Fingolimod Towa: detailed information

Patient Information Leaflet

Fingolimod Towa 0.5 mg Hard Capsules

Equivalent Medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

What Fingolimod Towa is
Fingolimod Towa contains the active substance fingolimod.
What Fingolimod Towa is used for
Fingolimod Towa is used in adults and children and adolescents (aged 10 years and older) for the
treatment of relapsing-remitting multiple sclerosis (MS), particularly in:

Patients who have not responded to therapy with a treatment for MS, or
Patients with rapidly evolving severe MS.

Fingolimod Towa does not cure MS, but helps reduce the number of relapses and slows down the
progression of physical disability caused by MS.
What is multiple sclerosis
MS is a chronic disease that affects the central nervous system (CNS), which includes the brain and
spinal cord. In MS, inflammation destroys the protective sheath (called myelin) that surrounds the
nerves in the CNS, preventing the nerves from functioning properly. This process is called
demyelination.
Relapsing-remitting MS is characterized by recurrent attacks (relapses) of neurological symptoms
reflecting an inflammatory state of the central nervous system. Symptoms vary from patient to
patient, but usually include difficulty walking, numbness, vision or balance problems. Symptoms of a
relapse may completely disappear when the relapse ends, but some impairments may persist.
How Fingolimod Towa works
Fingolimod Towa helps protect the nervous system from attacks by the immune system by reducing
the ability of certain white blood cells (lymphocytes) to circulate freely throughout the body, thereby
preventing them from reaching the brain and spinal cord. This limits nerve damage caused by MS.
Fingolimod Towa also reduces some of the body's immune responses.

2. What you should know before taking Fingolimod Towa

Do not take Fingolimod Towa

if you have a reduced immune response (due to an immunodeficiency syndrome, an illness, or medicines that suppress the immune system).
if your doctor suspects you may have a rare brain infection called progressive multifocal leukoencephalopathy (PML) or if PML has been confirmed.
if you currently have a severe infection or a chronic ongoing infection, such as hepatitis or tuberculosis.
if you have active cancer.
if you suffer from severe liver problems.
if you have had a heart attack, angina, stroke, or a warning of a stroke, or certain types of heart failure within the last 6 months.
if you have certain types of irregular or abnormal heartbeat (arrhythmia), including patients whose electrocardiogram (ECG) shows a prolonged QT interval before starting treatment with Fingolimod Towa.
if you are taking or have recently taken medicines for irregular heartbeat, such as quinidine, disopyramide, amiodarone, or sotalol.
if you are pregnant or are a woman of childbearing age who is not using effective contraceptive measures.
if you are allergic to fingolimod or to any of the other ingredients of this medicine (listed in section 6). If any of these apply to you or you are unsure, talk to your doctor before taking Fingolimod Towa.

Warnings and precautions
Talk to your doctor before taking Fingolimod Towa:

if you have severe breathing problems during sleep (severe sleep apnea).
if you have been told you have an abnormal electrocardiogram (ECG).
if you experience symptoms of a slow heart rate (e.g., dizziness, nausea, or palpitations).
if you are taking or have recently taken medicines that slow the heart rate (such as beta-blockers, verapamil, diltiazem, ivabradine, digoxin, anticholinesterase drugs, or pilocarpine).
if you have previously experienced episodes of sudden loss of consciousness or fainting (syncope).
if you intend to get vaccinated.
if you have never had chickenpox.
if you have or have had vision problems or other signs of swelling in the central area of vision (macula) at the back of the eye (a condition known as macular edema, see below), if you have or have had inflammation or infection of the eye (uveitis), or if you have diabetes (which can cause eye problems).
if you have liver problems.
if you suffer from high blood pressure that cannot be controlled with medication.
if you suffer from severe lung problems or if you have a smoker's cough. If any of these apply to you or you are unsure, talk to your doctor before taking Fingolimod Towa.

Slow heart rate (bradycardia) and irregular heartbeat
At the beginning of treatment, or when switching from the daily dose of 0.25 mg to the first dose of 0.5 mg, Fingolimod Towa causes a slowing of the heart rate. As a result, you may experience dizziness or fatigue, awareness of your heartbeat, or a drop in blood pressure. If these effects are severe, contact your doctor immediately, as immediate treatment may be necessary. Fingolimod Towa may also cause an irregular heartbeat, especially after the first dose. Irregular heartbeat usually returns to normal within less than a day. A slow heart rate usually returns to normal within one month. During this period, 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 after taking the first dose of Fingolimod Towa or when switching from the daily dose of 0.25 mg to the first dose of 0.5 mg. During this time, your pulse and blood pressure will be monitored hourly so that appropriate measures can be taken if any adverse effects occur at the start of treatment. You must have an electrocardiogram (ECG) performed before taking the first dose of Fingolimod Towa and again at the end of the 6-hour monitoring period. Your doctor may continuously monitor your ECG during this time. If, after 6 hours, your heart rate is very low or continues to decrease, or if your ECG shows abnormalities, you may need to remain under observation for a longer period (at least an additional 2 hours, and possibly until the following morning), until these issues resolve. The same may apply if you restart Fingolimod Towa after an interruption of treatment, depending on how long the interruption was and how long you had been taking Fingolimod Towa before the interruption.
If you have or are at risk of having an irregular or abnormal heartbeat, if your ECG is abnormal, or if you have heart problems or heart failure, Fingolimod Towa may not be suitable for you.
If you have previously experienced episodes of sudden loss of consciousness or reduced heart rate, Fingolimod Towa may not be suitable for you. You will be evaluated by a cardiologist (a heart specialist) who will advise you on how to start treatment with Fingolimod Towa, including monitoring until the following morning.
If you are taking medicines that can reduce heart rate, Fingolimod Towa may not be suitable for you. You will be evaluated by a cardiologist who will determine whether you can switch to alternative medicines that do not reduce heart rate, allowing you to start treatment with Fingolimod Towa. If such a change in therapy is not possible, the cardiologist will advise you on how to start treatment with Fingolimod Towa, including monitoring until the following morning.

If you have never had chickenpox
If you have never had chickenpox, your doctor will check your immunity against the virus that causes it (varicella zoster virus). If you are not protected against the virus, vaccination may be required before starting treatment with Fingolimod Towa. If this applies to you, your doctor will delay the start of treatment with Fingolimod Towa until one month after completing the full vaccination course.

Infections
Fingolimod Towa reduces the number of white blood cells (particularly lymphocytes). White blood cells fight infections. While taking Fingolimod Towa (and up to 2 months after stopping treatment), you may be more susceptible to infections. Any existing infection may worsen. Infections can be serious and life-threatening.
If you think you have an infection, have a fever, flu-like symptoms, herpes zoster, or have a headache accompanied by neck stiffness, sensitivity to light, nausea, rash, and/or confusion or seizures (these may be symptoms of meningitis and/or encephalitis caused by a fungal or viral herpes infection), contact your doctor immediately, as this could be serious and life-threatening.

In patients treated with Fingolimod Towa, human papillomavirus (HPV) infection has been reported, including papillomas, dysplasia, condylomas, and HPV-related cancers. Your doctor will assess whether you need HPV vaccination before starting treatment. If you are a woman, your doctor will also recommend HPV screening.

PML
PML is a rare brain disease caused by an infection that can lead to severe disability or death. Your doctor will schedule magnetic resonance imaging (MRI) scans before starting treatment and during treatment to monitor the risk of PML.
If you feel that your multiple sclerosis (MS) is worsening or if you notice any new symptoms, such as changes in mood or behavior, new or worsening weakness on one side of the body, changes in vision, confusion, memory lapses, or language and communication difficulties, speak to your doctor as soon as possible. These may be symptoms of PML. Also speak with your partner or caregiver and inform them about your treatment. They may notice symptoms you might not recognize yourself.
If you develop PML, it can be treated, and fingolimod treatment will be stopped. Some people experience an inflammatory reaction when fingolimod is cleared from the body. This reaction (known as immune reconstitution inflammatory syndrome or IRIS) can lead to worsening of the condition, including worsening brain function.

Macular edema
Before starting treatment with Fingolimod Towa, if you have or have had vision problems or other signs of swelling in the central area of vision (macula) at the back of the eye, if you have or have had inflammation or infection of the eye (uveitis), or if you have diabetes, your doctor may ask you to undergo an eye examination.
Your doctor may ask you to have an eye examination 3–4 months after starting treatment with Fingolimod Towa.
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. Fingolimod Towa can cause swelling of the macula, a condition known as macular edema. Swelling usually occurs within the first 4 months of treatment with Fingolimod Towa.
The risk of macular edema is higher if you have diabetes or if you have had an eye inflammation called uveitis. In such cases, your doctor may want to perform regular checks to detect early signs of macular edema.
If you have previously experienced macular edema, talk to your doctor before restarting treatment with Fingolimod Towa.
Macular edema can cause some of the visual symptoms (optic neuritis) that also occur during MS attacks. In the early stages, there may be no symptoms. Be sure to inform your doctor of any changes in vision. Your doctor may ask you to undergo an eye examination, especially if:

the central area of vision is blurred or has shadows;
a blind spot develops in the central area of vision;
you have difficulty distinguishing colors or fine details.

Liver function tests
If you have severe liver problems, you must not take Fingolimod Towa. Treatment with Fingolimod Towa may affect your liver function. You may not notice any symptoms, but if you notice yellowing of the skin or the whites of the eyes, unusually dark urine (brown-colored), pain on the right side of the stomach area (abdomen), fatigue, unusual loss of appetite, or unexplained nausea and vomiting, contact your doctor immediately.
If you experience any of these symptoms after starting treatment with Fingolimod Towa, contact your doctor immediately.
Before, during, and after treatment, your doctor will ask you to have blood tests to check your liver function. If the results indicate a liver problem, treatment with Fingolimod Towa may need to be stopped.

High blood pressure
Since Fingolimod Towa causes a slight increase in blood pressure, your doctor may monitor your blood pressure regularly.

Lung problems
Fingolimod Towa has a mild effect on lung function. Patients with severe lung problems or a smoker's cough may be more likely to experience adverse effects.

Blood count
The intended effect of treatment with Fingolimod Towa is to reduce the number of white blood cells in the blood. These usually return to normal levels within 2 months after stopping treatment. If you need blood tests, inform your doctor that you are taking Fingolimod Towa. Otherwise, your doctor may not be able to correctly interpret the test results, and for certain types of tests, your doctor may need to draw more blood than usual.
Before starting treatment with Fingolimod Towa, your doctor will confirm whether your white blood cell count is sufficient and may ask you to have regular blood counts. If your white blood cell count is too low, treatment with Fingolimod Towa may need to be stopped.

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

Cancer
Skin tumors have been reported in patients with MS treated with Fingolimod Towa. Contact your doctor immediately if you notice the appearance of any skin nodule (e.g., shiny, pearly nodule), spot, or open sore that does not heal within a few weeks. Symptoms of skin cancer may include unusual growths or changes in the skin (e.g., unusual moles) with changes in color, thickness, or size over time. A skin examination is required before starting treatment with Fingolimod Towa to check for skin nodules. Your doctor will also perform periodic skin checks during treatment with Fingolimod Towa. If skin problems occur, your doctor may refer you to a dermatologist who, after examination, may decide it is important for you to have regular check-ups.
A type of cancer of the lymphatic system (lymphoma) has been reported in patients with MS treated with Fingolimod Towa.

Sun exposure and sun protection
Fingolimod weakens your immune system. This increases the risk of developing tumors, particularly skin tumors. You should limit exposure to sunlight and UV rays:

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

Unusual brain lesions associated with an MS relapse
Rare cases of unusually large brain lesions associated with an MS relapse have been reported in patients treated with Fingolimod Towa. In case of a severe relapse, your doctor will assess whether an MRI is needed to evaluate this condition and decide whether you should stop taking Fingolimod Towa.

Switching from other treatments to Fingolimod Towa
Your doctor may switch you directly from treatment with interferon-beta, glatiramer acetate, or dimethyl fumarate to Fingolimod Towa if there are no signs of abnormalities caused by the previous treatment. Your doctor may perform a blood test to rule out such abnormalities.
After stopping natalizumab, you may need to wait 2–3 months before starting treatment with Fingolimod Towa. For switching from teriflunomide, your doctor may advise you to wait for a certain period or proceed with an accelerated elimination procedure. If you have been treated with alemtuzumab, careful evaluation and discussion with your doctor are needed to determine whether Fingolimod Towa is suitable for you.

