Lecigon

Leaflet accompanying the packaging: information for the user

Lecigon, 20 mg/mL + 5 mg/mL + 20 mg/mL, gel for intestinal administration

Levodopa + Carbidopa + Entacapone

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Lecigon and what is it used for
• 2. Important information before using Lecigon
• 3. How to use Lecigon
• 4. Possible side effects
• 5. How to store Lecigon
• 6. Contents of the packaging and other information

1. What is Lecigon and what is it used for

Lecigon is used to treat Parkinson's disease. It is used in advanced cases when oral medications no longer provide sufficient effect.
Lecigon is a gel intended for continuous administration, which is administered through a pump and a catheter directly into the small intestine. Lecigon contains three active substances:

• levodopa
• carbidopa (in the form of carbidopa monohydrate)
• entacapone

How Lecigon works

In a person with Parkinson's disease, the dopamine level in the brain is low. Levodopa is converted into dopamine in the brain, thereby alleviating the symptoms of Parkinson's disease. Carbidopa and entacapone improve the effect of levodopa on Parkinson's disease.

2. Important information before using Lecigon

When not to use Lecigon

• -If the patient is allergic to levodopa, carbidopa, entacapone, or any of the other ingredients of this medicine (listed in section 6).
• -If the patient has an eye disease called narrow-angle glaucoma (acute form of glaucoma).
• -If the patient has severe heart failure.
• -If the patient has severe heart rhythm disorders (arrhythmia).
• -If the patient has recently had a stroke.
• -If the patient has severe liver disease.
• -If the patient is taking antidepressant medicines called selective MAO-A inhibitors (e.g., moclobemide) and non-selective MAO inhibitors (e.g., phenelzine). Treatment with these medicines should be stopped at least two weeks before starting treatment with Lecigon. See also the section "Lecigon and other medicines".

and should be discontinued at least two weeks before starting treatment with Lecigon. See also the section "Lecigon and other medicines".

• -If the patient has an adrenal gland tumor that causes excessive production of adrenaline and noradrenaline (pheochromocytoma).
• -If the patient's body produces too much cortisol (Cushing's syndrome).
• -If the patient has elevated levels of thyroid hormones (hyperthyroidism).
• If the patient has ever had a malignant neuroleptic syndrome (a severe, rare reaction that can occur during treatment with or after discontinuation of certain medicines).
• -If the patient has ever had rhabdomyolysis (a severe, rare muscle disease that affects the kidneys).
• -If the patient has had skin cancer or has unusual skin moles that have not been examined by a doctor.

Warnings and precautions

Before starting treatment with Lecigon, the patient should discuss with their doctor if they have or have had:

• -Heart attack or any other cardiovascular disease, including angina pectoris and heart rhythm disorders.
• -Asthma or any other respiratory problems.
• -Kidney or liver disease.
• -Hormonal disorders.
• -Stomach ulcer.
• -Seizures (epileptic fits).
• -Serious psychological problems, such as psychosis.
• -An eye disease called wide-angle glaucoma.
• -Abdominal surgery.
• -Polyneuropathy or a condition related to polyneuropathy. Increasing weakness, pain, numbness, or loss of sensation in the fingers or toes. Symptoms of polyneuropathy have been reported in patients treated with intestinal gel containing levodopa and carbidopa. Before starting treatment with Lecigon, the doctor will examine the patient for symptoms of polyneuropathy and will then perform periodic examinations.

In case of any of the following symptoms during treatment with Lecigon

the patient should immediately contact their doctor:

• -Malignant neuroleptic syndrome:A serious condition characterized by muscle stiffness, spasms, tremors, sweating, fever, rapid heartbeat, large fluctuations in blood pressure, uncontrolled behavior, disorientation, loss of consciousness.
• -Rhabdomyolysis:A serious condition characterized by unexplained muscle pain, spasms, or weakness. Rhabdomyolysis may be caused by malignant neuroleptic syndrome. → More information on malignant neuroleptic syndrome and rhabdomyolysis can be found in section 3 "Discontinuation or dose reduction of Lecigon" and section 4 "Possible side effects".
• -Problems related to the catheter or procedure:Abdominal pain, nausea, or vomiting. This may be due to serious problems related to the catheter or procedure, such as blockage, wound, or intestinal injury.

