Patient leaflet - Compound Macrogol Vale 13.8 g powder for oral solution
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 long-term (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 13.125 g
Sodium chloride 350.7 mg
Sodium hydrogen carbonate 178.5 mg
Potassium chloride 46.6 mg
When made into a drink with 125 ml of water, each sachet provides:
Sodium 65 mmol/l
Chloride 53 mmol/l
Hydrogen carbonate 17 mmol/l
Potassium 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, alpha-tocopherol) 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: Macrogol Mylan 13,8 g Pulver zur Herstellung einer Lösung zum Einnehmen
United Kingdom: Compound Macrogol 13.8 g powder for oral solution