Fingolimod Accord 0.5 mg hard capsules EFG: detailed information

Patient Information Leaflet

Introduction

Patient Information Leaflet

Fingolimod Accord 0.5 mg hard capsules EFG

fingolimod

Read the entire leaflet carefully before you start taking 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 or pharmacist.
This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

What Fingolimod Accord is and what it is used for
What you need to know before taking Fingolimod Accord
How to take Fingolimod Accord
Possible side effects
How to store Fingolimod Accord
Contents of the pack and other information

1. What Fingolimod Accord is and what it is used for

What Fingolimod Accord is

The active substance in Fingolimod Accord is fingolimod.

What Fingolimod Accord is used for

Fingolimod Accord is used in adults and in children and adolescents (10 years of age and older) to treat relapsing-remitting multiple sclerosis (MS), particularly in:

Patients who do not respond to treatment despite receiving therapy for MS.

Patients who rapidly develop severe MS.

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

What multiple sclerosis is

MS is a chronic disease affecting the central nervous system (CNS), which consists of the brain and spinal cord. In MS, inflammation destroys the protective covering (called myelin) that surrounds the nerves in the CNS, impairing normal nerve function. This process is known as demyelination.

Relapsing-remitting MS is characterized by repeated attacks (relapses) of neurological symptoms reflecting inflammation occurring in the CNS. Symptoms vary from patient to patient but typically include difficulty walking, loss of sensation in parts of the body (numbness), vision problems, or balance disorders. Symptoms of a relapse may completely disappear when the attack ends, although some problems may persist.

How Fingolimod Accord works

Fingolimod Accord helps combat immune system attacks on the CNS by reducing the ability of certain white blood cells (lymphocytes) to move freely throughout the body and by preventing them from reaching the brain and spinal cord. This limits nerve damage caused by multiple sclerosis. Fingolimod Accord also reduces some of the immune responses in your body.

2. What you need to know before starting to take Fingolimod Accord

Do not take Fingolimod Accord

if you have a reduced immune response (due to an immunodeficiency syndrome, a disease, or medications that suppress the immune system).
if your doctor suspects you may have a rare brain infection known as progressive multifocal leukoencephalopathy (PML) or if you have been diagnosed with PML.
if you have a severe active infection or a chronic active infection such as hepatitis or tuberculosis.
if you have active cancer.
if you have severe liver problems.
if you have had a heart attack, angina, stroke, transient ischemic attack (TIA), or any type of heart failure within the past 6 months.
if you have any type of irregular or abnormal heartbeat (arrhythmia), including patients in whom the electrocardiogram (ECG) shows QT interval prolongation before starting treatment with Fingolimod Accord.
if you are taking or have recently taken medications for irregular heartbeat (heart rhythm) such as quinidine, disopyramide, amiodarone, or sotalol.
if you are pregnant or if you are a woman of childbearing potential and are not using an effective contraceptive method.
if you are allergic to fingolimod or to any of the other ingredients of this medicine (listed in section 6).

If any of the above apply to you or you are unsure, inform your doctor before taking Fingolimod Accord.

Warnings and precautions

Talk to your doctor before starting Fingolimod Accord

if you have severe breathing problems while sleeping (severe sleep apnea).
if you have been told you have an abnormal electrocardiogram (ECG).
if you have symptoms of a slow heart rate (e.g., dizziness, nausea, or palpitations).
if you are taking or have recently taken medications that slow your heart rate (such as beta-blockers, verapamil, diltiazem, ivabradine, digoxin, anticholinesterase agents, or pilocarpine).
if you have a history of sudden loss of consciousness or fainting (syncope).
if you are planning to get vaccinated.
if you have never had chickenpox.
if you have or have had disorders or other signs of inflammation in the central vision area (the macula) at the back of the eye (an eye disorder known as macular edema, see below), inflammation or infection of the eye (uveitis), or if you have diabetes (which may cause eye problems).
if you have liver problems.
if you have high blood pressure that cannot be controlled with medication.
if you have severe lung problems or "smoker's cough".

If any of the above apply to you or you are unsure, inform your doctor before taking Fingolimod Accord.

