Trientina Tillomed

Package leaflet: Information for the user

Trientina Tillomed 167 mg hard capsules

Read this entire 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Trientina Tillomed is and what it is used for
2. What you need to know before taking Trientina Tillomed
3. How to take Trientina Tillomed
4. Possible side effects
5. How to store Trientina Tillomed
6. Contents of the pack and other information

1. What Trientina Tillomed is and what it is used for

Trientina Tillomed contains trientine. This medicine is used for the treatment of Wilson's disease. Wilson's disease is an inherited condition in which the body is unable to transport copper normally or to remove it as a secretion from the liver into the intestine. This means that small amounts of copper from food and drink accumulate to excessive levels and may cause liver damage and problems with the nervous system. This medicine works mainly by binding to copper in the body, allowing it to be eliminated through the urine and thereby helping to reduce copper levels. It may also bind copper in the intestine, thus reducing the amount absorbed by the body.
Trientina Tillomed is administered to adults, adolescents, and children aged 5 years and older who do not tolerate another medicine indicated for the treatment of this disease, called penicillamine.
It controls the amount of copper in the body by binding to it. The copper can then be eliminated from the body.

2. What you need to know before taking Trientina Tillomed

Do not take Trientina Tillomed:

• 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, pharmacist, or nurse before taking Trientina Tillomed.
If you were previously taking another medicine containing trientine, your doctor may adjust the daily dose, the number of capsules, or the number of daily administrations when switching to Trientina Tillomed.
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 Trientina Tillomed to control your symptoms and copper levels.
Inform your doctor if you experience any adverse effects, as this may indicate that the dose of trientine needs to be increased or reduced.
This medicine may also reduce iron levels in the blood, and your doctor may prescribe iron supplements (see section "Other medicines and Trientina Tillomed" below).
If you have kidney or liver problems, your doctor will regularly check that your treatment dose is appropriate and does not affect kidney or liver 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 the previous penicillamine treatment.

Children and adolescents
Your doctor will perform more frequent monitoring to ensure copper levels are maintained at an appropriate level for normal growth and mental development.

Other medicines and Trientina Tillomed
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
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 Trientina Tillomed at a different time of day to maintain its effectiveness.
If you are taking iron supplements, ensure that at least two hours pass between taking Trientina Tillomed and the iron supplements.

Trientina Tillomed with food and drink
Swallow the capsules 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 medicine, food, or milk.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine. You and your doctor should carefully discuss the potential benefits of treatment, while also considering any possible risks associated with continuing therapy. Your doctor will advise you on the most appropriate treatment and dosage for your situation.
If you are pregnant and taking Trientina Tillomed, you will be monitored throughout pregnancy for any effects on the baby and for changes in your blood copper levels.
At birth, the baby’s blood copper and ceruloplasmin levels will also be monitored. It is not known whether trientine 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 Trientina Tillomed, taking into account the benefits of breastfeeding for the baby and the benefits of Trientina Tillomed therapy for the mother. Your doctor will determine the most appropriate treatment and dosage for your individual situation.

Driving and using machines
Trientine is not expected to affect your ability to drive or operate tools or machinery.

Trientina Tillomed contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e., essentially "sodium-free".

