Prospecto: information for the user

Fingolimod Accord 0.5 mg hard capsules EFG

fingolimod

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

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

3.How to take Fingolimod Accord

4.Possible adverse effects

5.Storage of Fingolimod Accord

6.Contents of the package and additional information

What is Fingolimod Accord

The active ingredient of Fingolimod Accord is fingolimod.

What is Fingolimod Accord 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 treatment for MS.

or

•Patients who rapidly develop severe MS.

Fingolimod Accord does not cure MS, but helps to reduce the number of relapses and slow down the progression of physical disabilities due to MS.

What is multiple sclerosis

MS is a chronic disease that affects the central nervous system (CNS), consisting of the brain and spinal cord. In MS, inflammation destroys the protective covering (called myelin) that surrounds the nerves in the CNS and prevents nerves from functioning correctly. This process is called demyelination.

Relapsing-remitting MS is characterized by repeated attacks (relapses) of CNS symptoms that are a reflection of the inflammation that occurs in the CNS. Symptoms vary from patient to patient, but usually include difficulties walking, numbness in some part of the body (tingling), vision problems, or balance disorders. Symptoms of a relapse may disappear completely when the relapse ends, but some problems may persist.

How Fingolimod Accord works

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

Do not take Fingolimod Accord

•if you have a weakened immune response (due to immunodeficiency syndrome, a disease, or medications that suppress the immune system).

•if you have an active severe infection or an active chronic infection such as hepatitis or tuberculosis.

•if you have an active cancer.

•if you have severe liver problems.

•if, in the last 6 months, you have had a heart attack, angina, stroke, or warning of a stroke, or any type of heart failure.

•if you have any type of irregular or abnormal heart rhythm (arrhythmia), including patients in whom the electrocardiogram (ECG) shows prolongation of the QT interval before starting treatment with Fingolimod Accord.

•if you are taking or have recently taken medications for irregular heartbeats (such as quinidine, disopyramide, amiodarone, or sotalol).

•if you are pregnant or if you are a fertile woman and do not use an effective contraceptive method.

•if you are allergic to fingolimod or to any of the other components of this medication (including those listed in section 6).

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

Warnings and precautions

Consult your doctor before starting to take Fingolimod Accord

•if you have severe respiratory problems when sleeping (severe sleep apnea).

•if you have been told that you have an abnormal electrocardiogram.

•if you have symptoms of slow heart rhythm (e.g., dizziness, nausea, or palpitations).

•if you are taking or have recently taken medications that slow down your heart rhythm(such as beta-blockers, verapamil, diltiazem, or ivabradine, digoxin, anticholinesterase agents, or pilocarpine).

•if you have a history of sudden loss of consciousness or fainting (syncope).

•if you plan to get vaccinated.

•if you have never had chickenpox.

•if you have or have had eye inflammation or other signs of inflammation in the central vision area (macula) of the back of the eye (a condition known as macular edema, see below) or if you have diabetes(which can 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 cases apply to you or you are unsure, inform your doctor before taking Fingolimod Accord.

Slow heart rhythm (bradycardia) and irregular heartbeats

At the start of treatment or after taking the first dose of 0.5 mg, in the case that you have changed the previous dose of 0.25 mg once a day, Fingolimod Accord causes a decrease in heart rhythm. As a result, you may feel dizzy or tired, be aware of your heartbeat, or have a decrease in blood pressure.If these effects are severe, inform your doctor as you may need immediate treatment.Fingolimod Accord can also make your heartbeats irregular, especially after the first dose. Irregular heartbeats usually normalize in less than a day. The slow heart rhythm usually normalizes within a month. During this period, you can generally not expect any clinically significant heart rhythm effects.

Your doctor will ask you to stay in the consultation or hospital for a minimum of 6 hours, with pulse and blood pressure checks every hour, after taking the first dose of Fingolimod Accord or after taking the first dose of 0.5 mg, in the case that you have changed the previous dose of 0.25 mg once a day, to take the necessary measures if adverse effects appear at the start of treatment. You will need to have an electrocardiogram before the first dose of Fingolimod Accord and after the 6-hour monitoring period. Your doctor may continuously monitor your electrocardiogram during this time. If, after the 6-hour period, you have a very slow or decreasing heart rhythm, or if your electrocardiogram shows abnormalities, you will need to be monitored for a longer period (at least 2 hours more and possibly throughout the night, until this is resolved). The same may apply if you are restarting Fingolimod Accord after a pause in treatment, depending on both the duration of the pause and how long you were taking Fingolimod Accord before the pause.

