LECIGON 20 mg/mL + 5 mg/mL + 20 mg/mL INTESTINAL GEL

Introduction

Package Leaflet: Information for the Patient

Lecigon 20 mg/ml + 5 mg/ml + 20 mg/ml Intestinal Gel

Levodopa/Carbidopa Monohydrate/Entacapone

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack

1. What is Lecigon and what is it used for
2. What you need to know before you use Lecigon
3. How to use Lecigon
4. Possible side effects
5. Storing Lecigon
6. Contents of the pack 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 medicines (medicines taken by mouth) no longer have a sufficient effect.

Lecigon is a gel for continuous administration that is supplied through a pump and a tube 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 levels of dopamine in the brain are low. Levodopa is converted into dopamine in the brain, thereby alleviating the symptoms of Parkinson's disease. Carbidopa and entacapone improve the effect that levodopa has on Parkinson's disease.

2. What you need to know before you use Lecigon

Do not use Lecigon

• if you are allergic to levodopa, carbidopa, entacapone, or any of the other ingredients of this medicine (listed in section 6).
• You have a serious eye problem called 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 medicines for depression called selective MAO-A inhibitors (such as moclobemide) and non-selective MAO inhibitors (such as phenelzine). Treatment with these medicines must be stopped at least two weeks before starting treatment with Lecigon. See also section “Other medicines 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 rare and serious reaction that can occur when treating or stopping the use of certain medicines).
• You have ever had rhabdomyolysis (a rare and severe muscle disease that affects the kidneys).
• You have ever had skin cancer, or have unusual moles or marks on the skin that have not been examined by your doctor.

Warnings and precautions

Talk to your doctor before you start usingthis medicine if you have or have had:

• A heart attack or any other cardiovascular disease, including angina pectoris and irregular heartbeats.
• Asthma or any other lung problem.
• Kidney or liver disease.
• A hormonal problem.
• A stomach ulcer.
• Seizures (convulsions).
• A serious psychological problem, such as psychosis.
• An eye problem called wide-angle glaucoma.
• Surgery in the upper part of the stomach.
• Polyneuropathy or a medical condition associated with polyneuropathy. Progressive weakness, pain, numbness, or loss of sensation in the fingers or toes.
• (Symptoms of polyneuropathy) in patients treated with intestinal gel of levodopa/carbidopa. Your doctor will check for signs and symptoms of polyneuropathy before starting treatment with Lecigon and periodically thereafter.

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

• Neuroleptic malignant syndrome:

A serious condition with a combination of muscle stiffness, cramps, tremors, sweating, fever, rapid pulse, severe fluctuations in blood pressure, abnormal behavior, confusion, loss of consciousness.

• Rhabdomyolysis:

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

• Tube or surgery problems:

Stomach pain, nausea, or vomiting. This may be due to serious problems caused by the tube or surgery, such as blockage, wound, or damage to the intestine.

Talk to your doctor if you experience any of the following symptoms during treatmentwith this medicine:

• You feel depressed, have suicidal thoughts, or if you or others notice any mental changes.
• You notice unusual birthmarksor moles on the skin that have appeared suddenly or worsened.
• You develop involuntary movements(dyskinesia). If you have not been treated previously with entacapone (one of the active substances of Lecigon), the symptoms may be due to entacapone enhancing the effects of levodopa and carbidopa (other active substances of Lecigon). Your doctor may need to reduce the dose.
• You feel that the effect of the treatment worsens suddenly or gradually, for example, you have difficulty moving/slow movements (bradykinesia). This could be due to the tube coming out of its position in the small intestine or being blocked. It could also be due to the pump not working properly.
• You develop diarrhea. It may be necessary to monitor your weight to avoid any significant weight loss, or it may be necessary to stop treatment. Prolonged or persistent diarrhea can be a sign of inflammation in the intestine. In such cases, your doctor should review your treatment with Lecigon.
• You experience a loss of appetitethat worsens over time, a feeling of weakness, and weight lossin a short period. A general medical examination, including a liver function test, may be required.

If you are unable to handle the pump and tube, you must get help from a caregiver (e.g., nurse, nursing assistant, or family member) to avoid complications (problems).

Impulse control disorders - Changes in behavior

Tell 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 addictive gambling, overeating, or overspending, abnormally increased sexual desire, or an increase in thoughts or feelings of sex. Your doctor may need to adjust your dose or stop your treatment. For more information, see section 4 “Possible side effects”.

Dopamine dysregulation syndrome

Tell your doctor if you or your family/caregiver notice that you are developing symptoms similar to those of addiction, which cause a desire to take increasingly higher doses of Lecigon and other medicines 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 for any changes.

Lecigon and cancer

Lecigon contains hydrazine, which is formed when carbidopa (an active substance of Lecigon) is broken down. Hydrazine could damage your genes, which may possibly cause cancer. However, it is not known if the amount of hydrazine produced when taking the recommended dose of Lecigon can cause harm or disease.

Surgery

Before undergoing any surgery, including dental surgery, tell your doctor or dentist that you are using Lecigon.

Urinalysis

The active substances levodopa and carbidopa may produce misleading results in urinalyses. Inform the healthcare professional that you are using Lecigon if you are asked to provide a urine sample.

Children and adolescents

Lecigon must not be administered to children or adolescents under 18 years of age.

Other medicines and Lecigon

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Do not useLecigon if you are taking:

• Medicines for depression called selective MAO-A inhibitors (such as moclobemide) and non-selective MAO inhibitors (such as phenelzine). Treatment with these medicines must 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. Tell your doctor if you are taking:

• Medicines for depression called tricyclic medicines (such as clomipramine, amitriptyline, and nortriptyline). Other types of antidepressant medicines may also affect or be affected by Lecigon.
• Medicines for Parkinson's disease called selective MAO-B inhibitors (such as selegiline), amantadine, and dopamine agonists (such as piribedil) and anticholinergics (such as biperiden).
• Medicines for urinary incontinence (such as oxybutynin), asthma, and chronic obstructive pulmonary disease (COPD) (such as ipratropium and tiotropium). These medicines are known as anticholinergics.
• Medicines to lower blood pressure (called antihypertensives). Using these and Lecigon at the same time may cause low blood pressure when standing up after sitting or lying down. It may be necessary to adjust the dose of your antihypertensive medicine.
• Warfarin (a medicine to prevent blood clot formation). If you are being treated with Lecigon, the effect of warfarin should be checked.

Some medicines may reduce the effectof Lecigon. Tell your doctor if you are taking:

• Any oral iron product (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 with at least 2-3 hours of difference. If you do not use your pump at night, you can take the iron supplement before going to bed.
• Medicines for psychosis (such as phenothiazines, butyrophenones (e.g., haloperidol), and risperidone).
• Medicines for nausea (such as metoclopramide).
• Medicines for epilepsy (such as clonazepam and phenytoin).
• Medicines for anxiety and sleeping pills, known as benzodiazepines (such as diazepam, oxazepam, and nitrazepam).
• Medicines for tuberculosis (isoniazid).
• Medicines for gastrointestinal cramps (papaverine).

Using Lecigon with food and drink

Lecigon is not absorbed well if administered immediately after eating protein-rich foods (e.g., meat, fish, dairy products, nuts, and seeds). Tell your doctor if you follow a protein-rich 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 using this medicine.

Lecigon is not recommended during pregnancy or in women of childbearing potential who do not use contraception, unless the doctor determines that the benefits to the mother outweigh the potential risks to the fetus.

You must not breastfeed while being treated with Lecigon.

Driving and using machines

Lecigon may have a major influence on the ability to drive and use machines. Do not drive or use machines until you are sure how Lecigon affects you.

• Lecigon may make you feel strong drowsiness or, on occasion, may cause you to fall asleep suddenly (sleep attacks).
• Lecigon may lower your blood pressure, for example, when standing up after sitting or lying down, which may make you feel dizzy.

Wait until you feel completely awake or until you 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 medicine contains 166 mg of sodium (a major component of cooking/table salt) in each cartridge. This is equivalent to 8.3% of the maximum recommended daily intake of sodium for adults.

3. How to use Lecigon

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

How Lecigon is administered

Lecigon is a gel that circulates through a portable pump (Crono LECIG) and a tube directly into the top of your intestine. The pump is connected to a probe that has been surgically placed in your intestine through the abdominal wall.

The pump administers a small dose throughout the day. This means that the level of the medication in your blood remains the same. It also means that some side effects, such as those affecting movement, are less common compared to medications taken orally.

Before the probe is inserted into the small intestine, the doctor may choose to check if the treatment with Lecigon works for you. In such cases, the gel is administered through a tube that passes through the nose, throat, and stomach to the small intestine.

A user manual for the pump is supplied 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 few weeks of treatment.

Usually, a higher dose (called a bolus dose) is administered in the morning when treatment is initiated so that the blood reaches the correct levels of medication quickly. After this, a continuous maintenance dose is administered during waking hours (generally around 16 hours). If necessary, your doctor may decide to administer Lecigon for 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 dose (bolus dose), the maintenance dose, and additional doses, must not 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 locked to prevent accidental exceeding of the recommended daily dose.

Open cartridge

The medication cartridge is for single use and must not be used for more than 24 hours, even if medication remains. The dosing pump with the installed cartridge can be carried close to the body for up to 16 hours. During nighttime treatment, the pump must not be used next to the body, but it can, for example, be kept on the bedside table. If there was an interruption in treatment during the night, you can continue using the open cartridge the next day, but only until 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 occurs first).

The gel may become slightly yellowish/reddish towards the end of its shelf life. This has no impact on the effect of the treatment.

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 ingested.

Signs of overdose may include:

• Spasms or cramps in the eyelids that make it difficult to open the eyes.
• Involuntary muscle contractions and persistent 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 make up for forgotten 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 too quickly can cause serious illnesses called neuroleptic malignant syndrome and rhabdomyolysis. There is a high risk that these conditions will occur if you are also being treated with a medication for a serious psychological problem. For more information about these conditions, see section 3 "If you interrupt or reduce the dose of Lecigon".

If treatment is interrupted, you will receive another treatment instead. If treatment with Lecigon is permanently suspended, the probe will be removed and the wound can heal.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them. To reduce the risk of side effects, it is essential that the dose of the medication is adjusted individually with the proper setting of the pump.

Severe side effects of Lecigon

Contact a doctor immediately if you experience any of the following symptoms during your treatment with Lecigon - you may need urgent medical treatment:

• Itching, hives, swelling of the face, lips, tongue, or throat, which can make breathing or swallowing difficult. Drop in blood pressure. This could be a sign of a severe allergic reaction(rare 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 can be symptoms of a severe illness called neuroleptic malignant syndrome(affects an unknown number of patients).

• Unexplained muscle pain, muscle cramps, or muscle weakness that can be a sign of rhabdomyolysis, a rare and severe muscle disorder with degradation of muscle cells that can seriously affect the kidneys (frequency not known (cannot be estimated from the data)). Rhabdomyolysis can be caused by neuroleptic malignant syndrome.

To obtain more information about neuroleptic malignant syndrome and rhabdomyolysis, see section 3 "If you interrupt or reduce the dose of Lecigon".

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

• Infection with symptoms such as fever with a severely deteriorated general condition or fever with symptoms of local infection, such as sore throat/mouth or difficulty urinating. This can be a sign that the white blood cells are affected, a condition called agranulocytosis(frequency not known (cannot be estimated from the available data)). Your doctor will take a blood sample to check for 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): this is due to low blood pressure.
• Nausea, constipation, diarrhea.
• Pain in muscles, tissues, and skeleton.
• 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 blood, deficiency of vitamin B6 and B12.
• Loss of appetite, weight gain.
• Nightmares, malaise, restlessness, confusion, hallucinations, psychotic disorders.
• Sleep attacks, drowsiness, sleep disorders.
• Dizziness, fainting, headache.
• Decreased sensation of touch, sensation of tingling or numbness in the skin.
• Nervous disorder, with malaise, pain, and tingling, particularly in the feet (polyneuropathy).
• Involuntary muscle contractions and persistent contractions that cause repeated twisting movements or an 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 disease distinct from infarction (e.g., angina pectoris).
• High or low blood pressure.
• Breathing difficulties, pneumonia due to foreign material in the lungs.
• Pain in the mouth or throat.
• Abdominal distension, abdominal pain, abdominal discomfort, sensitive stomach with pain, acidity, bloating, vomiting.
• Dry mouth, altered taste perception.
• Difficulty swallowing, sore throat.
• Contact dermatitis, itching, skin rash.
• Excessive sweating.
• Pain, pain in the joints, neck pain, muscle spasms.
• Urinary incontinence, difficulty urinating.
• Feeling of weakness, fatigue, chest pain.
• Gait disorder.
• Swelling in the legs or feet.

Impulse control disorders – Changes in your behavior.This is a common side effect (may affect up to 1 in 10 people):

Inability to resist the temptation to perform an action that may be harmful, including:

• A strong impulse to gamble excessively, despite serious consequences for you or your family.
• A change or increase in sexual thoughts and behaviors that concern you or others greatly. This could include an increased sexual desire.
• An uncontrollable and excessive need to buy things and spend money.
• Binge eating (consuming large amounts of food in a short time) or compulsive eating (consuming more food than normal and more than necessary to satisfy hunger).

Inform your doctor if you, your family, or your caregiver notice any of these behaviors. Your doctor will explain ways to control or reduce the symptoms.

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

• Lower number of white blood cells or platelets in blood, which can 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, heart attack.
• Inflammation in the veins.
• Change in voice.
• Inflammation in the large intestine, bleeding in the gastrointestinal tract.
• Abnormally large production of saliva.
• Abnormal liver function test results.
• Redness of the skin, hives.
• Hair loss, discoloration of nails, skin, hair, or sweat.
• Malaise.

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

• Abnormal thoughts.
• Abnormal breathing pattern.
• Teeth grinding, tongue pain, discolored saliva.
• Hiccup.
• Skin cancer (malignant melanoma) (see section 2 "Do not use Lecigon").
• Prolonged and painful erection.

Have been reported (affect an unknown number of patients):

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

Side effects of the pump, probe, or surgery

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

• Abdominal pain.
• Wound infection after surgery.
• Thick scars at the incision site.
• Problems with probe insertion, such as pain or swelling in the mouth or throat, difficulty swallowing, stomach upset, pain or swelling, injury to the throat, mouth, or stomach, internal bleeding, vomiting, stomach swelling, anxiety.
• Problems at the incision site, redness, pain, stoma leakage, pain or irritation.

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

• Abdominal discomfort, upper abdominal pain.
• Infection at the surgery site or in the intestine, infection after surgery when the probe was placed in the intestine.
• Inflammation of the peritoneum (peritonitis).
• The probe changes position from the intestine to the stomach, for example, or is blocked, which can cause a decrease in response to treatment.
• Gastrointestinal tract problems due to the stoma (where the probe enters the abdomen), pain at the incision site, cessation of bowel movements after surgery, and problems, discomfort, or bleeding as a result of the treatment procedure.

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

• Inflammation of the large intestine or pancreas.
• Pancreatitis (inflammation of the pancreas).
• The probe penetrates the wall of the large intestine.
• Obstruction in the intestines, bleeding, or ulcer in the small intestine.
• A part of the intestine folds into the adjacent section (intussusception).
• Obstruction of the tube due to undigested food that has become stuck around the tube.
• Abscess after insertion of the tube into the intestine.

Have been reported (affect an unknown number of patients):

• Reduced blood flow in the small intestine.
• The probe penetrates the wall of the stomach or small intestine.
• 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 ingredients 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 completely.
• Symptoms on one side of the face, including drooping eyelids (Horner's syndrome).
• Pupil dilation 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 side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Lecigon

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown 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.

Open cartridge: Use immediately. The medication can be used for up to 24 hours after removal from the refrigerator. The dosing pump with the installed cartridge can be carried close to the body for up to 16 hours. During nighttime treatment, the pump must not be used next to the body, but it can, for example, be kept on the bedside table. Discard any unused amount after 24 hours.

The cartridges are designed for single use. Do not reuse an open cartridge.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Container Contents and Additional Information

Composition of Lecigon

• The active ingredients 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 carmellose, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), and water.

Appearance of the Product and Container Contents

Lecigon intestinal gel is a viscous, opaque yellow or yellow-red gel, contained in a plastic cartridge that contains 47 ml of intestinal gel.

A container contains 7 cartridges.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

LobSor Pharmaceuticals AB

Kålsängsgränd 10 D

SE-753 19 Uppsala, Sweden

Manufacturer:

Bioglan AB

Borrgatan 31, Malmo S.t. Petri

Malmö, Skane Lan

211 24, Sweden

or

STADA Arzneimittel AG

Stadastrasse 2-18,

61118 Bad Vilbel

Germany

Further information on this medicinal product can be obtained from the local representative of the Marketing Authorization Holder:

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

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, intestinal gel

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 Лекигимон 20 mg/ml + 5 mg/ml + 20 mg/ml гел за интестинално приложение

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 zel dojelitowy

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 the Last Revision of this Leaflet:October 2023

Other Sources of Information

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).