Cuprior

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



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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). 
 
The recommended dose is between 450 mg and 975 mg (3 to 6½ film-coated tablets) per day in 2 to 
4 divided doses.  
 
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). 
 
Paediatric population 
The starting dose in paediatrics is lower than for adults and depends on age and body weight.  
 
Children ≥ 5 years  
The dose is usually between 225 mg and 600 mg per day (1½ to 4 film-coated tablets) in 2 to 4 divided 
doses.  
 
 



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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. 
 
The recommended doses of Cuprior are expressed as mg of trientine base (i.e. not in mg of the 
trientine tetrahydrochloride salt).  
  
Method of administration 
Cuprior is for oral use. The film-coated tablets should be swallowed with water. The scored film-
coated tablet can be divided in two equal halves, if required, to provide a more precise dose or 
facilitate administration. 
 
It is important that Cuprior is given on an empty stomach, at least one hour before meals or two hours 
after meals and at least one hour apart from any other medicinal product, food, or milk (see section 
4.5).  
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
4.4 Special warnings and precautions for use 
 
When switching a patient from another formulation trientine, caution is advised because doses 
expressed in trientine base may not be equivalent (see section 4.2).   
 
Trientine is a chelating agent which has been found to reduce serum iron levels. Iron supplements may 
be necessary in  case of iron deficiency anaemia and should be administered at a different time (see 
section 4.5).  
 
The combination of trientine with zinc is not recommended. There are only limited data on 
concomitant use available and no specific dose recommendations can be made. 
 
In patients who were previously treated with D-penicillamine, lupus-like reactions have been reported 
during subsequent  treatment with trientine, however it is not possible to determine if there is a causal 
relationship with trientine. 
 
Monitoring 
Patients receiving Cuprior should remain under regular medical supervision and be monitored for 
appropriate control of symptoms and copper levels in order to optimise the dose (see section 4.2).  
 
The aim of maintenance treatment is to maintain free copper levels in the serum within acceptable 
limits. The most reliable index for monitoring therapy is the determination of serum free copper which 
is calculated using the difference between the total copper and the ceruloplasmin-bound copper 
(normal level of free copper in the serum is usually 100 to 150 microgram/L).  
 
The measurement of copper excretion in the urine may be performed during therapy. Since chelation 
therapy leads to an increase in urinary copper levels, this may/will not give an accurate reflection of 
the excess copper load in the body but may be a useful measure of treatment compliance. 
 
Worsening of clinical symptoms, including neurological deterioration, may occur at the beginning of 
chelation therapy due to excess of free serum copper during the initial response to treatment. Close 
monitoring is required to optimise the dose or to adapt treatment if necessary. 
 
Special populations 
Overtreatment carries the risk of copper deficiency. Monitoring for manifestations of overtreatment 
should be undertaken, particularly when copper requirements may change, such as in pregnancy (see 



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section 4.6) and in children where appropriate control of copper levels are required to ensure proper 
growth and mental development. 
 
Patients with renal impairment receiving trientine should remain under regular medical supervision for 
appropriate control of symptoms and copper levels. Close monitoring of renal function is also 
recommended in these patients (see section 4.2). 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
No interaction studies have been performed. 
 
Trientine has been found to reduce serum iron levels, possibly by reducing its absorption, and iron 
supplements may be required. Since iron and trientine may inhibit absorption of each other, iron 
supplements should be taken after at least two hours have elapsed from the administration of trientine. 
 
As trientine is poorly absorbed following oral intake and the principal mechanism of action requires its 
systemic exposure (see section 5.1), it is important that the film-coated tablets are taken on empty 
stomach at least one hour before meals or 2 hours after meals and at least one hour apart from any 
other medicinal product, food, or milk (see section 4.2).  This maximises the absorption of trientine 
and reduces the likelihood of the medicinal product binding to metals in the gastrointestinal tract. 
However, no food interaction studies have been performed and so the extent of the food effect on 
systemic trientine exposure is unknown.  
 
Although there is no evidence that calcium or magnesium antacids alter the efficacy of trientine, it is 
good practice to separate their administration. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
There is a limited amount of data from the use of trientine in pregnant women. 
 
