Truberzi

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Eluxadoline

Available from:

Allergan Pharmaceuticals International Limited

ATC code:

A07

INN (International Name):

eluxadoline

Therapeutic group:

Antidiarrheals, intestinal antiinflammatory / antiinfective agents

Therapeutic area:

Irritable Bowel Syndrome; Diarrhea

Therapeutic indications:

Truberzi is indicated in adults for the treatment of irritable bowel syndrome with diarrhoea (IBS D).

Product summary:

Revision: 6

Authorization status:

Withdrawn

Authorization date:

2016-09-19

Patient Information leaflet

Medicinal product no longer authorised
33
B. PACKAGE LEAFLET
Medicinal product no longer authorised
34
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TRUBERZI 75 MG FILM-COATED TABLETS
Eluxadoline
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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 Truberzi is and what it is used for
2.
What you need to know before you take Truberzi
3.
How to take Truberzi
4.
Possible side effects
5.
How to store Truberzi
6.
Contents of the pack and other information
1.
WHAT TRUBERZI IS AND WHAT IT IS USED FOR
Truberzi is a medicine that contains the active substance eluxadoline.
It is used to treat irritable bowel
syndrome (‘IBS’) with diarrhoea (IBS-D) in adults.
IBS is a common gut disorder. The main symptoms of IBS-D include:
-
stomach ache;
-
stomach discomfort;
-
diarrhoea;
-
urgent bowel movements.
Truberzi acts on the surface of your gut to restore the normal
function of your bowels and block the
sensation of pain and discomfort in IBS-D patients.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRUBERZI
_ _
DO NOT TAKE TRUBERZI:
-
if you are allergic to eluxadoline or any of the other ingredients of
this medicine (listed in
section 6);
-
if you have, or have had, pancreatitis (inflammation of the pancreas);
-
if you don’t have a gallbladder by birth or your gallbladder has
been surgicall

Summary of Product characteristics

Medicinal product no longer authorised
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Truberzi 75 mg film-coated tablets.
Truberzi 100 mg film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Truberzi
75 mg film-coated tablets
Each film-coated tablet contains 75 mg of eluxadoline.
Truberzi 100 mg film-coated tablets
Each film-coated tablet contains 100 mg of eluxadoline.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Truberzi
75 mg film-coated tablets
Modified capsule-shaped, pale yellow to light-tan film-coated tablet
of approximately 7 mm x 17 mm,
debossed with “FX75” on one side.
Truberzi
100 mg film-coated tablets
Modified capsule-shaped, pink-orange to peach film-coated tablet of
approximately 8 mm x 19 mm,
debossed with “FX100” on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Truberzi is indicated in adults for the treatment of irritable bowel
syndrome with diarrhoea (IBS-D).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The treatment should be initiated and supervised by a physician
experienced in diagnosis and
management of gastrointestinal disorders.
The recommended dose is 200 mg daily (one 100 mg tablet, twice daily).
For patients who are unable to tolerate the 200 mg daily dose (one 100
mg tablet, twice daily), the
dose can be lowered to 150 mg daily (one 75 mg tablet twice daily).
_Elderly _
In principle, general dose recommendations also apply to patients aged
65 years and above.
However, given the potential for increased sensitivity to experience
undesirable effects, it may be
considered to initiate eluxadoline treatment in a dosage of 150 mg
daily (one 75 mg tablet twice daily).
Medicinal product no longer autho