20 mg / ml + 5 mg / ml + 20 mg / ml intestinal gel
levodopa / carbidopamonohydrate / entacapone

What Lecigon is and what it is used for

Lecigon is used to treat Parkinson’s disease. It is used in severe illness when oral drugs (drugs taken by mouth) have not given sufficient effect.

Lecigon is a gel for continuous supply that is given through a pump and a probe (tube) directly into the small intestine. Lecigon contains three active substances:

  • levodopa
  • carbidopa (in the form of carbidopamonohydrate)
  • entakapon

How Lecigon works

In Parkinson’s disease, the levels of the substance dopamine in the brain are low. Levodopa is converted to dopamine in the brain, thus relieving the symptoms of Parkinson’s disease. Carbidopa and entacapone improve the effect of levodopa on Parkinson’s disease.

Levodopa / carbidopa monohydrate/entacapone contained in Lecigon may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before using Lecigon

Do not use Lecigon if you:

  • is allergic to levodopa , carbidopa, entacapone or any of the other ingredients of this medicine (listed in section 6).
  • have an eye disease called narrow-angle glaucoma (a type of glaucoma that is acute ).
  • have severe heart failure .
  • have severe cardiac arrhythmia (irregular heartbeat).
  • recently had a stroke .
  • have a serious liver disease.
  • take certain antidepressants, so-called selective MAO-A inhibitors (such as moclobemide) and non-selective MAO inhibitors (such as phenelzine). Treatment with these drugs must be stopped at least two weeks before starting treatment with Lecigon. See also section “Other medicines and Lecigon”.
  • have pheochromocytoma ( tumor of the adrenal gland that leads to overproduction of adrenaline and norepinephrine ).
  • have Cushing’s syndrome (overproduction of cortisol ).
  • have hyperthyroidism (overproduction of thyroid hormone).
  • previously suffered from malignant neuroleptic syndrome (a severe, rare, reaction that may occur during treatment or discontinuation of certain drugs).
  • previously afflicted with rhabdomyolysis (a serious, rare, muscular disease with renal impairment). have previously had skin cancer, or if you have any abnormal birthmarks or rashes on the skin that have not been examined by a doctor.

Warnings and cautions

Talk to your doctor before using Lecigon if you have or have had:

  • heart attack or other cardiovascular disease including angina and irregular heartbeat.
  • asthma or other lung disease.
  • kidney or liver disease.
  • hormonal disease.
  • stomach ulcer .
  • seizures.
  • severe mental illness, such as psychosis .
  • an eye disease called wide-angle glaucoma (a type of glaucoma ).
  • underwent surgery in the upper abdomen.

Contact a doctor immediately if you get any of the following symptoms during treatment with Lecigon:

  • Malignant neuroleptic syndrome:A severe condition with a combination of muscle stiffness, cramps, tremors, sweating, fever, rapid pulse , sharp blood pressure fluctuations, extravagant behavior, confusion, unconsciousness.
  • Rhabdomyolysis: A severe condition with unexplained muscle pain, muscle cramps or muscle weakness. Rhabdomyolysis can be caused by malignant neuroleptic syndrome.
    • For more information on malignant neuroleptic syndrome and rhabdomyolysis , see section 3 “If you stop using Lecigon or lower your dose” and section 4 “Possible side effects”.
  • Problems from the probe or operation:Stomach pain, nausea or vomiting. This may be due to serious problems caused by the probe or surgery e.g. blockages, ulcers or injuries in the intestine.

Talk to your doctor if you are being treated with Lecigon:

  • feeling depressed , having suicidal thoughts or noticing other mental changes .
  • Detects abnormal birthmarks or rashes on the skin that you have not seen before or that have changed.
  • get involuntary movements ( dyskinesia ). If you have not been treated with entacapone before (one of the active substances in Lecigon), the symptoms may be due to the fact that entacapone enhances the effect of levodopa and carbidopa (active substances that are also included in Lecigon). Your doctor may need to reduce your dose .
  • experience that the effect of the treatment suddenly or gradually deteriorates , e.g. that you have difficulty moving / slow movements ( bradykinesia ). This may be because the probe has jumped out of position in the small intestine, it has become clogged or the pump is not working properly.
  • gets diarrhea . Your weight may need to be monitored to avoid any significant weight loss or treatment may need to be stopped. Prolonged or persistent diarrhea can be a sign of inflammation in the intestine and your doctor will then need to review your treatment with Lecigon.
  • experiences loss of appetite that worsens over time, weakness and weight loss within a short period of time. A general medical examination including examination of liver function may be needed.

In case of impaired ability to handle the pump and probe, you must seek the help of a healthcare provider (eg nurse, health care assistant, or relative) to avoid complications (problems).

Disrupted impulse control – changes in your behavior

Tell your doctor if you, your family, or caregivers notice that you develop urges or desires that make you behave in ways that are unusual for you or if you can not resist the impulse, drive, or temptation to perform certain activities that may harm you or others. These behaviors are called “disturbed impulse control” and may include gambling addiction, compulsive eating or spending of money, abnormally high sex drive or an increase in sexual thoughts or feelings. Your doctor may need to adjust your dose or discontinue your treatment. For more information, see section 4 “Possible side effects”.

Dopaminergic dysregulation syndrome

Tell your doctor if you or your family/caregiver notice that you are developing addictive symptoms that lead to a craving for higher doses of Lecigon and other medicines used to treat Parkinson’s disease.

Regular checks

During long-term treatment with Lecigon, your doctor may need to have regular check-ups of liver and kidney function, blood counts, heart and blood vessels, and examine the skin to detect any skin changes.

Lecigon and cancer

Lecigon contains hydrazine, which is formed during the breakdown of carbidopa (an active substance in Lecigon). Hydrazine can be harmful to the genes and this can cause cancer. It is not known whether the amount of hydrazine added at the recommended dose of Lecigon can cause injury or illness.

Operation

If you need to have surgery, including dental surgery, tell your doctor or dentist that you are using Lecigon.

Urine sample

The active substances levodopa and carbidopa may cause misleading results in urine tests. Therefore, mention that you are taking Lecigon if you are taking a urine sample.

Children and young people

Lecigon should not be given to children or adolescents under 18 years of age.

Other drugs and Lecigon

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not use Lecigon if you are taking :

  • certain antidepressants, so-called selective MAO-A inhibitors (such as moclobemide) and non-selective MAO inhibitors (such as phenelzine). Treatment with these drugs must be stopped at least two weeks before starting treatment with Lecigon.

Lecigon may potentiate the effects and side effects of other medicines and other medicines may increase the effects and side effects of Lecigon. Talk to your doctor if you are taking:

  • certain antidepressants, so-called tricyclic drugs (such as clomipramine, amitriptyline and nortriptyline). Other types of antidepressants could also affect or be affected by Lecigon.
  • certain other medicines for Parkinson’s disease , so-called selective MAO-B inhibitors (such as selegiline ), amantadine and dopamine agonists (such as piribedil) and anticholinergics (such as biperiden).
  • drugs for urinary incontinence (such as oxybutynin), asthma and chronic obstructive pulmonary disease , COPD (such as ipratropium and tiotropium). These are so-called anticholinergic drugs.
  • certain asthma and allergy medicines (such as salbutamol and terbutaline ) and adrenaline . These are so-called sympathomimetic drugs.
  • antihypertensive drugs. Concomitant use with Lecigon may cause a drop in blood pressure when you get up from a sitting or lying position. The dose of one of the antihypertensive drugs may need to be adjusted.
  • warfarin (a medicine to prevent blood clots). If you are being treated, started, stopped or changed treatment with Lecigon, the effect of warfarin should be monitored .