The patient should contact their doctor if they experience any of the following symptoms during treatment with Lecigon:

• -Feeling of depression, suicidal thoughtsor any psychological changesobserved by the patient or another person.
• -Unusual birthmarksor pigmented molesthat have suddenly appeared or worsened.
• -Involuntary movements(dyskinesia). If the patient has not been previously treated with entacapone (one of the active substances of Lecigon), the symptoms may be due to the fact that entacapone enhances the effect of levodopa and carbidopa (other active substances of Lecigon). The doctor may need to reduce the dose.

as the effect of the treatment suddenly or gradually worsens, e.g., difficulties in moving/slow movements (bradykinesia) appear. This may be due to the catheter being pulled out of the small intestine or the catheter being blocked. This may also be due to the pump not working properly.

• -Diarrhea occurs. The patient's weight may need to be monitored to avoid significant weight loss, or treatment may need to be discontinued. Prolonged or persistent diarrhea may be a sign of intestinal inflammation. In such cases, the doctor will assess the treatment with Lecigon.
• -Loss of appetite, which worsens over time, feeling of weakness, weight lossin a short time. A general medical examination, including liver function tests, may be required.

If the patient is unable to use the pump and catheter, they must seek assistance from a caregiver (e.g., nurse, nursing assistant, or close relative) to avoid complications (problems).
Impulse control disorders — changes in behavior
The patient should inform their doctor if they, their family, or caregivers notice any unusual behavior or if they are unable to resist the impulse, temptation, or compulsion to perform certain actions that may harm themselves or others. Such behaviors are called impulse control disorders and may include: compulsive gambling, overeating or overspending, and an increased sex drive. The doctor may need to adjust the dose or discontinue treatment. More information can be found in section 4 "Possible side effects".
Dopaminergic dysregulation syndrome
The patient should inform their doctor if they or their family or caregivers notice symptoms similar to addiction, leading to a desire to take increasingly higher doses of Lecigon and other medicines used to treat Parkinson's disease.
Regular check-ups
In the case of long-term treatment with Lecigon, the doctor may recommend regular monitoring of liver and kidney function, blood morphology, heart and blood vessels, and skin examination to detect any skin changes.
Lecigon and tumors
Lecigon contains hydrazine, which is formed during the breakdown of carbidopa (an active substance of Lecigon). Hydrazine may cause genetic damage, which may lead to cancer. However, it is not known whether the amount of hydrazine produced during the administration of the recommended dose of Lecigon may cause damage or disease.
Surgery
Before undergoing any surgery, including dental surgery, the patient should inform their doctor or dentist about the use of Lecigon.
Urinalysis
The active substances levodopa and carbidopa may affect the results of urinalysis. If the patient is asked to provide a urine sample, they should inform the medical staff about the use of Lecigon.

Children and adolescents

Lecigon should not be administered to children and adolescents under 18 years of age.

Lecigon and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Lecigon should notbe used if the patient is taking:

• -Antidepressant medicines called selective MAO-A inhibitors (e.g., moclobemide) and non-selective MAO inhibitors (e.g., phenelzine). Treatment with these medicines should be stopped at least two weeks before starting treatment with Lecigon.

