Movicol Liquid Orange Flavour, Concentrate for Oral Solution

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Macrogol 3350; Sodium chloride; Sodium hydrogen carbonate; Potassium chloride

제공처:

Norgine B.V.

ATC 코드:

A06AD; A06AD65

INN (International Name):

Macrogol 3350; Sodium chloride; Sodium hydrogen carbonate; Potassium chloride

복용량:

13.9mg/25 millilitre(s)

약제 형태:

Concentrate for oral solution

처방전 유형:

Product subject to prescription which may be renewed (B)

치료 영역:

Osmotically acting laxatives; macrogol, combinations

승인 상태:

Marketed

승인 날짜:

2012-01-06

환자 정보 전단

1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MOVICOL
®
LIQUID ORANGE FLAVOUR, CONCENTRATE 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 Liquid Orange flavour is and what it is used for
2.
What you need to know before you take Movicol Liquid Orange flavour
3.
How to take Movicol Liquid Orange flavour
4.
Possible side effects
5.
How to store Movicol Liquid Orange flavour
6.
Contents of the pack and other information
1.
WHAT MOVICOL LIQUID ORANGE FLAVOUR IS AND WHAT IT IS USED FOR
The name of this medicine is Movicol Liquid Orange flavour concentrate
for oral
solution. It is a laxative for the treatment of chronic constipation
in adults, adolescents
and elderly. It is not recommended for children below 12 years of age.
Movicol Liquid Orange flavour helps you to have a comfortable bowel
movement even
if you have been constipated for a long time.
YOU MUST NOT USE
Movicol Liquid Orange flavour if you have a very bad constipation
called faecal impaction.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MOVICOL LIQUID ORANGE FLAVOUR
DO NOT TAKE MOVICOL LIQUID ORANGE FLAVOUR 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
2
-
an allergy to the active substances or any of the other ingredients of
Movicol
Liquid Orange flavour (listed in section 6).
WARNINGS AND PRECAUTIONS
When taking Movicol L

제품 특성 요약

Health Products Regulatory Authority
17 May 2021
CRN009VJN
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Movicol Liquid Orange Flavour, Concentrate for Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 25 ml of Movicol Liquid Orange flavour contains the following
active substances:
Macrogol 3350 13.125 g
Sodium chloride 0.3507 g
Sodium hydrogen carbonate 0.1785 g
Potassium chloride 0.0466 g
The concentration of electrolyte ions present when a 25 ml dose is
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
This corresponds to the following amount of each electrolyte in each
diluted dose of 125 ml:
Sodium 8.125 mmol
Chloride 6.625 mmol
Potassium 0.675 mmol
Hydrogen carbonate 2.125 mmol
Excipients with known effect:
74.5 mg ethyl alcohol per 25 ml
11.3 mg methyl parahydroxybenzoate (E218) per 25 ml
5.6 mg ethyl parahydroxybenzoate (E214) per 25 ml
45.6 mg benzyl alcohol per 25 ml
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for oral solution.
Clear, colourless liquid
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of chronic constipation
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
A course of treatment for constipation with Movicol Liquid Orange
flavour 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: 25 ml diluted in 100 ml of water
1-3 times daily in divided doses, according to
individual response.
Health Products Regulatory Authority
17 May 2021
CRN009VJN
Page 2 of 5
For extended use, the dose can be adjusted down to 1 or 2 doses per
day of 25 ml diluted