Patient leaflet - Macrogol 10 g powder for oral solution
1. What Macrogol is and what it is used for
Macrogol contains the active substance macrogol 4000 and belongs to a group of medicines called osmotic laxatives.
Macrogol carries water to your stool, which loosens and increases stool volume, helping to overcome sluggish bowels.
Macrogol is not absorbed into the bloodstream or broken down in the body.
Macrogol is used for the treatment of constipation in adults and children aged 8 years and over. Macrogol is a powder that you dissolve in a glass of water (at least 50 ml) and then drink. Macrogol works gradually within 24 to 48 hours. The treatment of constipation with any medicine should only be in addition to a healthy lifestyle and diet.
2. What you need to know before you take Macrogol
Do not take Macrogol:
if you are allergic (hypersensitive) to
macrogol (polyethylene glycol) or any of the other ingredients of this medicine (listed in section 6).
if you have an existing severe intestinal
disease such as:
inflammatory bowel disease (such as
ulcerative colitis, Crohn’s disease, abnormal dilation of the bowel
perforation of the bowel or risk of
perforation of the bowel
- ileus or suspicion of intestinal obstruction
painful abdominal conditions of unknown
cause
Do not take this medicine if any of the above applies to you. If you are not sure, talk to your pharmacist or doctor before taking the medicine.
Warnings and precautions
Cases of allergic reactions involving rash and swelling of the face or throat (angioedema) have been reported in adults after taking products containing macrogol (polyethylene
glycol). Isolated severe allergic reactions have been reported causing faintness, collapse or breathing difficulties and feeling generally unwell. If you experience any of these symptoms you should stop taking Macrogol and seek medical help immediately.
As this medicine can sometimes cause diarrhoea, check with a doctor or pharmacist before taking this medicine if you:
- have impaired liver or kidney function
- are taking diuretics (water tablets) or are elderly as you may be at risk of low sodium (salt) or potassium levels in the blood If you experience sudden abdominal pain or rectal bleeding when taking Macrogol for bowel preparation, contact your doctor or seek medical advice immediately.
Before taking Macrogol, talk to your doctor or pharmacist if you know that you have a swallowing disorder.
Avoid mixing Macrogol - PEG laxative and starch-based food thickeners if you have difficulties with swallowing. This may result in a watery liquid which could get into your lungs and cause pneumonia if you can’t swallow properly.
Other medicines and Macrogol
There is a possibility that the absorption of other medicinal products could be transiently reduced during use with Macrogol, particularly medicinal products with a narrow therapeutic index or short half-life such as digoxin, anti-epileptics, coumarins and immunosuppressive agents, leading to decreased efficacy. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
If you need to thicken fluids in order to swallow them safely, Macrogol may counteract the effect of the thickener.
Pregnancy and breast-feeding
Macrogol can be used during 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.
Driving and using machines
No studies on the effects on the ability to drive and /or use machines have been performed.
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 medicinal product. This medicine contains a small amount of a sugar called sorbitol, can be used if you are diabetic, or if you are on a galactose-free diet. This medicine contains less than 1 mmol sodium (23 mg) per each sachet, that is to say essentially ‘sodium-free’.
3. How to take Macrogol
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 and children over 8 years
- The recommended dose is one to two sachets per day, preferably taken as a single dose in the morning
- Start by taking one sachet each day and if needed increase to two sachets each day
Package leaflet: Information for the user
Macrogol 10 g powder for oral solution
Macrogol 4000
Version: 14
Date & Time: 05.11.2025 & 6:00 pm Submission: N05093_u15f
The daily dose can be adjusted
according to the effect obtained and may range from one sachet every other day (especially in children) up to a maximum of two sachets per day
Dissolve the contents of the sachet
in a glass of water (at least 50 ml) immediately before use and drink the liquid
Please note:
Macrogol usually takes 24 to 48 hours to
work
In the management of children with
constipation, the duration of treatment with Macrogol should not exceed 3 months
Improvement in the frequency of your bowel
movements after taking Macrogol can be maintained by keeping to a healthy lifestyle and diet.
Talk to your pharmacist or doctor if the
symptoms worsen or do not improve
If you take more Macrogol than you should
Taking too much Macrogol may cause diarrhoea, stomach pains or vomiting. The diarrhoea usually disappears when treatment is stopped or the dose reduced.
If you suffer from severe diarrhoea or vomiting you should contact a doctor as soon as possible as you may require treatment to prevent loss of salts (electrolytes) due to fluid loss.
If you forget to take Macrogol
Take the next dose as soon as you remember but do not take a double dose to make up for a forgotten dose.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects that are usually mild and do not last long include:
In children:
Common (may affect up to 1 in 10 people)
- Abdominal (belly) pain
Diarrhoea which may also cause soreness
around the back passage (anus)
Uncommon (may affect up to 1 in 100 people)
- Nausea (feeling sick) or vomiting
- Abdominal (belly) bloating
Not known (frequency cannot be estimated from available data)
Allergic (hypersensitivity) reactions (rash,
hives (urticaria), swelling of the face or throat, breathing difficulties, faintness or collapse)
In adults:
Common (may affect up to 1 in 10 people)
- Abdominal (belly) pain
- Abdominal (belly) bloating
- Nausea (feeling sick)
- Diarrhoea
Uncommon (may affect up to 1 in 100 people)
- Vomiting
- Urgent need to go to the toilet
- Faecal incontinence
Not known (frequency cannot be estimated from available data)
Low blood levels of potassium which can
cause muscle weakness, twitching or abnormal heart rhythm
Low blood levels of sodium which can cause
tiredness and confusion, muscle twitching, fits and coma
Dehydration caused by severe diarrhoea
especially in the elderly
- Symptoms of an allergic reaction such as skin redness, rash, hives (urticaria), swelling of the face or throat, breathing difficulties, faintness or collapse
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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store 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 after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 Macrogol contains
The active substance is macrogol 4000 Each sachet contains 10 g of macrogol
4000
The other ingredients
Saccharin Sodium and Orange Grape Fruit
Flavour (contains orange oil, grape fruit oil, orange juice, citral, acetaldehyde, linalool, ethyl butyrate, alpha terpeniol, octonal, beta & gamma hexenol, maltodextrin, gum arabic, sorbitol (E420), butylated hydroxyanisole (E320)).
What Macrogol looks like and contents of the pack
Macrogol is white or almost white free flowing powder of waxy or paraffin like appearance with orange odour, packed in sachets containing 10, 20 and 30 pack sizes for the preparation of an oral solution
Not all pack sizes may be marketed
Marketing Authorisation Holder
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000
Malta
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom