Patient Information Leaflet
Lecigon 20 mg/ml + 5 mg/ml + 20 mg/ml Intestinal Gel
Levodopa/carbidopa monohydrate/entacapone
Read this leaflet carefully before you start using this medicine, as it contains important information for you.
1. What Lecigon is and what it is used for
2. What you need to know before you start using Lecigon
3. How to use Lecigon
4. Possible side effects
5. Storage of Lecigon
6. Contents of the pack and additional information
Lecigon is a continuous administration gel that is supplied through a pump and a catheter directly into the small intestine. Lecigon contains three active principles:
How Lecigon works
In a person with Parkinson's disease, dopamine levels in the brain are low. Levodopa is converted into dopamine in the brain, thus alleviating the symptoms of Parkinson's disease. Carbidopa and entacapone improve the effect that levodopa has on Parkinson's disease.
Warnings and precautions
Consult your doctorbefore starting to usethis medication if you have or have ever had:
Consult your doctor immediately if you experience any of the following symptoms during your treatment with this medication:
A severe condition with a combination of muscle rigidity, cramps, tremors, sweating, fever, rapid pulse, severe blood pressure fluctuations, abnormal behavior, confusion, loss of consciousness.
A severe condition with unexplained muscle pain, cramps, or weakness. Rhabdomyolysis can be caused by neuroleptic malignant syndrome.
Stomach pain, nausea, or vomiting. This may be due to serious problems caused by the pump or surgery, such as blockage, injury, or damage to the intestine.
Talk to your doctor if you experience any of the following symptomsduring treatmentwith this medication:
If you cannot handle the pump and the catheter, you should get help from a caregiver (e.g., nurse, nursing assistant, or family member) to avoid complications (problems).
Mood disorders - Changes in behavior
Inform your doctor if you, your family, or your caregiver notice that you are developing impulses or desires to behave in an unusual way, or if you cannot resist the impulse or temptation to perform certain activities that could harm you or others. These behaviors are called “impulse control disorders” and may include compulsive gambling, excessive eating or spending, abnormal sexual desire, or an increase in sexual thoughts or feelings. Your doctor may need to adjust your dose or interrupt your treatment. For more information, see section 4 “Possible side effects”.
Dopamine dysregulation syndrome
Inform your doctor if you or your family/caregiver notice that you are developing symptoms similar to those of addiction that cause a desire to consume increasing doses of Lecigon and other medications used to treat Parkinson's disease.
Regular checks
With long-term treatment with Lecigon, your doctor may need to perform regular checks of your liver and kidney function, blood counts, heart, and blood vessels, and examine your skin to detect any changes in your skin.
Lecigon and cancer
Lecigon contains hydrazine, which is formed when carbidopa (active ingredient of Lecigon) breaks down. Hydrazine could damage your genes, which may possibly cause cancer. However, it is not known if the amount of hydrazine produced by taking the recommended dose of Lecigon can cause damage or disease.
Surgery
Before undergoing any operation, including dental surgery, inform your doctor or dentist that you are using Lecigon.
Urine tests
The active ingredients levodopa and carbidopa may produce misleading results in urine tests. Inform your healthcare professional that you are using Lecigon if they ask you to provide a urine sample.
Children and adolescents
Lecigon should not be administered to children or adolescents under 18 years old.
Other medications and Lecigon
Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.
Do notuseLecigon if you are taking:
Lecigon mayenhance the effect and side effects of other medicationsand other medications mayenhance the effect and side effects of Lecigon. Inform your doctor if you are taking:
Some medications mayreduce the effectof Lecigon. Inform your doctor if you are taking:
Use of Lecigon with food and drinksandbeverages
Lecigon is not absorbed well if taken immediately after consuming high-protein foods (e.g., meat, fish, dairy products, nuts, and seeds). Inform your doctor if you follow a high-protein diet.
Pregnancy,breastfeeding, and fertility
If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.
Lecigon is not recommended during pregnancy or in women of childbearing age who do not use contraceptive methods, unless your doctor determines that the benefits for the mother outweigh the possible risks to the fetus.
You should not breastfeed while taking Lecigon.
Driving and using machines
Lecigon may have a significant impact on your ability to drive and use machines. Do not drive or use machines until you are sure how Lecigon affects you.
Wait until you feel completely awake or no longer feel dizzy before driving, using tools or machines, or performing any activity in which lack of concentration may put you or others at risk.
Lecigon contains sodium
This medication contains 166 mg of sodium (main component of table salt/for cooking) in each cartridge. This is equivalent to 8.3% of the maximum recommended daily sodium intake in adults.
Follow the exact administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.
How to use Lecigon
Lecigon is a gel that circulates through a portable pump (Crono LECIG) and a tube directly into the upper part of your intestine. The pump is connected to a catheter that has been surgically placed in your intestine through the abdominal wall.
The pump administers a small dose during the day. This means that the medication level in your blood remains constant. It also means that some side effects, such as those affecting movement, are less severe compared to oral medications.
Before the catheter is inserted into the small intestine, your doctor may choose to check if the treatment with Lecigon is working. In such cases, the gel is administered through a tube that passes through the nose, throat, and stomach into the small intestine.
A manual for using the pump is provided with the pump.
Dose
Your doctor will adjust the dose individually based on your previous medication. It may be necessary to adjust the dose during the first weeks of treatment.
Generally, a higher dose (called a bolus dose) is administered in the morning when treatment begins to quickly reach the correct medication levels in the blood. After this, a maintenance dose is administered continuously during waking hours (usually around 16 hours). If necessary, your doctor may decide to administer Lecigon up to 24 hours a day.
Additional doses may also be administered as needed. Some people may also need to increase or decrease the continuous maintenance dose during the day. Your doctor will decide how and when you will receive additional doses or if it is necessary to adjust the dose during the day.
The total daily dose, including the morning bolus dose, maintenance dose, and additional doses, cannot exceed 100 ml (which corresponds to 2,000 mg of levodopa, 500 mg of carbidopa, and 2,000 mg of entacapone).
If the user has dementia, the doctor may decide that the pump can only be manipulated by a healthcare professional or a family member. The pump can be blocked to prevent accidental overdose of the recommended daily dose.
Used cartridge
The medication cartridge is for single use and should not be used more than 24 hours, even if there is still medication left. The pump with the installed cartridge can be carried near the body for up to 16 hours. During nighttime treatment, the pump should not be used near the body, but it can, for example, be placed on the nightstand. If there was an interruption in treatment during the night, you can continue using the opened cartridge the next day, but only up to 24 hours after it was first opened. Do not remove the cartridge from the pump until you have finished using it (i.e., after 24 hours have passed since it was opened or when it is empty, whichever comes first).
The gel may turn slightly yellow/orange towards the end of its shelf life. This does not affect the treatment effect.
If you use more Lecigon than you should
In case of overdose, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 40 20 indicating the medication and the amount taken.
The signs of overdose may include:
If you forget to use Lecigon
Turn on the pump as prescribed as soon as possible. Do not take a double dose to compensate for the missed doses.
If you interrupt treatment with Lecigon
Do not stop using Lecigon or reduce your dose without consulting your doctor.
This is because a sudden reduction in dose or interruption of treatment with Lecigon can cause severe diseases called malignant neuroleptic syndrome and rhabdomyolysis. There is a high risk of these conditions occurring if you are also being treated with a medication for a severe psychological problem. For more information about these conditions, see section 4 “Possible side effects”.
If treatment is interrupted, you will receive another treatment instead. If Lecigon treatment is suspended permanently, the catheter will be removed and the wound will heal.
If you have any other questions about using this medication, ask your doctor, pharmacist, or nurse.
Like all medications, this medication may cause side effects, although not everyone will experience them. To reduce the risk of side effects, it is essential that the medication dose be adjusted individually with the proper pump setting.
Severe side effects of Lecigon
Immediately contact a doctor if you experience any of the following symptoms during treatment with Lecigon - you may need urgent medical treatment:
For more information on malignant neuroleptic syndrome and rhabdomyolysis, see section 3 “If you interrupt or reduce the dose of Lecigon”.
Other side effects of Lecigon
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Impulse control disorders – Changes in behavior.This is a common side effect (may affect up to 1 in 10 people):
Difficulty resisting the temptation to perform an action that may be harmful, which includes:
Inform your doctor if you, your family, or caregiver notice any of these behaviors. Your doctor will explain how to control or reduce the symptoms.
Infrequent (may affect up to 1 in 100 people):
Rare (may affect up to 1 in 1,000 people):
Reported (affect an unknown number of patients):
Side effects of the pump, tube, or surgery
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Infrequent (may affect up to 1 in 100 people):
Reported (affect an unknown number of patients):
Side effects when levodopa and carbidopa are taken orally
The following side effects have been reported with levodopa and carbidopa (the same active principles as Lecigon) when taken orally. These side effects may also occur with Lecigon.
Rare (may affect up to 1 in 1,000 people):
Very rare (may affect up to 1 in 10,000 people):
Reporting side effects
If you experience any type of side effect, consult your doctor,pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date that appears on the cartridge label and the box after EXP.
Unopened cartridge: Store and transport refrigerated (between 2°C and 8°C). Do not freeze. Store in the original packaging to protect it from light.
Opened cartridge: Use immediately. The medication can be used up to 24 hours after removal from the refrigerator. The pump with cartridge installed can be carried near the body for 16 hours. During nighttime treatment, the pump should not be used in contact with the body, but can, for example, be placed on the nightstand. Dispose of any unused amount after 24 hours.
Cartridges are designed for single use. Do not reuse an opened cartridge.
Medicines should not be disposed of through drains or in the trash. Deposit containers and unused medications at the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of containers and unused medications. By doing so, you will help protect the environment.
Aspect of the product and content of the package
Lecigon intestinal gel is a viscous, opaque yellow or yellowish-red gel, contained in a plastic cartridge containing 47 ml of intestinal gel.
A package contains 7 cartridges.
Holder of the marketing authorization and responsible for manufacturing
Holder of the marketing authorization
LobSor Pharmaceuticals AB
Kålsängsgränd 10 D
SE-753 19 Uppsala, Sweden
Responsible for manufacturing:
Bioglan AB
Borrgatan 31, Malmö S.t. Petri
Malmö, Skane Lan
211 24, Sweden
or
STADA Arzneimittel AG
Stadastrasse 2-18,
61118 Bad Vilbel
Germany
You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:
Laboratorio STADA, S.L.
Frederic Mompou, 5
08960 Sant Just Desvern (Barcelona)
Spain
This medication is authorized in the Member States of the European Economic Area with the following names:
AustriaLecigimon 20mg/ml + 5mg/ml + 20mg/ml Gel zur intestinalen Anwendung
BelgiumLecigimon 20 mg/ml + 5 mg/ml + 20 mg/ml, gel intestinal
Lecigimon 20mg/ml + 5mg/ml + 20mg/ml gel voor intestinaal gebruik
Lecigimon 20mg/ml + 5mg/ml + 20 mg/ml Gel zur intestinalen Anwendung
Bulgaria??????? 20 mg/ml + 5 mg/ml + 20 mg/ml ??? ?? ????????? ? ???????
CroatiaLecigon 20 mg/ml + 5 mg/ml + 20 mg/ml intestinalni gel
Czech RepublicLecigimon 20 mg/ml + 5 mg/ml + 20 mg/ml intestinální gel
DenmarkLecigon enteralgel
FinlandLecigon 20mg/ml + 5mg/ml + 20mg/ml geeli suoleen
FranceLecigimon 20 mg/ml + 5 mg/ml + 20 mg/ml, gel intestinal
GermanyLecigon 20mg/ml + 5mg/ml + 20mg/ml Gel zur intestinalen Anwendung
HungaryLecigon 20 mg/ml + 5 mg/ml + 20 mg/ml intesztinális gél
IrelandLecigon 20 mg/ml + 5 mg/ml + 20 mg/ml intestinal gel
ItalyLecigimon 20 mg/ml + 5 mg/ml + 20 mg/ml gel intestinale
NetherlandsLecigon 20mg/ml + 5mg/ml + 20mg/ml gel voor intestinaal gebruik
NorwayLecigon 20 mg/ml + 5 mg/ml + 20 mg/ml intestinalgel
PolandLecigon 20 mg/ml + 5 mg/ml + 20 mg/ml zel dojelitowy
PortugalLecigon 20 mg/ml + 5 mg/ml + 20 mg/ml gel intestinal
RomaniaLecigon 20mg/5mg/20mg/ml gel intestinal
SlovakiaLecigon 20 mg/ml + 5mg/ml + 20 mg/ml intestinálny gél
SloveniaLecigon 20mg/5mg/20mg v 1ml intestinalni gel
SpainLecigon 20 mg/ml + 5 mg/ml + 20 mg/ml gel intestinal
SwedenLecigon 20 mg/ml + 5 mg/ml + 20 mg/ml intestinal gel
Last review date of this leaflet:October 2023
Other sources of information
The detailed information about this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).
Have questions about this medication or your symptoms? Connect with a licensed doctor for guidance and personalized care.