Fingolimod TilloMed: detailed information

Package leaflet: Information for the patient

Fingolimod Tillomed 0.5 mg hard capsules

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine, as 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 they have the same symptoms as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

What Fingolimod Tillomed is
Fingolimod Tillomed contains the active substance fingolimod.
What Fingolimod Tillomed is used for
Fingolimod 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 does not cure MS, but helps reduce the number of relapses and slows 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 covering (called myelin) that surrounds the nerves of the CNS, impairing the nerves' ability to function properly. This process is known as demyelination.
Relapsing-remitting MS is characterized by recurrent attacks (relapses) of neurological symptoms reflecting an inflammatory state of the CNS. Symptoms vary from patient to patient, but usually involve difficulty walking, numbness, vision or balance problems. Symptoms of a relapse may completely disappear once the relapse ends, although some symptoms may persist.
How Fingolimod Tillomed works
Fingolimod helps protect the CNS 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 or spinal cord. This limits nerve damage caused by MS. Fingolimod also reduces certain immune responses of the body.

2. What you need to know before taking Fingolimod Tillomed

Do not take Fingolimod Tillomed:

if you have a reduced immune response (due to an immunodeficiency syndrome, a disease, 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 have a severe ongoing infection or a chronic ongoing 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, or transient ischemic attack (TIA) within the last 6 months, or certain types of heart failure.
if you have certain types of irregular or abnormal heartbeat (arrhythmia), including patients whose electrocardiogram (ECG) shows a prolonged QT interval before starting fingolimod therapy.
if you are currently 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 potential who is not using effective contraception.
if you are allergic to fingolimod or 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 Tillomed.
Warnings and precautions
Talk to your doctor before taking Fingolimod Tillomed:

if you have severe breathing problems during sleep (severe sleep apnea).
if you have been told that you have an abnormal electrocardiogram (ECG).
if you experience symptoms of a slow heart rate (e.g., dizziness, nausea, or palpitations).
if you are currently taking or have recently taken medicines that slow the heart rate, such as beta-blockers, verapamil, diltiazem, ivabradine, digoxin, anticholinesterase agents, 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 visual disturbances 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), eye inflammation or infection (uveitis), or if you have diabetes (which can cause eye problems).
if you have liver problems.
if you have uncontrolled high blood pressure despite medication.
if you have severe lung problems or a smoker's cough. If any of these apply to you or you are unsure, talk to your doctor before taking Fingolimod Tillomed.

Slow heartbeat (bradycardia) or irregular heartbeat
At the beginning of treatment or when switching from the 0.25 mg daily dose to the first 0.5 mg dose, fingolimod 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 symptoms are severe, contact your doctor immediately, as
immediate treatment may be required. Fingolimod may cause an irregular heartbeat, especially after the first dose. The irregular heartbeat usually returns to normal within less than a day. The slow heart rate typically returns to normal within one month. During this period, clinically significant effects on heart rate are not usually expected.

Your doctor will ask you to remain at the clinic or hospital for at least 6 hours after taking the first dose of fingolimod or when switching from the 0.25 mg daily dose to the first 0.5 mg dose. 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 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 decreasing, 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 next morning) until these issues resolve. The same may apply if you restart fingolimod after an interruption, depending on how long the interruption was or how long you had been taking fingolimod 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 conditions or heart failure, fingolimod may not be suitable for you. If you have previously experienced episodes of sudden loss of consciousness or reduced heart rate, fingolimod 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, including monitoring until the next morning.

If you are taking medicines that can reduce heart rate, fingolimod may not be suitable for you. You will be evaluated by a cardiologist who will assess whether you can switch to alternative medicines that do not reduce heart rate, allowing you to start fingolimod therapy. If such a change is not possible, the cardiologist will provide instructions on how to start treatment with fingolimod, including monitoring until the next 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 fingolimod treatment. If so, your doctor will delay the start of fingolimod treatment until one month after completing the full vaccination course.

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

Human papillomavirus (HPV) infection, including warts, dysplasia, condyloma, and HPV-related cancers, has been reported in patients treated with fingolimod. 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 your MS is worsening or notice any new symptoms, such as mood or behavioral changes, 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 talk to 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) may lead to worsening of the condition, including worsening brain function.

