Macrogol Oral Powder Compound
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Macrogol Oral Powder, Compound Powder for oral solution
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to take Macrogol Oral Powder, Compound carefully to get the best results from it.
• 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 after 14 days for chronic constipation, or after 3 days for faecal impaction.
• If any of the side effects gets serious,
or if you notice any side effects not listed in this leaflet, please tell your doctor or your pharmacist.
In this leaflet:
1. What Macrogol Oral Powder, Compound is and what it is used for
2. Before you take Macrogol Oral Powder, Compound
3. How to take Macrogol Oral Powder, Compound
4. Possible side effects
5. How to store Macrogol Oral Powder, Compound
6. Further Information
If any of these apply to you, please talk to your doctor or pharmacist for further advice.
Take special care with Macrogol Oral Powder, Compound
If you develop side effects such as swelling, shortness of breath, feeling tired, dehydration (symptoms include increasing thirst, dry mouth and weakness) or heart problems you should stop taking Macrogol Oral Powder, Compound and contact your doctor immediately.
Do not take Macrogol Oral Powder, Compound for longer periods of time unless you have been instructed to do so by your doctor; for example if you take drugs that can cause constipation or if you have a disease which causes constipation for example Parkinson’s disease or multiple sclerosis (MS).
Taking other medicines
Please inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
There is no documented experience from the use of macrogol in pregnant women or during breast-feeding. However no effects during pregnancy or on the breastfed newborn/infant are anticipated, since systemic exposure to macrogol is negligible. Therefore Macrogol Oral Powder, Compound can be used during pregnancy or while breast-feeding if necessary. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Macrogol Oral Powder, Compound has no effect on the ability to drive or use machines.
The name of this medicine is Macrogol Oral Powder, Compound
It is a laxative for the treatment of chronic constipation in adults, children (aged 12 years and above) and the elderly.
• It 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 (complete severe constipation).
Do not take Macrogol Oral Powder, Compound
• if you are allergic (hypersensitive) to macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium chloride or any of the other ingredients listed in section 6.
• if you have a perforated gut wall.
• if you have a blockage in your intestine (gut obstruction, ileus) for example by paralysis of the intestine.
• if you have severe inflammatory bowel disease like ulcerative colitis, Crohn’s disease or toxic megacolon.
Always take Macrogol Oral Powder, Compound exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.
This medicine can be taken at any time with or without food or drink.
Chronic Constipation (constipation for a long time)
Dosage - adults and children above 12 years
1 sachet one to three times daily. The normal dose for most patients is 1-2 sachets per day. Depending on the individual response 3 sachets per day might be needed. The dose depends on the severity of your constipation. The dose can be adjusted down to the lowest effective dose after a couple of days. The time of the treatment is normally 2 weeks.
If the symptoms persist after 2 weeks of treatment contact your doctor.
Children (below 12 years of age)
Not recommended.
Patients with renal insufficiency
No dosage change is necessary for treatment of chronic constipation.
Patients with a heart condition
Do not take more than 2 sachets in one hour.
Faecal Impaction (complete severe constipation)
Before you take this medicine for faecal impaction, it should be confirmed that you have this condition.
Dosage — adults and children above 12 years
The usual dose for faecal impaction (complete severe constipation) is 8 sachets daily. The 8 sachets should be taken within a 6 hour period each day for up to 3 days if required.
Children (below 12 years of age)
Not recommended.
Patients with renal insufficiency
No dosage change is necessary for treatment of faecal impaction.
Patients with a heart condition
Do not take more than 2 sachets in one hour.
Method of Administration
Dissolve the contents of 1 sachet in a glass of water (125ml or V pint), stir well and drink.
If you are being treated for faecal impaction it may be easier to dissolve all 8 sachets in 1 litre of water.
If you take more Macrogol Oral Powder, Compound than you should
You may develop diarrhoea. Stop taking Macrogol Oral Powder, Compound until it clears, then start again at a lower dose. If you are worried contact your doctor or pharmacist.
If you forget to take Macrogol Oral Powder, Compound
Take the dose as soon as you remember and then continue on as before. Do not take a double dose to make up for a forgotten dose.
• Other side effects include: headaches, high and low levels of potassium in the blood.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Keep out of the reach and sight of children.
Do not use Macrogol Oral Powder, Compound 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, Compound 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.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Like all medicines, Macrogol Oral Powder, Compound can cause side effects, although not everybody gets them.
If you experience any of the following side effects, stop taking Macrogol Oral Powder, Compound and see your doctor immediately:
• a serious allergic reaction which causes difficulty in breathing or dizziness, or swelling of the face, lips, tongue or throat.
• signs of an allergy, such as a rash, itching or shortness of breath.
The following side effects have also been reported:
• Common (occur in more than 1 in 100 users): stomach rumbling, swollen stomach or stomach pain, suffering from wind, vomiting, feeling sick, indigestion or a sore anus (bottom). If you experience mild diarrhoea when you start to take Macrogol Oral Powder, Compound your condition will generally get better if you reduce the amount of Macrogol Oral Powder, Compound you take.
• Very rare (occur in less than 1 in 10,000 users): hives, reddening of the skin or a nettle rash, swelling of the hands, feet or ankles.
What Macrogol Oral Powder, Compound sachets contain
The active substances are macrogol 3350 (13.125g), sodium chloride (350.7mg), sodium hydrogen carbonate (178.5mg) and potassium chloride (46.6mg).
The other ingredients are lemon flavour and acesulfame potassium (E950) as a sweetener.
The lemon flavour contains the following ingredients: acacia gum (E414) and flavouring.
What Macrogol Oral Powder, Compound looks like and contents of the pack
Macrogol Oral Powder, Compound is a white powder packed in sachets. It is available in boxes of 8, 10, 20, 30, 50 or 100 sachets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and 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 approved in 02/2015 E