Slow heart rate (bradycardia) and irregular heartbeats

At the start of treatment or after taking the first 0.5 mg dose, in case you have been switched from a previous dose of 0.25 mg once daily, Fingolimod Accord causes a decrease in heart rate. As a result, you may feel dizzy or tired, become aware of your heartbeat, or your blood pressure may drop. If these effects are severe, inform your doctor immediately, as you may require immediate treatment. Fingolimod Accord may also cause irregular heartbeats, especially after the first dose. Irregular heartbeats usually return to normal within less than a day. The slow heart rate typically returns to normal within one month. During this time, clinically significant effects on heart rate are generally not expected.

Your doctor will ask you to remain in the clinic or hospital for at least 6 hours, with hourly monitoring of pulse and blood pressure, after taking the first dose of Fingolimod Accord or after taking the first 0.5 mg dose if you have been switched from a previous dose of 0.25 mg once daily, so that appropriate measures can be taken if adverse effects occur at the beginning of treatment. You will have an electrocardiogram (ECG) before the first dose of Fingolimod Accord and again after the 6-hour monitoring period. Your doctor may continuously monitor your ECG during this time. If after the 6-hour period your heart rate is very slow or decreasing, or if your ECG shows abnormalities, you will need to be monitored for a longer period (at least 2 additional hours and possibly overnight) until the issue resolves. The same may apply if you are restarting Fingolimod Accord after a treatment interruption, depending on the duration of the interruption and how long you had previously taken Fingolimod Accord before the interruption.

If you have, or are at risk of having, irregular or abnormal heartbeats, if your ECG is abnormal, or if you have heart disease or heart failure, Fingolimod Accord may not be suitable for you.

If you have previously experienced sudden fainting or a slow heart rate, Fingolimod Accord may not be appropriate for you. You will be evaluated by a cardiologist (heart specialist) who will advise on how to start treatment with Fingolimod Accord, including overnight monitoring.

If you are taking other medications that may slow your heart rate, Fingolimod Accord may not be suitable for you. A cardiologist must evaluate you and consider whether you can switch to alternative medications that do not slow the heart rate to allow treatment with Fingolimod Accord. If such a switch is not possible, the cardiologist will advise on how to start treatment with Fingolimod Accord, including overnight monitoring.

If you have never had chickenpox

If you have not had chickenpox, your doctor will check your immunity to the virus that causes it (varicella zoster virus). If you are not protected against the virus, you may need to be vaccinated before starting treatment with Fingolimod Accord. If so, your doctor will delay the start of Fingolimod Accord treatment by one month after completing the vaccination series.

Infections

Fingolimod Accord reduces the number of white blood cells in the blood (especially lymphocytes). White blood cells fight infections. During treatment with Fingolimod Accord (and up to two months after stopping treatment), you may be more likely to get infections. An existing infection may even worsen. Infections can be serious and potentially fatal. If you think you have an infection, have a fever, flu-like symptoms, herpes (shingles), or have a headache accompanied by neck stiffness, light sensitivity, nausea, rash, and/or confusion (seizures) (which may be symptoms of meningitis and/or encephalitis caused by a fungal or herpes virus infection), contact your doctor immediately as this could be serious and life-threatening.

Human papillomavirus (HPV) infection, including warts, dysplasia, and HPV-related cancers, has been reported in patients treated with Fingolimod Accord. Your doctor will assess whether you need HPV vaccination before starting treatment. If you are a woman, your doctor will also recommend regular HPV screening.

PML

PML is a rare brain disorder caused by an infection that can lead to severe disability or death. Your doctor will perform magnetic resonance imaging (MRI) scans before starting treatment and during treatment to monitor the risk of PML.

If you think your MS is worsening or notice any new symptoms, such as changes in mood or behavior, worsening or new weakness on one side of the body, vision changes, confusion, memory problems, or difficulty speaking and communicating, inform your doctor as soon as possible. These may be symptoms of PML. Also, talk to your family members or caregivers about your treatment. Symptoms may appear without your awareness.

If you develop PML, it can be treated and your treatment with Fingolimod Accord will be stopped. Some people experience an inflammatory reaction when Fingolimod Accord is cleared from the body. This reaction (known as immune reconstitution inflammatory syndrome or IRIS) may cause worsening of the disease, including worsening brain function.

Macular edema

Before starting treatment with Fingolimod Accord, your doctor may request an eye examination if you have or have had visual disorders or other signs of inflammation in the central vision area (the macula) at the back of the eye, eye inflammation or infection (uveitis), or diabetes.

After starting treatment with Fingolimod Accord, your doctor may request an eye examination 3 to 4 months after starting treatment.

The macula is a small area of the retina located at the back of the eye that allows you to see shapes, colors, and fine details clearly and sharply. Fingolimod Accord may cause inflammation of the macula, a condition known as macular edema. This inflammation usually occurs within the first four months of treatment with Fingolimod Accord.

If you have diabetes or have had eye inflammation known as uveitis, you are more likely to develop macular edema. In these cases, your doctor will want you to have regular eye examinations to detect macular edema.

If you have had macular edema, discuss this with your doctor before continuing treatment with Fingolimod Accord.

Macular edema may cause the same visual symptoms as an MS attack (optic neuritis). You may not have symptoms at first. You must inform your doctor of any changes you notice in your vision. Your doctor may want to perform an eye examination, especially if:

The center of your visual field becomes blurry or contains shadows.
A blind spot appears in the center of your visual field.
You have difficulty seeing colors or small details.

Liver function tests

If you have severe liver problems, you must not take Fingolimod Accord. Fingolimod Accord can affect liver function. You may not experience any symptoms, but if you notice yellowing of the skin or whites of the eyes, abnormally dark urine (brown-colored), pain in the right side of your abdomen, fatigue, loss of appetite, or nausea and vomiting without apparent cause, inform your doctor immediately.

If you experience any of these symptoms after starting treatment with Fingolimod Accord, inform your doctor immediately.

Before, during, and after treatment, your doctor will order blood tests to monitor your liver function. You may need to stop treatment with Fingolimod Accord if test results indicate a liver problem.

High blood pressure

Since Fingolimod Accord causes a slight increase in blood pressure, your doctor will want you to have your blood pressure monitored regularly.

Lung problems

Fingolimod Accord has a mild effect on lung function. Patients with severe lung problems or "smoker's cough" are more likely to experience adverse effects.

Blood count

The expected effect of treatment with Fingolimod Accord is to reduce the number of white blood cells in your blood. This effect usually returns to normal within 2 months after stopping treatment. If you have blood tests, inform your doctor that you are taking Fingolimod Accord, as otherwise your doctor may not understand the test results. For certain blood tests, your doctor may need more blood than usual.

Before starting treatment with Fingolimod Accord, your doctor will confirm you have enough white blood cells in your blood and may want to repeat checks regularly. If you do not have enough white blood cells, you may need to stop treatment with Fingolimod Accord.

Reversible posterior encephalopathy syndrome (PRES)

Rarely, a condition called reversible posterior encephalopathy syndrome (PRES) has been reported in multiple sclerosis patients treated with Fingolimod Accord. Symptoms may include sudden, severe headache, confusion, seizures, and vision changes. Inform your doctor immediately if you experience any of these symptoms during treatment with Fingolimod Accord, as it may be serious.

Cancer

Cases of skin cancer have been reported in MS patients treated with Fingolimod Accord. Inform your doctor immediately if you notice any skin nodules (e.g., shiny, pearl-like nodules), spots, or open sores that do not heal for weeks. Symptoms of skin cancer may include abnormal growth or changes in skin tissue (e.g., unusual moles) that change in color, shape, or size over time. Before starting treatment with Fingolimod Accord, a skin examination is required to check for skin nodules. Your doctor will also perform periodic skin checks during treatment with Fingolimod Accord. If any skin problems arise, your doctor may refer you to a dermatologist, who may decide whether regular visits are necessary.

A type of cancer of the lymphatic system (lymphoma) has been reported in MS patients treated with Fingolimod Accord.