Lecigon may enhance the effect and side effects of other medicines, and other medicines may enhance the effect and side effects of Lecigon. The patient should tell their doctor if they are taking any of the following medicines:

• -Antidepressant medicines called tricyclic antidepressants (e.g., clomipramine, amitriptyline, and nortriptyline). Other types of antidepressant medicines may also affect Lecigon or Lecigon may affect these medicines.
• -Medicines used to treat Parkinson's disease called selective MAO-B inhibitors (e.g., selegiline), amantadine, and dopamine agonists (e.g., piribedil) and anticholinergic medicines (e.g., biperiden).
• -Medicines used to treat urinary incontinence (e.g., oxybutynin), asthma, and chronic obstructive pulmonary disease (COPD) (e.g., ipratropium and tiotropium). These medicines are known as anticholinergic medicines.
• -Certain medicines used to treat asthma and allergies (e.g., salbutamol and terbutaline) and adrenaline. These medicines are known as sympathomimetics.
• -Medicines that lower blood pressure (known as antihypertensive medicines). Using these medicines and Lecigon at the same time may cause drops in blood pressure when changing position from sitting or lying down to standing. The dose of the antihypertensive medicine may need to be adjusted.
• -Warfarin (a medicine that prevents blood clots). If the patient is being treated with Lecigon or is starting, stopping, or changing treatment with Lecigon, the effects of warfarin should be checked.

Some medicines may reduce the effect of Lecigon. The patient should tell their doctor if they are taking any of the following medicines:

• Any product containing iron taken orally (tablets, capsules, solution). Iron may interfere with the absorption of levodopa from the gastrointestinal tract (and vice versa). Therefore, Lecigon and the iron product should be taken at an interval of at least 2-3 hours. If the patient does not use the pump at night, they can take the iron product before going to bed.
• -Medicines used to treat psychosis (e.g., phenothiazine derivatives, butyrophenone (e.g., haloperidol) and risperidone).
• -Medicines used to treat nausea (e.g., metoclopramide).
• -Medicines used to treat epilepsy (e.g., clonazepam and phenytoin).
• -Anxiolytic and sedative medicines, known as benzodiazepines (such as diazepam, oxazepam, and nitrazepam).
• -Medicines used to treat tuberculosis (isoniazid).
• -Medicines used to treat stomach and intestinal spasms (papaverine).

Using Lecigon with food and drink

Lecigon is not absorbed well if taken immediately after consuming high-protein foods (e.g., meat, fish, dairy products, nuts, and seeds). The patient should inform their doctor if they are following a high-protein diet.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Lecigon is not recommended for use during pregnancy or in women of childbearing age not using contraception, unless the doctor considers that the benefits to the mother outweigh the potential risk to the fetus.
The patient should not breastfeed while using Lecigon.

Driving and using machines

Lecigon has a major influence on the ability to drive and use machines. The patient should not drive or use machines until they are sure how Lecigon affects them.

• Lecigon may cause a feeling of excessive sleepiness or sudden sleep attacks (sleep attacks).
• Lecigon may cause a drop in blood pressure, e.g., when changing position from sitting or lying down to standing, and may cause dizziness.

The patient should wait until they feel fully awake or no longer feel dizzy or lightheaded before driving, using tools or machines, or performing any activities where lack of concentration may put them or others at risk.

Lecigon contains sodium

This medicine contains 166 mg of sodium (the main component of common salt) per cartridge. This corresponds to 8.3% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Lecigon

This medicine should always be used exactly as prescribed by the doctor, nurse, or pharmacist. If the patient is unsure, they should consult their doctor, nurse, or pharmacist.

How Lecigon is administered

Lecigon is a gel that is administered through a portable pump (Crono LECIG) and a catheter directly into the upper part of the intestine. The gel is contained in a cartridge placed in the pump. The pump is connected to the catheter, which has been surgically inserted into the intestine through the abdominal wall.
The pump delivers a small dose throughout the day. This means that the concentration of the medicine in the blood remains constant. This also means that some side effects, e.g., those affecting movement, are less pronounced compared to oral medicines.
Before inserting the catheter into the small intestine, the doctor may decide to check if treatment with Lecigon is effective. In such cases, the gel is administered through a catheter that passes through the nose, throat, and stomach into the small intestine.
A user manual is included with the pump.

