TEVICON 13.7 Grams Powder for Oral Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

MACROGOL 3350, POTASSIUM CHLORIDE, SODIUM CHLORIDE, SODIUM HYDROGEN CARBONATE

Available from:

Teva Pharma B.V.

ATC code:

A06AD65

INN (International Name):

MACROGOL 3350, POTASSIUM CHLORIDE, SODIUM CHLORIDE, SODIUM HYDROGEN CARBONATE

Dosage:

13.7 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:

2011-02-18

Patient Information leaflet

Page 1 of 5 

PACKAGE LEAFLET: INFORMATION FOR THE USER 

TEVICON 13.7 G,_ _POWDER FOR ORAL SOLUTION, SACHET  

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 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 _Tevicon_ is and what it is used for 
2.  What you need to know before you take _Tevicon_ 
3.  How to take _Tevicon_ 
4.  Possible side effects 
5.  How to store _Tevicon_ 
6.  Contents of the pack and other Information 

1. WHAT TEVICON IS AND WHAT IT IS USED FOR 

The name of this medicine is Tevicon13.7g Sachet, Powder
for Oral Solution.  

It is a laxative for the treatment of chronic constipation in
adults, children (aged 12 years and 
above) and the elderly. 

It helps you to have a comfortable bowel movement even if you
have been constipated for a 
long time. It also works in very bad constipation called faecal
impaction (complete severe 
constipation). 

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE _TEVICON_ 

DO NOT TAKE _TEVICON_ 


if you are allergic to macrogol 3350, sodium chloride,
sodium hydrogen carbonate, 
potassium chloride or any of the other ingredients listed in
section 6. 


if you have a perforated gut wall. 


if you have a blockage in your intestine (gut obstruction,
ileus) for example by paralysis 
of the intestine.  


if you have severe inflammatory bow

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tevicon 13.7g Powder for Oral Solution, Sachet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains the following active ingredients:
Macrogol 3350
13.125 g
Sodium chloride
350.7 mg
Sodium hydrogen carbonate 178.5 mg
Potassium chloride
46.6 mg
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
5.4 mmol/l
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral solution.
A white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Tevicon is indicated for the treatment of chronic constipation and resolving 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
_Adults, adolescents and older people: _1 –3 sachets daily in divided doses. Normal dose for most patients is 1-2 sachets
per day. Depending on the individual response 3 sachets per day might be needed.
A course of treatment for constipation does not normally exceed 2 weeks, although this can be repeated if required.
For extended use, the lowest effective dose should be used.
Special populations
_Paediatric population_
Tevicon should not be used in children below 12 years of age. Alternative products are available for children.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 02/02/2016_
_CRN 2166125_
_page number: 1_
_Patients with renal insufficiency_
No dosage change is necessary for the treatment of chronic constipation.
FAECAL IMPACTION
A course of treatment for faecal impaction does not