Some medicines may reduce the effect of Lecigon. Talk to your doctor if you are taking: 

  • oral iron preparations (tablets, capsules, solution). Iron may impair the absorption of levodopa from the gastrointestinal tract (and vice versa). You should therefore take Lecigon and iron supplements at least 2-3 hours apart. If you do not use the pump during the night, you can take the iron preparation before bedtime.
  • drugs for psychosis (such as phenothiazines, butyrophenones (eg, haloperidol ) and risperidone ).
  • antiemetic drugs (such as metoclopramide).
  • antiepileptic drugs (such as clonazepam and phenytoin ).
  • sedatives and hypnotics, so-called benzodiazepines (such as diazepam , oxazepam and nitrazepam).
  • drugs against tuberculosis ( isoniazid ).
  • medicines for convulsions in the gastrointestinal tract (papaverine).

Lecigon with food, drink and alcohol

Lecigon is less well absorbed immediately after consuming protein-rich foods (eg meat, fish, dairy products, nuts, and seeds). Talk to your doctor if you are on a high protein diet.

Pregnancy, breastfeeding and fertility

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.

Lecigon is not recommended during pregnancy or in women of childbearing potential not using contraception unless the doctor considers that the benefits to the mother outweigh the potential risks to the fetus.

You should not breastfeed while being treated with Lecigon.

Driving and using machines

Lecigon can have a significant effect on the ability to drive and use machines. Do not drive or use machines until you know how Lecigon affects you.

  • Lecigon can make you feel very sleepy, or sometimes you suddenly fall asleep (sleep attacks).
  • Lecigon can cause a drop in blood pressure e.g. when getting up from a sitting or lying position as well as dizziness.

Wait until you feel properly awake or do not feel dizzy before driving, using tools or machines, or performing other activities where diminished attention may put you or others at risk.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

How to use Lecigon

How to use Lecigon

Always use this medicine exactly as your doctor, nurse or pharmacist has told you. If you are not sure, talk to your doctor, nurse, or pharmacist.

How Lecigon is given

Lecigon is a gel that is given through a portable pump (Crono LECIG) and a probe directly into the upper part of the small intestine. Gel one is provided in a cartridge that is connected to the pump. The pump is connected to a probe that has been operated on in the intestine via the abdominal wall.

During the day, a small dose is added continuously. This means that the level of drugs in the blood becomes more even and the risk of side effects, such as movement disorders, is less compared to drugs taken by mouth.

Before the probe is inserted into the small intestine, the doctor can choose to check if the treatment with Lecigon works for you. A gel is then given via a probe that goes through the nose, pharynx, and stomach to the small intestine.

A manual with instructions for using the pump is supplied with the pump.

Dosage

The doctor will adjust the doses individually to you based on previous medication. Dosage one may need to be fine-tuned during the first few weeks of treatment.

In the morning when the treatment is started, a larger dose is given to quickly reach the right drug levels in the blood (so-called bolus dose ). Thereafter, a continuous maintenance dose is given during the waking hours (usually about 16 hours). If necessary, your doctor may decide to give you Lecigon for up to 24 hours a day.

If necessary, extra doses can also be given. Individuals may also need to increase or decrease the continuous maintenance dose during the day. How and when you take these extra doses or adjust the dose during the day will be decided by your doctor in consultation with you.

The total daily dose, including morning dose ( bolus dose ), maintenance dose, and extra dose, should not exceed 100 ml (equivalent to 2000 mg levodopa, 500 mg carbidopa, and 2000 mg entacapone).

If the user has dementia, the doctor may decide that the pump should only be handled by a healthcare professional or relative. The pump can be locked to avoid accidentally exceeding the daily recommended dose.

Started cartridge

Ampoules with medicines are for single use only and should not be used for more than 24 hours, even if there are medicines left. Dosing pump with mounted ampoule can be carried close to the body for up to 16 hours and during treatment at night, the pump should not be carried next to the body but can e.g. be stored on the bedside table. If you have had a break in treatment during the night, you can continue to use the started ampoule the next day, but only for up to 24 hours after it was first opened. Do not remove the ampoule from the pump before using it (ie either after 24 hours after opening or when it is closed, whichever comes first).

Gel one may turn pale yellow/reddish at the end of the shelf life. This does not affect the effectiveness of the treatment.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. To reduce the risk of side effects, it is important to adjust the dose of the drug individually with the appropriate setting of the pump.

Serious side effects are with Lecigon

Contact a doctor immediately if you get any of the following symptoms during treatment with Lecigon – you may need emergency medical treatment:

  • Itching , hives , swelling of the face, lips, tongue or throat, which may make it difficult to breathe or swallow. Drop in blood pressure. This may be a sign of a severe allergic reaction  (rare side effect).
  • A combination of muscle stiffness, cramps, tremors, sweating, fever, rapid pulse , sharp blood pressure fluctuations, extravagant behavior, confusion, unconsciousness. These can be symptoms of a serious condition called malignant neuroleptic syndrome  (occurring in an unknown number of users).
  • Unexplained muscle pain, muscle cramps or muscle weakness which may be signs of rhabdomyolysis , a serious, rare, muscle disease with breakdown of muscle cells and which may cause severe kidney damage (no known frequency (can not be calculated from the available data)) . Rhabdomyolysis can be caused by malignant neuroleptic syndrome.
    For more information on neuroleptic malignant syndrome and rhabdomyolysis, see section 3 “If you stop using Lecigon or lower your dose”.
  • Stomach pain, nausea or vomiting. This may be due to serious problems caused by the probe or surgery e.g. blockages, ulcers or injuries in the intestine (common side effect) .
  • Infection with symptoms such as fever with severely deteriorating general condition or fever with local infection symptoms such as sore throat / throat / mouth or difficulty urinating. This may be a sign that the white blood cells are affected, so-called agranulocytosis (no known frequency – can not be calculated from the available data) . Your doctor will take a blood test to check this.
  • Suicidal ideation or suicide attempt (less common side effect) .

Other side effects that may occur with Lecigon:

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

  • Weight loss.
  • Anxiety, anxiety, depression, insomnia.
  • Involuntary movements ( dyskinesia ).
  • Exacerbated symptoms of Parkinson’s disease .
  • Dizziness when getting up from a sitting or lying position ( orthostatic hypotension ) due to a drop in blood pressure.
  • Nausea, constipation, diarrhea.
  • Pain in muscles, connective tissue and skeleton.
  • Abnormal color of the urine (chromatury).
  • Risk of falling.

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

  • Anemia .
  • Elevated levels of amino acids (eg homocysteine ) in the blood, deficiency of vitamins B6 and B12.
  • Decreased appetite, weight gain.
  • Nightmares, extravagant behavior, restlessness, confusion, hallucinations, psychosis.
  • Sleep attacks, drowsiness, sleep disorders.
  • Dizziness, fainting, headache.
  • Decreased sensation when touching, feeling of tingling or numbness in the skin.
  • Nerve disease with discomfort, pain and numbness mainly in the feet ( polyneuropathy ).
  • Involuntary persistent muscle contractions that lead to twisting repeated movements or abnormal posture ( dystonia ), excessive movements (hyperkinesia), tremors ( tremor ).
  • Changes in the effect on Parkinson’s symptoms (on-off episodes).
  • Dimsyn.
  • Irregular heart rhythm, coronary heart disease other than myocardial infarction (eg angina).
  • High or low blood pressure .
  • Shortness of breath, pneumonia due to foreign matter in the lungs.
  • Pain in the mouth or throat.
  • Stretched abdomen, abdominal pain, abdominal discomfort, sensitive stomach with, among other things, pain, heartburn, gas tension in the abdomen, vomiting.
  • Dry mouth , altered taste experience.
  • Difficulty swallowing, pain in the throat.
  • Contact dermatitis, itching , rash.
  • Heavy sweating.
  • Pain, joint pain, neck pain, muscle spasms.
  • Urinary leakage (urinary incontinence), difficulty urinating, urinary tract infection.
  • Weakness, fatigue, chest pain.
  • Gait disorder.
  • Swelling in legs or feet.

Disrupted impulse control – changes in your behavior. This is a common side effect ( may affect up to 1 in 10 people ).

