Cufence 200 mg hard capsules
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Cufence 100 mg hard capsules
Cufence 200 mg hard capsules
trientine
Read the entire 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 questions, ask your doctor, pharmacist, or nurse.
- This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if such effects are not listed in this leaflet. See section 4.
Contents of the leaflet
- What Cufence is and what it is used for
- What you need to know before taking Cufence
- How to take Cufence
- Possible adverse effects
- How to store Cufence
- Contents of the pack and other information
1. What Cufence is and what it is 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 adverse 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 starting to take Cufence
Do not take Cufence
If you are allergic to trientine or to any of the other ingredients of this medicine (listed in section 6).
Signs of an allergic reaction may include, among others, skin rash, itching, facial swelling, fainting, and breathing difficulties.
Warnings and precautions
Your doctor will need to regularly monitor your disease symptoms and your copper levels in blood and urine. Regular monitoring is especially important at the beginning of treatment or when the dose is changed, in growing children and in pregnant women, to ensure that copper levels remain at an appropriate level. Your doctor may need to increase or decrease the dose of Cufence.
Neurological problems (for example, tremor, lack of coordination, difficulty speaking, muscle stiffness, and worsening of muscle spasms) may occur, particularly in patients who have recently started treatment with Cufence. If you experience any of these symptoms while taking Cufence, you must inform your doctor immediately.
Pseudolupus reactions (symptoms may include persistent skin rash, fever, joint pain, and fatigue) have been reported in some patients who switched to trientine-containing medication from penicillamine-containing medication. However, it has not been possible to determine whether the reaction was due to trientine or to prior treatment with penicillamine.
Other medicines and Cufence
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
If you are taking iron tablets or medications that neutralize stomach acid, allow at least 2 hours before or after taking Cufence, as they may reduce its effectiveness. It is recommended to take trientine at least one hour before or after any other medication.
Taking Cufence with food and drinks
Take this medicine with water only. Do not take it with other beverages, milk, or food, as they may reduce the medicine's effectiveness. 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 might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. It is very important to continue treatment to maintain normal copper levels during pregnancy. You should discuss thoroughly with your doctor the potential benefits of treatment, while also considering any possible risks. Your doctor will advise you on the best treatment and dosage for your situation. If you become pregnant while taking Cufence, speak with 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 available information indicates that Cufence is not excreted in breast milk, but it is not certain that the baby is free of risk. It is important that you inform your doctor if you are breastfeeding or intend to breastfeed. Your doctor will help you decide whether it is better to discontinue breastfeeding or to stop taking Cufence, taking into account the benefits of breastfeeding for the child and the benefits of Cufence for the mother. Your doctor will advise you on the best treatment and dosage for your situation.
Driving and using machines
It is unlikely that Cufence will affect your ability to drive or operate tools or machinery.
3. How to take Cufence
Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Adults (including elderly patients)
The usual dose is between 800 and 1,600 mg per day, taken orally.
Use in children and adolescents (from 5 to 17 years of age)
The dose in children and adolescents depends on age and body weight, and will be adjusted by the doctor. At the beginning of treatment, the dose ranges between 400 and 1,000 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, according to your doctor's instructions. 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 indicated for long-term use because Wilson's disease is a lifelong condition. Do not stop or change your treatment without discussing it with your doctor, even if you feel better.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Sometimes (frequency unknown; cannot be estimated from 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 diarrhoea
- Nervous system problems (for example, tremor, lack of coordination, difficulty speaking, muscle stiffness, worsening of muscle spasms)
Other possible side effects include:
Frequent (may affect up to 1 in 10 people)
- Nausea (especially when starting treatment)
Uncommon (may affect up to 1 in 100 people)
- Skin rash
- Anaemia (you may feel unusually tired)
Reporting of adverse effects
If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Cufence
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer packaging after EXP. The expiry date is the last day of the month indicated.
Use within 3 months after first opening the bottle. Keep the bottle tightly closed to protect from moisture. Do not use if the capsules become sticky or moist.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Cufence
The active substance is trientine.
- Each Cufence 100 mg hard capsule contains 150 mg of trientine dihydrochloride, equivalent to 100 mg of trientine.
- Each Cufence 200 mg hard capsule contains 300 mg of trientine dihydrochloride, equivalent to 200 mg of trientine.
The other components are:
- Capsule contents: magnesium stearate and colloidal anhydrous 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 of the product and contents of the pack
Cufence 100 mg, hard capsules
White opaque HDPE bottle with a child-resistant HDPE screw cap and induction-sealed closure, containing a sachet of dried silica gel as desiccant. Each hard capsule is white, oval-shaped, size 3 (15.8 mm x 5.85 mm), printed with "Cufence" in grey ink.
Pack size: one bottle containing 200 hard capsules.
Cufence 200 mg, hard capsules
Amber glass bottle with a polypropylene cap and induction-sealed closure, containing a sachet of dehydrated silica gel as desiccant. Each capsule is white, oval-shaped, size 0 (21.8 mm x 7.66 mm), printed with "Cufence" in grey ink.
Pack size: one bottle containing 100 hard capsules.
Only certain pack sizes may be marketed.
Marketing Authorization Holder
Univar Solutions BV
Schouwburgplein 30
3012 CL Rotterdam
The Netherlands
Manufacturer
Aesica Pharmaceuticals GmbH
Alfred-Nobel Strasse 10
40789 Monheim
Germany
Date of the most recent revision of this leaflet: <{MM/YYYY}><{month YYYY}>.
Other sources of information
Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu. Links to other websites on rare diseases and orphan medicinal products are also provided.