Studies in animals have shown reproductive toxicity, which was probably a result of trientine-induced 
copper deficiency (see section 5.3). 
 
Cuprior should only be used in pregnancy after careful consideration of the benefits compared with the 
risks of treatment in the individual patient. Factors which need to be born in mind include the risks 
associated with the disease itself, the risk of those alternative treatments which are available and the 
possible teratogenic effects of trientine (see section 5.3). 
 
Since copper is required for proper growth and mental development, dose adjustments may be 
required to ensure that the foetus will not become copper deficient and close monitoring of the patient 
is essential (see section 4.4). 
 
The pregnancy should be closely monitored in order to detect possible foetal abnormality and to assess 
maternal serum copper levels throughout the pregnancy. The dose of trientine used should be adjusted 
in order to maintain serum copper levels within the normal range.  
 
Babies born to mothers being treated with trientine should be monitored for serum copper levels where 
appropriate. 
 
Breast-feeding 
It is unknown whether trientine is excreted in human milk. A risk to the newborns/infants cannot be 
excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain 
from Cuprior therapy taking into account the benefit of breast-feeding for the child and the benefit of 
therapy for the woman. 
 



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Fertility 
It is unknown whether trientine has an effect on human fertility. 
 
4.7 Effects on ability to drive and use machines 
 
Cuprior has no or negligible influence on the ability to drive and use machines.  
 
4.8 Undesirable effects 
 
Summary of the safety profile 
The most commonly reported adverse reaction with trientine is nausea. Serious iron deficiency 
anaemia and severe colitis may occur during treatment.   
 
Tabulated list of adverse reactions 
The following adverse reactions have been reported with the use of trientine for Wilson’s disease.  
Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon 
(≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be 
estimated from the available data). 
 

System organ class Adverse reactions 
Blood and lymphatic system disorders Not known: iron deficiency anaemia. 
Gastrointestinal disorders Common: nausea.  

Not known: duodenitis, colitis (including 
severe colitis). 

Skin and subcutaneous tissue disorder Uncommon: skin rash, pruritus, erythema.  
Not known: urticaria. 

 
Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
Occasional cases of trientine overdose have been reported. In cases up to 20 g of trientine base there 
were no apparent adverse effects reported. A large overdose of 40 g of trientine base resulted in self-
limiting dizziness and vomiting with no other clinical sequelae or significant biochemical 
abnormalities reported.  
 
There is no antidote for trientine acute overdose. 
 
Chronic over treatment can lead to copper deficiency and reversible sideroblastic anaemia.  
Overtreatment and excess copper removal can be monitored using values of urine copper excretion 
and of non-ceruloplasmin bound copper. Close monitoring is required to optimise the dose or to adapt 
treatment if necessary (see section 4.4). 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Other alimentary tract and metabolism products, various alimentary tract 
and metabolism products, ATC code: A16AX12. 
 



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Mechanism of action  
Trientine is a copper-chelating agent whose principal mechanism of action is to eliminate absorbed 
copper from the body by forming a stable complex that is then eliminated through urinary excretion. 
Trientine may also chelate copper in the intestinal tract and so inhibit copper absorption. 
 
5.2 Pharmacokinetic properties 
 
Absorption 
The absorption of trientine following oral administration is low and variable in patients with Wilson 
disease. The pharmacokinetic profile of Cuprior has been evaluated after a single oral dose of 450, 
600 mg and 750 mg trientine in healthy male and female subjects. Plasma levels of trientine rose 
rapidly following administration with the median peak level reached after 1.25 to 2 hours. The 
trientine plasma concentration then declined in a multiphasic manner, initially rapidly, followed by a 
slower elimination phase. The overall pharmacokinetic profiles were similar between males and 
females, although males had higher levels of trientine.   
 
Distribution 
Little is known on the distribution of trientine in organs and tissues.  
 
Biotransformation 
Trientine is acetylated in two majors metabolites, N(1)-acetyltriethylenetetramine (MAT) and 
N(1),N(10)-diacetyltriethylenetetramine (DAT). MAT may also participate to the overall clinical 
activity of Cuprior, however the extent of MAT to the overall effect of Cuprior on copper levels  
remains to be determined. 
 
Elimination 
Trientine and its metabolites are rapidly excreted in the urine, although low levels of trientine could 
still be detected in the plasma after 20 hours. Unabsorbed trientine is eliminated through faecal 
excretion. 
 
Linearity/non-linearity 
Plasma exposures in humans have shown a linear relationship with oral doses of trientine. 
 
5.3 Preclinical safety data 
 
Preclinical data obtained with trientine have shown adverse reactions not observed in clinical studies, 
but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to 
clinical use as follows: 
 
Repeat dose toxicity 
In mice administered in drinking water, trientine displayed increased frequencies of inflammation of 
the lung interstitium and liver periportal fatty infiltration. Hematopoietic cell proliferation was seen in 
the spleen of males. Kidney and body weights were reduced in males as was the incidence of renal 
cytoplasmic vacuolisation. The NOAEL was established at approximately 92 mg/kg/day for males and 
99 mg/kg/day for females. In rats administered oral trientines doses, up to 600 mg/kg/day for 26 
weeks, histopathology revealed a dose-related incidence and severity of focal chronic interstitial 
pneumonitis accompanied by fibrosis of the alveolar wall. The microscopic changes in lung were 
considered indicative of a persistent inflammatory reaction or persistent toxic effect on alveolar cells. 
Taking into account that trientine has irritating properties, it was estimated that the observed chronic 
interstitial pneumonitis was explained by a cytotoxic effect of trientine upon accumulation into 
bronchiolar epithelial cells and alveolar pneumocytes. These findings were not reversible. The rat 
NOAEL was considered 50 mg/kg/day for females, a NOAEL was not established for males. 
Dogs receiving oral doses of trientine up to 300 mg/kg/day, showed neurological and/or 
musculo-skeletal clinical symptoms (abnormal gait, ataxia, weak limbs, body tremors) in repeat-dose 
toxicity studies, attributed to the copper-depleting activity of trientine. The NOAEL was established at 



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50 mg/kg/day resulting in safety margins of about 4 in males and 17 in females, towards human 
therapeutic exposures. 
 
Genotoxicity 
Overall, trientine has shown positive effects in in vitro genotoxicity studies, including the Ames test 
and genotoxicity tests in mammalian cells. In vivo, trientine was however negative in the mouse 
micronucleus test. 
 
Reproductive and developmental toxicity 
When rodents were fed throughout pregnancy a diet containing trientine, the frequency of resorptions 
and the frequency of abnormal fetuses at term showed a dose-related increase. These effects are 
possibly due to trientine induced-copper and zinc deficiency.  
 
Local tolerance 
In silico data predict that trientine displays irritating and sensitising properties. Positive results for 
sensitization potential in Guinea pig maximization tests were reported. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Tablet core: 
Mannitol.  
Colloidal anhydrous silica. 
Glycerol dibehenate. 
 
Tablet film-coating: 
Polyvinyl alcohol. 
Talc. 
Titanium dioxyde (E171). 
Glycerol monocaprylocaprate (Type I). 
Iron oxide yellow (E172). 
Sodium laurilsulfate. 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
30 months. 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special storage conditions. 
 
6.5 Nature and contents of container  
 
OPA/Alu/PVC-Alu blisters, each blister contains 8 film-coated tablets. 
Pack size: 72 or 96 film-coated tablets. 
Not all pack sizes may be marketed 
 
6.6 Special precautions for disposal  
 
No special requirements. 



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7. MARKETING AUTHORISATION HOLDER 
 
gmp-orphan SA 
Pépinière Paris Santé Cochin 
27-29 rue du Faubourg Saint-Jacques 
75014 Paris 
France 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/17/1199/001 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 5 September 2017 
 
 
10. DATE OF REVISION OF THE TEXT 
 
 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 
 



9 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 

 

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE  

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 

 



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A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 

Name and address of the manufacturer(s) responsible for batch release 

DELPHARM EVREUX 
5 rue du Guesclin 
27000 Evreux 
France 
 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product 
Characteristics, section 4.2). 
 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
AUTHORISATION  

 Periodic safety update reports  
 

The requirements for submission of periodic safety update reports for this medicinal product are set 
out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 
2001/83/EC and any subsequent updates published on the European medicines web-portal. 

The marketing authorisation holder shall submit the first periodic safety update report for this 
product within 6 months following authorisation.  
 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 
EFFECTIVE USE OF THE MEDICINAL PRODUCT 

 Risk Management Plan (RMP) 
 

The MAH shall perform the required pharmacovigilance activities and interventions detailed in the 
agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent 
updates of the RMP. 

An updated RMP should be submitted: 

 At the request of the European Medicines Agency; 

 Whenever the risk management system is modified, especially as the result of new 
information being received that may lead to a significant change to the benefit/risk profile or 
as the result of an important (pharmacovigilance or risk minimisation) milestone being 
reached.  



11 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



12 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



13 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Cuprior 150 mg film-coated tablets  
trientine  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains trientine tetrahydrochloride equivalent to 150 mg trientine. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Film-coated tablet 
72 film-coated tablets 
96 film-coated tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Package leaflet online at QR code to be included  http://www.cuprior.com 
 
Oral use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
Take on an empty stomach, at least one hour before meals or two hours after meals and at least one 
hour apart from any other medicine, food, or milk. 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 



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10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
gmp-orphan SA 
Pépinière Paris Santé Cochin 
27-29 rue du Faubourg Saint-Jacques 
75014 Paris, France  
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/17/1199/001 72 film-coated tablets 
EU/1/17/1199/002 96 film-coated tablets 
 
 
 
13. BATCH NUMBER 
 
Lot  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Cuprior 150 mg  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: {number}  
SN: {number}  
NN: {number}  
 
 



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MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Cuprior 150 mg film-coated tablets 
trientine 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
gmp-orphan SA 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
 



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B. PACKAGE LEAFLET 



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Package leaflet: Information for the patient 
 

Cuprior 150 mg film-coated tablets 
trientine 

 
You can find the information also when flashing the QR code below with a smartphone or via the 
website QR code to be included  http://www.cuprior.com 
 
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 taking Cuprior. 
 
If you were already taking another trientine medicine, your doctor may modify your daily dose, the 
number of tablets or the number of intake in the day when switching to Cuprior treatment.  
 
Your symptoms may initially get worse after starting the treatment. If this happens, you must tell your 
doctor. 
 



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Your doctor will regularly check your blood and urine to ensure that  you receive the right dose of 
Cuprior to properly control your symptoms and copper levels.  
 
You should tell your doctor if you get any side effects as this may indicate that your dose of Cuprior 
needs to be adjusted up or down.  
 
This medicine may also reduce the level of iron in your blood and your doctor may prescribe iron 
supplements (see section “Other medicines and Cuprior” below). 
 
If you have kidney problems, your doctor will regularly check that the treatment dose is appropriate 
and does not affect the functioning of your kidney. 
 
The association of trientine with another medicine that contains zinc is not recommended.  
 
Lupus-like reactions (symptoms may include persistent rash, fever, joint pain, and tiredness) have 
been reported in some patients switched to trientine medicine after penicillamine medicine. However it 
was not possible to determine if the reaction was due to trientine or to previous penicillamine 
treatment.  
 
Children and adolescents 
Your doctor will carry out checks more frequently to ensure your copper levels are maintained at a 
suitable level for normal growth and mental development.  
This medicine is not recommended for children aged below 5 years of age. 
 
Other medicines and Cuprior 
Tell your doctor if you are taking, have recently taken, or might take any other medicines.  
 
In particular, you must tell your doctor if you are already taking iron supplements or if you take 
indigestion remedies (medicines that reduce discomfort after eating). If you take these medicines you 
may need to take Cuprior at a different time in the day because otherwise Cuprior may not be as 
effective. If you take iron supplements, make sure that at least two hours have passed between taking 
Cuprior and taking your iron supplements. 
 
Pregnancy and breast-feeding  
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor for advice before taking this medicine.  
 
It is very important to continue treatment to reduce copper during pregnancy. You and your doctor 
should fully discuss the potential benefits of treatment whilst considering any possible risks that there 
may be. Your doctor will advise you which treatment and which dose is best in your situation. 
 
If you are pregnant and taking Cuprior, you will be monitored throughout your pregnancy for any 
effects on the baby or changes in your copper levels. When your baby is born, the copper level in the 
baby’s blood will also be monitored.  
 
It is not known if Cuprior can pass into breast milk. It is important to tell your doctor if you are 
breast-feeding or plan to do so. Your doctor will then help you decide whether to stop breast-feeding 
or to stop taking Cuprior, considering the benefit of breast-feeding to the baby and the benefit of 
Cuprior to the mother. Your doctor will decide which treatment and which dose is best in your 
situation. 
 
Driving and using machines 
Cuprior is not expected to affect your ability to drive a car or use any tools or machines. 
 
 
 
 



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3. How to take Cuprior 
 
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure.  
 
In adults of all ages, the recommended total daily dose is 3 to 6½ tablets per day (making a total of 
between 450 and 975 mg). This daily total will be divided into 2 to 4 smaller doses to be taken during 
the day. Your doctor will tell you how many tablets you should take and how often in the day. Tablets 
can be divided in half if needed. 
 
Use in children and adolescents 
The dose that you will take is usually lower than for an adult and depends on your age and body 
weight.  
The usual total daily dose is between 225 and 600 mg (1½ to 4 tablets daily), which will be divided 
into 2 to 4 smaller doses to be taken during the day. Your doctor will tell you how many tablets you 
should take and how often in the day. 
 
Once you have started the treatment, your doctor may adjust the dose based on the response to 
treatment. 
 
Swallow the tablets with water on an empty stomach, at least one hour before meals or two hours after 
meals and at least one hour apart from any other medicines, food, or milk. 
 
If you take iron supplements, take them at least two hours after taking a dose of Cuprior. 
 
If you take more Cuprior than you should 
Take Cuprior only as it is prescribed for you. If you think you may have taken more Cuprior than you 
were told to, contact your doctor or pharmacist. 
 
If you forget to take Cuprior 
Do not take a double dose to make up for a forgotten dose. Just take your next dose at its regularly 
scheduled time. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
If you stop taking Cuprior 
This medicine is for long-term use. Do not stop your treatment without the advice of your doctor even 
if you feel better because Wilson’s disease is a life-long condition. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
The following side effects have been reported: 
 
Common (may affect up to 1 in 10 people) 
- feeling sick (nausea)  
 
Uncommon (may affect up to 1 in 100 people) 
- skin rashes 
- itching 

 
Not known (frequency cannot be estimated from available data) 
- stomach upsets and discomfort, including severe stomach pains (duodenitis)   



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- inflammation of the gut which may lead to e.g. abdominal pain, recurring diarrhoea and blood in 
stools (colitis) 

- decrease in the number of red blood cells due to low iron level in your blood (iron deficiency 
anaemia)  

- urticaria (nettle rash or hives). 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 
 
5. How to store Cuprior 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The 
expiry date refers to the last day of that month. 
 
This medicine does not require any special storage conditions. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Cuprior contains  
The active substance is trientine. Each film-coated tablet (tablet) contains trientine tetrahydrochloride 
equivalent to 150 mg trientine.  
The other ingredients are: 
Tablet core: mannitol, colloidal anhydrous silica and glycerol dibehenate. 
Tablet film-coating: polyvinyl alcohol, talc, titanium dioxyde (E171), glycerol monocaprylocaprate 
(Type I), iron oxide yellow (E172) and sodium laurilsulfate 
 
 
What Cuprior looks like and contents of the pack 
Yellow, 16 mm x 8 mm oblong film-coated tablet with a score line on each side.  The film-coated 
tablet can be divided into equal doses. 
 
OPA/Alu/PVC-Alu blisters, each blister contains 8 film-coated tablets. Cuprior is available in packs 
containing 72 or 96 film-coated tablets. 
Not all pack sizes may be marketed. 
 
 
Marketing Authorisation Holder  
gmp-orphan SA 
Pépinière Paris Santé Cochin 
27-29 rue du Faubourg Saint-Jacques 
75014 Paris 
 
France 
 
Manufacturer 
Delpharm Evreux 
5 rue du Guesclin 



21 

27000 Evreux 
France 
 
 
This leaflet was last revised in. 
 
Other sources of information 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. There are also links to other websites about rare diseases and treatments.  
 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET