150 mg film-coated tablets 
trientine

1. What Cuprior is and what it is used for

Cuprior is a medicine used to treat Wilson’s disease and contains the active substance trientine.

Wilson’s disease is an inherited condition in which the body cannot transport copper around the body in a normal way or remove copper in a normal way by excretion from the liver to the intestines. This means that small amounts of copper from food and drink can accumulate and reach too high levels, leading to liver damage and problems in the nervous system. This drug works mainly by binding to copper in the body so that it is instead excreted in the urine, which helps to lower copper levels. It can also bind to copper in the intestines and thus reduce the amount of copper absorbed in the body.

Cuprior is given to adults, adolescents, and children older than 5 years who cannot tolerate another medicine used to treat this disease, called penicillamine.

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 cautions

Talk to your doctor or pharmacist before taking Cuprior.

If you have already taken medicine with trientine, your doctor may change your daily dose, the number of tablets, or the number of doses per day when you switch to Cuprior.

Your symptoms may start to get worse after you start treatment. If this happens, you must tell your doctor.

Your doctor will regularly check your blood and urine to make sure you have the right dose of Cuprior to keep your symptoms and copper levels under control.

You should tell your doctor if you experience any side effects as this may indicate that your dose of Cuprior should be adjusted up or down.

This medicine may also lower 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 dose one of the treatments is appropriate and does not affect your kidney function.

Concomitant use of trientine with other zinc-containing medicinal products is not recommended.

Lupus-like reactions (symptoms such as prolonged itching, fever, joint pain, and fatigue may occur) have been reported in some patients switching from penicillamine to trientine. However, it is not possible to determine whether the reaction was due to trientine or the previous treatment with penicillamine.

Children and young people

Your doctor will perform checks more often to make sure your copper levels are kept within appropriate levels for normal growth and mental development.

This medicine is not recommended for children under 5 years of age.

Other medicines and Cuprior

Tell your doctor if you are taking, have recently taken, or might take any other medicines.

Tell your doctor in particular if you are already taking iron supplements or if you are taking medicines for indigestion (medicines that reduce discomfort after eating). If you are taking these medicines, you may need to take Cuprior at another time of the day as otherwise Cuprior treatment may be less effective. If you are taking iron supplements, make sure that at least two hours have passed between when you took Cuprior and your iron supplements.

Pregnancy and breastfeeding

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 using this medicine.

You must continue to take Cuprior during pregnancy to reduce your copper content. You and your doctor should discuss the potential benefits of treatment about the potential risks. Your doctor will advise you on which treatment and dose are appropriate for your situation.

If you are pregnant and taking Cuprior, you will be monitored during pregnancy for effects on your baby or changes in your copper levels. When your baby is born, the levels of copper in your baby’s blood will be monitored.

It is not known if Cuprior passes into breast milk. You must tell your doctor if you are breast-feeding or planning to do so. Your doctor will then help you decide whether to stop breastfeeding or stop taking Cuprior, taking into account the benefits of breastfeeding to your baby and the benefits of Cuprior to your mother. Your doctor will decide which treatment and dose are appropriate for your situation.

Driving and using machines

Cuprior is not expected to affect your ability to drive or use tools or machines.

3. How to take Cuprior

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

For adults of all ages, the recommended daily dose a 3 to 6 ½ tablets per day (a total of 450 to 975 mg). This daily dose will be divided into 2 to 4 smaller doses to be taken during the day. Your doctor will tell you how many tablets to take and how often during the day. Tablets can be divided in half if needed.

Use for children and adolescents

The dose you will take is usually lower than for an adult and depends on your age and body weight.

The usual daily dose is between 225 and 600 mg (1 ½ to 4 tablets daily), which can be divided into 2 to 4 smaller doses taken during the day. Your doctor will tell you how many tablets to take and how often during the day.

After starting treatment, your doctor may adjust the dose based on the effect of the 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 other medicines, food, or milk.

If you are taking iron supplements, wait at least two hours to take them after a dose of Cuprior.

If you take more Cuprior then you should

Take Cuprior only if it is prescribed for you. If you think you have taken too much Cuprior, contact your doctor or pharmacist.

If you forget to take Cuprior

Do not take a double dose to make up for a forgotten dose. Take your next dose at its usual time.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

If you stop taking Cuprior

This medicine is for long-term use. Do not stop your treatment without first getting advice from your doctor as Wilson’s disease is a lifelong condition.

If you have any further questions on the use of this product, 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):

  • nausea

Uncommon (may affect up to 1 in 100 people)

  • rash
  • itching
  • anemia

Has been reported (occurs in an unknown number of users)

  • stomach problems and discomfort, including severe abdominal pain (duodenitis)
  • inflammation of the intestines which, for example, can lead to abdominal pain, recurrent diarrhea, and blood in the stool ( colitis ).
  • reduction in the number of red blood cells due to low iron content in your blood (iron deficiency anemia)
  • urticaria ( hives or hives).

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 expiration date is the last day of the specified month.

This medicine does not require any special storage.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

What Cuprior contains

The active substance is trientine. Each film-coated tablet (tablet) contains trientine tetrahydrochloride, equivalent to 150 mg trientine.

Other ingredients are:

Tablet core: mannitol, colloidal anhydrous silica, and glycerol behenate.

Tablet film-coating: polyvinyl alcohol, talc, titanium dioxide (E171), glycerol monocaprylocaprate (type 1), iron oxide yellow (E172), and sodium lauryl sulfate

Cuprior appearance and pack sizes

Yellow, 16 mm x 8 mm oval film-coated tablets with a notch on each side. The film-coated tablet can be divided into two equal doses.

OPA / Alu / PVC-Aluminum blister, each blister contains 8 film-coated tablets. Cuprior is available in packs of 72 or 96 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Orphan

226 Voltaire Boulevard

75011 Paris

France

Manufacturer

Delpharm Evreux

5 rue du Guesclin

27000 Evreux

France

Muhammad Nadeem

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