Movicol 13.8g sachet, powder for oral solution

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Macrogol 3350; Sodium bicarbonate; Sodium chloride; Potassium chloride

Saadav alates:

Novalus Healthcare Limited

ATC kood:

A06AD65

INN (Rahvusvaheline Nimetus):

Macrogol 3350; Sodium bicarbonate; Sodium chloride; Potassium chloride

Annus:

13.8 gram(s)

Ravimvorm:

Powder for oral solution

Retsepti tüüp:

Product subject to prescription which may be renewed (B)

Terapeutiline ala:

macrogol, combinations

Volitamisolek:

Authorised

Loa andmise kuupäev:

2017-03-01

Infovoldik

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
-
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 Movicol should not replace your regular liquid
intake.
Heart conditions
Follow the special instructions in section 3 if you are taking Movicol
for faecal impaction
Other medicines and Movicol
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines. Some

Toote omadused

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 13.1250 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 125ml 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.
_Product imported from France:_
_Powder_ in a sachet.
4 CLINICAL PARTICULARS
As per PA0101/023/002
5 PHARMACOLOGICAL PROPERTIES
As per PA0101/023/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Lemon Flavour, Acesulfame Potassium
6.2 INCOMPATIBILITIES
None are known.
6.3 SHELF LIFE
The shelf life expiry date of this product is the date shown on the
container and outer carton of the product as marketed
in the country of origin.
Reconstituted solution: maximum of 6 hours.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_0_
_8_
_/_
_0_
_3_
_/_
_2_
_0_
_1_
_7_
_C_
_R_
_N_
_ _
_2_
_1_
_8_
_6_
_2_
_2_
_7_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store in the original package in order to protect from moisture
Sachet: Do not store above 25°C.
Reconstituted solution: Store at 2 - 8°C (in a refrigerator and
covered).
6.5 NATURE AND CONTENTS OF CONT