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.

• Keep this leaflet, as 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, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

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 used for the treatment of Parkinson's disease. It is used in advanced cases when oral medications (medications taken orally) no longer produce a sufficient effect.

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:

• Levodopa
• Carbidopa (in the form of carbidopa monohydrate)
• Entacapone

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.

No use Lecigon

• if you are allergic to levodopa, carbidopa, entacapone, or any of the other ingredients of this medication (listed in section 6).
• You have a narrow-angle glaucoma (a type of acute glaucoma).
• You have severe heart problems.
• You have severe irregular heartbeats (arrhythmia).
• You have recently had a stroke.
• You have severe liver problems.
• You are taking medications for depression called MAO-A inhibitors (such as moclobemide) and non-selective MAO inhibitors (such as phenelzine). The treatment with these medications must be interrupted at least two weeks before starting treatment with Lecigon. See also section “Other medications and Lecigon”.
• You have a tumor of the adrenal gland that causes an overproduction of adrenaline and noradrenaline (pheochromocytoma).
• Your body produces too much cortisol (Cushing's syndrome).
• Your thyroid hormone levels are too high (hyperthyroidism).
• You have ever had neuroleptic malignant syndrome (a severe and rare reaction that can occur when treating or stopping the use of certain medications).
• You have ever had rhabdomyolysis (a severe and rare muscle disease that affects the kidneys).
• You have ever had skin cancer, or you have moles or unusual skin marks that have not been examined by your doctor.

Warnings and precautions

Consult your doctorbefore starting to usethis medication if you have or have ever had:

• A heart attack or any other cardiovascular disease, including angina and irregular heartbeats.
• Asthma or any other respiratory problem.
• A kidney or liver disease.
• A hormonal problem.
• A stomach ulcer.
• Seizures (convulsions).
• A severe mental health problem, such as psychosis.
• A glaucoma called wide-angle glaucoma.
• Surgery on the upper part of the stomach.
• Polineuropathy or a medical condition associated with polineuropathy. Progressive weakness, pain, numbness, or loss of sensation in the fingers or feet.
• (Symptoms of polineuropathy) in patients treated with gel intestinal of levodopa/carbidopa. Your doctor will check for signs and symptoms of polineuropathy before starting treatment with Lecigon and periodically thereafter.

Consult your doctor immediately if you experience any of the following symptoms during your treatment with this medication:

• Neuroleptic malignant syndrome:

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.

• Rhabdomyolysis:

A severe condition with unexplained muscle pain, cramps, or weakness. Rhabdomyolysis can be caused by neuroleptic malignant syndrome.

• For more information on neuroleptic malignant syndrome and rhabdomyolysis, see section 3 “If you interrupt or reduce the dose of Lecigon” and section 4 “Possible side effects”.

• Problems with the pump or surgery:

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:

• You feeldepressed, havesuicidal thoughts, or if you or others notice anychange in mental state.
• You noticeunusual birthmarksor moles on your skin that have appeared suddenly or worsened.
• You developinvoluntary movements(dyskinesia). If you have not been treated with entacapone (one of the active ingredients of Lecigon) before, the symptoms may be due to entacapone potentiating the effects of levodopa and carbidopa (other active ingredients of Lecigon). Your doctor may need to reduce the dose.
• You feel that theeffect of treatment worsens suddenly or gradually, for example, you have difficulty moving/slow movements (bradykinesia). This could be due to the pump being out of position in the small intestine or blocked. It could also be due to the pump not working correctly.
• You developdiarrhea. You may need to monitor your weight to avoid significant weight loss, or you may need to interrupt treatment. Prolonged or persistent diarrhea may be a sign of inflammation in the intestine. In this case, your doctor will need to review your treatment with Lecigon.
• You experience aloss of appetitethat worsens over time, asense of weakness, andweight lossin a short period of time. You may need a general medical examination, including a liver function check.

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:

• Medications for depression called MAO-A inhibitors (such as moclobemide) and non-selective MAO inhibitors (such as phenelzine). The treatment with these medications must be interrupted at least two weeks before starting treatment with Lecigon.

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:

• Medications for depression called tricyclic antidepressants (such as clomipramine, amitriptyline, and nortriptyline). Other types of antidepressants may also affect or be affected by Lecigon.
• Medications for Parkinson's disease called MAO-B inhibitors (such as selegiline), amantadine, and dopamine agonists (such as piribedil) and anticholinergics (such as biperiden).
• Medications for urinary incontinence (such as oxybutynin), asthma, and chronic obstructive pulmonary disease (COPD) (such as ipratropium and tiotropium). These medications are known as anticholinergics.
• Medications to lower blood pressure (called antihypertensives). The use of these and Lecigon at the same time may cause low blood pressure when standing up after sitting or lying down. You may need to adjust the dose of your antihypertensive medication.
• Warfarin (a medication to prevent blood clotting). If you are being treated with Lecigon, you must check the effect of warfarin.

Some medications mayreduce the effectof Lecigon. Inform your doctor if you are taking:

• Any iron product taken orally (tablets, capsules, solution). Iron may affect the absorption of levodopa from the gastrointestinal tract (and vice versa). Therefore, you should take Lecigon and your iron supplement at least 2-3 hours apart. If you do not use your pump at night, you can take the iron supplement before bedtime.
• Medications for psychosis (such as phenothiazines, butyrophenones (e.g., haloperidol), and risperidone).
• Medications for nausea (such as metoclopramide).
• Medications for epilepsy (such as clonazepam and phenytoin).
• Medications for anxiety and sleeping pills, known as benzodiazepines (such as diazepam, oxazepam, and nitrazepam).
• Medications for tuberculosis (isoniazid).
• Medications for gastrointestinal cramps (papaverine).

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.

• Lecigon may cause you to feel strong drowsiness or, occasionally, you may fall asleep suddenly (sleep attacks).
• Lecigon may cause you to feel dizzy, for example, when standing up after sitting or lying down.

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:

• Spasms or cramps in the eyelids that make it difficult to open your eyes.
• Uncontrollable and persistent muscle contractions that cause repeated twisting movements or an abnormal body position (dystonia).
• Involuntary movements (dyskinesia).
• Unusually fast, slow, or irregular heartbeats.
• Confusion or concern/anxiety.
• Discoloration of the skin, tongue, eyes, or urine.

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:

• Itching, hives, swelling of the face, lips, tongue, or throat, which may make breathing or swallowing difficult. Low blood pressure. This could be a sign of asevere allergic reaction(infrequent side effect).

• A combination of muscle stiffness, cramps, tremors, sweating, fever, rapid pulse, severe fluctuations in blood pressure, abnormal behavior, confusion, loss of consciousness. These may be symptoms of a serious disease calledmalignant neuroleptic syndrome(affects an unknown number of patients).

• Unexplained muscle pain, muscle cramps, or muscle weakness, which may be a sign ofrhabdomyolysis, a rare and serious muscle disorder with muscle cell degradation that could severely affect the kidneys (unknown frequency (cannot be estimated from the data)). Rhabdomyolysis may be caused by malignant neuroleptic syndrome.

For more information on malignant neuroleptic syndrome and rhabdomyolysis, see section 3 “If you interrupt or reduce the dose of Lecigon”.

• Stomach pain, nausea, or vomiting. This may be due toserious problems caused by the tube or surgery, such as blockage, wound, or damage to the intestine (common side effect).

• Infection with symptoms such as fever with a very poor general condition or fever with local infection symptoms, such as sore throat or difficulty urinating. This may be a sign that the white blood cells are affected, a condition calledagranulocytosis(unknown frequency (cannot be estimated from the available data)). Your doctor will take a blood sample to check for it.

• Thoughts of suicide or suicide attempts (infrequent side effect).

Other side effects of Lecigon

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

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

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

• Anemia.
• High levels of amino acids (e.g., homocysteine) in the blood, vitamin B6 and B12 deficiency.
• Loss of appetite, weight gain.
• Nightmares, discomfort, restlessness, confusion, hallucinations, psychotic disorders.
• Daytime sleep attacks, somnolence, sleep disorders.
• Dizziness, fainting, headache.
• Decreased sensation of touch, tingling, or numbness in the skin.
• Nervous disorder, with discomfort, pain, and tingling, particularly in the feet (polyneuropathy).
• Involuntary and persistent muscle contractions that cause repetitive twisting or abnormal body position (dystonia), excessive movements (hyperkinesia), tremors.
• Changes in the effect on Parkinson's disease symptoms (ON/OFF episodes).
• Blurred vision.
• Irregular heart rhythm, cardiovascular disease other than myocardial infarction (e.g., angina pectoris).
• High or low blood pressure.
• Difficulty breathing, pneumonia caused by foreign material in the lungs.
• Mouth or throat pain.
• Abdominal distension, abdominal pain, abdominal discomfort, stomach sensitivity with pain, acid reflux, bloating, vomiting.
• Dry mouth, altered taste perception.
• Difficulty swallowing, throat pain.
• Contact dermatitis, itching, skin rash.
• Intense sweating.
• Pain, joint pain, neck pain, muscle spasms.
• Urinary incontinence (incontinence), difficulty urinating.
• Feeling of weakness, fatigue, chest pain.
• Gait disorder.
• Swelling in the legs or feet.

