CUFENCE 200 mg Kapsułka Twarda
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Treść ulotki
Cufence 100 mg hard capsules, 200 mg hard capsules
trientina
Read this leaflet carefully before taking this medicine as 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. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet
- 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
1. What is Cufence and what is it used for
Cufence is a medicine used for the treatment of Wilson's disease in adults, adolescents and
children aged 5 years and over. It is intended for use by patients who cannot
take another medication, D-penicillamine, due to its undesirable effects.
Cufence contains the active ingredient trientine, a copper chelating agent that is used to
remove excess copper from the body. Cufence binds to copper, which is then eliminated
from the body.
2. What you need to know before taking 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 can include skin rash, itching, swelling of the face, fainting
and breathing problems.
Warnings and precautions
The doctor will need to regularly check the symptoms of the disease and the levels of copper in the blood and
urine. Regular monitoring is particularly important at the beginning of treatment or when the
dose is changed, in children who are growing and in pregnant women, to ensure that
copper levels are maintained at adequate levels. The doctor may need to increase or decrease the
dose of Cufence.
Problems of the nervous system (e.g. tremors, lack of coordination,
speech disorders, muscle stiffness and worsening of muscle spasms) may occur, especially in
patients who are at the beginning of treatment with Cufence. If you notice such problems during
treatment with Cufence, you should immediately inform your doctor.
In some patients who switched from penicillamine to trientine, reactions similar to those of
lupus have been reported (symptoms may include persistent skin rashes, fever, joint pain and
fatigue). However, it has not been possible to establish whether such reactions were attributable 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, take them
at least 2 hours before or after taking Cufence, because they may reduce the effect of Cufence.
It is recommended to take trientine at least one hour apart from any other medicine
Cufence with food and drink
Take this medicine only with water. Do not take it with other drinks, milk or food because
they may reduce the effect of the medicine. Avoid eating or drinking (except water) for 2
hours before and 1 hour after taking Cufence.
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant or are breastfeeding with
breast milk, 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 the potential benefits of treatment thoroughly, considering
at the same time any possible risks. Your doctor will advise you which treatment and which
dosage are best 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 for any
effects on the baby or changes in its copper levels.
Limited information suggests that Cufence does not pass into breast milk, but it is
not certain that there are no risks to the newborn. It is important that you inform your doctor if you are
breastfeeding or intend to do so. The doctor will then help you decide whether to stop
breastfeeding or stop taking Cufence, considering the benefits of breastfeeding for the baby and the benefits of Cufence for the mother. The doctor will decide which treatment and which
dosage are best for your situation.
Driving and using machines
It is unlikely that trientine will affect your ability to drive or use machines.
3. How to take Cufence
Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Adults (including the elderly)
The recommended dose is between 800 and 1,600 mg per day, to be taken orally.
Use in children and adolescents (from 5 to 17 years)
In children and adolescents, the dose depends on age and body weight and will be adjusted by the
doctor. At the beginning of treatment, the dose may vary from 400 to 1,000 mg per day.
Method of administration
The doctor will decide the correct dose for you.
The total daily dose can be divided between 2-4 smaller doses, as indicated by the doctor.
Swallow the capsules whole with a glass of water on an empty stomach, at least 1 hour before or 2 hours
after any food.
Patients who have difficulty swallowing should contact their doctor.
If you take more Cufence than you should
If you take an excessive amount of the medicine, you may experience nausea, vomiting and dizziness. In such
cases, 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 normally scheduled time.
Do not take a double dose to make up for a missed dose.
If you stop taking Cufence
This medicine is for long-term use, as Wilson's disease is a condition that
lasts for life. Do not stop or change treatment without talking to your doctor, even
if you feel better.
If you have any doubts about 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.
Occasionally (frequency unknown, not estimable 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 diarrhea
- Problems of the nervous system (for example tremors, lack of coordination, speech disorders, muscle stiffness, worsening of muscle spasms).
Other side effects may include:
Effectscommon (may affect up to 1 in 10 people):
- Nausea (especially at the beginning of treatment)
Effects uncommon(may affect up to 1 in 100 people):
- Skin rashes
- Anemia (you may feel unusual tiredness)
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor, pharmacist or nurse. You can also report side effects directly through
the national reporting system as detailed in Annex V. By reporting side
effects you can help provide more information on the safety of this medicine.
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 and the outer carton
after ‘Exp.’. The expiry date refers to the last day of that month.
Use within 3 months of first opening the bottle. Keep the bottle tightly closed to protect the
medicine from moisture. Do not use if the capsules become sticky or damp.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Package Contents and Other Information
What Cufence Contains
The active ingredient 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 ingredients are:
- Capsule content: magnesium stearate, anhydrous colloidal silica
- Capsule shell: gelatin, titanium dioxide (E171)
- Printing ink: shellac, propylene glycol (E1520), titanium dioxide (E171), black iron oxide (E172), yellow iron oxide (E172)
Description of the Appearance of Cufence and Package Contents
Cufence 100 mg hard capsules
Opaque white HDPE bottle with a child-resistant HDPE screw cap and heat-sealed foil
with a desiccant sachet of silica gel. Each hard capsule is white, oval in shape
and measures 3 (15.8 mm x 5.85 mm), with “Cufence 100” printed in grey ink.
Package size: 1 bottle containing 200 hard capsules.
Cufence 200 mg hard capsules
Amber glass bottle with a polypropylene cap and heat-sealed foil with a desiccant sachet of
silica gel. Each hard capsule is white, oval in shape and measures 0 (21.8 mm
x 7.66 mm), with “Cufence” printed in grey ink.
Package size: 1 bottle containing 100 hard capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Univar Solutions BV
Schouwburgplein 30
3012 CL Rotterdam
Netherlands
Manufacturer
Aesica Pharmaceuticals GmbH
Alfred-Nobel Strasse 10
40789 Monheim
Germany
Other Sources of Information
More detailed information on this medicine is available on the European Medicines Agency website, https://www.ema.europa.eu . Furthermore, links to other websites on rare diseases
and related therapeutic treatments are provided.
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- Kraj rejestracji
- Postać farmaceutycznaHard capsule, 200 MG
- Kod ATCA16AX12
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki KUFENKEPostać farmaceutyczna: Hard capsule, 167 MGSubstancja czynna: trientineProducent: TILLOMED ITALIA SRLWymaga receptyPostać farmaceutyczna: Tablet, 500 MGSubstancja czynna: sodium phenylbutyrateProducent: IMMEDICA PHARMA ABBez recepty
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Często zadawane pytania
KUFENKE wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w KUFENKE jest trientine. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
KUFENKE jest produkowany przez UNIVAR SOLUTION BV. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie KUFENKE jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić KUFENKE w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (trientine) to m.in. KUPRIOR, TRIENTINA TILLOMED, AMMONAPS. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
