CUPRIOR 150 mg FILM-COATED TABLETS

Introduction

Patient Information: Summary of Product Characteristics

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.

Contents of the pack

1. What is Cuprior and what is it used for

1. What you need to know before you take Cuprior
2. How to take Cuprior
3. Possible side effects
4. Storage of Cuprior

1. Contents of the pack and further information

1. What is Cuprior and what is it used for

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

Wilson's disease is a hereditary disease in which the body cannot transport copper in the normal way or cannot eliminate copper in the normal way in the form of liver secretion into the intestine. For this reason, the small amounts of copper ingested with food and drinks accumulate in excessive levels, which can cause liver damage and problems in the nervous system. This medicine works mainly by binding to copper in the body, which can then be eliminated in the urine, helping to reduce copper levels. It can also bind to copper in the intestine, reducing the amount of copper absorbed by the body.

Cuprior is administered to adults, adolescents, and children aged 5 years or older who cannot tolerate another medicine 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

Consult your doctor or pharmacist before starting to take Cuprior.

If you were already taking another medicine with trientine, your doctor may change your daily dose, the number of tablets, or the number of intakes per day when replacing your treatment with Cuprior.

Your symptoms may worsen when you start treatment. In this case, you should inform your doctor.

Your doctor will perform periodic blood and urine tests to ensure you are receiving the correct dose of Cuprior to control your symptoms and copper levels.

You should inform your doctor if you experience any side effects, as this could indicate that your dose of Cuprior needs to be adjusted upwards or downwards.

This medicine can also reduce iron levels in the blood, so your doctor may prescribe iron supplements (see section "Other medicines and Cuprior" below).

If you have kidney problems, your doctor will periodically check that the treatment dose is suitable and not affecting kidney function.

The combination of trientine with another medicine containing zinc is not recommended.

Pseudolupus reactions (with symptoms such as persistent skin rash, fever, joint pain, and fatigue) have been reported in some patients who switched to trientine after receiving the medicine penicillamine. However, it was not possible to determine whether the reaction was caused by trientine or by previous treatment with penicillamine.

Children and adolescents

Your doctor will perform more frequent reviews to ensure that your copper levels are maintained at an adequate level for growth and mental development. This medicine is not recommended in 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.

In particular, you should inform your doctor if you are already taking iron supplements or if you take any remedy for indigestion (medicines that reduce discomfort after eating). If you are taking these medicines, you will need to take Cuprior at a different time of day, otherwise, Cuprior will not be effective. If you take iron supplements, make sure that at least two hours have passed between taking Cuprior and taking the iron supplements.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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 that you continue treatment to reduce copper levels during pregnancy. You should discuss the possible benefits of treatment with your doctor, taking into account the risks that may exist. Your doctor will advise you on the best treatment and dose in your situation.

If you are pregnant and taking Cuprior, you will be monitored throughout your pregnancy to detect any effects on the baby or any changes in your copper levels. When your child is born, the copper level in the baby's blood will also be checked.

It is not known whether Cuprior passes into breast milk. It is important that you inform your doctor if you are breastfeeding or planning to breastfeed. Your doctor will help you decide whether to stop breastfeeding or stop taking Cuprior, considering the benefit of breastfeeding for the baby and the benefit of Cuprior for the mother. Your doctor will decide on the best treatment and dose in your situation.

Driving and using machines

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

Cuprior contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; this is essentially "sodium-free".

3. How to take Cuprior

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Adults

In adults of all ages, the recommended daily dose is 3 to 6 tablets and a half per day (which corresponds to a total of 450 to 975 mg). This total daily dose will be divided into 2 to 4 smaller doses taken throughout the day. Your doctor will indicate how many tablets you should take and how often during the day. The tablets can be divided in half if necessary.

Use in children and adolescents (5 to 18 years)

The dose for children and adolescents will normally be lower than the dose corresponding to adults and will depend on age and body weight.

The usual total daily dose is between 225 and 600 mg (between 1 and a half and 4 tablets per day), which will be divided into 2 to 4 smaller doses taken throughout the day. Your doctor will indicate how many tablets you should take and how often during the day. The tablets can be split in half if necessary.

Once you have started treatment, your doctor may adjust the dose depending on your response to treatment.

Swallow the tablets with water. Take this medicine on an empty stomach, at least one hour before or two hours after mealsand at least one hour apart from other medicines, food, or milk.

If you take iron supplements, take them at least two hours after the dose of Cuprior.

If you take more Cuprior than you should

Take Cuprior only as prescribed by your doctor. If you think you have taken more Cuprior than you should, consult your doctor or pharmacist.

If you take more than you should, you may experience nausea, vomiting, and dizziness.

If you forget to take Cuprior

Do not take a double dose to make up for forgotten doses. Skip the missed dose and take the next dose at the usual 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 indicated for long-term treatment. Do not stop treatment unless your doctor tells you to, even if you feel better, as Wilson's disease is a lifelong 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)

• nausea

Uncommon (may affect up to 1 in 100 people)

• skin rash
• redness of the skin (erythema)
• itching
• anemia

Frequency not known (cannot be estimated from the available data)

• stomach discomfort and upset, such as severe stomach pain (duodenitis)
• inflammation of the intestine that can cause, for example, abdominal pain, recurrent diarrhea, and blood in the stool (colitis)

• reduction in the number of red blood cells due to low iron levels in the blood (iron deficiency anemia)
• hives (urticaria).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are 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. Storage of 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 is the last day of the month stated.

This medicine does not require any special storage conditions.

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

6. Contents of the pack and further information

Composition of Cuprior

• The active substance is trientine. Each film-coated tablet contains trientine tetrahydrochloride equivalent to 150 mg of trientine.
• The other ingredients are:

Core of the tablet: mannitol, colloidal anhydrous silica, and dibehenate of glycerol.

Coating of the tablet: polyvinyl alcohol, talc, titanium dioxide (E171), glycerol monocaprylocaprate (type I), yellow iron oxide (E172), and sodium lauryl sulfate (see section 2 "Cuprior contains sodium").

Appearance of the product and pack size

Cuprior are film-coated tablets, yellow, elongated, 16 x 8 mm in size, with a score line on each face.

Cuprior is available in blister packs of 72 or 96 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder

Orphalan

226 Boulevard Voltaire

75011 Paris

France

Manufacturer

Delpharm Evreux

5 rue du Guesclin

27000 Evreux

France

Date of last revision of this leaflet:

You can also find this information by scanning the QR code below with a mobile phone or on the website QR codehttp://www.cuprior.com

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu. There are also links to other websites on rare diseases and orphan medicines.