Fimodigo

Leaflet accompanying the packaging: patient information

Fimodigo, 0.5 mg hard capsules

fingolimod

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet to be able to read it again if necessary.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for this person. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Fimodigo and what is it used for
• 2. Important information before taking Fimodigo
• 3. How to take Fimodigo
• 4. Possible side effects
• 5. How to store Fimodigo
• 6. Package contents and other information

1. What is Fimodigo and what is it used for

What is Fimodigo

The active substance in Fimodigo is fingolimod.

What is Fimodigo used for

Fimodigo is used in adults and children and adolescents (aged 10 and over) to treat relapsing-remitting multiple sclerosis (MS), particularly in:

• patients who have not responded to MS treatment or
• patients with rapidly evolving severe MS.

Fimodigo does not cure MS, but it helps reduce the number of relapses and slows down the progression of disability caused by MS.

What is multiple sclerosis

MS is a chronic disease of the central nervous system (CNS), consisting of the brain and spinal cord. In MS, the inflammatory process destroys the nerve sheath (called myelin) in the CNS, preventing it from functioning properly. This phenomenon is called demyelination.

How Fimodigo works

Fimodigo helps protect the CNS from immune system attacks by reducing the ability of certain white blood cells (lymphocytes) to move freely in the patient's body and preventing them from entering the brain and spinal cord. In this way, the medicine limits nerve damage caused by MS. Fimodigo also weakens some immune system reactions.

2. Important information before taking Fimodigo

When not to take Fimodigo

• if the patient has a reduced immune response(due to immunodeficiency syndrome, disease, or taking immunosuppressive medications);
• if the patient has a severe active infection or chronic active infection, such as hepatitis or tuberculosis;
• if the patient has an active malignant disease;
• if the patient has severe liver disease;
• if the patient has had a heart attack, angina pectoris, stroke, or symptoms of stroke in the last 6 months;
• if the patient has a certain type of irregular or abnormal heartbeat(arrhythmia), including patients who have had an electrocardiogram (ECG) showing a prolonged QT interval before starting treatment with Fimodigo;
• if the patient is currently taking or has recently taken medications for irregular heartbeat, such as quinidine, disopyramide, amiodarone, or sotalol;
• if the patient is pregnant or breastfeeding;
• if the patient is allergic to fingolimod or any of the other ingredients of this medicine. If this is the case, the patient should tell their doctor and not take Fimodigo.

Warnings and precautions

Before starting treatment with Fimodigo, the patient should discuss the following with their doctor:

• if the patient has severe respiratory disorders during sleep (sleep apnea);
• if the patient has been informed that their ECG is abnormal;
• if the patient has symptoms of slow heart rate (e.g., dizziness, nausea, or palpitations);
• if the patient is taking medications that slow heart rate(such as beta blockers, verapamil, diltiazem, or ivabradine, digoxin, cholinesterase inhibitors, or pilocarpine);
• if the patient has a history of sudden loss of consciousness or fainting;
• if the patient plans to receive a vaccination;
• if the patient has never had chickenpox;
• if the patient has or has had vision problemsor other symptoms of macular edema (a condition where the macula, the part of the eye responsible for central vision, becomes swollen);
• if the patient has liver problems;
• if the patient has high blood pressure that cannot be controlled with medication;
• if the patient has severe lung disease or a cough typical of smokers. If any of these situations occur, the patient should tell their doctor before taking Fimodigo.

Low heart rate (bradycardia) and irregular heartbeat

At the beginning of treatment or after taking the first dose of 0.5 mg, fingolimod slows down the heart rate. As a result, the patient may feel dizzy, tired, have palpitations, or experience low blood pressure. If these symptoms are severe, the patient should tell their doctor immediately, as they may require immediate treatment. Fingolimod may also cause irregular heartbeat, especially after taking the first dose. Irregular heartbeat usually returns to normal within less than one day. Low heart rate usually returns to normal within one month. During this period, no clinically significant effect on heart rate is expected.