Inability to resist the impulse to perform an act that may be harmful, which may include:

  • strong impulse to excessive gambling despite serious consequences for you or your family.
  • altered or increased sexual interest and behavior that significantly disturbs you or others, e.g. an increased sexual drive.
  • uncontrollable 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 more than is needed to satisfy your hunger).

Tell your doctor if you, your family, or carers notice any of these behaviors. The doctor will discuss ways to manage or reduce the symptoms.

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

  • Reduction in the number of white blood cells or platelets in the blood which can lead to bleeding.
  • Suicide.
  • Confusion, feeling of elation, fear, nightmares.
  • Difficulty coordinating muscle movements, seizures.
  • Twitching or cramping of the eyelids that can make it difficult to open the eyes, double vision, damage to the optic nerve , narrow-angle glaucoma ( acute elevated pressure in the eye).
  • Palpitations, heart attack.
  • Inflammation of veins.
  • Voice change.
  • Inflammation of the colon, bleeding in the gastrointestinal tract.
  • Abnormally large saliva production.
  • Deviating results from liver function tests.
  • Reddening of the skin, hives .
  • Hair loss, discoloration of nails, skin, hair or sweat.
  • Feeling sick.

Rare (may affect up to 1 in 1,000 people):

  • Abnormal thoughts.
  • Abnormal breathing pattern.
  • Tooth grinding, pain in the tongue, discoloration of saliva.
  • Hiccup.
  • Skin cancer (malignant melanoma ) (see section 2, “Do not use Lecigon”).
  • Persistent and painful erection .

Has been reported (occurs in the unknown number of users):

  • Inflammation of the liver ( hepatitis ).
  • Deviating laboratory values ​​from blood and urine samples.
  • Impairment of memory, dementia.
  • Ask for a higher dose of Lecigon that is greater than that required to control motor systems, known as dopaminergic dysregulation syndrome. Some patients experience severe abnormal involuntary movements ( dyskinesias ), mood swings or other side effects after taking larger doses of Lecigon.

Side effects of the pump, probe, or operation:

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

  • Stomach pain
  • Infection in the wound after surgery.
  • Thick scarring at the site of incision.
  • Problems with tube insertion such as pain or swelling in the mouth or throat, difficulty swallowing, stomach discomfort, pain or swelling, damage to the throat, mouth or stomach, internal bleeding, vomiting, gas tension in the stomach, anxiety.
  • Problems with incisions, redness , sores, ostomy leaks, pain or irritation.

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

  • Stomach upset, pain in the upper abdomen.
  • Infection at the surgical incision or in the intestine, infection after surgery when the probe has been placed in the intestine.
  • Peritonitis.
  • The probe changes position from the intestine to, for example, the stomach or becomes blocked – which can lead to a worsened treatment response.
  • Problems in the digestive tract because of the stoma (where the probe is inserted into the abdomen), pain at the incision, stop magtarmrörelse RNA after surgery and problems, pain or bleeding as a result of the treatment procedure.

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

  • Inflammation of the colon or pancreas.
  • Inflammation of the pancreas ( pancreatitis ).
  • The probe passes through the colon wall.
  • Stops in the intestines, bleeding or ulcers on the small intestine.
  • A part of the intestine is inserted into another, adjacent part of the intestine (invagination).
  • Blockage of the probe due to undigested food stuck around the probe.
  • Abscess after insertion of the probe into the intestine.

Has been reported (occurs in the unknown number of users):

  • Reduced blood flow in the small intestine.
  • The probe passes through the stomach wall or small intestine.

The side effect is when the substances levodopa and carbidopa are taken by mouth

The following car effects have been reported when levodopa and carbidopa (two of the active substances found in Lecigon) are taken orally. These side effects may also occur with Lecigon.

Rare (may affect up to 1 in 1,000 people):

  • Anemia due to increased degradation of red blood cells .
  • Inability to open mouth completely.
  • Symptoms from one half of the face with drooping eyelids (Horner’s syndrome).
  • Enlargement of the pupil, a spasmodic movement of the eyeballs into a fixed position, usually upwards.
  • Inflammation of small blood vessels that, among other things, cause small raised bruises (Henoch-Schönlein’s purpura).

