Fingolimod teva: detailed information

Package leaflet: Information for the user

Fingolimod Teva, 0.25 mg, hard capsules
Fingolimod Teva, 0.5 mg, hard capsules
Fingolimodum
Please read all of 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 further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific person. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you get any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

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

1. What Fingolimod Teva is and what it is used for
What Fingolimod Teva is
The active substance in Fingolimod Teva is fingolimod.
What Fingolimod Teva is used for
Fingolimod Teva is used in adults and children and adolescents (aged 10 years and older) for the
treatment of relapsing-remitting multiple sclerosis (MS, Latin: Sclerosis multiplex), particularly in:

patients who have not responded to MS treatment

patients who have rapidly evolving, severe MS.

Fingolimod Teva does not cure MS, but helps reduce the number of relapses and slows the
progression of disability caused by MS.
What is multiple sclerosis
MS is a chronic disease of the central nervous system (CNS), which consists of the brain and
spinal cord. In MS, the inflammatory process damages the nerve sheaths (called myelin) in the
CNS, preventing nerves from functioning properly. This phenomenon is called demyelination.
Relapsing-remitting MS is characterised by repeated relapses (recurrences) of neurological
symptoms, reflecting inflammatory activity in the CNS. Symptoms vary between patients but
typically include walking difficulties, numbness, vision or balance problems. Symptoms of relapses
may completely resolve, but some impairments may persist.
How Fingolimod Teva works
Fingolimod Teva helps protect the CNS from immune system attacks by reducing the ability of
certain white blood cells (lymphocytes) to move freely throughout the body and by preventing them
from entering the brain and spinal cord. In this way, the medicine limits nerve damage caused by
MS. Fingolimod Teva also reduces some of the body's immune responses.

2. What you need to know before taking Fingolimod Teva

Do not take Fingolimod Teva

if you have a weakened immune response (due to immunodeficiency syndrome, disease, or taking medicines that suppress the immune system);
if your doctor suspects you have a rare brain infection called progressive multifocal leukoencephalopathy (PML), or if you have been diagnosed with PML;
if you have severe active infection or chronic active infection, such as hepatitis or tuberculosis;
if you have active cancer;
if you have severe liver disease;
if you have had a heart attack, angina, stroke, or stroke warning signs, or certain types of heart failure within the last 6 months;
if you have a certain type of irregular or abnormal heartbeat (arrhythmia), including patients whose electrocardiogram (ECG) showed QT interval prolongation before starting treatment with Fingolimod Teva;
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 of childbearing age and are not using effective contraception;
if you are allergic to fingolimod or any of the other ingredients of this medicine (listed in section 6). If this applies or you are unsure, please tell your doctor before taking Fingolimod Teva.

Warnings and precautions
Before starting Fingolimod Teva, discuss with your doctor:

if you have severe breathing problems during sleep (sleep apnoea);
if you have been told your ECG recording is abnormal;
if you have symptoms of slow heartbeat (e.g. dizziness, nausea, or palpitations);
if you are taking or have recently taken medicines that slow heart rate (such as beta-blockers, verapamil, diltiazem, ivabradine, digoxin, cholinesterase inhibitors, or pilocarpine);
if you have previously experienced sudden loss of consciousness or fainting;
if you plan to be vaccinated;
if you have never had chickenpox;
if you have or have had vision problems or other symptoms of swelling in the centre of your visual field (macula) at the back of the eye (a condition called macular oedema, see below), inflammation or infection of the eye (uveitis), or if you have diabetes (which may cause vision problems);
if you have liver problems;
if you have high blood pressure that cannot be controlled with medication;
if you have severe lung disease or a smoker's cough. If any of these apply or you are unsure, please tell your doctor before taking Fingolimod Teva.