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

If you have had sudden fainting episodes in the past or decreased heart rhythm, Fingolimod Accord may not be suitable for you. You will be evaluated by a cardiologist (heart specialist) who will advise you on how to start treatment with Fingolimod Accord, including monitoring during the night.

If you are taking other medications that can slow down your heart rhythm, Fingolimod Accord may not be suitable for you. A cardiologist will evaluate you, and it will be they who decide if you can switch to alternative medications that do not slow down your heart rhythm to allow treatment with Fingolimod Accord. If this change is impossible, the cardiologist will advise you on how to start treatment with Fingolimod Accord, including monitoring during the night.

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, your doctor will probably delay starting treatment with Fingolimod Accord until you have completed the vaccination cycle. If so, your doctor will wait a month before starting treatment with Fingolimod Accord.

Infections

Fingolimod Accord reduces the number of white blood cells in your blood (especially the number of lymphocytes). White blood cells fight infections. During treatment with Fingolimod Accord (and for up to 2 months after you stop treatment), you may be more susceptible to infections. You may even exacerbate an existing infection. Infections can be severe and potentially life-threatening. If you think you have contracted an infection, have a fever, have symptoms similar to the flu, have herpes (cold sore) or have a headache accompanied by neck stiffness, sensitivity to light, nausea, rash, and/or confusion (attacks) (which can be symptoms of meningitis and/or encephalitis caused by a fungal infection or herpes virus), contact your doctor immediately, as it can be severe and life-threatening.

If you think your MS is worsening (e.g., weakness or changes in vision) or if you notice any new symptoms, inform your doctor immediately, as they may be symptoms of a rare brain disorder caused by an infection called progressive multifocal leukoencephalopathy (PML). PML is a serious disease that can cause severe disability or death. Your doctor will evaluate the need for a magnetic resonance imaging (MRI) scan to assess your condition and decide if you need to stop taking Fingolimod Accord.

Human papillomavirus (HPV) infection, including papilloma, dysplasia, warts, and cancer associated with HPV, has been reported in patients treated with Fingolimod Accord.Your doctor will evaluate if you need to be vaccinated against HPV before starting treatment. If you are a woman, your doctor will also recommend HPV screening.

Macular edema

Before starting treatment with Fingolimod Accord, your doctor may request an eye examination if you have or have had visual disturbances or other signs of inflammation in the central vision area (macula) of 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 or 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 details clearly and clearly. Fingolimod Accord can cause inflammation of the macula, and this condition is known as macular edema. Inflammation usually occurs within the first 4 months of treatment with Fingolimod Accord.

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

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

Macular edema can cause the same visual symptoms as an MS attack (optic neuritis). At first, you may not have any symptoms. 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 trouble seeing colors or small details.

Liver function tests

If you have severe liver problems, you should not take Fingolimod Accord. Fingolimod Accord can affect liver function. You may not perceive any symptoms, but if you notice a yellowish tone on your skin or in the white part of your eye, abnormally dark urine (brown), abdominal pain on the right side, fatigue, decreased appetite, nausea, or vomiting without apparent cause,inform your doctor immediately.

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

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

High blood pressure

As Fingolimod Accord causes a slight increase in blood pressure, your doctor will want to regularly monitor your blood pressure.

Lung problems

Fingolimod Accord has a mild effect on lung function. Patients with severe lung problems or "smoker's cough" are more likely to develop 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 normalizes within 2 months after stopping treatment. If you need to have blood tests, inform your doctor that you are taking Fingolimod Accord, as if you do not, the doctor may not understand the test results. For certain blood tests, your doctor may need to take more blood than usual.

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

Posterior reversible encephalopathy syndrome (PRES)

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

Cancer

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

Cases of lymphoma, a type of cancer of the lymphatic system, have been reported in patients with MS treated with Fingolimod Accord.

Exposure to the sun and sun protection

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

•wearing protective clothing.

•regularly applying a high-protection sunscreen.

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 evaluate the need for an MRI scan to assess your condition and decide if you need to stop taking Fingolimod Accord.

Changing other treatments to Fingolimod Accord

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

Women of childbearing age

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

Pregnancy

Do not use Fingolimod Accord during pregnancy, or if you are a woman of childbearing age and do not use an effective contraceptive method. If Fingolimod Accord is used during pregnancy, there is a risk of causing harm to the fetus. The rate of congenital malformations observed in babies exposed to Fingolimod Accord during pregnancy is approximately 2 times higher than that observed in the general population (where the rate of congenital malformations is approximately 2-3%). The most frequently reported malformations included cardiac, renal, and musculoskeletal malformations.