Macular edema
Before starting fingolimod treatment, if you have or have had visual disturbances or other signs of swelling in the central area of vision (macula) at the back of the eye, eye inflammation or infection (uveitis), or 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 fingolimod 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 sharply. Fingolimod may cause swelling of the macula, a condition known as macular edema. Swelling usually occurs within the first 4 months of fingolimod treatment.

The risk of macular edema is higher if you have diabetes or have had eye inflammation called uveitis. In these cases, your doctor will want to perform regular checks to detect early signs of macular edema.

If you have previously had macular edema, talk to your doctor before restarting fingolimod treatment.

Macular edema may cause visual symptoms (optic neuritis) that also occur during MS relapses. In the early stages, there may be no symptoms. Make sure to inform your doctor of any changes in vision. Your doctor may ask you to have 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. Fingolimod treatment may affect your liver function. You may not notice any symptoms, but if you experience yellowing of the skin or whites of the eyes, abnormally dark-colored urine (brown), pain on the right side of the stomach area (abdomen), fatigue, unusual lack of appetite, or unexplained nausea and vomiting, inform your doctor immediately.
If you experience any of these symptoms after starting fingolimod treatment, inform your doctor immediately.

Before, during, and after treatment, your doctor will ask you to have blood tests to monitor liver function. If test results indicate a liver problem, fingolimod treatment may need to be stopped.

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

Lung problems
Fingolimod has a mild effect on lung function. Undesirable effects may occur more easily in patients with severe lung problems or a smoker's cough.

Blood count
The intended effect of fingolimod treatment 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. Otherwise, your doctor may not be able to correctly interpret test results, and for certain tests, your doctor may need to draw more blood than usual.

Before starting fingolimod treatment, your doctor will confirm that your white blood cell count is adequate and may ask you to have it checked regularly. If your white blood cell count is too low, fingolimod treatment may need to be stopped.

Reversible posterior encephalopathy syndrome (PRES)
PRES has been rarely reported in patients with MS treated with fingolimod. Symptoms may include sudden onset of severe headache, confusion, seizures, and vision changes. Inform your doctor immediately if any of these symptoms occur during fingolimod treatment, as they may be serious.

Cancer
Skin tumors have been reported in MS patients treated with fingolimod. Contact your doctor immediately if you notice any new skin nodules (e.g., shiny, pearly nodules), spots, or open sores that do 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 fingolimod treatment to check for skin nodules. Your doctor will also perform periodic skin checks during fingolimod treatment. If skin problems occur, your doctor may refer you to a dermatologist, who may recommend regular follow-up examinations.

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

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

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. 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.

Switching from other treatments to fingolimod
Your doctor may switch you directly from interferon-beta, glatiramer acetate, or dimethyl fumarate treatment to fingolimod if there are no signs of abnormalities from 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 fingolimod treatment. For switching from teriflunomide, your doctor may advise waiting for a certain period or performing an accelerated elimination procedure. If you have been treated with alemtuzumab, careful evaluation and discussion with your doctor are needed to determine whether fingolimod is suitable for you.

Women of childbearing potential
Fingolimod may harm the unborn child if used during pregnancy. Before starting fingolimod treatment, your doctor will explain the risks and ask you to take a pregnancy test to ensure you are not pregnant. Your doctor will also give you a reminder card explaining why you must not become pregnant while taking fingolimod and what you should do to avoid pregnancy. 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 treatment
Do not stop taking fingolimod or change your dose without first talking to your doctor.
Inform your doctor immediately if you think your MS is worsening after stopping fingolimod treatment. This may be serious (see “If you stop taking Fingolimod Tillomed” in section 3 and section 4, “Possible side effects”).

Use in the elderly
Experience with fingolimod in elderly patients (over 65 years of age) is limited. If you have any doubts, consult your doctor.

Children and adolescents
Fingolimod Tillomed is not intended for use in children under 10 years of age, as it has not been studied in MS patients 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 fingolimod treatment, your doctor will check your vaccination status. If certain vaccinations have not been received, they may need to be administered before starting fingolimod treatment.
The first time you take fingolimod or when switching from the 0.25 mg daily dose to the 0.5 mg daily dose, 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, inform your doctor.
If you have depression or anxiety or become depressed or anxious during fingolimod treatment, inform your doctor. You may need closer monitoring.

