Movicol Plain 13.7 g sachet powder for oral solution

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Macrogol 3350; Sodium bicarbonate; Sodium chloride; Potassium chloride

Dostupno od:

Norgine Healthcare B.V.

ATC koda:

A06AD; A06AD65

INN (International ime):

Macrogol 3350; Sodium bicarbonate; Sodium chloride; Potassium chloride

Farmaceutski oblik:

Powder for oral solution

Područje terapije:

Osmotically acting laxatives; macrogol, combinations

Status autorizacije:

Not marketed

Datum autorizacije:

2009-02-13

Uputa o lijeku

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MOVICOL® PLAIN 13.7G SACHET, POWDER FOR ORAL SOLUTION
(Macrogol 3350, Sodium Chloride, Sodium Hydrogen Carbonate, Potassium
Chloride)
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 megacolon
- an allergy to the active substances of Movicol Plain (listed in
section 6).
WARNINGS AND PRECAUTIONS
When taking Movicol Plain you should continue to take plenty of
fluids. The fluid
content of Movicol should not replace your regular liquid intake.
HEA

Svojstava lijeka

Health Products Regulatory Authority
27 April 2023
CRN00DFS6
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Movicol Plain 13.7 g sachet powder for oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet of Movicol Plain contains the following active
ingredients:
Macrogol 3350
13.1250 g
Sodium Chloride
0.3508 g
Sodium Hydrogen Carbonate
0.1786 g
Potassium Chloride
0.0502 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
Hydrogen Carbonate
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 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.
_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 recommende