Thursday, 8 September 2016

MOVICOL 13.8g sachet, powder for oral solution






MOVICOL 13.8g sachet, powder for oral solution



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.



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 MOVICOL 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

  • 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>



In this leaflet:


  • 1. What is MOVICOL and what is it used for?

  • 2. Before you take MOVICOL

  • 3. How to take MOVICOL

  • 4. Possible side effects

  • 5. Storing MOVICOL

  • 6. Further information




What is MOVICOL and what is it 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.




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


Heart conditions


Follow the special instructions in section 3 if you are taking MOVICOL for faecal impaction




Pregnancy and breast feeding


If you are pregnant or breast feeding talk to your doctor before taking MOVICOL.




Driving and using machines


MOVICOL 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. Please inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.





How to take MOVICOL


This medicine can be taken at any time with or without food or drink



Constipation:


A dose of MOVICOL is 1 sachet.


Take this 1 –3 times a day according to the severity of your constipation.




Faecal impaction:


A dose is 8 sachets a day of MOVICOL 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 ¼ 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.


Usually for long term treatment that 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 diarrhoea. Stop taking MOVICOL until it clears, and then start again at a lower dose. 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.





Possible side effects


Like all medicines, MOVICOL can have side effects.


Some people may have an allergic reaction, such as an itchy skin, a nettle rash, and may become breathless or have difficulty in breathing. They may also feel weak, increasingly tired, very thirsty with a headache or get puffy ankles. If you experience any of these side effects, stop taking MOVICOL and tell your doctor immediately.


Sometimes people have stomach ache or rumbles. They 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 which generally get better if you reduce the amount of MOVICOL 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.




Storing MOVICOL


Keep all medicines out of the reach and sight of children


Do not use MOVICOL after the expiry date on the sachet.


Do not store above 25°C.


Once you have made up MOVICOL in water, if you cannot drink it straight away keep it covered and in the fridge (2 – 8°C). Throw away any solution not used within a 6 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.




Further Information


Each 13.8g sachet of MOVICOL contains the following:


Macrogol 3350: 13.125 g


Sodium Chloride: 0.3507 g


Sodium Bicarbonate: 0.1785 g


Potassium Chloride: 0.0466 g


MOVICOL also contains lime and lemon flavour, and acesulfame potassium as a sweetener. Lemon and lime flavour contains the following ingredients: acacia solids, maltodextrin, lime oil, lemon oil, citral, citric acid and water.


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 looks like and contents of the pack


MOVICOL is available in boxes of 2, 6, 8, 10, 20, 30, 50, 60 or 100 sachets. Not all pack sizes may be marketed.




Marketing authorisation holder:



Norgine Ltd

Moorhall Rd

Harefield

Middx

UB9 6NS

U.K.




Manufacturer:



Norgine Ltd

New Road

Hengoed

Mid Glamorgan

CF82 8SJ

U.K.




This medicinal product is authorised in the Member States of the EEA under the following names:


Austria: MOVICOL-Pulver

Belgium: MOVICOL

Bulgaria: MOVICOL

Denmark: MOVICOL

Germany: MOVICOL V or ISOMOL or MOVICOL

Greece: MOVICOL

Finland: MOVICOL

France: MOVICOL

Ireland: MOVICOL

Italy: MOVICOL

Luxembourg: MOVICOL

Malta: MOVICOL

Netherlands: MOVICOLon

Norway: MOVICOL

Poland: MOVICOL

Portugal: MOVICOL

Slovakia: MOVICOL

Spain: MOVICOL

Sweden: MOVICOL

Switzerland: MOVICOL

United Kingdom: MOVICOL


.




This leaflet was last approved in July 09


PL 00322/0070





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