Other medicines and Fingolimod Tillomed
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 Tillomed with these medicines, as this may intensify the effect on the immune system (see also “Do not take Fingolimod Tillomed”).
Corticosteroids, due to possible additive effects on the immune system.
Vaccines. If you need a vaccination, consult your doctor first. During and up to 2 months after fingolimod treatment, 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 if given during this period.
Medicines that slow the heart rate, such as beta-blockers (e.g., atenolol). Concomitant use of fingolimod with these medicines may intensify the effect on heart rate in the first days of fingolimod treatment.
Medicines for irregular heartbeat, such as quinidine, disopyramide, amiodarone, or sotalol. You must not use fingolimod if you are taking these medicines, as they may intensify the effect on irregular heartbeat (see also “Do not take Fingolimod Tillomed”).
Other medicines
- protease inhibitors, anti-infectives such as ketoconazole, azole antifungals, clarithromycin, or telithromycin
- carbamazepine, rifampicin, phenobarbital, phenytoin, efavirenz, or St. John’s wort (potential risk of reduced effectiveness of fingolimod).

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning a pregnancy, ask your doctor for advice before taking this medicine.

Pregnancy
Do not use fingolimod during pregnancy, if you are planning a pregnancy, or if you are a woman of childbearing potential and not using effective contraception. If fingolimod is used during pregnancy, there is a risk of harm to the unborn child. The rate of congenital malformations observed in infants exposed to fingolimod 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 potential:

before starting fingolimod treatment, your doctor will inform you of the risks 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 fingolimod treatment 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 Tillomed.
If you become pregnant while taking Fingolimod Tillomed, inform your doctor immediately. Your doctor will decide to stop treatment (see “If you stop taking Fingolimod Tillomed” in section 3 and section 4, “Possible side effects”). You will also need specialized prenatal monitoring.

Breastfeeding
Do not breastfeed during treatment with Fingolimod Tillomed. Fingolimod 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 drive vehicles, including bicycles, and use machines safely. Fingolimod should not affect your ability to drive or use machines.
However, at the start of treatment, you must remain at your doctor's office or in the hospital for 6 hours after taking the first dose of fingolimod. Your ability to drive and use machines may be impaired during this time and potentially afterward.

3. How to take Fingolimod Tillomed

Treatment with fingolimod will be supervised by a physician experienced in the treatment of multiple sclerosis.
Always take this medicine exactly as instructed 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 is based on body weight:

Children and adolescents with body weight equal to or less than 40 kg: one 0.25 mg capsule daily
Children and adolescents with body weight above 40 kg: one 0.5 mg capsule daily

Children and adolescents who start treatment with one 0.25 mg capsule daily and subsequently reach a stable body weight above 40 kg will be instructed by the doctor to switch to one 0.5 mg capsule daily. In this case, repeating the first-dose observation period is recommended.

Do not exceed the recommended dose.
Fingolimod Tillomed is for oral use.
Take Fingolimod Tillomed once daily with a glass of water. Fingolimod Tillomed capsules must always be swallowed whole, without opening them. Fingolimod Tillomed may be taken with or without food. Taking Fingolimod Tillomed at the same time each day will help you remember to take the medicine.
If you have any doubts about the duration of treatment with Fingolimod Tillomed, consult your doctor or pharmacist.

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

If you forget to take Fingolimod Tillomed
If you have been taking Fingolimod Tillomed 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 observe you when you take the next dose.
If you have been taking Fingolimod Tillomed 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 observe you when you take the next dose. However, if you have missed taking the medicine for up to 2 weeks, you may take the next dose as planned.
Never take a double dose to make up for a forgotten dose.

