Movical Powder For Oral Solution
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Please read all of this leaflet carefully before taking your medicine.
■ Keep this leaflet. You may need to read it again.
■ If you have any further questions, ask your doctor or pharmacist.
■ This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
■ If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
PATIENT INFORMATION LEAFLET
Your medicine is available using the name Movicol Powder for Oral Solution but will be referred to as Movicol Powder throughout the leaflet.
In this leaflet:
1. What is Movicol Powder and what is it used for?
2. Before you take Movicol Powder
3. How to take Movicol Powder
4. Possible side effects
5. Storing Movicol Powder
6. Further information
1. What is Movicol Powder and what is it used for?
The name of this medicine is Movicol Powder. 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.
Movicol Powder helps you to have a comfortable bowel movement even if you have been constipated for a long time. Movicol Powder also works in very bad constipation called faecal impaction.
2. Before you take Movicol Powder
Do not take Movicol 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 substances or any of the other ingredients of Movicol Powder
Heart conditions
Follow the special instructions in section 3 if you are taking Movicol Powder for faecal impaction.
Pregnancy and breast-feeding
Movicol Powder can be taken during pregnancy and whilst breast-feeding. If you are pregnant, trying to become pregnant or breast-feeding, ask your pharmacist or doctor for advice before taking Movicol Powder.
Driving and using machines
Movicol Powder does not affect your ability to drive or use machines.
Taking other medicines
Some medicines, e.g. anti-epileptics, may not work as effectively during use with Movicol Powder. Please inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.
3. How to take Movicol Powder
This medicine can be taken at any time with or without food or drink.
Constipation:
A dose of Movicol Powder is 1 sachet.
Take this 1-3 times a day according to the severity of your constipation.
Faecal impaction:
A dose of 8 sachets a day of Movicol Powder is needed for the treatment of faecal impaction. 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 1/4 pint of water to the glass. Stir well until all the powder has dissolved and the Movicol Powder solution is clear or slightly hazy, then drink it. If you are taking Movicol Powder for faecal impaction it may be easier to dissolve 8 sachets in 1 litre of water.
Duration of treatment Constipation:
Treatment with Movicol Powder usually lasts for about 2 weeks. If you need to take Movicol 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 Movicol Powder for longer than 2 weeks.
Usually for long term treatment the dose can be lowered to either 1 or 2 sachets a day.
Faecal impaction:
Treatment with Movicol Powder can be for up to 3 days.
If you take more Movicol Powder than you should
You may develop excessive diarrhoea, which can lead to dehydration. If this occurs, stop taking Movicol Powder and drink plenty of fluids. If you are worried contact your doctor or pharmacist.
If you forget to take Movicol Powder
Take the dose as soon as you remember to take it.
4. Possible side effects
Like all medicines Movicol Powder can have side effects.
Tell your doctor immediately and stop taking Movicol 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 Movicol Powder. These side effects generally get better if you reduce the amount of Movicol Powder you take.
If any of the above are troublesome or last more than a few days or if you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
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. Storing Movicol Powder
■ Keep all medicines out of the sight and reach of children.
■ Sachet: do not store above 25°C.
■ Solution: store at 2-8°C (in a refrigerator and covered).
■ Discard any solution not used within 6 hours.
■ Do not use after the expiry date printed on the carton or sachet.
■ 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.
■ If your doctor tells you to stop taking the medicine, please take them back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to. If the powder becomes discoloured or shows signs of deterioration, you should seek the advice of your pharmacist.
6. Further information
Each 13.8g sachet contains:
■ Macrogol 3350: 13.125g
■ Sodium Chloride: 0.3507g
■ Sodium Bicarbonate: 0.1785g
■ Potassium Chloride: 0.0466g
Movicol Powder also contains citrus flavour, and acesulfame K (E950) as a sweetener.
Movicol Powder is a free flowing white, almost odourless powder for oral solution which dissolves in water to give a colourless solution with an odour of lemons.
When it is made into a drink with 125 millilitres of water, each sachet gives the equivalent of:
■ Sodium: 65 millimoles/litre
■ Chloride: 53 millimoles/litre
■ Potassium: 5.4 millimoles/litre
■ Bicarbonate: 17 millimoles/litre
What Movicol Powder looks like and contents of the pack
Movicol Powder is available in boxes of 20 sachets.
Each sachet contains 13.8 grams of Movicol Powder.
Manufacturer
Manufactured by: Norgine Limited, New Road, Hengoed,
Mid Glamorgan, CF82 8SJ, UK.
Or
LABORATOIRES MACORS, Rue des Caillottes, Z.I. Plaine des Isles, 89000 AUXERRE, France.
Or
SOPHARTEX, 21 Rue du Pressoir, 28500 VERNOUILLET, France.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0147 [~P~|
If you wish to receive this leaflet in Braille, large font or audio format please contact 01302 365000 and ask for the Regulatory Department.
MOVICOL® is a registered trademark of Velinor AG.
Leaflet revision date: 18.03.14
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