CUFENCE 200 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Cufence 100 mg Hard Capsules

Cufence 200 mg Hard Capsules

trientine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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.

Contents of the pack

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

1. What is Cufence and what is it used for

Cufence is indicated for the treatment of Wilson's disease in adults, adolescents, and children aged 5 years and older. It is used in patients who cannot take another medicine, D-penicillamine, due to side effects.

Cufence contains the active substance trientine, a copper-chelating agent 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 you take Cufence

Do not take 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, among others, skin rash, itching, swelling of the face, fainting, and breathing difficulties.

Warnings and precautions

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

Problems in the nervous system (such as tremors, lack of coordination, difficulty speaking, muscle stiffness, and worsening of muscle spasms) may occur, especially in patients who have just started treatment with Cufence. If you notice any of these while taking Cufence, you should inform your doctor immediately.

Pseudolupus reactions (symptoms could include persistent skin rash, fever, joint pain, and fatigue) have been described in some patients who have switched to trientine after penicillamine. However, it has not been possible to determine whether the reaction was due to trientine or 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 stomach acid, leave at least 2 hours before or after taking Cufence, as they may reduce its effect. It is recommended to take trientine at least 1 hour before or after any other medicine.

Taking Cufence with food and drinks

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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 that you continue treatment to maintain normal copper levels during pregnancy. You should discuss the possible benefits of treatment with your doctor, taking into account any risks that may exist. Your doctor will advise you on the best treatment and dose for your situation. If you become pregnant while taking Cufence, talk to your doctor.

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

The limited information available indicates that Cufence is not excreted in breast milk, but there is no certainty that the baby is risk-free. It is important that you inform your doctor if you are breastfeeding or plan to breastfeed. Your doctor will help you decide whether to stop breastfeeding or stop taking Cufence, considering the benefit of breastfeeding for the child and the benefit of Cufence for the mother. Your doctor will advise you on the best treatment and dose for your situation.

Driving and using machines

Cufence is unlikely to affect your ability to drive or use tools or machines.

3. How to take Cufence

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist again.

Adults (including elderly patients)

The usual dose is between 800 and 1600 mg per day, taken orally.

Use in children and adolescents (5 to 17 years old)

The dose in children and adolescents depends on age and body weight, and will be adjusted by the doctor. At the start of treatment, the dose varies between 400 and 1000 mg per day.

Method of administration

Your doctor will decide the correct dose for you.

The total daily dose may be divided into 2 to 4 smaller doses, as indicated by the doctor. Swallow the capsules whole with water, on an empty stomach, at least 1 hour before or 2 hours after meals.

Patients who have difficulty swallowing should contact their doctor.

If you take more Cufence than you should

If you take more medicine than you should, you may experience nausea, vomiting, and dizziness. You should contact your doctor or another healthcare professional immediately.

If you forget to take Cufence

If you forget to take a dose, take the next dose at the scheduled time.

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

If you stop taking Cufence

This medicine is intended for long-term use because Wilson's disease is a lifelong condition. Do not stop or change treatment without discussing it 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.

4. Possible side effects

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

Sometimes (frequency not known; cannot be estimated from the available data) treatment with this medicine may cause inflammation of the small intestine or colon. If you experience any of the following side effects, contact your doctor immediately:

• Severe stomach pain
• Persistent diarrhea
• Nervous system problems (such as tremors, lack of coordination, difficulty speaking, muscle stiffness, and 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
• Anemia (you may feel unusually tired)

Reporting of side effects

If you experience 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 through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing 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 outer packaging after EXP. The expiry date is the last day of the month stated.

Use within 3 months of first opening the bottle. Keep the bottle tightly closed to protect it from moisture. Do not use if the capsules become sticky or damp.

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

6. Contents of the pack and other information

Composition of Cufence

The active substance is trientine.

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

The other ingredients are:

• Capsule content: magnesium stearate and anhydrous colloidal silica
• Capsule shell: gelatin and titanium dioxide (E171)
• Printing ink: shellac, propylene glycol (E1520), titanium dioxide (E171), black iron oxide (E172), and yellow iron oxide (E172)

Appearance and packaging

Cufence 100 mg, hard capsules

Opaque white HDPE bottle with a child-resistant screw cap and induction-sealed with a dry silica gel sachet as a desiccant. Each hard capsule is white, oval-shaped, size 3 (15.8 mm x 5.85 mm), and printed with "Cufence" in gray ink.

Pack size: one bottle of 200 hard capsules

Cufence 200 mg, hard capsules

Ambber glass bottle with a polypropylene cap and induction-sealed with a dry silica gel sachet as a desiccant. Each hard capsule is white, oval-shaped, size 0 (21.8 mm x 7.66 mm), and printed with "Cufence" in gray ink.

Pack size: one bottle of 100 hard capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Univar Solutions BV

Schouwburgplein 30

3012 CL Rotterdam

Netherlands

Manufacturer

Aesica Pharmaceuticals GmbH

Alfred-Nobel Strasse 10

40789 Monheim

Germany

Date of last revision of this leaflet: <{MM/AAAA}><{month AAAA}>.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu. There are also links to other websites on rare diseases and orphan medicines.