Dosage

The doctor adjusts the dose individually based on previously used medicines. It may be necessary to precisely adjust the dose during the first few weeks of treatment.
A higher dose (called a bolus) is usually administered in the morning when treatment is started to quickly achieve the desired concentration of the medicine in the blood. Then, during waking hours (usually about 16 hours), a constant maintenance dose is administered. If necessary, the doctor may decide to administer Lecigon for up to 24 hours a day.
Additional doses may also be administered if necessary. Some people may also require an increase or decrease in the constant maintenance dose during the day. The doctor will decide on the method and time of taking additional doses or modifying the dose during the day after consulting with the patient.
The total daily dose, including the morning dose (bolus), maintenance dose, and additional doses, must not exceed 100 mL (which corresponds to 2000 mg of levodopa, 500 mg of carbidopa, and 2000 mg of entacapone).
If the user has dementia, the doctor may decide that the pump can only be operated by medical personnel or the patient's relative. The pump can be locked to prevent accidental exceeding of the recommended daily dose.
Open cartridge
The cartridge containing the medicine is intended for single use only and must not be used for more than 24 hours, even if it still contains medicine. The pump with the installed cartridge can be worn on the body for up to 16 hours. During nighttime treatment, the pump should not be worn on the body, but it can be placed, for example, on a bedside table. If treatment is interrupted at night, the open cartridge can be continued the next day, but only for up to 24 hours from the moment of first opening. The cartridge should not be removed from the pump before its use is completed (i.e., before 24 hours from its opening or before it is empty, whichever comes first).
At the end of the shelf life, the gel may become slightly yellow or reddish. This does not affect the treatment effect.

Using a higher dose of Lecigon than recommended

The patient should contact their doctor if they experience symptoms of overdose.
Symptoms of overdose include:

• -Twitching or spasms of the eyelids that make it difficult to open the eyes.
• -Involuntary, persistent muscle spasms that lead to repetitive twisting movements or abnormal body position (dystonia).
• -Involuntary movements (dyskinesia).
• -Abnormally fast, slow, or irregular heartbeat.
• -Disorientation or tendency to worry and (or) restlessness.
• Changes in skin color, tongue, eyes, or urine.

Missing a dose of Lecigon

The patient should start the pump as soon as possible according to the instructions. They should not take a double dose to make up for the missed dose.

Discontinuing or reducing the dose of Lecigon

The patient should not stop using Lecigon or reduce the dose without consulting their doctor.
Sudden reduction of the dose or too rapid discontinuation of Lecigon may lead to serious conditions called malignant neuroleptic syndrome and rhabdomyolysis. There is a high risk of these conditions if the patient is being treated with Lecigon due to serious psychological problems at the same time. More information about these conditions can be found in section 4 "Possible side effects".
If treatment is discontinued, the patient will receive alternative treatment. If treatment with Lecigon is permanently discontinued, the catheter will be removed, and the wound will be left to heal.
If the patient has any further doubts about using this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Lecigon can cause side effects, although not everybody gets them.
To minimize the risk of side effects, it is essential to adjust the dose individually by properly setting the pump.

Serious side effects of Lecigon

If the patient experiences any of the following symptoms during treatment with Lecigon, they should immediately contact their doctor — urgent medical attention may be necessary:

• Itching, hives, swelling of the face, lips, tongue, or throat, which may make breathing or swallowing difficult. Drop in blood pressure. These may be symptoms of a severe allergic reaction(rare side effect).
• Combination of muscle stiffness, spasms, tremors, sweating, fever, rapid heartbeat, large fluctuations in blood pressure, uncontrolled behavior, disorientation, loss of consciousness. These may be symptoms of a serious condition called malignant neuroleptic syndrome(affects an unknown number of users).
• Unexplained muscle pain, spasms, or weakness, which may be symptoms of rhabdomyolysis, a severe, rare muscle disease that can seriously affect the kidneys (frequency not known (frequency cannot be estimated from the available data)). Rhabdomyolysis may be caused by malignant neuroleptic syndrome.

More information about malignant neuroleptic syndrome and rhabdomyolysis can be found in section 3 "Discontinuation or dose reduction of Lecigon".

• Abdominal pain, nausea, or vomiting. This may be due to serious problems related to the catheter or procedure, such as blockage, wound, or intestinal injury (common side effect).
• Infection with symptoms such as fever, with severe deterioration of general condition or fever with local signs of infection, such as sore throat and (or) difficulty urinating. This may indicate an effect on white blood cells, a condition called agranulocytosis(frequency not known - frequency cannot be estimated from the available data). The doctor will take a blood sample to check this.
• Suicidal thoughts or attempts (uncommon side effect).

Other side effects of Lecigon

Very common (may affect more than 1 in 10 people):

• -Weight loss.
• -Anxiety, depression, insomnia.
• -Involuntary movements (dyskinesia).
• -Worsening of Parkinson's disease symptoms.
• -Dizziness when standing up or changing position (orthostatic hypotension) - due to low blood pressure.
• -Nausea, constipation, diarrhea.
• -Muscle, tissue, and bone pain.
• -Abnormal urine color (chromaturia).
• -Risk of falls.
• -Urinary tract infection.

Common (may affect up to 1 in 10 people):

• -Anemia.
• -High levels of amino acids (e.g., homocysteine) in the blood, deficiency of vitamins B6 and B12.
• -Loss of appetite, weight gain.
• -Nightmares, uncontrolled behavior, anxiety, disorientation, hallucinations, psychotic disorders.
• -Sleep attacks, drowsiness, sleep disturbances.
• -Dizziness, fainting, headaches.
• -Reduced sense of touch, feeling of numbness or tingling of the skin.
• -Nerve disorders with discomfort, pain, and tingling, especially in the feet (polyneuropathy).
• -Involuntary, persistent muscle spasms that lead to repetitive twisting movements or abnormal body position (dystonia), excessive movements (hyperkinesia), tremors.
• -Changes in the effect on Parkinson's disease symptoms (on/off episodes).
• -Blurred vision.
• -Irregular heartbeat, cardiovascular diseases other than heart attack (e.g., angina pectoris).
• -High or low blood pressure.
• -Breathing difficulties, pneumonia caused by foreign material in the lungs.
• -Mouth or throat pain.
• -Abdominal bloating, abdominal pain, discomfort in the abdominal cavity, tenderness, and stomach pain, heartburn, bloating, vomiting.
• -Dry mouth, change in taste.
• -Difficulty swallowing, throat pain.
• -Contact dermatitis, itching, skin rash.
• -Excessive sweating.
• -Pain, muscle pain, neck pain, muscle spasms.
• -Urinary incontinence, difficulty urinating.
• -Feeling of weakness, fatigue, chest pain.
• -Gait disturbances.
• -Swelling of the feet or ankles.

Impulse control disorders — changes in behavior.This is a common side effect (may affect up to 1 in 10 people):
Unable to resist the impulse, temptation, or compulsion to perform actions that may be harmful, including:

• -Pathological gambling, despite significant harm to the patient or their family.
• -Changes or increases in sexual thoughts and behaviors, which are a significant problem for the patient or others. This may include increased sex drive.
• -Uncontrolled and excessive need to buy things and spend money.
• -Binge eating (eating large amounts of food in a short time) or compulsive eating (eating more food than normal and in amounts greater than needed to satisfy hunger). If the patient or their family members notice any of these behaviors, they should inform their doctor. The doctor will discuss ways to manage or alleviate the symptoms.

Uncommon (may affect up to 1 in 100 people):

• -Lower number of white blood cells or platelets, which may cause bleeding.
• -Suicide.
• -Disorientation, elevated mood (euphoric mood), fear, nightmares.
• -Coordination problems, seizures (epileptic fits).
• -Twitching or spasms of the eyelids that make it difficult to open the eyes, double vision, optic nerve damage, narrow-angle glaucoma (acute form of increased eye pressure).
• -Palpitations, heart attack.
• -Phlebitis.
• -Change in voice.
• -Colitis, gastrointestinal bleeding.
• -Excessive saliva production.
• -Abnormal liver function test results.
• -Redness of the skin, hives.
• -Hair loss, changes in nail, skin, hair, or sweat color.
• -Malaise.

