LAXATEV 13.8 Grams Powder for Oral Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

MACROGOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE

Available from:

Teva Pharma B.V.

ATC code:

A06AD65

INN (International Name):

MACROGOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE

Dosage:

13.8 Grams

Pharmaceutical form:

Powder for Oral Solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Osmotically acting laxatives

Authorization status:

Authorised

Authorization date:

2014-02-28

Patient Information leaflet

Macrogol, UK/H/5431/01, 29.11.16
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
LAXATEV 13.8 G 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 or pharmacist.
-
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What _Laxatev_ is and what it is used for
2.
What you need to know before you take _Laxatev_
3.
How to take _Laxatev_
4.
Possible side effects
5.
How to store _Laxatev_
6.
Contents of the pack and other information
1. WHAT LAXATEV IS AND WHAT IT IS USED FOR
The name of this medicine is _Laxatev 13.8 g powder for Oral
Solution_. It is a laxative for the
treatment of chronic constipation and of very bad constipation (called
faecal impaction) in adults,
adolescents and elderly. It is not recommended for children below 12
years of age.
_ _
It helps you to have a comfortable bowel movement even if you have
been constipated for a long time.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE _LAXATEV_
DO NOT TAKE _LAXATEV_
-
if you are allergic 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 perforated gut (bowel) wall
-
if you have a blockage in your intestine (gut obstruction, ileus)
-
if you have severe inflammatory bowel disease such as ulcerative
colitis, Crohn’s disease or toxic
megacolon.
WARNINGS AND PRECAUTIONS
When taking _Laxatev_ you should continue to take plenty of fluids.
The fluid content of _Laxatev_
should not replace your regular liquid intake.
OTHER MEDICINES AND _LAXATEV_
Tell your doctor or pharmacist if you are

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Laxatev 13.8g Powder for Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains the following 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 when made up to 125 ml of
solution is as follows:
Sodium
65 mmol/l
Chloride
53 mmol/l
Hydrogen carbonate
17 mmol/l
Potassium
5 mmol/l
Excipient with known effect: sorbitol
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.
For the treatment of faecal impaction, defined as refractory
constipation with faecal loading of the rectum and/or colon.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Posology:_
CHRONIC CONSTIPATION
A course of treatment for constipation with Laxatev 13.8 g 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 of age): Not recommended. Alternative
products are available for children.
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