Cuprior

Основна информация

  • Търговско наименование:
  • Cuprior
  • Използвай за:
  • Хората
  • Вид на лекарството:
  • алопатични наркотици

Документи

Локализация

  • Предлага се в:
  • Cuprior
    Европейски съюз
  • Език:
  • английски

Терапевтична информация

  • Терапевтична група:
  • Other alimentary tract and metabolism products,
  • Терапевтична област:
  • Hepatolenticular Degeneration
  • Терапевтични показания:
  • Cuprior is indicated for the treatment of Wilson's disease in adults, adolescents and children ≥ 5 years intolerant to D-penicillamine therapy.,
  • Каталог на резюме:
  • Revision: 3

Състояние

  • Източник:
  • EMA - European Medicines Agency
  • Статус Оторизация:
  • Authorised
  • Номер на разрешението:
  • EMEA/H/C/004005
  • Дата Оторизация:
  • 04-09-2017
  • EMEA код:
  • EMEA/H/C/004005
  • Последна актуализация:
  • 27-12-2019

Доклад обществена оценка

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© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.

EMA/267439/2017

EMEA/H/C/004005

EPAR summary for the public

Cuprior

trientine

This is a summary of the European public assessment report (EPAR) for Cuprior. It explains how the

Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is

not intended to provide practical advice on how to use Cuprior.

For practical information about using Cuprior, patients should read the package leaflet or contact their

doctor or pharmacist.

What is Cuprior and what is it used for?

Cuprior is a medicine used to treat patients aged 5 years and older with Wilson’s disease, a genetic

condition in which copper absorbed from food builds up in the body, particularly in the liver and the

brain, causing damage. Cuprior is used in patients who cannot take D-penicillamine, another medicine

for this condition.

Cuprior contains the active substance trientine. It is a hybrid medicine. This means that it is similar to

a ‘reference medicine’ (in this case Trientine Dihydrochloride 300 mg capsules) also containing

trientine. The difference between Cuprior and the reference medicine is that Cuprior contains another

form of trientine (trientine tetrahydrochloride) and does not need to be stored in a refrigerator.

How is Cuprior used?

Cuprior can only be obtained with a prescription and treatment should be started by a specialist with

experience in the management of Wilson’s disease.

Cuprior is available as 150 mg tablets. In adults, the total recommended daily dose is from 3 to 6.5

tablets, and in children from 1.5 to 4 tablets. The tablets are taken in 2 to 4 divided doses. Doses are

adjusted according to patient response and levels of copper in the body. Cuprior should be taken on an

empty stomach, at least one hour before or two hours after meals.

For further information, see the package leaflet.

Cuprior

EMA/267439/2017

Page 2/2

How does Cuprior work?

The active substance in Cuprior, trientine, is a chelating agent. It works by attaching to copper in the

body and forming a complex that is then eliminated in the urine.

How has Cuprior been studied?

The company provided data from the published literature, which show that trientine significantly

increases copper elimination in the urine.

The company also carried out a study to compare the levels of trientine in the blood after having taken

Cuprior with those for the reference medicine. Results showed that Cuprior produces higher levels of

the active substance in the blood than the reference medicine. To take account of this difference,

Cuprior is used at lower doses.

What are the benefits and risks of Cuprior?

Since Cuprior is a hybrid medicine, its benefits and risks are taken as being the same as the reference

medicine’s.

Why is Cuprior approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Cuprior’s benefits

are greater than its risks and recommended that it be approved for use in the EU.

The CHMP noted that trientine has been used for over 30 years to treat patients with Wilson’s disease.

Although Cuprior releases more trientine in the body than the reference medicine, this difference can

be addressed by lowering the dose, which is in any case adjusted according to patient response and

levels of copper in the body.

What measures are being taken to ensure the safe and effective use of

Cuprior?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe

and effective use of Cuprior have been included in the summary of product characteristics and the

package leaflet.

Other information about Cuprior

The European Commission granted a marketing authorisation valid throughout the European Union for

Cuprior on

5 September 2017

The full EPAR for Cuprior can be found on the Agency’s website: ema.europa.eu/Find medicine/Human

medicines/European public assessment reports. For more information about treatment with Cuprior,

read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

The summary of the opinion of the Committee for Orphan Medicinal Products for Cuprior can be found

on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation

This summary was last updated in 09-2017.

Листовка за пациента: състав, показания, Нежелани лекарствени реакции, дозиране, взаимодействия, бременност, кърмене

B. PACKAGE LEAFLET

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

What Cuprior is and what it is used for

What you need to know before you take Cuprior

How to take Cuprior

Possible side effects

How to store Cuprior

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.

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.

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 6

½

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 (1

½

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)

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

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.