Therefore, if you are a woman of childbearing age:

•before starting treatment with Fingolimod Accord, your doctor will inform you about the risk to the fetus and request a pregnancy test to ensure you are not pregnant,

and

•during treatment with Fingolimod Accord and for 2 months after stopping treatment, you must use an effective contraceptive method to avoid becoming pregnant. Discuss effective contraceptive methods with your doctor.

Your doctor will give you a card explaining why you should not become pregnant while taking Fingolimod Accord.

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

Breastfeeding

Do not breastfeed during treatment with Fingolimod Accord.Fingolimod Accord passes into breast milk, and there is a risk of severe adverse effects in the baby.

Driving and operating machinery

Your doctor will inform you if your disease allows you to drive vehicles, including bicycles, and use machinery safely. Fingolimod Accord is not expected to affect your ability to drive and use machinery.

However, after taking the first dose of Fingolimod Accord, you will need to stay in the doctor's office or hospital for 6 hours. During this period and possibly afterwards, your ability to drive and use machinery may be impaired.

The treatment with Fingolimod Accord will be supervised by a doctor with experience in treating multiple sclerosis.

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

The recommended dose is:

Adults

The dose is one capsule of 0.5 mg per day.

Children and adolescents (10 years of age and older)

The dose depends on body weight:

•Children and adolescents with a weight equal to or less than 40 kg:one capsule of 0.25 mg per day.

•Children and adolescents with a weight greater than 40 kg:one capsule of 0.5 mg per day.

Children and adolescents who start with one capsule of 0.25 mg per day and later reach a stable weight greater than 40 kg, the doctor will instruct them to change to one capsule of 0.5 mg per day. In this case, it is recommended to repeat the observation period of the first dose.

Fingolimod Accord is only available in hard capsules of 0.5 mg that are not suitable for children and adolescents with a body weight equal to or less than 40 kg.

There are other medications available with fingolimod 0.25 mg.

Consult your doctor or pharmacist.

Do not exceed the recommended dose.

Fingolimod Accord is taken orally.

Take Fingolimod Accord once a day with a glass of water. Fingolimod Accord capsules must always be swallowed whole, without opening. You can take Fingolimod Accord with or without food.

Taking Fingolimod Accord every day at the same time will help you remember when to take the medication.

If you have doubts 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 forgot to take Fingolimod Accord

If you have been taking Fingolimod Accord for less than 1 month and forget to take 1 dose for an entire day, talk to 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 forget to take your treatment for more than 2 weeks, talk to 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 forget to take your treatment for a period of up to 2 weeks, you can take the next dose as planned.

Never take a double dose to compensate for missed doses.

If you interrupt treatment with Fingolimod Accord

Do not stop taking Fingolimod Accord or change the dose that should be taken without consulting your doctor first.

Fingolimod Accord will remain in your body for up to 2 months after treatment is stopped. The number of white blood cells in the blood (lymphocyte count) may remain low during this period and it is possible that the adverse effects described in this leaflet will 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 resume treatment with Fingolimod Accord after a pause of more than 2 weeks, the effect on heart rate that may occur at the start of treatment may recur and you will need to be monitored by your doctor to resume treatment. Do not restart treatment with Fingolimod Accord after stopping it for more than 2 weeks without consulting your doctor.

Your doctor will decide if you need to be followed up after stopping treatment with Fingolimod Accord and how. Inform your doctor immediately if you think your MS is worsening after stopping treatment with Fingolimod Accord, as it could be serious.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Some side effects can be serious or potentially serious:

Common(may affect up to 1 in 10 people)

•Cough with mucus (phlegm), chest discomfort, fever (signs of respiratory changes)

•Herpes virus infection (cold sore or shingles) with symptoms such as blisters, itching, prickling, or skin pain, especially on the upper body or face. Other symptoms you may have are fever and weakness in the early stages of the infection, followed by numbness, itching, or red spots with intense pain

•Slow heart rate (bradycardia), irregular heart rhythm

•A type of skin cancer known as basal cell carcinoma (BCC) that often presents as a pearl-like nodule, although it can also have other forms

•It is known that the population with multiple sclerosis has depression and anxiety more frequently, and also 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 (inflammation 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, blurry vision, problems seeing colors or details

