MOVICOL 13.8g sachet, powder for oral solution

Kraj: Malta

Język: angielski

Źródło: Malta Medicines Authority

Dostępny od:

Norgine Healthcare B.V. Antonio Vivaldistraat 150 1083 HP Amsterdam , Netherlands

Kod ATC:

A06AD65

INN (International Nazwa):

POTASSIUM CHLORIDE 46.6 mg SODIUM CHLORIDE 350.7 mg SODIUM BICARBONATE 178.5 mg MACROGOL 3350 13.125 g

Forma farmaceutyczna:

POWDER FOR ORAL SOLUTION

Skład:

POTASSIUM CHLORIDE 46.6 mg SODIUM CHLORIDE 350.7 mg SODIUM BICARBONATE 178.5 mg MACROGOL 3350 13.125 g

Typ recepty:

OTC

Dziedzina terapeutyczna:

DRUGS FOR CONSTIPATION

Status autoryzacji:

Authorised

Data autoryzacji:

2006-03-27

Ulotka dla pacjenta

MOVICOL
1.3 Product Information
1.3.1 SPC, Labelling and Package Leaflet
Norgine
Confidential
Page 1 of 5 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MOVICOL
® 13.8G SACHET, POWDER FOR ORAL SOLUTION
Macrogol 3350, Sodium Chloride, Sodium Bicarbonate, Potassium Chloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor,
pharmacist or nurse has told you.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice.

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.

You must talk to a doctor if you do not feel better or if you feel
worse.
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
-
an allergy to the active substances or any of the other ingredients of
Movicol
(listed in section 6).
WARNINGS AND PRECAUTIONS
When taking Movicol you should continue to take plenty of fluids. The
fluid content
of M

Charakterystyka produktu

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 substances:
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.
PATIENTS WITH IMPAIRED CARDIOVASCULAR FUNCTION:
For the treatment o