The doctor will ask the patient to stay in the doctor's office or clinic for at least 6 hours after taking the first dose of Fimodigo or after taking the first dose of 0.5 mg if the treatment is changed from a daily dose of 0.25 mg, with hourly measurements of pulse and blood pressure, so that if any side effects occur at the beginning of treatment, appropriate treatment can be applied. Before the first dose of Fimodigo and after completing the 6-hour observation, the patient will undergo an ECG. During this time, the doctor may continuously monitor the patient's heart activity using an electrocardiogram. If after 6 hours of observation, the patient has a very slow or decreasing heart rate or if the ECG shows abnormalities, the doctor may need to extend the monitoring of the patient's condition (for at least 2 hours longer or possibly until the next day) until these symptoms resolve. The same procedure may be recommended if the patient resumes treatment with Fimodigo after a break in treatment, depending on how long the break lasted and how long the patient took Fimodigo before the break.

If the patient has irregular or abnormal heartbeat, or risk factors for these events, or abnormal ECG or heart disease, or heart failure, Fimodigo may not be suitable for them.

If the patient has a history of sudden loss of consciousness or slow heart rate, Fimodigo may not be suitable for them. The doctor may need to consult a cardiologist (a heart specialist) who will advise on how to start treatment with Fimodigo, including how to monitor the patient at night.

If the patient is taking medications that slow heart rate, Fimodigo may not be suitable for them. The doctor may need to consult a cardiologist to check if the patient can switch to other medications that do not slow heart rate, to allow treatment with Fimodigo. If such a change in treatment is not possible, the cardiologist will advise the patient on how to start treatment with Fimodigo, taking into account monitoring until the next day after administration of the first dose of Fimodigo.

Patients who have never had chickenpox

If the patient has never had chickenpox, the doctor will check the patient's immunity to the varicella-zoster virus. If the patient is not protected against the virus, they may need to be vaccinated before starting treatment with Fimodigo. If this is the case, the doctor will delay the start of treatment with Fimodigo by one month after the full vaccination cycle.

Infections

Fingolimod reduces the number of white blood cells (especially lymphocytes). White blood cells fight infections. During treatment with Fimodigo (and up to 2 months after stopping treatment), the patient may be more susceptible to infections. Existing infections may worsen. Infections can be severe and life-threatening. If the patient thinks they have an infection, have a fever, flu-like symptoms, shingles, or a headache with stiff neck, sensitivity to light, nausea, rash, and/or confusion or seizures (which may be symptoms of meningitis and/or encephalitis caused by fungal or viral infections), they should contact their doctor immediately, as this condition can be severe.

If the patient experiences any of the above symptoms after starting treatment with Fimodigo, they should tell their doctor immediately.

Before, during, and after treatment, the doctor will order blood tests to monitor liver function. If the test results indicate liver dysfunction, treatment with Fimodigo may be discontinued.

High blood pressure

The doctor may regularly check the patient's blood pressure, as Fimodigo can cause a slight increase in blood pressure.

Lung diseases

Fimodigo has a minor effect on lung function. Patients with severe lung disease or a cough typical of smokers are at higher risk of side effects.

Blood cell count

The expected effect of fingolimod is a decrease in the number of white blood cells in the blood. Their number usually returns to normal within 2 months after stopping treatment. If blood tests need to be performed, the patient should inform their doctor that they are taking Fimodigo. Otherwise, the doctor may not be able to interpret the test results, and in the case of certain tests, the doctor may order more blood to be drawn than usual.

Before starting treatment with Fimodigo, the doctor will check if the patient has a sufficient number of white blood cells in the blood to start treatment and may order regular repeat tests. If there are not enough white blood cells, it may be necessary to discontinue treatment with Fimodigo.

Reversible posterior encephalopathy syndrome (PRES)

In patients with MS treated with fingolimod, there have been rare reports of a condition called reversible posterior encephalopathy syndrome (PRES). The symptoms of this condition may include severe headache, confusion, seizures, and/or vision changes. If the patient experiences any of these symptoms during treatment with Fimodigo, they should tell their doctor immediately, as this condition can be severe.

