Laxido Orange, powder for oral solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

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

Available from:

Galen Pharma Ireland Limited

ATC code:

A06AD; A06AD65

INN (International Name):

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

Dosage:

13.8 gram(s)

Pharmaceutical form:

Powder for oral solution

Therapeutic area:

Osmotically acting laxatives; macrogol, combinations

Authorization status:

Marketed

Authorization date:

2008-07-21

Patient Information leaflet

1.3.1 Package Leaflet
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LAXIDO ORANGE, POWDER 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 Laxido Orange is and what it is used for
2.
What you need to know before you take Laxido Orange
3.
How to take Laxido Orange
4.
Possible side effects
5.
How to store Laxido Orange
6.
Contents of the pack and other information
1.
WHAT LAXIDO ORANGE IS AND WHAT IT IS USED FOR
Laxido Orange contains macrogol 3350 and the electrolytes sodium
chloride, sodium hydrogen
carbonate and potassium chloride.
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 LAXIDO ORANGE
DO NOT TAKE LAXIDO ORANGE:
-
if you are allergic (hypersensitive) to macrogol 3350, sodium
chloride, sodium hydrogen
carbonate, potassium chloride, or any of the other ingredients of this
medicine (listed in
section 6)
-
if you have a perforation in the wall of your intestine
-
if you have a blockage in your intestine
-
if you have paralysis of the intestine (for example, your in

Summary of Product characteristics

Health Products Regulatory Authority
29 November 2021
CRN00CLKM
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Laxido Orange, powder for oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains the following quantitative composition of active
ingredients:
Macrogol 3350 13.125g
Sodium Chloride 350.7mg
Sodium Hydrogen Carbonate 178.5mg
Potassium Chloride 46.6mg
The content of electrolyte ions per sachet following reconstitution in
125ml of water is equivalent to:
Sodium 65mmol/l
Chloride 53mmol/l
Hydrogen Carbonate (Bicarbonate) 17mmol/l
Potassium 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. Laxido Orange is also
effective in resolving faecal impaction, defined as refractory
constipation with faecal loading of the rectum and/or colon.
Laxido Orange is indicated in adults, adolescents and the elderly.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Laxido Orange is for oral use.
Posology
_Chronic Constipation:_
A course of treatment for chronic constipation with Laxido Orange 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 Laxido Orange does not
normally exceed 3 days.
Adults, adolescents and the elderly: 8 sachets daily, all of which
sh