Movicol Chocolate 13.9 g sachet powder for oral solution

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Macrogol 3350; Sodium bicarbonate; Sodium chloride; Potassium chloride

Tersedia dari:

Norgine Healthcare B.V.

Kode ATC:

A06AD; A06AD65

INN (Nama Internasional):

Macrogol 3350; Sodium bicarbonate; Sodium chloride; Potassium chloride

Bentuk farmasi:

Powder for oral solution

Area terapi:

Osmotically acting laxatives; macrogol, combinations

Status otorisasi:

Not marketed

Tanggal Otorisasi:

2008-11-13

Selebaran informasi

1
PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MOVICOL
®
CHOCOLATE 13.9G, 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 Chocolate is and what it is used for
2.
What you need to know before you take Movicol Chocolate
3.
How to take Movicol Chocolate
4.
Possible side effects
5.
How to store Movicol Chocolate
6.
Contents of the pack and other information
1.
WHAT MOVICOL CHOCOLATE IS AND WHAT IT IS USED FOR
The name of this product is Movicol Chocolate 13.9 g 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 Chocolate helps you to have a comfortable bowel movement even
if you
have been constipated for a long time. Movicol Chocolate also works in
very bad
constipation known as faecal impaction.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MOVICOL CHOCOLATE
DO NOT TAKE MOVICOL CHOCOLATE 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 Chocolate (listed in section 6).
WARNINGS AND PRECAUTIONS
When taking Movicol Chocolate you should continue to take plenty of
fluid

Karakteristik produk

Health Products Regulatory Authority
27 April 2023
CRN00DFS6
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Movicol Chocolate 13.9 g sachet powder for oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet of Movicol Chocolate contains the following active
substances:
Macrogol 3350 13.1250g
Sodium Chloride 0.3507g
Sodium Hydrogen Carbonate 0.1785g
Potassium Chloride 0.0317g
The content of electrolyte ions per sachet when made up to 125 ml of
solution is as follows:
Sodium 65 mmol/l
Chloride 51 mmol/l
Potassium 5.4 mmol/l
Hydrogen Carbonate 17 mmol/l
Excipient(s) with known effect
Movicol Chocolate contains benzyl alcohol 14.1 mg per sachet.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral solution. White to light brown free flowing powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of chronic constipation in adults and children above
the age of 12. Movicol Chocolate 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 Chocolate 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 UNDER 12 YEARS OF AGE: Not recommended. Alternative Movicol
products are available for children.
FAECAL IMPACTION
A course of treatment for faecal impaction with Movicol Chocolate does
not normally exceed 3 day