Cancer

In patients with MS treated with fingolimod, there have been reports of skin cancers. If the patient notices any lumps on their skin (e.g., shiny lumps with a pearl-like color), spots, or open sores that do not heal within a few weeks, they should tell their doctor immediately. Symptoms of skin cancer may include abnormal growths or changes in skin tissue (e.g., unusual moles) that change color, shape, or size over time.

Before starting treatment with Fimodigo, it is necessary to examine the patient's skin to detect any lumps. The doctor will also perform regular skin checks during treatment with Fimodigo. If skin problems occur, the doctor may refer the patient to a dermatologist, who may decide on the need for regular visits after consulting with them.

In patients with MS treated with fingolimod, there have been reports of a type of lymphoma (a cancer of the lymphatic system).

Exposure to sunlight and protection from ultraviolet radiation

Fingolimod weakens the immune system. This increases the risk of developing cancers, especially skin cancers. The patient should limit exposure to sunlight and ultraviolet radiation by:

• wearing protective clothing.
• regularly applying sunscreen with a high level of protection against ultraviolet radiation.

Unusual changes in the brain associated with MS relapse

In patients treated with fingolimod, there have been rare reports of unusually large changes in the brain associated with MS relapse. In the case of a severe MS relapse, the doctor may consider performing an MRI to assess this condition and decide on the possible need to discontinue Fimodigo.

Changing treatment from other medicines to Fimodigo

The doctor may change treatment directly from interferon beta, glatiramer acetate, or dimethyl fumarate to Fimodigo if there are no symptoms of abnormalities caused by previous treatment. The doctor may order a blood test to rule out these abnormalities.

After stopping treatment with natalizumab, it may be necessary to wait 2 to 3 months before starting treatment with Fimodigo. When changing treatment from teriflunomide, the doctor may advise the patient to wait for a certain period or undergo an accelerated elimination procedure for the medicine. Patients previously treated with alemtuzumab require careful evaluation and discussion with their doctor before deciding whether Fimodigo is suitable for them.

Women of childbearing age

If Fimodigo is used during pregnancy, it may harm the unborn child. Before starting treatment with Fimodigo, the doctor will explain the risk to the patient and ask them to perform a pregnancy test to rule out pregnancy. The doctor will give the patient a card explaining why they should not become pregnant while taking Fimodigo.

Patients must use effective contraception during treatment and for 2 months after stopping treatment (see "Pregnancy and breastfeeding").

Worsening of MS after stopping Fimodigo

The patient should not stop taking Fimodigo or change the dose without first consulting their doctor.

The patient should tell their doctor immediatelyif they think their MS is getting worse after stopping Fimodigo. This situation can be serious (see "Stopping Fimodigo" in section 3 and section 4 "Possible side effects").

Elderly patients

Experience with fingolimod in elderly patients (over 65 years) is limited. In case of doubts, the patient should consult their doctor.

Children and adolescents

Fimodigo is not intended for use in children under 10 years of age, as it has not been studied in this age group with MS.

The warnings and precautions mentioned above also apply to children and adolescents.

Particularly important for children and adolescents and their caregivers are the following:

• before starting treatment with Fimodigo, the doctor will check the patient's vaccination status. If the patient has not received certain vaccinations, they may need to be vaccinated before starting treatment with Fimodigo.
• when taking Fimodigo for the first time or when changing the daily dose from 0.25 mg to 0.5 mg, the doctor will monitor the patient's heart rate and pulse (see "Low heart rate (bradycardia) and irregular heartbeat" above).
• if the patient experiences seizures or convulsions before or during treatment with Fimodigo, they should tell their doctor.
• if the patient experiences depression or anxiety or feels low or anxious while taking Fimodigo, they should tell their doctor. The patient may need to be monitored more closely.

