrogol-ratiopharm powder for oral solution contains 0.63 mmol (25 mg) 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.
Macrogol-ratiopharm powder for oral solution contains 8.1 mmol (187 mg) sodium per sachet. This
should be taken into consideration if you are on a controlled sodium diet.
The lemon lime flavour in Macrogol-ratiopharm powder 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 Macrogol-ratiopharm 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.
This medicine can be taken at any time with or without food.
Adults, children (aged 12 years and above) and the elderly:
The recommended dose for constipation is one sachet taken one to three times daily according to your
individual response.
Use in children (below 12 years of age)
Macrogol-ratiopharm powder is not recommended for children under 12 years old. Alternative
products are available for children below 12 years of age.
Method of administration
Open the sachet and pour the contents into a glass. Add about 125 ml of water to the glass. Stir well
until all the powder has dissolved and the solution is clear or slightly hazy, 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 Macrogol-ratiopharm 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 advise you to reduce your dose to one sachet taken one
or two times daily.
You may develop excessive diarrhoea, which can lead to dehydration. If this occurs, stop taking
Macrogol-ratiopharm powder and drink plenty of fluids. If you are worried

If you take more Macrogol-ratiopharm powder for oral solution than you should
You may develop excessive diarrhoea, which can lead to dehydration. If this occurs, stop taking
Macrogol-ratiopharm powder and drink plenty of fluids. If you are worried contact your doctor or
pharmacist.
If you forget to take Macrogol-ratiopharm 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 Macrogol-ratiopharm powder for oral solution
To get the most benefit from Macrogol-ratiopharm powder for oral solution, always finish the course
of treatment according to the directions in this package leaflet or as your doctor or pharmacist has told
you.. 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.
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 Macrogol-ratiopharm powder for
oral solution and see your doctor immediately:
signs of allergic reaction, such as shortness of breath or difficulty in breathing, swelling of the face,
lips, tongue or throat, nettle rash, itching, skin rash or reddening of the skin,
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.
Other side effects include:
stomach pains
stomach rumbles
diarrhoea. You may have mild diarrhoea when starting to take Macrogol-ratiopharm powder
which generally gets better if you reduce the number of sachets you take
vomiting (being sick)
nausea (feeling sick)
anal discomfort (uncomfortable sensation around the bottom)
swollen stomach
wind
swollen hands, feet or ankles
headaches
indigestion
high or low levels of potassium in the blood.

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 Macrogol-ratiopharm 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.
If reconstituted Macrogol-ratiopharm powder solution cannot be taken straight away, it should be
used within six hours. After six hours, any unused solution should be discarded.
Do not throw away any medicines via wastewater or . 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 Macrogol-ratiopharm 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 Macrogol-ratiopharm powder for oral solution looks like and contents of the pack
Macrogol-ratiopharm 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 pack sizes may be 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 November 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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