Sun exposure and sun protection

Fingolimod weakens your immune system, increasing the risk of developing cancer, especially skin cancer. You should limit your exposure to sunlight and UV rays by:

wearing appropriate protective clothing.
regularly applying sunscreen with a high UV protection factor.

Unusual brain lesions associated with MS relapses

Rare cases of large and unusual brain lesions associated with MS relapses have been reported in patients treated with Fingolimod Accord. In the case of severe relapses, your doctor will assess whether an MRI scan is needed to evaluate your condition and decide whether you need to stop taking Fingolimod Accord.

Switching from other treatments to Fingolimod Accord

Your doctor may switch you directly from interferon beta, glatiramer acetate, or dimethyl fumarate to Fingolimod Accord if there are no signs of abnormalities caused by the previous treatment. Your doctor may need to perform a blood test to rule out such abnormalities. After stopping natalizumab, you may need to wait 2–3 months before starting Fingolimod Accord. To switch from teriflunomide, your doctor may advise you to wait or undergo an accelerated elimination procedure. If you have been treated with alemtuzumab, a thorough evaluation is required, and you should discuss with your doctor whether Fingolimod Accord is suitable for you.

Women of childbearing age

If Fingolimod Accord is used during pregnancy, it may harm the fetus. Before starting treatment with Fingolimod Accord, your doctor will explain the risks and request a pregnancy test to confirm you are not pregnant. Your doctor will give you a card explaining why you must not become pregnant while taking Fingolimod Accord and what you should do to prevent pregnancy. During treatment and for 2 months after stopping treatment, you must use an effective contraceptive method (see section "Pregnancy and breastfeeding").

If you become pregnant while taking Fingolimod Accord, inform your doctor immediately. Your doctor will decide to stop treatment (see section 3 "If you stop taking Fingolimod Accord" and section 4 "Possible side effects"). You will receive specific prenatal follow-up.

Breastfeeding

You must not breastfeed during treatment with Fingolimod Accord. Fingolimod Accord passes into breast milk and there is a risk that the baby may experience serious adverse effects.

Driving and using machines

Your doctor will advise you whether your condition allows you to safely drive vehicles, including bicycles, and operate machinery. Fingolimod Accord is not expected to affect your ability to drive and use machines.

However, at the start of treatment, you will need to remain at the clinic or hospital for 6 hours after taking the first dose of Fingolimod Accord. During this time and possibly afterward, your ability to drive and use machines may be impaired.

3. How to take Fingolimod Accord

Treatment with Fingolimod Accord will be supervised by a doctor experienced in the management of multiple sclerosis.

Always follow exactly the instructions for use of this medicine as given by your doctor. If you are unsure, consult your doctor again.

The recommended dose is:

Adults

The dose is one 0.5 mg capsule per day.

Children and adolescents (aged 10 years and older)

The dose depends on body weight:

Children and adolescents weighing ≤ 40 kg: one 0.25 mg capsule per day.
Children and adolescents weighing > 40 kg: one 0.5 mg capsule per day.

For children and adolescents who start with a 0.25 mg capsule per day and later reach a stable weight above 40 kg, the doctor will instruct them to switch to one 0.5 mg capsule per day. In this case, it is recommended to repeat the first-dose observation period.

Fingolimod Accord is only available in 0.5 mg hard capsules, which are not suitable for children and adolescents with a body weight ≤ 40 kg.

Other fingolimod-containing medicines with a strength of 0.25 mg are available.

Please consult your doctor or pharmacist.

Do not exceed the recommended dose.

Fingolimod Accord is administered orally.

Take Fingolimod Accord once daily with a glass of water. Fingolimod Accord capsules must always be swallowed whole and must not be opened. You may take Fingolimod Accord with or without food.

Taking Fingolimod Accord at the same time each day will help you remember when to take your medicine.

If you have any questions about the duration of treatment with Fingolimod Accord, consult your doctor or pharmacist.

If you take more Fingolimod Accord than you should

If you have taken more Fingolimod Accord than you should, inform your doctor immediately.

If you forget to take Fingolimod Accord

If you have been taking Fingolimod Accord for less than 1 month and miss a dose for a full day, speak with your doctor before taking the next dose. Your doctor may decide to keep you under observation when you take the next dose.