If you stop taking Fingolimod Tillomed
Do not stop taking fingolimod and do not change the dose without first consulting your doctor.
Fingolimod 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 time, and the side effects described in this leaflet may still occur. After stopping fingolimod treatment, it may be necessary to wait 6–8 weeks before starting a new treatment for MS.
If it is necessary to restart fingolimod after a treatment interruption of more than 2 weeks, the effect on heart rate that normally occurs at the beginning of treatment may occur again: therefore, restarting treatment will require observation in an outpatient clinic or hospital setting. Do not restart fingolimod treatment after an interruption of more than two weeks without consulting your doctor.
Your doctor will decide whether and how monitoring is needed after stopping fingolimod treatment. Inform your doctor immediately if you think your MS is worsening after stopping fingolimod treatment. This could be serious.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

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

Cough with phlegm, chest disorder, fever (signs of lung disorders)
Herpes virus infection (shingles or herpes zoster), 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 heart rate (bradycardia), irregular heartbeat
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 with increased frequency in people with MS and have been reported in paediatric patients treated with fingolimod
Weight loss

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

Pneumonia with symptoms such as fever, cough, difficulty breathing
Macular oedema (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 centre of vision, blurred vision, problems distinguishing colours or details
Reduced platelet count in the blood, 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 colour 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 (PRES). Symptoms may include sudden onset of 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 ulceration, 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)
Tumour associated with human herpesvirus 8 infection (Kaposi’s sarcoma)

Not known (frequency cannot be estimated from the 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
Signs of liver disease (including liver failure), such as yellowing of the skin or the whites of the eyes (jaundice), nausea or vomiting, pain in the right side of the stomach area (abdomen), dark (brown-coloured) urine, unusual loss of appetite, fatigue, and abnormal liver function tests. In a very small 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 occur that you may not personally notice, such as changes in mood or behaviour, memory lapses, language and communication difficulties, which may require further medical evaluation to rule out the risk of PML. Therefore, if you think your MS is worsening, or if you or someone close to you notices any new or unusual symptoms, it is very important that you contact your doctor as soon as possible
Inflammatory disease after stopping treatment with fingolimod (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-coloured or bluish-red nodules, often 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 influence the risk of developing Merkel cell carcinoma
After stopping treatment with fingolimod, MS symptoms may return and possibly worsen compared to before or during treatment
Autoimmune form of anaemia (reduction in red blood cells) where red blood cells are destroyed (autoimmune haemolytic anaemia)

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

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

Influenza virus infection with symptoms such as tiredness, chills, sore throat, joint or muscle pain, fever
Feeling of pressure or pain in the cheeks and forehead (sinusitis)
Headache
Diarrhoea
Back pain
Blood tests showing higher than normal liver enzyme levels
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 light sensitivity (migraine)
Low levels of white blood cells in the blood (lymphocytes, leucocytes)
Weakness
Skin rash with itching, redness, and burning (eczema)
Itching
Increased levels of fats (triglycerides) in the blood
Hair loss
Shortness of breath
Depression
Blurred vision (see also the section on macular oedema “Some side effects may be or become serious”)
Hypertension (fingolimod 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 the available data):

Peripheral swelling

If any of these side effects become severe, contact 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fingolimod Tillomed

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature. Store in the original packaging to protect the medicine from moisture.
Do not dispose of medicines 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 Tillomed contains
The active substance is fingolimod.
Each capsule contains 0.5 mg of fingolimod (as hydrochloride).
The other components are:
Capsule contents: Anhydrous calcium hydrogen phosphate, magnesium stearate.
Capsule shell: Gelatin, titanium dioxide (E171), yellow iron oxide (E172).
Ink: Shellac (E904), propylene glycol (E1520), concentrated ammonia solution (E527), potassium hydroxide (black ink only), black iron oxide (E172) (black ink only).

Description of the appearance of Fingolimod Tillomed and pack contents
Fingolimod Tillomed: 15.8 mm long hard capsule with an opaque bright yellow cap imprinted with HP 334 in black ink and an opaque white body.
Fingolimod Tillomed is available in PVC/PVDC//aluminum split blisters containing 7x21, 28x1, 30x1, 98x1 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Tillomed Italia S.r.l.
Viale G. Richard 1, Tower A
20143 Milan (MI), Italy

Manufacturer
Tillomed Malta Limited,
Malta Life Sciences Park,
LS2.01.06 Industrial Estate,
San Gwann, SGN 3000, Malta

This medicinal product is authorized in EEA member states under the following names:
Country Medicinal Product Name
kova kapseli
hårda kapslar
Ireland: