Laxido, 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 Limited

ATC code:

A06AD; A06AD65

INN (International Name):

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

Dosage:

13.125 g/350.7 mg/178.5 mg/46.6  milligram(s)

Pharmaceutical form:

Powder for oral solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Osmotically acting laxatives; macrogol, combinations

Authorization status:

Not marketed

Authorization date:

2008-07-21

Patient Information leaflet

1.3.1.1 Package Leaflet
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
LAXIDO, 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 is and what it is used for
2.
What you need to know before you take Laxido
3.
How to take Laxido
4.
Possible side effects
5.
How to store Laxido
6.
Contents of the pack and other information
1.
WHAT LAXIDO IS AND WHAT IT IS USED FOR
Laxido 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
DO NOT TAKE LAXIDO:
-
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 your intestine
-
if you have a blockage in your intestine
-
if you have paralysis of the intestine (for example, your intestines
may stop working due to
intestinal surgery or severe infection)
-
if you have ulcerative colitis, Crohn�

Summary of Product characteristics

Health Products Regulatory Authority
21 December 2018
CRN008MDD
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Laxido, 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 is also effective in
resolving faecal
impaction, defined as refractory constipation with faecal loading of
the rectum
and/or colon.
Laxido is indicated in adults, adolescents and the elderly.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Laxido is for oral use.
POSOLOGY
_Chronic Constipation:_
A course of treatment for chronic constipation with Laxido does not
normally exceed
2 weeks, although this can be repeated if required. As for all
laxatives, prolonged use
Health Products Regulatory Authority
21 December 2018
CRN008MDD
Page 2 of 7
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 does not
normally exceed 3
days.
Adults, adolescents and the elderly