Fimodigo 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:

• immunosuppressive or immunomodulatory medications, including other MS treatments, such as interferon beta, glatiramer acetate, natalizumab, mitoxantrone, teriflunomide, dimethyl fumarate, or alemtuzumab. Fimodigo should not be taken with these medicines, as it may increase the effect on the immune system (see also "When not to take Fimodigo").
• corticosteroids, due to the potential for additive effects on the immune system.
• vaccines. If the patient needs to receive a vaccine, they should consult their doctor first. During and up to 2 months after treatment with Fimodigo, patients should not receive certain types of live attenuated vaccines, as they may cause the infection they are intended to prevent. Other vaccines may also be less effective if given during this period.

medicines that slow heart rate(e.g., beta blockers, such as atenolol). Taking Fimodigo with these medicines may increase the effect on heart rate in the first days of treatment.

medicines for irregular heartbeat, such as quinidine, disopyramide, amiodarone, or sotalol. Fimodigo should not be taken by patients taking these medicines, as it may increase the effect on irregular heartbeat (see also "When not to take Fimodigo").

other medicines: protease inhibitors, antifungal medications such as ketoconazole, azole antifungals, clarithromycin, or telithromycin; carbamazepine, rifampicin, phenobarbital, phenytoin, efavirenz, or St. John's wort preparations (possible risk of reduced efficacy of Fimodigo).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.

Pregnancy

Fimodigo should not be taken during pregnancy, if the patient is trying to become pregnant, or if the patient may become pregnant and is not using effective contraception. If Fimodigo is taken during pregnancy, there is a risk of harm to the unborn child. The rate of birth defects in children exposed to fingolimod during pregnancy is about twice as high as in the general population (where the rate of birth defects is about 2-3%).

The most commonly reported birth defects include heart, kidney, and musculoskeletal defects.

Therefore, if the patient is of childbearing age:

• before starting treatment with Fimodigo, the doctor will inform the patient about the risk to the unborn child and ask them to perform a pregnancy test to ensure they are not pregnant, and
• the patient should use effective contraception during treatment with Fimodigo and for 2 months after stopping treatment to avoid becoming pregnant. The patient should discuss effective contraception methods with their doctor.

The doctor will give the patient a card explaining why they should not become pregnant while taking Fimodigo.

If the patient becomes pregnant while taking Fimodigo, they should tell their doctor immediately.

The doctor will decide whether to discontinue treatment (see "Stopping Fimodigo" in section 3 and section 4 "Possible side effects"). The patient will also need to attend prenatal check-ups.

Breastfeeding

Fimodigo should not be taken while breastfeeding. Fingolimod may pass into breast milk, posing a risk of serious side effects to the baby.

Driving and using machines

The doctor will inform the patient whether their condition allows them to drive vehicles safely, including riding a bicycle and operating machines. It is not expected that Fimodigo will affect the ability to drive vehicles and operate machines.

However, at the beginning of treatment, the patient must stay in the doctor's office or clinic for 6 hours after taking the first dose of Fimodigo. During this time and potentially after it, the ability to drive vehicles and operate machines may be impaired.

3. How to take Fimodigo

Treatment with Fimodigo will be supervised by a doctor with experience in treating multiple sclerosis.

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor.

The recommended dose is:

Adults:

The dose is one 0.5 mg capsule per day.

Children and adolescents (aged 10 and over):

The dose depends on body weight:

• children and adolescents weighing 40 kg or less: one 0.25 mg capsule per day. Other fingolimod products are available in a lower dose (0.25 mg capsules).
• children and adolescents weighing more than 40 kg: one 0.5 mg capsule per day.

Children and adolescents starting treatment with one 0.25 mg capsule per day and later reaching a stable weight over 40 kg will be advised by their doctor to change the dose to one 0.5 mg capsule per day. In this case, it is recommended to repeat the observation period as after the first dose of Fimodigo.

The patient should not exceed the recommended dose.

Fimodigo is intended for oral use.

Fimodigo should be taken once a day, with a glass of water. Fimodigo capsules should always be swallowed whole, without opening. Fimodigo can be taken with or without food.

Taking Fimodigo at the same time every day will help the patient remember to take their medicine.

If the patient has any questions about the duration of treatment with Fimodigo, they should consult their doctor or pharmacist.

Taking a higher dose of Fimodigo than recommended

If the patient takes too much Fimodigo, they should contact their doctor immediately.