3. How to take Trientina Tillomed

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
In adults of all ages, including elderly patients, the recommended total daily dose ranges between 4
and 8 capsules per day (corresponding to a total of 670–1340 mg of trientine base), to be taken orally. This
total daily dose should be divided into 2 or 4 smaller doses taken throughout the day. Your doctor will advise
you on how many capsules to take and how frequently each day.
Use in children
The dose required is generally lower than that for adults and depends on age and body weight. The total
daily dose ranges between 2 and 5 capsules (330–840 mg of trientine base), to be taken orally. This total
daily dose should be divided into 2 or 4 smaller doses taken throughout the day. Your doctor will advise
you on how many capsules to take and how frequently each day.
Once treatment has started, your doctor may adjust the dose based on your response to treatment.
Swallow the capsules 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, take them at least two hours apart from your dose of Trientina Tillomed.
If you take more Trientina Tillomed than you should
Take Trientina Tillomed only if it has been prescribed for you. If you think you have taken more Trientina
Tillomed than prescribed, contact your doctor or pharmacist immediately.
If you forget to take Trientina Tillomed
If you forget to take one or more doses, take another dose as soon as possible, then continue with your
next dose according to your regular schedule. Do not take a double dose to make up for the missed dose.
If you have any questions 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 everybody gets them. Occasionally, treatment with trientine may cause inflammation of the small intestine or colon. If you experience any of the following side effects, contact your doctor immediately.
The following side effects have been reported:

Common (may affect up to 1 in 10 people)

• feeling unwell (nausea)

Uncommon (may affect up to 1 in 100 people)

• skin rashes
• itching
• anaemia

Not known (frequency cannot be estimated from the available data)

• stomach discomfort and 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 red blood cells due to low iron levels in the blood (iron deficiency anaemia)
• urticaria

If you have Wilson's disease, you must inform your doctor if you experience any of the following symptoms:
worsening of the nervous system (e.g. tremors, lack of coordination, speech disorders, muscle rigidity, worsening of muscle spasms)

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 via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Trientina Tillomed

Keep this medicine out of the sight and reach of children.
This medicine does not require any special temperature conditions for storage. Keep the bottle tightly closed to protect the medicine from moisture.
Do not use this medicine after the expiry date which is stated on the carton and on the blister after Exp.
The expiry date refers to the last day of that month.
Do not dispose of any medicine 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 Trientina Tillomed contains
The active substance is trientine. Each hard capsule contains 250 mg of trientine dihydrochloride, equivalent to 167 mg of trientine.
The other components are:
Capsule contents: anhydrous colloidal silica (E551), stearic acid.
Capsule coating: gelatin, sodium lauryl sulfate, red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171).
Printing ink: shellac gum (E904), propylene glycol (E1520), potassium hydroxide (E525), black iron oxide (E172).

Description of the appearance of Trientina Tillomed and the contents of the pack
Opaque brown, size 1 hard gelatin capsule, printed with "HP551" in black ink on both the body and the cap. The capsule length ranges between 18.9 mm and 19.7 mm.
Trientina Tillomed capsules are available in white opaque HDPE bottles with a child-resistant PP closure.
Pack: 100 hard capsules.
Trientina Tillomed capsules are also available in Al-Al blisters.
Packs: 30, 72, 96, 100, 240 and 300 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Tillomed Italia S.r.l.
Viale G. Richard, 1 Torre A
20143 Milano (MI), Italy

Manufacturer
Tillomed Malta Limited,
Malta Life Sciences Park,
LS2.01.06 Industrial Estate,
San Gwann, SGN 3000, Malta
SGS Pharma Magyarorszag Kft.
Derkovits Gyula Utca 53,
Budapest XIX, 1193,
Hungary

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Austria: Cuivrin 167 mg Hartkapseln
Belgium: Trientine Tillomed 167 mg gélules
Triëntine Tillomed 167 mg harde capsules
Trientin Tillomed 167 mg Hartkapseln
France: Trientine Tillomed 167 mg, gélules
Germany: Trientin Tillomed 167 mg Hartkapseln
Greece: Trientine/Tillomed 167 mg καψάκιo, σκληρό
Ireland: Trientine 167 mg hard capsules
Italy: Trientina Tillomed
Luxembourg: Trientine Tillomed 167 mg, gélules
Norway: Trientine Tillomed Pharma GmbH
Netherlands: Triëntine Tillomed 167 mg harde capsules
Czech Republic: Trientine Tillomed 167 mg tvrdé tobolky
Slovakia: Trientine Tillomed 167 mg tvrdé kapsuly