Trientine 167 mg hard capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

TRIENTINE DIHYDROCHLORIDE

Available from:

Tillomed Pharma GmbH

ATC code:

A16AX12

INN (International Name):

TRIENTINE DIHYDROCHLORIDE

Pharmaceutical form:

Capsule, hard

Therapeutic area:

Trientine

Authorization status:

Not marketed

Authorization date:

2022-08-26

Patient Information leaflet

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
TRIENTINE 167 MG HARD CAPSULES
trientine
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 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, or pharmacist or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Trientine is and what it is used for
2.
What you need to know before you take Trientine
3.
How to take Trientine
4.
Possible side effects
5.
How to store Trientine
6.
Contents of the pack and other information
1.
WHAT TRIENTINE IS AND WHAT IT IS USED FOR
Trientine contains trientine. This medicine is used for the treatment
of Wilson’s disease.
Wilson’s disease is an inherited condition in which the body cannot
transport copper around the body
in the normal way or remove copper in the normal way as a secretion
from the liver into the gut. This
means that the small amounts of copper from food and drink build up to
excessive levels and can lead
to liver damage and problems in the nervous system. This medicine
mainly works by attaching to copper
in the body which then allows it to be removed in the urine instead,
helping to lower copper levels. It
may also attach to copper in the gut and so reduce the amount taken up
into the body.
Trientine is given to adults, adolescents and children aged 5 years
and over who cannot tolerate another
medicine that is used to treat this disease, called penicillamine.
It controls the amount of copper in the body by binding to it. The
copper can then be passed from the
body.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRIENTINE
DO NOT TAKE TRIENTINE:
-
if you are allergic to trientine or any of the

Summary of Product characteristics

Health Products Regulatory Authority
27 March 2023
CRN00DFC5
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Trientine 167 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 167 mg trientine equivalent to 250 mg
trientine dihydrochloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard
Brown opaque hard gelatin size 1 capsule imprinted with "HP551" in
black ink on the capsule body and cap, filled with white to
pale yellow powder. Capsule length is between 18.9 mm and 19.7 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of Wilson's disease in patients intolerant of
D-Penicillamine therapy, in adults, adolescents and children aged
5 years or older.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should only be initiated by specialist physicians with
experience in the management of Wilson's disease.
Posology
The starting dose would usually correspond to the lowest dose in the
range and the dose should subsequently be adapted
according to the patient's clinical response (see section 4.4).
Adults (including elderly):
The recommended dose is 670-1340 mg of trientine base (4-8 capsules)
daily in 2 to 4 divided doses. The recommended doses
are expressed as mg of the trientine base (i.e. not in mg of the
trientine dihydrochloride salt) (see section 4.4).
_Special populations_
_Elderly _
No dose adjustment is required in elderly patients.
_Renal impairment _
There is limited information in patients with renal impairment. No
specific dose adjustment is required in these patients (see
section 4.4).
_Hepatic impairment_
There is no data available for the use of trientine in patients with
impaired liver function. However, monitoring may be
necessary to avoid either toxicity or inefficacy (see section 4.4).
_Paediatric population _
The starting dose in paediatrics is lower than for adults and depends
on age and body weight.
_Children ≥ 5 years _
The weight-based dose is not established, but the