Cuprior 150 mg comprimidos recubiertos con pelicula

Patient Information Leaflet

Cuprior 150 mg Film-Coated Tablets

Trientine

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

1. Contents of the pack and additional information

Cuprior is a medication used to treat Wilson's disease, which contains the active ingredient trientine.

Wilson's disease is a hereditary disease in which the body cannot transport copper in a normal manner or cannot eliminate copper in a normal manner through liver secretion into the intestine. As a result, small amounts of copper ingested with food and drinks accumulate to excessive levels, which can cause liver damage and problems in the nervous system. This medication primarily acts by binding to the body's copper, which can then be eliminated in the urine, helping to reduce copper levels. It can also bind to copper in the intestine and thereby reduce the amount of copper absorbed by the body.

Cuprior is administered to adults, adolescents, and children 5 years of age or older who cannot tolerate another medication used to treat this disease called penicillamine.

Do not take Cuprior

-if you are allergic to trientine or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Cuprior.

If you were already taking another medication with trientine, your doctor may modify your daily dose, the number of tablets, or the number of daily doses when you switch to Cuprior.

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

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

You must inform your doctor if you experience any adverse effects, as this may indicate that you need to adjust your Cuprior dose up or down.

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

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

Trientine should not be associated with another medication that contains zinc.

Pseudolupus-like 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 penicillamine. However, it was not possible to determine if the reaction was caused by trientine or the previous treatment with penicillamine.

Children and adolescents

Your doctor will perform more frequent checks to ensure that your copper levels remain at an adequate level for growth and mental development. This medication is not recommended for children under 5 years old.

Other medications and Cuprior

Inform your doctor if you are taking, have taken recently, or may need to take any other medication.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor before using this medication.

It is very important that you continue treatment to reduce copper levels during pregnancy. You must 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 dosage for your situation.

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

We do not know if Cuprior passes into breast milk. It is essential that you inform your doctor if you are breastfeeding or plan to do so. Your doctor will help you decide whether to stop breastfeeding or stop taking Cuprior, taking into account the benefits of breastfeeding for the baby and the benefits of Cuprior for the mother. Your doctor will decide on the best treatment and dosage for your situation.

Driving and operating machinery

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

Cuprior contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, 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 amounts to a total of between 450 and 975 mg). This total daily dose will be divided into 2 to 4 smaller doses taken throughout the day. Your doctor will tell you how many tablets to take and how often to take them 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 usually be less 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 tablets and 4 tablets per day), which will be divided into 2 to 4 smaller doses taken throughout the day. Your doctor will tell you how many tablets to take and how often to take them during the day. The tablets can be divided in half if necessary.

When you start treatment, your doctor may adjust the dose depending on your response to treatment.

Swallow the tablets with water. Take this medication on an empty stomach, at least one hour before or two hours after meals, and at least one hour apart from other medications, food, or milk.At least one hour apart from other medications, food, or milkand, at least, with a one-hour difference with respect to other medications, food, or milk.

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

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 were told, 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 the missed doses. Skip the missed dose and take the next dose at the usual time.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

If you interrupt treatment with Cuprior

This medication is indicated for long-term treatments. Do not stop treatment unless your doctor tells you to, even if you feel better, since Wilson's disease is a lifelong condition.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The following adverse effects have been reported:

Frequent (may affect up to 1 in 10 patients)

• Nausea

Rare (may affect up to 1 in 100 patients)

• Skin eruptions
• Redness of the skin (erythema)
• Itching
• Anemia

Unknown frequency (cannot be estimated from available data)

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

• Decreased red blood cell count due to low iron levels in the blood (ferripenic anemia)
• Urticaria (hives)

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the national notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of Cuprior

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

Tablet core: mannitol, anhydrous colloidal silica, and dibehenate of glycerol.

Tablet coating: polyvinyl alcohol, talc, titanium dioxide (E171), glycerol monocaprilocaprato (type I), yellow iron oxide (E172), and sodium lauryl sulfate (see section 2 “Cuprior contains sodium”).

Appearance of the product and contents of the packaging

Cuprior are elongated, yellow, film-coated tablets, 16 x 8 mm, with a notch on each face.

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

Only some packaging sizes may be marketed.

Marketing Authorization Holder

Orphalan

226 Boulevard Voltaire

75011 Paris

France

Responsible for manufacturing

Delpharm Evreux

5 rue du Guesclin

27000 Evreux

France

Last review date of this leaflet:

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

Other sources of information

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