If you have been taking Fingolimod Accord for at least 1 month and have missed taking your treatment for more than 2 weeks, speak with your doctor before taking the next dose. Your doctor may decide to keep you under observation when you take the next dose. However, if you have missed taking your treatment for up to 2 weeks, you may take the next dose as originally scheduled.

Never take a double dose to make up for a missed dose.

If you stop taking Fingolimod Accord

Do not stop taking Fingolimod Accord or change your dose without first discussing it with your doctor.

Fingolimod Accord will remain in your body for up to two months after stopping treatment. The number of white blood cells (lymphocyte count) may remain low during this period, and the adverse effects described in this leaflet may still occur. After stopping treatment with Fingolimod Accord, you may need to wait 6–8 weeks before starting a new treatment for MS.

If you need to restart treatment with Fingolimod Accord after a break of more than two weeks, the effect on heart rate that may occur at the beginning of treatment could reappear, and medical monitoring will be required when restarting treatment. Do not restart treatment with Fingolimod Accord after an interruption of more than two weeks without first consulting your doctor.

Your doctor will decide whether follow-up is needed after stopping Fingolimod Accord treatment and how this should be managed. Inform your doctor immediately if you think your MS is worsening after stopping Fingolimod Accord, as this could be serious.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Some adverse effects may be serious or potentially serious:

Common (may affect up to 1 in 10 people)

Cough with sputum (phlegm), chest discomfort, fever (signs of pulmonary disorders)
Infection with herpes virus (shingles or herpes zoster) with symptoms such as blisters, stinging, itching, or skin pain, especially on the upper body or face. Other symptoms may include fever and weakness in the early phase of infection, followed by numbness, itching, or red patches with severe pain
Slow heartbeat (bradycardia), irregular heart rhythm
A type of skin cancer known as basal cell carcinoma (BCC), which often appears as a pearly-looking nodule, although it may also have other forms
Depression and anxiety are known to occur more frequently in people with multiple sclerosis, and have also been reported in pediatric patients treated with Fingolimod Accord
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 central vision area of the retina at the back of the eye) with symptoms such as shadows or a blind spot or loss of vision in the center of the visual field, blurred vision, problems seeing colors or details
Decrease in the number of blood platelets, increasing the risk of bleeding or bruising
Malignant melanoma (a type of skin cancer that usually develops from an unusual mole). Possible signs of melanoma include moles that may change over time in size, shape, thickness, or color, or the formation of new moles. Moles may itch, bleed, or ulcerate
Seizures, fits (more frequent in children and adolescents than in adults)

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

A condition called reversible posterior encephalopathy syndrome (RPES). Symptoms may include sudden, severe headache, confusion, seizures and/or visual disturbances
Lymphoma (a type of cancer affecting the lymphatic system)
Squamous cell carcinoma: a type of skin cancer that may appear as a firm, red nodule, a crusted sore, or a new sore on an existing scar

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

Abnormality in the electrocardiogram (ECG) (inversion of the T wave)
Tumor associated with human herpesvirus 8 infection (Kaposi's sarcoma)

Frequency not known (cannot be estimated from available data)

Allergic reactions, including symptoms such as rash or hives with itching, swelling of lips, tongue or face, which are more likely to occur on the day treatment with Fingolimod Accord is started.
Signs of liver disease (including liver failure), such as yellowing of the skin or whites of the eyes (jaundice), nausea or vomiting, pain on the right side of the stomach area (abdomen), dark (brown-colored) urine, reduced appetite, fatigue, and abnormal results in liver function tests. In a small number of cases, liver failure could lead to the need for a liver transplant.
Risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). Symptoms of PML may be similar to those of an MS relapse. Other symptoms may go unnoticed by the patient, such as changes in mood or behavior, memory loss, or difficulties with speech and communication, which your doctor may need to investigate further to rule out PML. Therefore, if you think your MS is worsening, or if you or people close to you notice any new or unusual symptoms, it is very important to inform your doctor as soon as possible.
Inflammatory disorder after stopping treatment with Fingolimod Accord (known as immune reconstitution inflammatory syndrome or IRIS)
Cryptococcal infections (a type of fungal infection), including cryptococcal meningitis with symptoms such as headache accompanied by neck stiffness, sensitivity to light, nausea and/or confusion.
Merkel cell carcinoma (a type of skin cancer). Possible signs of Merkel cell carcinoma include the formation of a painless flesh-colored or bluish-red nodule, usually on the face, head or neck. Merkel cell carcinoma may also appear as a firm, painless nodule or mass. Long-term sun exposure and a weakened immune system may affect the risk of developing Merkel cell carcinoma.
After stopping treatment with Fingolimod Accord, MS symptoms may reappear and may be worse than they were before or during treatment.
Autoimmune form of anemia (decrease in red blood cells) in which red blood cells are destroyed (autoimmune hemolytic anemia).

