MOVICOL PLAIN SACHET 13.7 Grams Powder for Oral Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

MACROGOL 3350, SODIUM CHLORIDE PH.EUR., SODIUM BICARBONATE, POTASSIUM CHLORIDE

Available from:

Norgine Limited

ATC code:

A06AD65

INN (International Name):

MACROGOL 3350, SODIUM CHLORIDE PH.EUR., SODIUM BICARBONATE, POTASSIUM CHLORIDE

Dosage:

13.7 Grams

Pharmaceutical form:

Powder for Oral Solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Osmotically acting laxatives

Authorization status:

Authorised

Authorization date:

2009-03-13

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 
MOVICOL
® 
PLAIN 13.7G SACHET, POWDER FOR ORAL SOLUTION 

READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT 
CONTAINS IMPORTANT INFORMATION FOR YOU.   

- Keep this leaflet. You may need to read it again.   

- If you have any further questions, ask your
doctor, pharmacist or nurse.   

- This medicine has been prescribed for you only. Do not pass
it on to others. It 
may harm them, even if their signs of
illness are the same as yours. 

- 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.   

WHAT IS IN THIS LEAFLET:   
1. What Movicol Plain is and what it is used for  
2. What you need to know before you take Movicol Plain   
3. How to take Movicol Plain   
4. Possible side effects   
5. How to store Movicol Plain   
6. Contents of the pack and other information 

1. WHAT MOVICOL PLAIN IS AND WHAT IT IS USED FOR   
The name of this medicine is Movicol Plain 13.7g 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 Plain helps you to have a comfortable bowel movement
even if you have 
been constipated for a long time. Movicol Plain also works in
very bad constipation 
called faecal impaction.   

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MOVICOL PLAIN   

DO NOT TAKE MOVICOL PLAIN IF YOUR DOCTOR HAS TOLD YOU THAT YOU
HAVE:   

- a blockage in your intestine (gut obstruction, paralysis of
the intestine (ileus))  

- a perforated gut wall   

- severe inflammatory bowel disease like ulcerative colitis,
Crohn’s disease or 
toxic megaco

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Movicol Plain 13.7g sachet, powder for oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet of MOVICOL Plain contains the following active
ingredients:
The content of electrolyte ions per sachet when made up to 125 ml of
solution is as follows:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral solution.
Free flowing white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of chronic constipation. MOVICOL Plain is also
effective in resolving faecal impaction, defined as
refractory constipation with faecal loading of the rectum and/or
colon.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
CHRONIC CONSTIPATION
A course of treatment for constipation with MOVICOL Plain does not
normally exceed two weeks, although this can
be repeated if required.
As for all laxatives, prolonged use is not usually recommended.
Extended use may be necessary in the care of patients
with severe chronic or resistant constipation, secondary to multiple
sclerosis or Parkinson’s Disease, or induced by
regular constipating medication, in particular opioids and
antimuscarinics.
_Adults, adolescents and older people:_ 1-3 sachets daily in divided
doses, according to individual response.
For extended use, the dose can be adjusted down to 1 or 2 sachets
daily.
_Children (below 12 years old):_ Not recommended. Alternative MOVICOL
products are available for children.
FAECAL IMPACTION
A course of treatment for faecal impaction with MOVICOL Plain does not
normally exceed 3 days.
Macrogol 3350
13.1250 g
Sodium Chloride
0.3508 g
Sodium Hydrogen Carbonate
0.1786 g
Potassium Chloride
0.0502 g
Sodium
65
mmol/l
Chloride
53
mmol/l
Potassium
5.4
mmol/l
Hydrogen Carbonate
17
mmol/l
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