•Decreased 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 signs of melanoma include moles that over time can change in size, shape, thickness, or color, or the formation of new moles. Moles can cause itching, bleeding, or ulceration

•Seizures, attacks (more common in children and adolescents than in adults)

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

•A disease called posterior reversible encephalopathy syndrome (PRES). Symptoms can include the sudden and intense onset of headache, confusion, seizures, and/or visual disturbances

•Lymphoma (a type of cancer that affects the lymphatic system)

•Squamous cell carcinoma: a type of skin cancer that can present as a firm, red nodule, a sore with a scab, or a new sore over an existing scar

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

•Electrocardiogram anomaly (T wave inversion)

•Kaposi's sarcoma (a type of cancer related to human herpesvirus 8 infection)

Frequency not known(cannot be estimated from available data)

•Allergic reactions, including symptoms such as rash or urticaria with itching, swelling of lips, tongue, or face, which is more likely to appear on the day treatment with Fingolimod Accord begins.

•Signs of liver disease (including liver failure), such as yellowing of the skin or the white part of the eyes (jaundice), nausea or vomiting, pain in the right side of the stomach (abdomen), dark urine (brown), less appetite than usual, fatigue, and abnormal liver function test results. In a small number of cases, liver failure could lead to liver transplantation.

•Risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). Symptoms of PML can be similar to those of MS. You may also experience symptoms that you may not notice yourself, such as mood or behavior changes, memory loss, difficulty speaking and communicating, which your doctor may need to investigate further to rule out PML. Therefore, if you think your MS is getting worse 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.

•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, red or pinkish-blue nodule, usually on the face, head, or neck. Merkel cell carcinoma can also present as a firm or soft nodule. Long-term sun exposure and a weakened immune system can affect the risk of developing Merkel cell carcinoma.

•After stopping treatment with Fingolimod Accord, your MS symptoms may return and may be worse than they were before or during treatment.

•Autoimmune hemolytic anemia (a decrease in the number of red blood cells) in which red blood cells are destroyed.

If you have any of these symptoms,inform your doctor immediately.

Other side 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

•Sinusitis (sensation of pressure or pain in the cheeks and forehead)

•Headache

•Diarrhea

•Back pain

•Blood test with alterations in liver enzyme levels

•Cough

Common(may affect up to 1 in 10 people)

•Tinea versicolor (fungal infection of the skin)

•Dizziness

•Severe headache, usually accompanied by nausea, vomiting, and sensitivity to light (migraine)

•Low white blood cell count (neutrophils)

•Weakness

•Eczema (itching, redness of the skin, and burning)

•Itching

•Increased levels of certain lipids (triglycerides) in the blood

•Hair loss

•Difficulty breathing

•Depression

•Blurry vision (see also the section on macular edema under the title "Some side effects can 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 neutrophil count

•Depressive mood

•Nausea

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

•Lymphoma (cancer of the lymphatic system)

Frequency not known(cannot be estimated from available data)

•Peripheral inflammation

If you consider any of the side effects you are experiencing to be serious, inform your doctor.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

•Do not use this medication after the expiration date that appears on the packaging and in the aluminum blister pack after CAD. The expiration date is the last day of the month indicated.

•Store at a temperature below 25 °C.

•Do not use any packaging that is damaged or shows signs of having been tampered with.

•Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Fingolimod Accord Composition

• The active ingredient is fingolimod. Each capsule contains 0.5 mg of fingolimod (as hydrochloride).
• The other components are:

• Capsule content: pregelatinized starch and magnesium stearate.
• Capsule coating: 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 package

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

Fingolimod Accord is available in blister packs of 7, 28, or 98 hard capsules.

Single-dose perforated blister packs of PVC/PVDC/aluminum that contain 7 x 1, 28 x 1, and 98 x 1 hard capsules.

It is possible that only some package sizes are marketed in your country.

Marketing Authorization Holder

Accord Healthcare S.L.U.

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

Edifici Est, 6th Floor,

08039 Barcelona,

Spain

Responsible Person

LABORATORI FUNDACIÓ DAU

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

08040 Barcelona, Spain

or

Accord Healthcare Polska Sp. z.o.o.

ul.Lutomierska 50,

95-200, Pabianice,

Poland

or

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

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

EL

Win Medica Pharmaceutical S.A.

Tel: +30 210 7488 821

Last review date of this leaflet: 04/2024

Other sources of information

The detailed information about this medicine is available on the European Medicines Agency website:http://www.ema.europa.eu.