Rare (may affect up to 1 in 1000 people):

• -Unusual thoughts.
• -Abnormal breathing pattern.
• -Teeth grinding, tongue pain, discoloration of saliva.
• -Hiccup.
• -Skin cancer (malignant melanoma) (see section 2 "When not to use Lecigon").
• -Prolonged and painful erection.

Reported (affects an unknown number of users):

• -Hepatitis.
• -Abnormal blood and urine test results.
• -Memory disorders, dementia.
• -Need to take higher doses of Lecigon than recommended to control motor symptoms, called dopaminergic dysregulation syndrome. In some patients, after taking high doses of Lecigon, severe, abnormal involuntary movements (dyskinesias), mood swings, or other side effects occur.

Side effects related to the pump, catheter, or surgical procedure:

Very common (may affect more than 1 in 10 people):

• -Abdominal pain.
• -Surgical wound infection.
• -Thick scar at the incision site.
• -Problems with inserting the catheter, such as pain or swelling of the mouth or throat, difficulty swallowing, discomfort in the stomach, pain or swelling, injury to the throat, mouth, or stomach, internal bleeding, vomiting, bloating, anxiety.
• -Problems at the incision site, redness, ulcer, leakage from the stoma, pain or irritation.

Common (may affect up to 1 in 10 people):

• -Discomfort in the abdominal cavity, pain in the upper abdomen.
• -Infection at the surgical site or in the intestine, postoperative infection, when the catheter is inserted into the intestine.
• -Peritonitis.
• -Change in the position of the catheter from the intestine to, for example, the stomach or blockage of the catheter, which may lead to a weakened response to treatment.
• -Problems related to the intestinal stoma (the site where the catheter enters the abdominal cavity), pain at the incision site, constipation after surgery, and discomfort or bleeding due to the procedure.

Uncommon (may affect up to 1 in 100 people):

• -Colitis or pancreatitis.
• -Pancreatitis.
• -Penetration of the catheter through the wall of the large intestine.
• -Intestinal obstruction, bleeding, or ulcer in the small intestine.
• -Part of the intestine folds into the adjacent segment (intussusception).
• -Blockage of the catheter caused by undigested food that gets stuck around the catheter.
• -Abscess after inserting the catheter into the intestine.

Reported (affects an unknown number of users):

• -Reduced blood flow in the small intestine.
• -Penetration of the catheter through the stomach or small intestine wall.
• -Blood infection (sepsis).

Side effects when levodopa and carbidopa are taken orally

The following side effects have been reported after taking levodopa and carbidopa orally (the same active substances as in Lecigon). These side effects may also occur with Lecigon.
Rare (may affect up to 1 in 1000 people):

• -Anemia caused by increased breakdown of red blood cells.
• -Inability to fully open the mouth.
• -Symptoms affecting half of the face, including drooping eyelids (Horner's syndrome).
• -Pupil dilation, convulsive eye movement to a fixed position, usually upward.
• -Vasculitis causing, among other things, bulging bruises (Schönlein-Henoch purpura).

Very rare (may affect up to 1 in 10,000 people):

• Blood morphology changes.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
PL-02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Lecigon

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cartridge label and on the carton after EXP.
Unopened cartridge: Store and transport in a refrigerated condition (2°C – 8°C). Do not freeze.
Store in the original packaging to protect from light.
Opened cartridge: Use immediately. The product can be used for up to 24 hours after removal from the refrigerator.
The pump with the installed cartridge can be worn on the body for up to 16 hours. During nighttime treatment, the pump should not be worn on the body, but it can be placed, for example, on a bedside table. Unused product should be discarded after 24 hours.
Cartridges are intended for single use only. An opened cartridge must not be used again.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Lecigon contains

• -The active substances of Lecigon are levodopa, carbidopa, and entacapone. 1 mL contains 20 mg of levodopa, 5 mg of carbidopa, and 20 mg of entacapone.
• -The other ingredients are: sodium carmellose, diluted hydrochloric acid (to adjust pH), sodium hydroxide (to adjust pH), and purified water.

