Macrogol Oral Powder Compound
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Macrogol Oral Powder, Compound
powder for oral solution in sachet
Read all of this leaflet carefully before you can 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 your doctor if you do not feel better or feel worse.
In this leaflet:
1. What Macrogol Oral Powder is and what it is used for
2. What you need to know before you take Macrogol Oral Powder
3. How to take Macrogol Oral Powder
4. Possible side effects
5. How to store Macrogol Oral Powder
6. Contents of the pack and other information
This medicinal product contains 8.125 mmol sodium per 125 mL. To be taken into consideration by patients on a controlled sodium diet.
Talk to your doctor or pharmacist before taking Macrogol Oral Powder Heart conditions
Follow the special instructions in section 3 if you are taking Macrogol Oral Powder for faecal impaction
Children and adolescents
Not recommended for children (below 12 years of age).
Other medicines and Macrogol Oral Powder
Tell your doctor or pharmacist if you are taking, or have recently taken or might take any other medicines.
Some medicines, e.g. anti-epileptics, may not work as effectively during use with Macrogol Oral Powder.
Pregnancy and breast-feeding
Macrogol Oral Powder can be taken during pregnancy and whilst breast-feeding. If you are pregnant, trying to become pregnant or breastfeeding ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Macrogol Oral Powder does not affect your ability to drive or use machines.
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The name of this medicine is Macrogol Oral Powder, Compound.
It is a laxative for the treatment of constipation in adults, adolescents and elderly. It is not recommended for children below 12 years of age. Macrogol Oral Powder, Compound helps you to have a comfortable bowel movement even if you have been constipated for a long time. It also works in very bad constipation called faecal impaction.
Do not take Macrogol Oral Powder if your doctor has told you that you have:
• a blockage in your intestine (gut obstruction, ileus)
• a perforated gut wall.
• severe inflammatory bowel disease like ulcerative colitis, Crohn’s disease or toxic megacolon
• an allergy to the active substance or any of the other ingredients of Macrogol Oral Powder (listed in section 6).
Warnings and precautions
When taking Macrogol Oral Powder you should continue to take plenty of fluids. The fluid content of Macrogol Oral Powder should not replace your regular liquid intake.
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.
Dissolve the content of each sachet in 125 ml (1/4 pint) of water and drink Constipation
A dose of Macrogol Oral Powder is 1 sachet dissolved in 125 ml (1/4 pint) of water.
Take this 1-3 times a day according to the severity of your constipation.
Faecal Impaction
Before you take Macrogol Oral Powder for faecal impaction, it should be confirmed that you have this condition.
A dose of 8 sachets a day of Macrogol Oral Powder is needed for the treatment of faecal impaction.
Each sachet dissolved in 125ml (1/4 pint) of water. The 8 sachets should be taken within 6 hours for up to 3 days if required. If you have a heart condition, do not take more than 2 sachets in any one hour. How to mix:
Open the sachet and pour the contents into a glass. Add about 125ml or V pint of water to the glass. Stir well and drink it. If you are taking Macrogol Oral Powder for faecal impaction it may be easier to dissolve all 8 sachets in 1 litre of water.
Duration of treatment:
Constipation:
Treatment with Macrogol Oral Powder usually lasts for about 2 weeks. If you need to take Macrogol Oral Powder 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 Macrogol Oral Powder for longer than 2 weeks.
If you need to take Macrogol Oral Powder for longer, please see your doctor.
Usually for long term treatment that dose can be lowered to either 1 or 2 sachets a day.
Faecal Impaction
Treatment with Macrogol Oral Powder can be for up to 3 days.
If you take more Macrogol Oral Powder than you should
You may develop excessive diarrhoea, which can lead to dehydration. Stop taking Macrogol Oral Powder until it clears and drink plenty of fluids, then start again at a lower dose. If you are worried contact your doctor or pharmacist.
If you forget to take Macrogol Oral Powder
Take the dose as soon as you remember to take it.
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 to protect the environment.
What Macrogol Oral Powder sachets contain
Each 13.7 g sachet of Macrogol Oral Powder contains the following:
Macrogol 3350 Sodium chloride Sodium hydrogen carbonate Potassium chloride
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately and stop taking Macrogol Oral Powder if you:
• Get a serious allergic reaction which causes difficulty in breathing or swelling of the face, lips, tongue or throat.
Other side effects include:
Allergic reactions which may cause a skin rash, itching, reddening of the skin or a nettle rash, swollen hands, feet or ankles, headaches and high and low levels of potassium in the blood.
Sometimes you may have indigestion, stomach ache or rumbles. You may also feel bloated, suffer from wind, feel sick or vomit, may also experience soreness of the anus (bottom) and may have mild diarrhoea when starting to take Macrogol Oral Powder. These side effects generally get better if you reduce the amount Macrogol Oral Powder 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 United Kingdom; Yellow Card Scheme; Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
13.125 g 0.3507 g 0.1785 g 0.0466 g
Macrogol Oral Powder also contains lemon flavour and acesulfame potassium (E950) as a sweetener. The lemon flavour contains the following ingredients: acacia gum (E414) and flavouring. When it is made into a drink with 125 millilitres of water, each sachet gives the equivalent of: Sodium 65 mmol/l
Chloride 53 mmol/l
Hydrogen carbonate 17 mmol/l
Potassium 5.4 mmol/l
What Macrogol Oral Powder looks like and contents of the pack
Macrogol Oral Powder is a white powder.
Macrogol Oral Powder is available in boxes of 8, 10, 20, 30, 50 or 100 sachets.
Not all pack sizes may be marketed.
The marketing authorisation holder
Chanelle Medical,
Loughrea, Co. Galway, Ireland.
Manufacturer
Chanelle Medical,
Loughrea, Co. Galway, Ireland
Distributor
Co-Pharma Limited
Unit 4, Metro Centre, Tolpits Lane,
Watford, Hertfordshire, WD18 9SS, UK
This leaflet was last revised in 07/2016
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Keep this medicine out of the sight and reach of children.
Do not use Macrogol Oral Powder after the expiry date which is stated on the carton and sachet.
The expiry date refers to the last day of that month. Unopened sachet: No special storage conditions. Once you have made up Macrogol Oral Powder in water, if you cannot drink it straight away keep it covered and store in a refrigerator (2°C - 8°C). Throw away any solution not used within a 24 hour period.