Laxaclear 5.9 g, powder for oral solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Macrogol 3350

Available from:

Helsinn Birex Pharmaceuticals Limited

ATC code:

A06AD; A06AD65

INN (International Name):

Macrogol 3350

Dosage:

5.9 gram(s)

Pharmaceutical form:

Powder for oral solution

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Osmotically acting laxatives; macrogol, combinations

Authorization status:

Not marketed

Authorization date:

2013-08-16

Patient Information leaflet

IE/H/0469/001/R/001
PACKAGE LEAFLET: INFORMATION FOR THE USER
LAXACLEAR 5.9 G, POWDER FOR ORAL SOLUTION
Macrogol 3350
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your pharmacist has 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 or pharmacist. This
includes any possible
side effects not listed in this leaflet.

If your symptoms of constipation worsen, you must talk to a doctor
immediately.

Talk to a doctor if your symptoms do not improve after 5 days of using
Laxaclear.
WHAT IS IN THIS LEAFLET
1.
What Laxaclear is and what it is used for
2.
What you need to know before you use Laxaclear
3.
How to use Laxaclear
4.
Possible side effects
5.
How to store Laxaclear
6.
Contents of the pack and other information
1.
WHAT LAXACLEAR IS AND WHAT IT IS USED FOR
Laxaclear contains an ingredient called ‘Macrogol 3350’ (or
‘polyethylene glycol’) and a
mixture of salts. It comes as a powder that you dissolve in water to
make a drink.
Laxaclear is used as a laxative for short-term relief of constipation.
It can be used in adults,
adolescents over 12 years of age and the elderly.
Constipation can often be relieved by eating fresh fruit and
vegetables, drinking plenty of
water and exercising. If these do not work, then Laxaclear can be
used.
You must talk to a doctor immediately if your symptoms of constipation
worsen.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE LAXACLEAR
DO NOT USE LAXACLEAR IF:

you are allergic to Macrogol 3350 (‘polyethylene glycol’) or any
of the other ingredients of
this medicine (listed in Section 6)

you have severe inflammatory bowel disease like ‘ulcerative
colitis’ or ‘Crohn’s disease’

you have severe bloating of your gut (‘toxic megacolon’)

you have a hole or tear in your gut wall


Summary of Product characteristics

Health Products Regulatory Authority
27 November 2018
CRN008RNM
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Laxaclear 5.9 g, powder for oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains 5.9g of Macrogol 3350
Excipients with known effect:
Laxaclear 5.9g contains 12.5 mmol (287.36 mg) of sodium, 1 mmol
(39.098 mg)of
potassium and 5 mg of aspartame (E951) per sachet. The vanilla flavour
contains
trace amounts of sulphur dioxide (E220) (15 ppm) and less than 1mg
benzyl alcohol
(0.0066 mg).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral solution.
White or almost white granular powder for oral solution which on
reconstitution
gives a clear colourless solution with a characteristic flavour of
vanilla.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For use as a short term laxative in cases of constipation in adults,
adolescents and the
elderly.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Paediatric population_
The safety and efficacy of Laxaclear in children aged 0-12 years have
not yet been
established. No data are available.
_Adults, Adolescents and Elderly_
The usual dose is 1-2 sachets per day in one intake. The maximum dose
is 4 sachets
per day. No dosage adjustment is necessary in the elderly.
Health Products Regulatory Authority
27 November 2018
CRN008RNM
Page 2 of 6
As with all laxatives, prolonged use is not recommended. A course of
treatment for
constipation with Laxaclear does not normally exceed 5 days, although
this can be
repeated if required.
No dosage adjustment is required in patients with renal impairment.
Method of administration
The sachets of powder are dissolved in 100ml of water, stirring to aid
dissolution,
prior to oral administration. The powder dissolves completely to give
a clear or
slightly hazy solution.
The effect of Laxaclear becomes apparent 24 to 48 hours after its
administration.
4.3 CONTRAINDICATIONS
1. Hypersensitivity to the active substance or to any of the
excipients li