If you experience any of these symptoms, contact your doctor immediately.

Other adverse effects

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

Influenza virus 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
Blood tests showing abnormal liver enzyme levels
Cough

Common (may affect up to 1 in 10 people)

Pityriasis versicolor (fungal infection of the skin)
Dizziness
Severe headache, usually accompanied by nausea, vomiting, and sensitivity to light (migraine)
Low levels of white blood cells (lymphocytes, leukocytes)
Weakness
Itchy rash, redness and burning of the skin (eczema)
Itching
Increased blood levels of certain lipids (triglycerides)
Hair loss
Difficulty breathing
Depression
Blurred vision (see also the section on macular edema under the heading "Some adverse effects may be serious or potentially serious")
Hypertension (Fingolimod Accord may cause a slight increase in blood pressure)
Muscle pain
Joint pain

Uncommon (may affect up to 1 in 100 people)

Low levels of certain white blood cells (neutrophils)
Depressed mood
Nausea

Rare (may affect up to 1 in 1,000 patients)

Cancer of the lymphatic system (lymphoma)

Frequency not known (cannot be estimated from available data)

Peripheral inflammation

If you consider any of the adverse effects you experience to be severe, inform your doctor.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Fingolimod Accord Storage

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 packaging and on the aluminium blister after EXP. The expiry date refers to the last day of the month indicated.
Store below 25 °C.
Do not use any packaging that is damaged or shows signs of tampering.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medicines and their packaging. This helps protect the environment.

6. Package contents and other information

Composition of Fingolimod Accord

The active substance is fingolimod.
Each capsule contains 0.5 mg of fingolimod (as hydrochloride).

_ The other components are:

Capsule contents: pregelatinized starch and magnesium stearate.
Capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172).
Printing ink: shellac (E904), propylene glycol (E1520), potassium hydroxide, black iron oxide (E172).

Appearance of the product and contents of the pack

Hard gelatin capsule (capsule) size “3”, opaque yellow / opaque white, with “FO 0.5mg” printed on the cap in black ink, containing white to off-white powder. Each capsule is approximately 15.8 mm in length.

Fingolimod Accord is available in PVC/PVDC/aluminum blister packs containing 7, 28 or 98 hard capsules.

Perforated unit-dose blisters of PVC/PVDC/aluminum containing 7 x 1, 28 x 1 and 98 x 1 hard capsules.

In your country, only some pack sizes may be marketed.

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n,

Edifici Est, 6th Floor,

08039 Barcelona,

Spain

Manufacturer

LABORATORI FUNDACIÓ DAU

C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona,

08040 Barcelona, Spain

Accord Healthcare Polska Sp. z.o.o.

ul. Lutomierska 50,

95-200, Pabianice,

Poland

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

The Netherlands

For any information about this medicine, please contact the local representative of the Marketing Authorization Holder:

AT / BE / BG / CY / CZ / DE / DK / EE / FI / FR / HR / HU / IE / IS / IT / LT / LV / LU / MT / NL / NO / PT / PL / RO / SE / SI / SK / ES

Accord Healthcare S.L.U.

Tel: +34 93 301 00 64

Win Medica A.E.

Tel: +30 210 7488 821

Date of the most recent revision of this leaflet: 05/2025

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu.