Macrogol-Ratiopharm Powder For Oral Solution
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.
- You must contact a doctor if your symptoms worsen or do not improve.
- 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 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 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 you should continue to take plenty of fluids. The fluid content of Macrogol-ratiopharm should not replace your regular liquid intake.
Other medicines and Macrogol-ratiopharm
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.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask talk to your doctor or pharmacist for advice before taking this medicine.
Macrogol-ratiopharm can be taken during pregnancy and whilst breast-feeding.
Driving and using machines
Macrogol-ratiopharm does not affect your ability to drive or use machines.
Macrogol-ratiopharm contains potassium, sodium and sorbitol
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 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 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 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,
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.
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 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 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 solution cannot be taken straight away, it should 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 <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 Macrogol-ratiopharm powder for oral solution contains
The active substances are:
Each sachet contains:
sodium hydrogen carbonate 0.1785 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, a-tocopherol) and lemon lime flavour (Lemon lime flavour contains: natural lemon oil, natural powder flavour lemon, powder flavour lime, maltodextrin, 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