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:

• A strong urge to gamble excessively, despite the severe effects on you or your family.
• Change or increase in sexual thoughts and behaviors that concern you or others. This may include an increase in sexual desire.
• 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 needed to satisfy hunger).

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):

• Less number of white blood cells or platelets in the blood, which may cause bleeding.
• Suicide.
• Confusion, elevated mood (euphoric mood), fear, nightmares.
• Difficulty coordinating muscle movements, seizures (convulsions).
• Spasms or cramps in the eyelids that make it difficult to open the eyes, double vision, damage to the optic nerve, narrow-angle glaucoma (acute elevated pressure in the eye).
• Palpitations, myocardial infarction.
• Phlebitis (inflammation of the veins).
• Change in voice.
• Colitis (inflammation of the large intestine), gastrointestinal tract bleeding.
• Abnormally large saliva production.
• Abnormal liver function test results.
• Redness of the skin, hives.
• Hair loss, nail discoloration, skin, hair, or sweat discoloration.
• Discomfort.

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

• Abnormal thoughts.
• Abnormal breathing pattern.
• Teeth grinding, tongue pain, discolored saliva.
• Hiccup.
• Basal cell carcinoma (melanoma malignum) (see section 2 “Do not use Lecigon”).
• Persistent and painful erection.

Reported (affect an unknown number of patients):

• Liver inflammation (hepatitis).
• Abnormal laboratory test results from blood and urine samples.
• Deterioration of memory, dementia.
• Desire for large doses of Lecigon, more than needed to control motor symptoms, known as dopamine dysregulation syndrome. Some patients experience abnormal involuntary movements (dyskinesias), mood changes, or other side effects after taking large doses of Lecigon.

Side effects of the pump, tube, or surgery

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

• Abdominal pain.
• Surgical site infection after surgery.
• Thick scars at the incision site.
• Problems with tube insertion, such as mouth or throat pain, difficulty swallowing, abdominal discomfort, pain or swelling, throat, mouth, or stomach injury, internal bleeding, vomiting, abdominal bloating, anxiety.
• Problems at the incision site, redness, pain, fistula, pain or irritation.

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

• Abdominal discomfort, upper abdominal pain.
• Infection at the surgical site or in the intestine, post-surgical infection when the tube was placed in the intestine.
• Peritonitis (inflammation of the peritoneum).
• The tube changes position from the intestine to the stomach, for example, or is blocked, which may reduce the response to treatment.
• Problems in the gastrointestinal tract due to the stoma (where the tube enters the abdomen), pain at the incision site, post-surgical bowel obstruction and problems, discomfort, or bleeding as a result of the treatment procedure.

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

• Colitis or pancreatitis (inflammation of the pancreas).
• The tube penetrates the wall of the large intestine.
• Intestinal obstruction, bleeding, or ulcer in the small intestine.
• Intestinal intussusception (part of the intestine folds into the adjacent section).
• Obstruction of the tube due to undigested food that has become stuck around the tube.
• Abcess after tube insertion in the intestine.

Reported (affect an unknown number of patients):

• Reduced blood flow to the small intestine.
• The tube penetrates 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 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):

• Anemia due to increased breakdown of red blood cells.
• Inability to open the mouth fully.
• Symptoms of half the face, including drooping eyelids (Horner's syndrome).
• Enlarged pupil in the eye, convulsive movement of the eyeballs to a fixed position, usually upwards.
• Inflammation of small blood vessels that causes, among other things, elevated hematomas (Henoch-Schönlein purpura).

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

• Modified blood count.

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.

Composition of Lecigon

• The active principles are levodopa, carbidopa monohydrate, and entacapone. 1 ml contains 20 mg of levodopa, 5 mg of carbidopa monohydrate, and 20 mg of entacapone.
• The other excipients are sodium carmelose, hydrochloric acid (to adjust the pH), sodium hydroxide (to adjust the pH), and water.

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/).