200 mg hard capsules 

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, 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 give it to others. It may harm them, even if they show symptoms similar to yours.

– If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information.

In this leaflet you will find information about: 
1. What Cufence is and what it is used for 
2. What you need to know before you use Cufence 
3. How to use Cufence 
4. Possible side effects 
5. How to store Cufence 
6. Contents of the packaging and other information 

1. What Cufence is and what it is used for

Cufence is a drug used to treat Wilson’s disease in adults, adolescents, and children 5 years of age or older. It is intended for patients who are unable to take another medicine, D-penicillamine, due to side effects.

Cufence contains the active substance trientine which is a copper chelating substance used to remove excess copper from the body. Cufence binds to copper which is then excreted from the body.

2. What you need to know before using Cufence

Do not use Cufence

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 skin rash, itching, facial swelling, fainting, and breathing problems.

Warnings and cautions

Your doctor must regularly check for symptoms of the disease and check the copper levels in your blood and urine. Regular monitoring is especially important at the beginning of your treatment or when your dose changes, in growing children and pregnant women to ensure that copper levels are maintained at an appropriate level. Your doctor may need to increase or decrease your dose of Cufence.

Nervous system problems may occur (eg tremors, lack of coordination, slurred speech, muscle stiffness, and worsening muscle spasms), especially in patients just starting treatment with Cufence. If you experience any of these problems while taking Cufence, talk to your doctor immediately.

Lupus-like reactions (symptoms may include persistent rash, joint pain, and fatigue) have been reported in some patients who switched from medicines containing penicillamine to medicines containing trientine. However, it was not possible to determine whether the reaction was due to trientine or the previous treatment with penicillamine.

Other medicines and Cufence

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 neutralize the acid in your stomach (antacids), leave at least 2 hours before or after taking Cufence as iron tablets and antacids may reduce the effect of Cufence.

Cufence with food, drink, and alcohol

Take this medicine with water only. Do not take it with other drinks or food as it may reduce the effect of the medicine. Avoid eating or drinking 1 hour before or 2 hours after taking Cufence.

Pregnancy, breastfeeding, and fertility

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 discuss in detail the possible benefits of the treatment and also consider any risks that may exist. Your doctor will recommend which treatment and dose are best for your situation. Talk to your doctor if you become pregnant while taking Cufence.

If you are pregnant and taking Cufence, you will be closely monitored during pregnancy for signs of effects on your baby or changes in your copper levels.

The limited information available indicates 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 planning to do so. Your doctor will help you decide whether to stop breastfeeding or stop taking Cufence by considering the benefits of breastfeeding for your baby and the benefits of Cufence treatment for you. Your doctor will decide which treatment and dose are best for your situation.

Driving and using machines

Trientine probably does not affect the ability to drive and use machines.

3. How to use Cufence

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Adults (including the elderly)

The usual dose is between 4 and 8 capsules daily taken by mouth.

Use for children and adolescents (5 to 17 years)

In children and adolescents, the dose depends on age and body weight and will be adjusted by a doctor. At the beginning of treatment, the dose varies between 2 and 5 capsules daily.

Method of administration

Your doctor will decide which dose is right for you.

The total daily dose can be divided into two to four smaller doses according to the doctor’s instructions. Swallow the capsules whole with water. Take the tablets on an empty stomach, at least 1 hour before or 2 hours after a meal.

Patients who have difficulty swallowing should consult a physician.

If you use more Cufence than you should  

If you take more medicines than you should, you may experience nausea, vomiting, and dizziness. You must contact a doctor or other healthcare professional immediately.

If you forget to use Cufence

If you forget to take a dose, take the next dose at the usual scheduled time. Do not take a double dose to make up for a forgotten dose.

If you stop using Cufence

This medicine is intended for long-term use because Wilson’s disease is a lifelong condition. Do not stop or change your treatment without talking to a doctor, even if you feel better.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Occasionally ( no known frequency, can not be calculated from the available data ) treatment with this drug may cause inflammation of the small intestine or colon. If you experience any of the following side effects, contact your doctor immediately :

  • severe abdominal pain
  • persistent diarrhea
  • problems with the nervous system (eg tremors, lack of coordination, slurred speech, muscle stiffness, and worsening muscle spasms).

Other side effects may include:

Common (may affect up to 1 in 10 people)

  • Nausea (especially at the start of treatment)

Uncommon (may affect up to 1 in 100 people)

  • Rash
  • Anemia (you may feel unusually tired)

5. How to store Cufence

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 bottle label and the carton. The expiration date is the last day of the specified month.

Use within 3 months after first opening the jar. Do not use if the capsules become sticky or wet.

Store in the original package. Moisture sensitive. Store in a refrigerator (2 ºC-8 ºC). Do not freeze.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is trientine. One capsule contains 300 mg of trientine dihydrochloride equivalent to 200 mg of trientine.
  • Other ingredients areCapsule contents: Magnesium stearate colloidal anhydrous silica
    Capsule shell: GelatineTitanium dioxide (E171)
    Printing ink: ShellackPropylene glycolTitanium dioxide (E171)Black iron oxide (E172)Yellow iron oxide (E172)

What the medicine looks like and the contents of the pack

Brown glass jar with a polypropylene lid and heat seal with a bag of dried silica as a desiccant. White and oval hard capsule in size 0 with “Cufence 200” printed in gray ink.

Pack size: 1 jar with 100 hard capsules.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Univar Solutions BV

Schouwburgplein 30

3012 CL Rotterdam



Aesica Pharmaceuticals GmbH

Alfred-Nobel Strasse 10

40789 Monheim


Muhammad Nadeem

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