Macrogol compound oral powder sachets sugar free

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

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

Available from:

Galen Ltd

ATC code:

A06AD65

INN (International Name):

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

Dosage:

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

Pharmaceutical form:

Powder

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01060400; GTIN: 5016298741162 5016298751178

Patient Information leaflet

1.3.1 Package Leaflet
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
COMPOUND MACROGOL ORAL POWDER SUGAR FREE
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 have 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 after 14 days for
chronic constipation, or after 3 days for faecal impaction.
WHAT IS IN THIS LEAFLET
:
1.
What Compound Macrogol Oral Powder Sugar Free is and what it is used
for
2.
What you need to know before you take Compound Macrogol Oral Powder
Sugar Free
3.
How to take Compound Macrogol Oral Powder Sugar Free
4.
Possible side effects
5.
How to store Compound Macrogol Oral Powder Sugar Free
6.
Contents of the pack and other information
1.
WHAT COMPOUND MACROGOL ORAL POWDER SUGAR FREE IS AND WHAT IT IS USED
FOR
Macrogol 3350 is a laxative used for the treatment of constipation,
especially if you have been
constipated for a long time. It is also used to treat a build up of
hard faeces in your bowel which
may be a result of long-term constipation (this is known as faecal
impaction). Macrogol 3350
makes your faeces softer and easier to pass, giving you relief from
constipation. The electrolytes
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 COMPOUND MACROGOL ORAL POWDER
SUGAR
FREE
DO NOT TAKE COMPOUND MACROGOL ORAL POWDER SUGAR FREE:
-
if you are allergic (hypersensitive) to macrogol 3350, sodium
chloride, sodium hydrogen
carbonate, potassium chloride or acesulfame potassium
-
if you have a perforation in the wall of

Summary of Product characteristics

OBJECT 1
COMPOUND MACROGOL ORAL POWDER SUGAR FREE.
Summary of Product Characteristics Updated 13-Nov-2015 | Galen Limited
1. Name of the medicinal product
Compound Macrogol Oral Powder Sugar Free.
2. Qualitative and quantitative composition
Each sachet contains the following quantitative composition of active
ingredients:
Macrogol 3350
Sodium Chloride
Sodium Hydrogen Carbonate
Potassium Chloride
13.125g
350.7mg
178.5mg
46.6mg
The content of electrolyte ions per sachet following reconstitution in
125ml of water is equivalent to:
Sodium
Chloride
Hydrogen Carbonate (Bicarbonate)
Potassium
65mmol/l
53mmol/l
17mmol/l
5.4mmol/l
For the 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. Compound Macrogol Oral
Powder Sugar Free is also effective
in resolving faecal impaction, defined as refractory constipation with
faecal loading of the rectum and/or
colon.
Compound Macrogol Oral Powder Sugar Free is indicated in adults,
adolescents and the elderly.
4.2 Posology and method of administration
Compound Macrogol Oral Powder Sugar Free is for oral use.
_Chronic Constipation:_
A course of treatment for chronic constipation with Compound Macrogol
Oral Powder Sugar Free 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 the elderly: 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.
_Faecal Impaction:_
A course of treatment for faecal impaction with