What Trientine Tillomed is and what it is used for
Trientine Tillomed contains trientine. This medicine is used to treat Wilson’s disease.
Wilson’s disease is an inherited condition in which the body cannot transport copper around or dispose of copper normally by excretion from the liver into the intestines. This means that small amounts of copper from food and drink can accumulate in excessively high levels in the body, which can lead to liver damage and problems in the nervous system. This medicine works mainly by binding to copper in the body so that it is instead excreted in the urine, helping to lower copper levels. It can also bind to copper in the intestines and thus reduce the amount of copper absorbed into the body.
Trientine Tillomed is given to adults, adolescents, and children aged 5 and over who cannot tolerate penicillamine, another medicine used to treat this disease.
The copper content in the body is kept under control by the medicine binding to copper. In this way, the body can get rid of the copper.
The trientine contained in Trientine Tillomed may also be approved to treat other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before taking Trientine Tillomed
Do not take Trientine Tillomed:
- if you are allergic to trientine or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Trientine Tillomed.
If you are already taking another medicine with trientine, the doctor may change your daily dose, the number of capsules, or the number of times per day that you take the medicine when you switch to treatment with Trientine Tillomed.
Your symptoms may get worse at the start of treatment. If this happens, you must contact your doctor.
You may regularly submit blood and urine samples so that the doctor can check that you are receiving the correct dose of Trientine Tillomed to keep your symptoms and the copper levels in your body under control.
If you get side effects, you should tell the doctor, because it may mean that the dose of trientine needs to be increased or decreased.
This medicine can also lower the level of iron in the blood, and the doctor may therefore prescribe iron supplements (see the section “Other medicines and Trientine Tillomed” below).
If you have kidney or liver problems, your doctor will regularly check that you are being treated with the right dose and that your kidney or liver function is not affected.
Trientine should not be used at the same time as medicines containing zinc.
Lupus-like reactions (with symptoms such as prolonged rash, fever, joint pain, and fatigue) have been reported in some patients who switched from penicillamine to trientine. However, it has not been possible to determine whether the reaction was due to trientine or to the previous treatment with penicillamine.
Children and young people
The doctor does more frequent checks to make sure your copper levels are at appropriate levels for normal growth and mental development.
Other medicines and Trientine Tillomed
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
In particular, tell your doctor if you are taking iron supplements or indigestion medicines (medicines that reduce discomfort after eating). If you are taking these medicines, you may need to take Trientine Tillomed at a different time of day as the treatment with trientine may otherwise be less effective.
If you take iron supplements, make sure that at least two hours pass between taking Trientine Tillomed and the iron supplement.
Trientine Tillomed with food and drink
Swallow the capsules with water on an empty stomach, at least one hour before a meal or two hours after a meal, and at least one hour before/after other medicines, food, or milk.
Pregnancy, breastfeeding, and fertility
If you are or will become pregnant or plan to have a child, you should consult a doctor before using this medicine. You and your doctor can then discuss all the potential benefits of continuing treatment and weigh these against the possible risks. Your doctor will tell you which treatment and dosage are appropriate for your situation.
If you are pregnant and taking Trientine Tillomed, you will be monitored during pregnancy to monitor any effects on the baby or changes in your copper levels.
After the baby is born, a follow-up is done to check the levels of copper and ceruloplasmin in the baby’s blood.
It is unknown whether Trientine Tillomed passes into breast milk. You must tell your doctor if you are breastfeeding or plan to breastfeed. The doctor can then help you decide whether you should stop breastfeeding or stop taking Trientine Tillomed, by assessing the benefits of breastfeeding for the baby and the benefits that Trientine Tillomed means for you. Your doctor will decide which treatment and dosage are appropriate for your situation.
Driving ability and use of machinery
Trientine Tillomed is not expected to affect your ability to drive or use tools and machines.
Trientine Tillomed contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. it is almost ‘sodium-free’.
How to take Trientine Tillomed
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
For adults of all ages (including elderly patients), the recommended daily dose is between 4 and 8 capsules per day (total between 0.67 and 1.34 g of trientine base), to be swallowed. This daily dose is divided into 2 to 4 smaller doses to be taken during the day. Your doctor will tell you how many capsules to take and at what times.
Children
If you are a child, you will usually receive a lower dose than an adult, and the dose depends on your age and body weight. The usual daily dose is between 2 and 5 capsules, to be swallowed. This daily dose is divided into 2 to 4 smaller doses to be taken during the day. Your doctor will tell you how many capsules to take and at what times.
Once you have started the treatment, the doctor may change the dose depending on the effect of the treatment.
Swallow the capsules with water on an empty stomach, at least one hour before a meal or two hours after a meal, and at least one hour before/after other medicines, food, or milk.
If you take iron supplements, wait at least two hours after a dose of Trientine Tillomed before taking the supplement.
If you have taken too much Trientine Tillomed
Always take this medicine as prescribed by your doctor. If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you forget to take Trientine Tillomed
If you forget one or more doses, take a dose as soon as you remember. Then take the next dose at the usual time. Do not take a double dose to make up for a missed dose.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Single cases of inflammation of the small or large intestine have been reported in connection with trientine treatment. 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 users)
- Nausea
Uncommon (may affect up to 1 in 100 users)
- Rash
- Itching
Has been reported (occurring in an unknown number of users)
- stomach problems and discomfort, including severe stomach pain (duodenitis)
- inflammation in the gastrointestinal tract, which can lead to, for example, stomach pains, recurrent diarrhea, and blood in the stool ( colitis )
- reduced number of red blood cells due to the low iron content in the blood (iron deficiency anemia)
- urticaria ( hives or hives).
If you have Wilson’s disease, contact your doctor if you experience any of the following:
problems with the nervous system (for example, tremors, impaired coordination, slurred speech, muscle stiffness, or worsening muscle spasms).
How to store Trientine Tillomed
Keep this medicine out of the sight and reach of children.
This medicine does not need to be stored at any particular temperature.
Close the jar well. Moisture sensitive.
Use before the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is 167 mg trientine, which corresponds to 250 mg trientine dihydrochloride.
Other ingredients:
Capsule contents: colloidal anhydrous silica, stearic acid
Capsule shell: gelatin, sodium lauryl sulfate, red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171), ink: shellac, propylene glycol, potassium hydroxide, black iron oxide (E172)
Appearance and package sizes of the medicine
Brown, opaque, hard gelatin capsule (size 1) with “HP551” printed in black ink on the capsule body and cap. The length of the capsule is between 18.9 mm and 19.7 mm.
Trientine Tillomed capsules are supplied in a white, opaque HDPE bottle with a child-resistant polypropylene (PP) closure.
Marketing Authorisation Holder
Tillomed Pharma GmbH
Mittelstrasse 5/5a
12529 Schönefeld
Germany
Manufacturer
MIAS Pharma Limited
Suite 2, Stafford House,
Strand Road, Portmarnock,
Co. Dublin, Ireland