MOVICOL 13.8 Grams Powder for Oral Solution

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Nopērc to tagad

Lietošanas instrukcija Lietošanas instrukcija (PIL)
29-01-2016
Produkta apraksts Produkta apraksts (SPC)
12-04-2018

Aktīvā sastāvdaļa:

MACROGOL 3350, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE

Pieejams no:

Norgine Limited

ATĶ kods:

A06AD65

SNN (starptautisko nepatentēto nosaukumu):

MACROGOL 3350, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE

Deva:

13.8 Grams

Zāļu forma:

Powder for Oral Solution

Receptes veids:

Product subject to prescription which may be renewed (B)

Ārstniecības joma:

Osmotically acting laxatives

Autorizācija statuss:

Authorised

Autorizācija datums:

1996-12-03

Lietošanas instrukcija

                                FONTS USED:
Frutiger LT Std-65 Bold
Frutiger LT Std-75 Black
Helvetica-Regular
AVERAGE TEXT SIZE 
(BODY TEXT):
8.0 pt
Frutiger LT Std-55 Roman
Frutiger LT Std-66 Bold Italic
10025906
1
CR/15/0257
MOVICOL L&L
07/12/15
Ireland
PIL
Hengeod
NOR-LFT1-V1
157 x 230mm
691
N/A
N/A
500756A02
Black
Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 
MOVICOL
®
 
 
_ _
13.8G 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 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
                                
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Produkta apraksts

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Movicol 13.8g sachet, powder for oral solution.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet of MOVICOL contains the following active substance:
Macrogol 3350
13.125 g
Sodium chloride
0.3507 g
Sodium bicarbonate
0.1785 g
Potassium chloride
0.0466 g
The content of electrolyte ions per sachet when made up to 125 ml of
solution is as follows:
Sodium
65 mmol/l
Chloride
53 mmol/l
Potassium
5.4 mmol/l
Bicarbonate
17 mmol/l
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 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 does not
normally exceed 2 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 does not
normally exceed 3 days.
ADULTS, ADOLESCENTS AND OLDER PEOPLE: 8 sachets daily, all of which
should be consumed within a 6 hour period.
CHILDREN (BELOW 12 YEARS OLD): Not recommended. Alternative MOVICOL
products are available for children.
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