Your medicine is called Trientine di hydrochloride 250 mg hard capsules. In this leaflet, it will be called as Trientine capsule.

Trientine dihydrochloride capsule is a medicine used for the treatment of Wilson’s disease in adults, adolescents and children aged 5 years or older. It is for use by patients who cannot take another medicine, D-Penicillamine, because of side effects

Trientine di hydrochloride contains the active substance trientine, a copper-chelating agent that is used to remove excess of copper from the body. Trientine di hydrochloride attaches to the copper, which is then passed from the body

Clinical experience for this medicine is limited and therefore, alternate dosing regimenshave not been well-characterized. This medicine can be used when continued treatment with penicillamine is no longer possible, but we cannot consider that Trientine dihydrochloride and penicillamineare interchangeable

1.      Do not take Cuprtin

If you are allergic to trientine or any of the other ingredients of this medicine (listed in section 6)

Signs of an allergic reaction include rash, itching, swelling of the face, fainting and breathing problems

Warnings and precautions

Your doctor will need to regularly check for symptoms of the disease and copper levels in your blood and urine. Regular monitoring is especially important at the start of your treatment or when your dose is changed, in growing children and pregnant women to ensure that copper levels are maintained at a suitable level. The doctor may need to increase or decrease your dose of Trientine capsules

Nervous system problems can occur (for example, shaking, lack of coordination, slurred speech, muscle stiffness and worsening of muscle spasms), especially in patients just starting treatment with Trientine capsule. If you notice these whilst taking Trientine capsules, you must tell your doctor immediately.

Lupus-like reactions (symptoms may include persistent rash, fever, joint pain, and tiredness) have been reported in some patients switched to trientine medicine after penicillamine medicine. However it was not possible to determine if the reaction was due to trientine or to previous penicillamine treatment.

Other medicines and Trientine capsule

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines If you are taking iron tablets or medicines that neutralise the acid in your stomach, leave atleast 2 hours before or after you have taken Trientine capsules because they may reduce Trientine capsule’s effect.

Trientine capsule with food and drink

Take this medicine with water only. Do not take it with other drinks or food because they may reduce the medicine’s effect. Avoid eating or drinking for 1 hour before, or 2 hours after taking Trientine capsules

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. It is very important to continue treatment to maintain normal copper levels during pregnancy. Youand your doctor should fully discuss the potential benefits of treatment whilst considering any possible risks that there may be.

Your doctor will advise you which treatment and which dose is best in your situation. If you become pregnant whilst taking Trientine capsules, talk to your doctor.

If you are pregnant and taking Trientine capsules, you will be monitored throughout your pregnancy for any effects on the baby or changes in your copper levels

It is not known whether trientine is excreted inhuman milk, hence caution should be taken while prescribing to breast-feeding patient. Itis important to tell your doctor if you are breast-feeding or plan to do so. Your doctor will then help you decide whether to stop breast-feeding or to stop taking Trientine capsules, considering the benefit of breast-feeding to the baby and the benefit of Trientine capsules to the mother. Your doctor will decide which treatment and which dose is best in your situation Driving and using machines

Trientine is not likely to have an effect on your ability to drive or use machines.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Adults (including the elderly)

The usual dose is between 750 – 1250 mg perday given in 2 to 4 divided doses, to be taken by mouth

Use in children and adolescents (5 to 17 years)

In children and adolescents, the dose depends on age and body weight and will be adjusted by your doctor. At the start of treatment, the dose varies between 500 – 750mg per day given in 2 to 4 divided doses.

Method of administration

Your doctor will decide the correct dose for you.

The total daily dose can be divided into 2 to 4smaller doses, as indicated by your doctor. Swallow the capsules whole with a drink of water on an empty stomach, at least 1 hour before or 2 hours after food. Do not open or chew the capsule.

Patients who have difficulties swallowing should contact their doctor.

If you take more Trientine capsule than you should

If you take more medicine than you should, you may get nausea, vomiting and dizziness. You must contact your doctor or another health care provider immediately.

If you forget to take Trientine capsule

If you forget to take a dose take your next dose at its usual scheduled time. Do not take adouble dose to make up for a forgotten dose

If you stop taking Trientine capsule

This medicine is for long-term use because Wilson’s disease is a life-long condition. Do not stop or change your treatment without speaking with your doctor even if you feel better

If you have any further questions on the use of this medicine, ask your doctor or pharmacist

Like all medicines, this medicine can cause side effects, although not everybody gets them. Occasionally (frequency unknown; cannot be estimated from available data) treatment with this medicine can cause inflammation of the small intestine or colon. If you have any of the following side effects, contact your doctor immediately.

·   Severe stomach pains

·   Persistent diarrhoea

·   Nervous system problems (for example shaking, lack of coordination, slurred speech, muscle stiffness, worsening of muscle spasms)

Other side effects may include

Common (may affect up to 1 in 10 people)

·   Nausea (especially when starting treatment) Uncommon (may affect up to 1 in 100 people)

·   Skin rashes

·   Anaemia (you may feel unusually tired)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly. By reporting side effects you can help provide more information on the safety of this medicine.

·      Store below 2°C - 8°C.

·      Keep out of reach of children.

·      Do not use this medicine after the expiry date which is stated on the pack after EXP. The expiry date refers to the last day of the month.

·      Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.