Cuprior
Italy
Table of Contents
Patient Information Leaflet
Cuprior 150 mg film-coated tablets
trientina
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
- Keep this leaflet. 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 other people, even if their symptoms are the same as yours, because it may be harmful.
- If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet
- What Cuprior is and what it is used for
- What you need to know before taking 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 containing the active substance trientine, used for the treatment of Wilson's disease.
Wilson's disease is an inherited disorder in which the body is unable to properly transport or eliminate
copper, such as secretion from the liver into the intestine. This means that small amounts of
copper from food and drink accumulate excessively and can cause liver damage and neurological problems.
This medicine works primarily by binding to copper in the body, allowing its elimination through urine, thereby helping to
reduce copper levels. It can also bind to copper in the intestine, thus reducing the amount absorbed by the body.
Cuprior is administered to adults, adolescents, and children aged 5 years and older
who are intolerant to another medicine indicated for the treatment of this disease, called
penicillamine.
2. What you need to know before taking Cuprior
Do not take Cuprior
- if you are allergic to trientine or to 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 previously taking another medicine containing trientine, your doctor may adjust the daily dose, number of tablets, or number of daily administrations when switching to treatment with Cuprior.
Symptoms may worsen after starting treatment. If this occurs, inform your doctor.
Your doctor will regularly perform blood and urine tests to ensure you are receiving the most appropriate dose of Cuprior to control your symptoms and copper levels.
Inform your doctor if you experience any adverse effects, as it may be necessary to increase or reduce the dose of Cuprior.
This medicine may also reduce iron levels in the 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 dosage is appropriate and does not affect kidney function.
The combination of trientine with another medicine containing zinc is not recommended.
Lupus-like syndrome reactions (symptoms may include persistent skin rash, fever, joint pain, and fatigue) have been reported in some patients who switched to trientine after treatment with penicillamine. However, it has not been possible to determine whether the reaction was due to trientine or to previous treatment with penicillamine.
Children and adolescents
Your doctor will perform more frequent checks to ensure copper levels are maintained at an adequate level for normal growth and mental development.
This medicine must not be used in children under 5 years of age.
Other medicines and Cuprior
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
In particular, you must inform your doctor if you are already taking iron supplements or medications for digestive disorders (medicines that reduce discomfort after meals). In such cases, you may need to take Cuprior at a different time of day to maintain its effectiveness. If you take iron supplements, ensure at least two hours have passed since taking Cuprior.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor before taking this medicine.
It is very important to continue treatment to reduce copper levels during pregnancy. You should carefully discuss with your doctor the potential benefits of treatment versus possible risks. Your doctor will advise you on the most appropriate treatment and dose for your situation.
If you are pregnant and taking Cuprior, you will be monitored during pregnancy to detect any effects on the baby or changes in your copper levels. At birth, your baby’s blood copper levels will also be monitored.
It is not known whether Cuprior passes into breast milk. It is important to inform your doctor if you are breastfeeding or intend to breastfeed. Your doctor will help you decide whether to discontinue breastfeeding or discontinue treatment with Cuprior, taking into account the benefits of breastfeeding for the baby and the benefits of treatment with Cuprior for the mother.
Your doctor will decide the most appropriate treatment and dose for your situation.
Driving and using machines
Cuprior is not expected to affect the ability to drive vehicles or operate tools or machinery.
Cuprior contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially ‘sodium-free’.
3. How to take Cuprior
Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults
In adults of all ages, the recommended total daily dose ranges from 3 tablets to 6 and a half tablets per day (equivalent to a total amount between 450 and 975 mg). This total daily dose should be divided into 2–4 smaller doses taken throughout the day. Your doctor will inform you how many tablets you should take and how frequently each day. If necessary, the tablets can be divided into two equal parts.
Use in children and adolescents (from 5 to 18 years of age)
The dose required is generally lower than that for adults and depends on age and body weight.
The usual total daily dose ranges between 225 and 600 mg (from one and a half to four tablets per day), divided into 2–4 smaller doses taken throughout the day. Your doctor will inform you how many tablets you should take and how frequently each day. Tablets may be split in half if necessary.
Once treatment has started, your doctor may adjust the dose based on your response to therapy.
Swallow the tablets with water. Take this medicine 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, take them at least two hours after your dose of Cuprior.
If you take more Cuprior than you should
Take Cuprior only as prescribed. If you think you have taken more Cuprior than you were instructed to, contact your doctor or pharmacist.
If you take more medicine than you should, symptoms such as nausea, vomiting, and dizziness may occur.
If you forget to take Cuprior
Do not take a double dose to make up for a missed dose. Skip the missed dose and take the next dose at the usual scheduled time.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.
If you stop treatment with Cuprior
This medicine is intended for long-term use. Even if you feel better, do not stop treatment without consulting your doctor, as Wilson's disease is a lifelong condition.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences 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
- skin redness (erythema)
- itching
- anemia
Not known (frequency cannot be estimated from the available data)
- stomach disorders, including severe stomach pain (duodenitis)
- inflammation of the intestine which may cause, for example, abdominal pain, recurrent diarrhoea and blood in the stools (colitis)
- decrease in the number of red blood cells due to low iron levels in the blood (iron deficiency)
- urticaria.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly through the national reporting system indicated in Annex 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 dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Cuprior contains
- The active substance is trientine. Each film-coated tablet (tablet) contains trientine tetrahydrochloride, equivalent to 150 mg of trientine.
- The other components are: Tablet core: mannitol, anhydrous colloidal silica, and glycerol dibehenate. Tablet coating: polyvinyl alcohol, talc, titanium dioxide (E171), glycerol monocaprylocaprate (Type I), yellow iron oxide (E 172), and sodium lauryl sulfate (see section 2, “Cuprior contains sodium”).
Description of the appearance of Cuprior and package contents
Cuprior tablets are yellow, film-coated tablets, 16 mm x 8 mm in size, oval-shaped with a score line on each side.
Cuprior is available in blisters containing 72 or 96 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Orphalan
226 Boulevard Voltaire
75011 Paris
France
Manufacturer
Delpharm Evreux
5 rue du Guesclin
27000 Evreux
France
Information can also be obtained by scanning the QR code below with a smartphone or via the website include QR code http://www.cuprior.com
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency,Error! Hyperlink reference not valid. http://www.ema.europa.eu/. In addition, links to other websites on rare diseases and their therapeutic treatments are provided.