Cuprior
Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
Upplýsingar fylgiseðill
(PIL)
26-03-2024
Vara einkenni
(SPC)
26-03-2024
Opinber matsskýrsla
(PAR)
03-10-2017
Virkt innihaldsefni:
Trientine tetrahydrochloride
Fáanlegur frá:
GMP-Orphan SA
ATC númer:
A16AX
INN (Alþjóðlegt nafn):
trientine
Meðferðarhópur:
Other alimentary tract and metabolism products,
Lækningarsvæði:
Hepatolenticular Degeneration
Ábendingar:
Cuprior is indicated for the treatment of Wilson's disease in adults, adolescents and children ≥ 5 years intolerant to D-penicillamine therapy.,
Vörulýsing:
Revision: 6
Leyfisstaða:
Authorised
Leyfisdagur:
2017-09-05
Upplýsingar fylgiseðill
16
B. PACKAGE LEAFLET
17
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CUPRIOR 150 MG FILM-COATED TABLETS
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.
-
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 Cuprior is and what it is used for
2.
What you need to know before you take Cuprior
3.
How to take Cuprior
4.
Possible side effects
5.
How to store Cuprior
6.
Contents of the pack and other information
1.
WHAT CUPRIOR IS AND WHAT IT IS USED FOR
Cuprior is a medicine used to treat Wilson’s disease that contains
the active substance trientine.
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.
Cuprior 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CUPRIOR
DO NOT TAKE CUPRIOR
-
if you are allergic to trientine or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before t
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1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Cuprior 150 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains trientine tetrahydrochloride
equivalent to 150 mg trientine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Yellow, 16 mm x 8 mm oblong film-coated tablet with a score line on
each side.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cuprior is indicated for the treatment of Wilson’s disease in
adults, adolescents and children ≥ 5 years
intolerant to D-penicillamine therapy.
_ _
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).
_ _
_Adult _
The recommended dose is between 450 mg and 975 mg (3 to 6 and a half
film-coated
tablets) per day
in 2 to 4 divided doses.
_Paediatric population _
The starting dose in paediatrics is lower than for adults and depends
on age and may be calculated
using body weight. The dose should subsequently be adapted according
to the child’s clinical response
(see section 4.4).
_Children and adolescents (_
≥
_5 years_
to 18
_ years) _
The dose is usually between 225 mg and 600 mg per day (1 and a half to
4 film-coated tablets) in 2 to
4 divided doses.
_Children aged < 5 years _
The safety and efficacy of trientine in children aged < 5 years have
not been established.
The pharmaceutical form is not suitable for administration to children
< 5 years.
3
The recommended doses of Cuprior are expressed as mg of trientine base
(i.e. not in mg of the
trientine tetrahydrochloride salt).
_Special populations _
_Elderly _
No dose adjustment is required in elderly patients.
_Renal impairment _
There is limit
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