Missing a dose of Fimodigo

If the patient takes Fimodigo for less than 1 month and forgets to take 1 dose for the whole day, they should contact their doctor before taking the next dose. The doctor may decide to keep the patient under observation during the next dose.

If the patient takes Fimodigo for at least 1 month and forgets to take the medicine for more than 2 weeks, they should contact their doctor before taking the next dose. The doctor may decide to keep the patient under observation during the next dose.

However, if the patient forgets to take the medicine for up to 2 weeks, they can take the next dose as planned.

The patient should not take a double dose to make up for a missed dose.

Stopping Fimodigo

The patient should not stop taking Fimodigo or change the dose without first consulting their doctor.

Fimodigo stays in the body for up to 2 months after stopping treatment. During this time, the number of white blood cells (lymphocytes) may also be reduced, and side effects listed in this leaflet may still occur. After stopping Fimodigo, the patient should wait 6-8 weeks before starting new MS treatment.

In patients resuming treatment with Fimodigo after more than 2 weeks of stopping the medicine, the effect on heart rate observed after the first dose may occur again, and monitoring of the patient's condition in the doctor's office or clinic will be necessary due to the resumption of treatment. The patient should not resume treatment with Fimodigo after a break of more than 2 weeks without consulting their doctor.

The doctor will decide how to monitor the patient after stopping Fimodigo. The patient should tell their doctor immediatelyif they think their MS is getting worse after stopping Fimodigo. This situation can be serious.

In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Fimodigo can cause side effects, although not everybody gets them.

Some side effects may be serious or become serious

Very common(may affect up to 1 in 10 people):

• Cough with expectoration, unspecified unpleasant chest sensation, fever (respiratory disorders)
• Herpesvirus infections (shingles or herpes) with symptoms such as blisters, burning, itching, or pain on the skin, usually on the upper part of the body or face. Other symptoms may include fever and weakness at the beginning of the infection, followed by numbness, itching, or red spots with severe pain
• Slow heart rate (bradycardia), irregular heartbeat
• A type of skin cancer called basal cell carcinoma (BCC), which often appears as a pearl-like nodule, although it can have other appearances
• Depression and anxiety are more common in patients with MS and have also been reported in children and adolescents treated with Fimodigo.
• Weight loss.

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

• Pneumonia with symptoms such as fever, cough, difficulty breathing
• Macular edema (swelling in the center of the retina, at the back of the eye) with symptoms such as shadows or blind spots in the center of the visual field, blurred vision, difficulty perceiving colors and details
• Reduced platelet count, which increases the risk of bleeding or bruising
• Malignant melanoma (a type of skin cancer that usually develops from an unusual mole). Possible symptoms of melanoma include moles that change color, shape, or size over time
• Seizures, convulsions (more common in children and adolescents than in adults)

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

• A condition called posterior reversible encephalopathy syndrome (PRES). Symptoms may include severe headache, confusion, seizures, and/or vision changes
• Lymphoma (a type of cancer affecting the lymphatic system)
• Squamous cell carcinoma: a type of skin cancer that can appear as a hard, red nodule, an ulcer covered with a scab, or a fresh ulcer in the area of an existing scar

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

• Abnormalities in the ECG (inversion of the T wave)
• A tumor associated with human herpesvirus 8 (Kaposi's sarcoma)

Frequency not known(frequency cannot be estimated from the available data):

• Allergic reactions, including symptoms such as rash or itchy hives, swelling of the lips, tongue, or face, which are more likely to occur on the day of starting treatment with Fimodigo
• Liver disease symptoms (including liver failure) such as yellowing of the skin or whites of the eyes (jaundice), nausea or vomiting, pain in the right upper abdomen, dark (brown) urine, decreased appetite, fatigue, and abnormal liver function test results. In very rare cases, liver failure may require a liver transplant
• Risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML symptoms may be similar to an MS relapse. They may also include symptoms that the patient is not aware of, such as changes in mood or behavior, transient memory loss, difficulty speaking or communicating, which the doctor should evaluate to rule out PML. Therefore, if the patient thinks their MS is getting worse or if the patient or their caregivers notice any new or unusual symptoms, it is very important to tell their doctor immediately
• Cryptococcal infections (a type of fungal infection), including cryptococcal meningitis with symptoms such as headache, stiff neck, sensitivity to light, nausea, and/or confusion
• Merkel cell carcinoma (a type of skin cancer). Possible symptoms of Merkel cell carcinoma include a painless nodule with a raw meat color, usually located on the face, head, or neck. Merkel cell carcinoma can also appear as a hard, painless nodule or mass. Long-term sun exposure and weakened immune system may affect the risk of developing Merkel cell carcinoma
• After stopping Fimodigo, MS symptoms may relapse and worsen compared to the period before treatment and during treatment.
• Autoimmune hemolytic anemia (a condition where red blood cells are destroyed).

If the patient experiences any of these side effects, they should tell their doctor immediately.

Other side effects

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

• Influenza infection with symptoms such as fatigue, chills, sore throat, joint or muscle pain, fever
• Feeling of pressure or pain in the cheeks and forehead (sinusitis)
• Headache
• Diarrhea
• Back pain
• Increased liver enzyme activity in blood tests
• Cough

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

• Fungal skin infections (dermatophytosis) (ringworm)
• Dizziness
• Severe headache, usually accompanied by nausea, vomiting, and sensitivity to light (migraine symptoms)
• Low white blood cell count (lymphocytes, leukocytes)
• Weakness
• Itchy, red, burning rash (erythema)
• Itching
• Increased triglyceride levels in the blood
• Hair loss
• Shortness of breath
• Depression
• Blurred vision (see also "Macular edema" under "Some side effects may be serious or become serious")
• High blood pressure (Fimodigo may cause a mild increase in blood pressure)
• Muscle pain
• Joint pain

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

• Low neutrophil count
• Depressed mood
• Nausea

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

• Lymphoma (a type of cancer affecting the lymphatic system)

Frequency not known(frequency cannot be determined from the available data):

• Peripheral edema

If any of these symptoms occur with significant severity, the patient should tell their doctor.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:

Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl.

Side effects can also be reported to the marketing authorization holder.

Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Fimodigo

The medicine should be stored out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister pack after "Expiry date" / "EXP". The expiry date refers to the last day of the month stated.

Do not store above 30°C.

Store in the original package to protect from moisture.

Do not use medicines from damaged or opened packages.

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. Package contents and other information

What Fimodigo contains

• The active substance of the medicinal product is fingolimod. Each hard capsule contains 0.5 mg of fingolimod (as fingolimod hydrochloride).
• The other ingredients are: Capsule filling: potassium citrate monohydrate, colloidal anhydrous silica, magnesium stearate. Capsule body: titanium dioxide (E 171), gelatin Capsule cap: titanium dioxide (E 172), iron oxide yellow (E 171), gelatin

What Fimodigo looks like and what the pack contains

Fimodigo 0.5 mg hard capsules (16 mm, size 3) have a white body and a yellow cap.
OPA/Aluminium/PVC/Aluminium blisters containing 7, 28 or 98 hard capsules in a cardboard box.
Single-dose OPA/Aluminium/PVC/Aluminium blisters containing 7, 28 or 98 hard capsules in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer/importer

Marketing authorisation holder:
Vipharm S.A
ul. A. i F. Radziwiłłów 9
05-850 Ożarów Mazowiecki
Poland
Manufacturer/Importer:
Synthon Hispania S.L.
C/ Castelló 1
Sant Boi De Llobregat
08830 Barcelona
Spain
Synthon B.V.
Microweg 22
6545 CM Nijmegen
Netherlands

This medicinal product is authorised in the Member States of the European

Economic Area under the following names:

Czech Republic:
Fimodigo
Netherlands:
Fimodigo 0.5 mg hard capsules
Poland:
Fimodigo
Slovakia:
Fimodigo 0.5 mg
Hungary:
Fimodigo 0.5 mg hard capsule
Date of last renewal of the authorisation:24.07.2024