What Lecigon looks like and contents of the pack

Lecigon intestinal gel is a yellow or yellow-red, non-transparent, viscous gel.
The container is a polypropylene (PP) cartridge. The wider end of the plastic cartridge is closed with a rubber plug, which serves as a piston. The narrower outlet of the cartridge is closed with a purple ENFit-type connector made of polypropylene. The cartridge contains 47 mL of intestinal gel.
One carton contains 7 cartridges.

Marketing authorization holder

LobSor Pharmaceuticals AB
Kålsängsgränd 10 D
753 19 Uppsala, Sweden

Manufacturer

Bioglan AB
Borrgatan 31
211 24 Malmö
Sweden
STADA Arzneimittel AG
Stadastrasse 2-18
61 118 Bad Vilbel
Germany
To obtain more detailed information on this medicine, the patient should contact the representative of the marketing authorization holder:
Stada Poland Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Phone: +48 22 737 79 20

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria
Lecigimon 20 mg/ml + 5 mg/ml + 20 mg/ml Gel zur intestinalen Anwendung
Belgium
Lecigimon 20 mg/ml + 5 mg/ml + 20 mg/ml, gel intestinal
Lecigimon 20 mg/ml + 5 mg/ml + 20 mg/ml gel voor intestinaal gebruik
Lecigimon 20 mg/ml + 5 mg/ml + 20 mg/ml Gel zur intestinalen Anwendung
Bulgaria
Лесигон 20 mg/ml + 5 mg/ml + 20 mg/ml гел за прилагане в червата
Croatia
Lecigon 20 mg/ml + 5 mg/ml + 20 mg/ml intestinalni gel
Czech Republic
Lecigimon 20 mg/ml + 5 mg/ml + 20 mg/ml intestinální gel
Denmark
Lecigon enteralgel
Finland
Lecigon 20 mg/ml + 5 mg/ml + 20 mg/ml geeli suoleen
France
Lecigimon 20 mg/ml + 5 mg/ml + 20 mg/ml, gel intestinal
Germany
Lecigon 20 mg/ml + 5 mg/ml + 20 mg/ml Gel zur intestinalen Anwendung
Hungary
Lecigon 20 mg/ml + 5 mg/ml + 20 mg/ml intesztinális gél
Ireland
Lecigon 20 mg/ml + 5 mg/ml + 20 mg/ml intestinal gel
Italy
Lecigimon 20 mg/ml + 5 mg/ml + 20 mg/ml gel intestinale
Netherlands
Lecigon 20 mg/ml + 5 mg/ml + 20 mg/ml gel voor intestinaal gebruik
Norway
Lecigon 20 mg/ml + 5 mg/ml + 20 mg/ml intestinalgel
Poland
Lecigon 20 mg/mL + 5 mg/mL + 20 mg/mL żel do podania dojelitowego
Portugal
Lecigon 20 mg/ml + 5 mg/ml + 20 mg/ml gel intestinal
Romania
Lecigon 20 mg/5 mg/20 mg/ml gel intestinal
Slovakia
Lecigon 20 mg/ml + 5 mg/ml + 20 mg/ml intestinálny gél
Slovenia
Lecigon 20 mg/5 mg/20 mg v 1 ml intestinalni gel
Spain
Lecigon 20 mg/ml + 5 mg/ml + 20 mg/ml gel intestinal
Sweden
Lecigon 20 mg/ml + 5 mg/ml + 20 mg/ml intestinal gel

Date of last revision of the leaflet: