• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

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.

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 Cufence.

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 Cufence. If you notice these whilst taking Cufence, 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.

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 at least 2 hours before or after you have taken Cufence because they may reduce Cufence’s effect. It is recommended that trientine is taken at least one hour apart from any other medicinal product.

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

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. You and 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 Cufence, talk to your doctor.

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

The limited information available suggests that Cufence does not pass into breast milk, but it is not certain that there is no risk to the baby. It is 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 Cufence, considering the benefit of breast-feeding to the baby and the benefit of Cufence to the mother. Your doctor will decide which treatment and which dose is best in your situation.

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

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 a dose take your next dose at its usual scheduled time.

Do not take a double dose to make up for a forgotten dose.

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 get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

The active substance is trientine.

• Each capsule of Cufence 100 mg contains 150 mg trientine dihydrochloride, equivalent to 100 mg trientine.
• Each capsule of Cufence 200 mg contains 300 mg trientine dihydrochloride, equivalent to 200 mg trientine.

The other ingredients are

Capsule content

Magnesium stearate

Colloidal anhydrous silica

Capsule shell

Gelatin

Titanium dioxide (E171)

Printing ink

Shellac

Propylene glycol

Titanium dioxide (E171)

Iron oxide black (E172)

Iron oxide yellow (E172)

Cufence 100 mg hard capsules

White opaque HDPE bottle with an HDPE child-resistant screw cap and induction heat seal liner with a sachet of dried silica gel as desiccant. Each hard capsule is white oval-shaped size 3 (15.8 mm x 5.85 mm) with ‘Cufence 100’ printed in grey ink.

Pack size: one bottle of 200 hard capsules.

Cufence 200 mg hard capsules

Amber glass bottle with a polypropylene cap and induction heat seal liner with a sachet of dried silica gel as desiccant. Each hard capsule is white oval-shaped size 0 (21.8 mm x 7.66 mm) with Cufence printed in grey ink.

Pack size: one bottle of 100 hard capsules.

Not all pack-sizes may be marketed.