Movicol
Package Leaflet: Information for the patient
Movicol®
Read all of this leaflet carefully before you 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, pharmacist or nurse 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 side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
• See section 4.
• You must talk to a doctor if you do not feel
better or if you feel worse._
What is in this leaflet:
1. What Movicol is and what it is used for
2. What you need to know before you take Movicol
3. How to take Movicol
4. Possible side effects
5. How to store Movicol
6. Contents of the pack and other information
1. What Movicol is and what it is used for
Movicol 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 helps you to have a comfortable bowel movement even if you have been constipated for a long time. Movicol also works in very bad constipation called faecal impaction.
2. What you need to know before you take Movicol
Do not take Movicol 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 (listed in section 6).
Warnings and precautions
When taking Movicol you should continue to take plenty of fluids. The fluid content of Movicol should not replace your regular liquid intake.
Heart conditions
Follow the special instructions in section 3 if you are taking Movicol for faecal impaction
Other medicines and Movicol
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Some medicines, e.g. anti-epileptics, may not work as effectively during use with Movicol.
Pregnancy and breast-feeding
Movicol 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.
Driving and using machines
Movicol does not affect your ability to drive or use machines.
3. How to take Movicol
This medicine can be taken at any time with or without food.
Dissolve the content of each sachet in 125ml (1/4 pint) of water and drink.
Constipation:
A dose of Movicol is 1 sachet dissolved in 125ml (1/4 pint) of water.
Take this 1-3 times a day according to the severity of your constipation.
Faecal impaction:
Before you take Movicol for faecal impaction, it should be confirmed that you have this condition.
A dose of 8 sachets a day of Movicol 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 1/4 pint of water to the glass. Stir well until all the powder has dissolved and the Movicol solution is clear or slightly hazy, then drink it. If you are taking Movicol for faecal impaction it may be easier to dissolve 8 sachets in 1 litre of water.
Duration of treatment:
Constipation:
Treatment with Movicol usually lasts for about 2 weeks.
If you need to take Movicol 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 for longer than 2 weeks. If you need to take Movicol for longer, please see your doctor. Usually for long-term treatment the dose can be lowered to either 1 or 2 sachets a day.
Faecal impaction:
Treatment with Movicol can be for up to 3 days.
If you take more Movicol than you should:
You may develop excessive diarrhoea, which can lead to dehydration. If this occurs, stop taking Movicol and drink plenty of fluids. If you are worried contact your doctor or pharmacist.
If you forget to take Movicol:
Take the dose as soon as you remember to take it.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately and stop taking Movicol 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. These side effects generally get better if you reduce the amount of Movicol you take.
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. How to store Movicol
• Keep out of the sight and reach of children.
• Do not store above 25°C.
• After reconstitution, store covered in a refrigerator (2°C-8°C). Discard any solution not used within 6 hours.
• Do not take the medicine after the expiry date which is stated on the carton and sachet label after ‘Exp'. The expiry date refers to the last day of that month.
• If the powder becomes discoloured or shows signs of deterioration seek the advice of your pharmacist.
• Remember if your doctor tells you to stop taking the powder, return any unused sachets to your pharmacist for safe disposal. Only keep this medicine if your doctor tells you to.
• 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.
6. Contents of pack and other information What Movicol contains
Each sachet contains 13.125g macrogol 3350, 0.3507g sodium chloride, 0.1785g sodium bicarbonate and 0.0466g potassium chloride as the active ingredients. When made into a drink with 125ml of water, each sachet gives the equivalent of 65mmoles/litre of sodium, 53mmoles/litres of chloride, 17mmoles/litre of bicarbonate and 5.4mmoles/litre of potassium.
The other ingredients are lemon flavour and acesulfame potassium as a sweetener.
What Movicol looks like and contents of the pack
Movicol is presented in a carton containing sachets with free flowing white powder.
Each carton contains 20 sachets.
Manufactured by: Norgine Ltd, Hengoed, Mid Glamorgan, CF 82 8SJ, Wales, UK.
OR
Laboratories Macors, Zl La Plaine des Isles,
89000 Auxerre, France.
OR
Laboratories Sophartex, 21 rue du Pressoir, 28500, Vernouille, France.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.
Movicol®: PL 18799/0697 j-yj
Leaflet date: 08.07.2016
Movicol is a registered trademark of Norgine Ltd.