Women of childbearing age
Fingolimod Towa may harm the unborn child if used during pregnancy. Before starting treatment with Fingolimod Towa, your doctor will explain the risks and ask you to take a pregnancy test to ensure you are not pregnant. Your doctor will give you a reminder card explaining why you must not become pregnant while taking Fingolimod Towa. It also explains what you must do to avoid pregnancy while taking Fingolimod Towa. You must use effective contraception during treatment and for 2 months after stopping treatment (see section “Pregnancy and breastfeeding”).

Worsening of MS after stopping Fingolimod Towa treatment
Do not stop taking Fingolimod Towa or change your dose without first talking to your doctor.
Inform your doctor immediately if you think your multiple sclerosis is worsening after stopping treatment with Fingolimod Towa. This can be serious (see “If you stop taking Fingolimod Towa” in section 3 and also section 4, “Possible side effects”).

Use in elderly patients
Experience with Fingolimod Towa in patients over 65 years of age is limited. If you have any doubts, consult your doctor.

Children and adolescents
Fingolimod Towa is not intended for use in children under 10 years of age, as it has not been studied in patients with MS in this age group.
The warnings and precautions listed above also apply to children and adolescents. The following information is particularly important for children, adolescents, and their caregivers:

Before starting treatment with Fingolimod Towa, your doctor will check your vaccination status. If you have not received certain vaccinations, they may need to be administered before starting treatment with Fingolimod Towa.
The first time you take Fingolimod Towa or when switching from the daily dose of 0.25 mg to the daily dose of 0.5 mg, your doctor will monitor your heart rate and heartbeat (see above “slow heart rate (bradycardia) and irregular heartbeat”).
If you experience seizures or epileptic fits before or while taking Fingolimod Towa, inform your doctor.
If you suffer from depression or anxiety, or if you become depressed or anxious during treatment with Fingolimod Towa, inform your doctor. You may need to be monitored more closely.

Other medicines and Fingolimod Towa
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Inform your doctor if you are taking any of the following medicines:

Medicines that suppress or modify the immune system, including other medicines used to treat MS, such as interferon beta, glatiramer acetate, natalizumab, mitoxantrone, teriflunomide, dimethyl fumarate, or alemtuzumab. You must not use Fingolimod Towa with these medicines, as this may intensify the effect on the immune system (see also “Do not take Fingolimod Towa”).
Corticosteroids, due to a possible additive effect on the immune system.
Vaccines. If you need to be vaccinated, consult your doctor first. During and up to 2 months after treatment with Fingolimod Towa, you must not receive certain types of vaccines (live attenuated vaccines), as they may trigger the infection they are meant to prevent. Other vaccines may not work as well as usual if administered during this period.
Medicines that slow the heart rate (such as beta-blockers, e.g., atenolol). Concomitant use of Fingolimod Towa with these medicines may intensify the effect on heart rate in the first days of treatment with Fingolimod Towa.
Medicines for irregular heartbeat, such as quinidine, disopyramide, amiodarone, or sotalol. You must not use Fingolimod Towa if you are taking these medicines, as they may intensify the effect on irregular heartbeat (see also “Do not take Fingolimod Towa”).
Other medicines: protease inhibitors, anti-infectives such as ketoconazole, azole antifungals, clarithromycin, or telithromycin; or carbamazepine, rifampicin, phenobarbital, phenytoin, efavirenz, or St. John’s wort (potential risk of reduced effectiveness of Fingolimod Towa).

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine.

Pregnancy
Do not use Fingolimod Towa during pregnancy, if you are planning a pregnancy, or if you are a woman of childbearing age not using effective contraceptive measures. If Fingolimod Towa is used during pregnancy, there is a risk of harm to the unborn child. The rate of congenital malformations observed in newborns exposed to Fingolimod Towa during pregnancy is about twice the rate observed in the general population (in which the rate of congenital malformations is approximately 2–3%). The most frequently reported malformations include cardiac, renal, and musculoskeletal malformations.
Therefore, if you are a woman of childbearing age:

before starting treatment with Fingolimod Towa, your doctor will inform you of the risk to the unborn child and ask you to take a pregnancy test to ensure you are not pregnant, and
you must use effective contraception during treatment with Fingolimod Towa and for two months after stopping treatment to avoid pregnancy. Discuss reliable contraceptive methods with your doctor.

Your doctor will give you a reminder card explaining why you must not become pregnant while taking Fingolimod Towa.
If you become pregnant while taking Fingolimod Towa, inform your doctor immediately. Your doctor will decide to stop treatment (see “If you stop taking Fingolimod Towa” in section 3 and also section 4, “Possible side effects”). You will also need specialized prenatal monitoring.

Breastfeeding
Do not breastfeed while taking Fingolimod Towa. Fingolimod Towa is excreted in breast milk and may cause serious adverse effects in the newborn.

Driving and using machines
Your doctor will advise you whether your condition allows you to safely drive vehicles, including bicycles, and use machinery. Fingolimod Towa should not affect your ability to drive or use machinery.
However, at the beginning of treatment, you must remain at your doctor’s office or in hospital for 6 hours after taking the first dose of Fingolimod Towa. Your ability to drive and use machinery may be impaired during this time and potentially afterwards.

3. How to take Fingolimod Towa

Treatment with Fingolimod Towa will be supervised by a physician experienced in the treatment of multiple sclerosis.
Always take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor.

Recommended dose:
Adults:
The dose is one 0.5 mg capsule once daily.
Children and adolescents (aged 10 years and older):
The dose depends on body weight:

Children and adolescents with body weight above 40 kg: one 0.5 mg capsule daily.

Fingolimod Towa 0.5 mg hard capsules are not suitable for pediatric patients with body weight equal to or below 40 kg.
Other medicinal products containing fingolimod are available at a lower dosage (e.g., 0.25 mg capsules).
Do not exceed the recommended dose.
Fingolimod Towa is for oral use.
Take Fingolimod Towa once daily with a glass of water. The capsules must always be swallowed whole, without opening them. Fingolimod Towa may be taken with or without food.
Taking Fingolimod Towa at the same time each day will help you remember to take your medicine.
If you have any doubts about how long to continue treatment with Fingolimod Towa, consult your doctor or pharmacist.

If you take more Fingolimod Towa than you should
If you have taken too many Fingolimod Towa capsules, inform your doctor immediately.

If you forget to take Fingolimod Towa
If you have been taking Fingolimod Towa for less than 1 month and miss a dose for a full day, contact your doctor before taking the next dose. Your doctor may decide to monitor you when you take the next dose.
If you have been taking Fingolimod Towa for at least 1 month and have missed taking the medicine for more than 2 weeks, contact your doctor before taking the next dose. Your doctor may decide to monitor you when you take the next dose. However, if you have missed taking the medicine for 2 weeks or less, you may take the next dose as scheduled.
Never take a double dose to make up for a forgotten dose.

If you stop taking Fingolimod Towa
Do not stop taking Fingolimod Towa or change the dose without first consulting your doctor.
Fingolimod Towa will remain in your body for up to 2 months after stopping treatment. The number of white blood cells (lymphocytes) may remain low during this period, and the side effects described in this leaflet may still occur. After stopping treatment with Fingolimod Towa, it may be necessary to wait 6–8 weeks before starting a new treatment for multiple sclerosis.
If restarting Fingolimod Towa after a treatment interruption of more than 2 weeks, the effect on heart rate that normally occurs at the beginning of treatment may reappear: therefore, restarting treatment will require observation in an outpatient clinic or hospital setting. Do not restart treatment with Fingolimod Towa after an interruption of more than two weeks without consulting your doctor.
Your doctor will decide whether and how monitoring is needed after stopping treatment with Fingolimod Towa. Inform your doctor immediately if you suspect a worsening of multiple sclerosis after stopping treatment with Fingolimod Towa. This may be serious.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Some side effects may be or become serious.

Common (may affect up to 1 in 10 people)

Cough with phlegm, chest discomfort, fever (signs of lung disorders)
Herpes virus infection (cold sores or shingles), with symptoms such as blisters, burning, itching or pain on the skin, usually on the upper body or face. Other symptoms may include fever and weakness in the early stages of infection, followed by numbness, itching or red spots with severe pain
Slow heartbeat (bradycardia), irregular heart rhythm
A type of skin cancer called basal cell carcinoma (BCC), which often appears as a pearly nodule, although it may also have other appearances
Depression and anxiety are known to occur more frequently in people with MS and have been reported in pediatric patients treated with Fingolimod Towa
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 blind spots in the center of vision, blurred vision, problems distinguishing colors or details
Reduction in 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 change in size, shape, thickness or color over time, or new moles. Moles may itch, bleed or ulcerate
Seizures, epileptic 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 onset of severe headache, confusion, seizures and/or vision 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, an ulcerated lesion with a crust, or a new ulceration on a pre-existing scar

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

Abnormal electrocardiogram (ECG) finding (T-wave inversion)
Tumor associated with human herpes virus 8 infection (Kaposi’s sarcoma)

Not known (frequency cannot be estimated from available data)

Allergic reactions, including symptoms such as skin rash or hives, swelling of the lips, tongue or face, which are more likely to occur on the first day of treatment with Fingolimod Towa
Signs of liver disease (including liver failure), such as yellowing of the skin or whites of the eyes (jaundice), nausea or vomiting, pain in the right side of the stomach area (abdomen), dark urine (brown-colored), unusual loss of appetite, fatigue, and abnormal liver function tests. In a very limited number of cases, liver failure may lead to liver transplantation
Risk of developing a rare brain infection called progressive multifocal leukoencephalopathy (PML). Symptoms of PML may resemble an MS relapse. Other symptoms may go unnoticed by the patient, such as changes in mood or behavior, memory lapses, language and communication difficulties, which may require further medical evaluation to rule out PML. Therefore, if you feel your MS is worsening, or if you or someone close to you notices any new or unusual symptoms, it is very important to contact your doctor as soon as possible
Inflammatory disease after discontinuation of Fingolimod Towa treatment (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, light sensitivity, nausea and/or confusion
Merkel cell carcinoma (a type of skin cancer). Possible signs of Merkel cell carcinoma include painless flesh-colored or bluish-red nodules, often on the face, head or neck. Merkel cell carcinoma may also present as a hard, painless nodule or mass. Long-term sun exposure and a weakened immune system may influence the risk of developing Merkel cell carcinoma
After stopping treatment with Fingolimod Towa, MS symptoms may reappear and may possibly worsen compared to their state before or during treatment
Autoimmune form of anemia (reduction in red blood cells) where red blood cells are destroyed (autoimmune hemolytic anemia)

If you experience any of these side effects, 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
Feeling of pressure or pain in the cheeks and forehead (sinusitis)
Headache
Diarrhea
Back pain
Blood tests showing higher levels of liver enzymes
Cough

Common (may affect up to 1 in 10 people)

Ringworm, a fungal skin infection (pityriasis versicolor)
Dizziness
Severe headache often accompanied by nausea, vomiting and sensitivity to light (migraine)
Low levels of white blood cells in the blood (lymphocytes, leukocytes)
Weakness
Skin rash with itching, redness and burning (eczema)
Itching
Increased levels of fat (triglycerides) in the blood
Hair loss
Shortness of breath
Depression
Blurred vision (see also the section on macular edema “Possible side effects may be or become serious”)
Hypertension (Fingolimod Towa 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 in the blood (neutrophils)
Depressed mood
Nausea

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

Cancer of the lymphatic system (lymphoma)

Not known (frequency cannot be estimated from available data)

Peripheral swelling

If any of these side effects become severe, inform your doctor.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

5. How to store Fingolimod Towa

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 carton, blister and bottle after
Exp. The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not use packages that are damaged or show signs of tampering.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Fingolimod Towa contains

The active substance is fingolimod.
Each hard capsule contains 0.5 mg of fingolimod (as hydrochloride).
The other components are: Capsule contents: pregelatinized starch, talc, magnesium stearate. Capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172). Printing ink: lacquer, propylene glycol, potassium hydroxide, black iron oxide (E172).

Description of the appearance of Fingolimod Towa and package contents
Fingolimod Towa 0.5 mg hard capsules have an opaque white body with a black "FI05" imprint, and an opaque yellow cap.
Pack sizes containing 7, 14, 28, 84 or 98 hard capsules in PVC-PVDC/aluminum blisters.
Pack sizes containing 30, 50, 60, 90 or 100 hard capsules in HDPE bottles with child-resistant cap (PP).
Not all pack sizes may be marketed.

Marketing Authorization Holder
TOWA PHARMACEUTICAL S.p.A.
Via Enrico Tazzoli, 6 - 20154 Milan, Italy

Manufacturer
TOWA Pharmaceutical Europe, S.L.
C/ de Sant Martí, 75-97, Martorelles, 08107 Barcelona, Spain