CosmoCol Plain oral powder sachets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sodium; Chloride; Potassium; Bicarbonate; Macrogol '3350'

Available from:

Stirling Anglian Pharmaceuticals Ltd

ATC code:

A06AD65

INN (International Name):

Sodium; Chloride; Potassium; Bicarbonate; Macrogol '3350'

Dosage:

65mmol/1litre ; 53mmol/1litre ; 5.4mmol/1litre ; 17mmol/1litre ; 105gram/1litre

Pharmaceutical form:

Powder

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01060400; GTIN: 5060384790091

Patient Information leaflet

Package Leaflet (MAH)
CosmoCol Plain powder for oral solution
Page 1
PL 42582/0010
PIL. PL 42582/0010
Feb 2015
PACKAGE LEAFLET: INFORMATION FOR THE USER
COSMOCOL PLAIN
POWDER FOR ORAL SOLUTION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
This medicine is available without prescription. However, you still
need to take CosmoCol
Plain carefully to get the best results from it.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
You must contact a doctor if your symptoms worsen or do not improve
after 14 days.
-
If you get any side effects talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What CosmoCol Plain is and what it is used for
2.
What you need to know before you take CosmoCol Plain
3.
How to take CosmoCol Plain
4.
Possible side effects
5.
How to store CosmoCol Plain
6.
Contents of the pack and other information
1.
WHAT COSMOCOL PLAIN IS AND WHAT IT IS USED FOR
CosmoCol Plain is a laxative used for the treatment of long term
(chronic) constipation and
faecal impaction (persistent constipation, where a large volume of
stools cause a blockage of
the rectum and / or colon). It is not
recommended for children below 12 years of age.
Macrogol 3350 makes your faeces softer and easier to pass, giving you
relief from
constipation. The electrolytes (salts) help to maintain your body’s
normal levels of sodium,
potassium and water while you are being. treated for constipation.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE COSMOCOL PLAIN
DO NOT TAKE COSMOCOL PLAIN
-
if you are allergic (hypersensitive) to macrogol 3350, sodium
chloride, sodium hydrogen
carbonate, potassium chloride, or any of the other ingredients in
CosmoCol Plain
-
if you have a perforated gut (bowel) wall
-
if you have a blockage in your intestine (gut obstruction, ileus)
-
if you have severe inflammatory bowel disease such as ulcerativ

Summary of Product characteristics

OBJECT 1
COSMOCOL PLAIN POWDER FOR ORAL SOLUTION
Summary of Product Characteristics Updated 13-Apr-2015 | Stirling
Anglian Pharmaceuticals Ltd
1. Name of the medicinal product
CosmoCol Plain powder for oral solution
2. Qualitative and quantitative composition
Each sachet contains the following quantitative composition of active
ingredients:
Macrogol 3350
13.125 g
Sodium Chloride
0.3507 g
Sodium Hydrogen Carbonate
0.1785 g
Potassium Chloride
0.0466 g
The content of electrolyte ions per sachet following reconstitution in
125 ml of water is equivalent to:
Sodium
65 mmol/l
Chloride
53 mmol/l
Hydrogen Carbonate
(Bicarbonate)
17 mmol/l
Potassium
5 mmol/l
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for oral solution
Single-dose sachet containing a free flowing white powder.
4. Clinical particulars
4.1 Therapeutic indications
For the treatment of chronic constipation.
For resolving faecal impaction. Faecal impaction is defined as
refractory constipation with faecal loading
in the rectum and/or colon confirmed by physical or radiological
examination of the abdomen and rectum.
4.2 Posology and method of administration
CosmoCol Plain powder for oral solution is for oral use.
CHRONIC CONSTIPATION
A course of treatment for chronic constipation with CosmoCol Plain
powder for oral solution does not
normally exceed 2 weeks, although this can be repeated if required. As
for all laxatives, prolonged use is
not usually recommended.
Adults, adolescents and the elderly: 1-3 sachets daily in divided
doses, according to individual response.
Children below 12 years old: Not recommended.
Patients with renal insufficiency: No dosage change is necessary.
FAECAL IMPACTION
Adults, adolescents and the elderly: A course of treatment for faecal
impaction does not normally exceed
3 days.
Dosage is 8 sachets daily, all of which should be consumed within a
6-hour period.
The above dosage regimen should be stopped once disimpaction has
occurred. An indicator of
disimpaction is the passage of a large volume of stool