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

  • Altered blood levels.

How to store Lecigon

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 label and carton after EXP. The expiration date is the last day of the specified month.

Unopened cartridge: Store in a refrigerator (2 ° C – 8 ° C). Do not freeze.

Store in the original package. Sensitive to light.

Opened cartridge: Use immediately. The product can be used for up to 24 hours when taken out of the refrigerator. The dosing pump with a mounted cartridge can be carried close to the body for up to 16 hours. During treatment at night, the pump should not be carried next to the body but can e.g. be stored on the bedside table. Discard any unused amount after 24 hours.

The cylinder cartridge is for single use only. Do not reuse an opened cartridge.

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

Contents of the pack and other information

Content declaration

  • The active substances are levodopa , carbidopamonohydrate and entacapone. 1 ml contains 20 mg levodopa , 5 mg carbidopamonohydrate and 20 mg entacapone.
  • The other ingredients are caramel sodium, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment) and purified water.

What the medicine looks like and contents of the pack

Lecigon intestinal gel is a yellow or yellow-reddish opaque viscous gel.

The medicament container is called cartridge of plastic and contains 47 ml of intestinal gel.

One pack contains 7 cartridges.

Marketing Authorization Holder and Manufacturer

LobSor Pharmaceuticals AB

Kålsängsgränd 10 D

753 19 Uppsala

info@lobsor.se

Manufacturer

Bioglan AB

Borrgatan 31

211 24 Malmö, Sweden

Information provided by:

NordicInfu Care AB

Box 14026

167 14 Bromma

info@infucare.se

This medicinal product is authorized under the European Economic Area under the names:

Belgium Lecigimon 20 mg / ml + 5 mg / ml + 20 mg / ml, intestinal gel

Lecigimon 20 mg / ml + 5 mg / ml + 20 mg / ml gel for intestinal use

Lecigimon 20 mg / ml + 5 mg / ml + 20 mg / ml Gel for intestinal use

Bulgaria Chession 20 mg / ml + 5 mg / ml + 20 mg / ml gel for taking in cervix

Denmark Lecigon enteral gel

Finland Lecigon 20 mg / ml + 5 mg / ml + 20 mg / ml yellow suolene

France Lecigimon 20 mg / ml + 5 mg / ml + 20 mg / ml, intestinal gel

Ireland Lecigon 20 mg / ml + 5 mg / ml + 20 mg / ml intestinal gel

Italy Lecigimon 20 mg / ml + 5 mg / ml + 20 mg / ml intestinal gel

Croatia Lecigon 20 mg / ml + 5 mg / ml + 20 mg / ml intestinal gel

Netherlands Lecigon 20 mg / ml + 5 mg / ml + 20 mg / ml gel for intestinal use

Norway Lecigon 20 mg / ml + 5 mg / ml + 20 mg / ml intestinal gel

Poland Lecigon 20 mg / ml + 5 mg / ml + 20 mg / ml gel dojelitowy

Portugal Lecigon 20 mg / ml + 5 mg / ml + 20 mg / ml intestinal gel

Romania Lecigon 20 mg / 5 mg / 20 mg / ml gel intestinal

Slovakia Lecigon 20 mg / ml + 5 mg / ml + 20 mg / ml intestinal gel

Slovenia Lecigon 20 mg / 5 mg / 20 mg in 1 ml intestinal gel

Spain Lecigon 20 mg / ml + 5 mg / ml + 20 mg / ml intestinal gel

Czech Lecigimon 20 mg / ml + 5 mg / ml + 20 mg / ml intestinal gel

Germany Lecigon 20 mg / ml + 5 mg / ml + 20 mg / ml Gel for intestinal and application

Hungary Lecigon 20 mg / ml + 5 mg / ml + 20 mg / ml intestinal gel

Austria Lecigimon 20 mg / ml + 5 mg / ml + 20 mg / ml Gel for intestinal use

Muhammad Nadeem

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