Movicol
S0064 Movicol Leaflet 20160419 3. HOW TO TAKE MOVICOL
S0064 Movicol Leaflet 20160419 3. HOW TO TAKE 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.
PACKAGE LEAFLET: INFORMATION FOR THE USER MOVICOL®
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
The name of this medicine is Movicol 13.8g sachet, powder for oral solution. 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 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 breastfeeding. If you are pregnant, trying to become pregnant or breastfeeding, 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.
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 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 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 14 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 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.
• Movicol should not be stored above 25°C. When reconstituted, store covered at 2 to 8°C and discard any solution not used in 6 hours.
• Store in the original package to protect from moisture.
• Do not use after the expiry date printed on the carton label or sachet.
• If your doctor tells you to stop taking the powder, please take it back to the pharmacist for safe disposal. Only keep the powder if your doctor tells you to.
• If the powder become discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Movicol contains
• Each sachet contains 13.125g of macrogol 3350, 0.3507g of sodium chloride, 0.1785g of sodium bicarbonate and 0.0466g of 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/litre of chloride, 17mmoles/litre of bicarbonate and 5.4mmoles/litre of potassium.
• Movicol also contains the following: lemon flavour and potassium acesulfame as a sweetener.
What Movicol looks like and contents of the pack
Movicol is a white powder presented in a sachet form. Each 13.8g
sachet contains Movicol as a powder for oral solution.
Movicol is available in boxes of 8, 20 and 30 sachets.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturers
This product is manufactured by
• Sophartex, 21, rue du Pressoir, 28500 Vernouillet, France.
Or
• Norgine Ltd, Hengoed, Mid Glamorgan, CF82 8SJ, UK.
Or
• Laboratoires Macors, Rue des Caillottes, Z.I. Plaine des Isles, 89000 Auxerre, France.
|~P~1 PL: 19488/0064
Leaflet revision date: 19 April 2016
S0064 Movicol Leaflet 20160419