Slow heartbeat (bradycardia) and irregular heartbeat
At the beginning of treatment or after the first dose of 0.5 mg in patients previously taking a daily
dose of 0.25 mg, Fingolimod Teva slows the heart rate. As a result, you may feel dizzy or tired,
experience palpitations, or have low blood pressure. If these symptoms are severe, tell your doctor,
as immediate treatment may be needed. Fingolimod Teva may also cause irregular heartbeat,
especially after the first dose. Irregular heartbeat usually returns to normal within less than one day.
Slow heartbeat usually returns to normal within one month. During this period, no clinically
significant effect on heart rate is expected.
Your doctor will ask you to stay in the doctor's office or clinic for at least 6 hours after taking the
first dose of Fingolimod Teva or the first 0.5 mg dose when switching from a daily dose of 0.25 mg,
with hourly monitoring of your pulse and blood pressure, so that appropriate treatment can be given
if any side effects occur at the start of treatment. An ECG will be performed before the first dose of
Fingolimod Teva and after the 6-hour observation period. During this time, your doctor may perform
continuous monitoring of your heart function with an electrocardiogram. If, after 6 hours of
observation, you have a very slow or decreasing heart rate or if your ECG shows abnormalities,
longer monitoring (for at least 2 additional hours or possibly until the next day) may be needed until
these symptoms resolve. The same procedure may be recommended if you restart Fingolimod Teva
after a treatment break, depending on the duration of the break and how long you had been taking
Fingolimod Teva before the break.
If you have irregular or abnormal heartbeat, risk factors for such events, abnormal ECG, heart
disease, or heart failure, Fingolimod Teva may not be suitable for you.
If you have a history of sudden loss of consciousness or slow heart function, Fingolimod Teva may
not be suitable. You may need to consult a cardiologist (a heart specialist) who will advise on how
to start treatment with Fingolimod Teva, including overnight monitoring.
If you are taking medicines that may reduce heart rate, Fingolimod Teva may not be suitable. You
may need to consult a cardiologist, who will check whether you can switch to other medicines that
do not reduce heart rate, to allow treatment with Fingolimod Teva. If such a change is not possible,
the cardiologist will advise you on how to start treatment with Fingolimod Teva, including
monitoring until the day after the first dose of Fingolimod Teva.
Patients who have never had chickenpox
If you have never had chickenpox, your doctor will check your immunity to varicella-zoster virus
(infection causing chickenpox and shingles). If you are not protected against the virus, you may
need vaccination before starting Fingolimod Teva. If this applies, your doctor will delay the start of
Fingolimod Teva treatment by one month after completing the full vaccination course.
Infections
Fingolimod Teva reduces the number of white blood cells (especially lymphocytes). White blood
cells fight infections. While taking Fingolimod Teva (and for up to 2 months after stopping
treatment), you may be more susceptible to infections. Existing infections may worsen. Infections
may be severe and life-threatening. If you suspect you have an infection, have a fever, flu-like
symptoms, shingles, or a headache with neck stiffness, light sensitivity, nausea, rash, and/or
confusion or seizures (which may be symptoms of meningitis and/or encephalitis caused by fungal
or herpes virus infections), contact your doctor immediately, as this condition may be severe and
life-threatening.
Infections with human papillomavirus (HPV) have been reported in patients treated with
Fingolimod Teva, including cases of warts, dysplasia, warts, and HPV-related malignant tumours.
Your doctor will consider whether you need HPV vaccination before starting treatment. In women,
your doctor will also recommend HPV screening tests.
PML
PML is a rare brain disorder caused by infection that may lead to severe disability or death. Your
doctor will order magnetic resonance imaging (MRI) scans before and during treatment to monitor
PML risk.
If you feel your MS is worsening or you notice new symptoms, such as mood or behaviour changes,
new weakness or worsening of existing weakness on one side of the body, vision changes,
confusion, temporary memory lapses, or speech and communication difficulties, talk to your doctor
as soon as possible. These may be symptoms of PML. You should also talk to your partner or
caregivers and inform them about your treatment. Symptoms may occur that you are not aware of.
If you develop PML, it can be treated, and treatment with Gilenya will be stopped. In some patients,
an inflammatory reaction may occur after Gilenya is removed from the body. This reaction (called
immune reconstitution inflammatory syndrome, IRIS) may lead to worsening of your condition,
including worsening brain function.
Macular oedema
Before starting Fingolimod Teva, your doctor may refer you for ophthalmological examination if
you currently have or have previously had vision problems or other symptoms of swelling in the
centre of your visual field (macula) at the back of the eye, eye inflammation or infection (uveitis),
or diabetes.
Your doctor may refer you for ophthalmological examination 3 to 4 months after starting
Fingolimod Teva treatment.
The macula is a small area of the retina at the back of the eye that enables clear, sharp vision of
shapes, colours, and other details. Fingolimod Teva may cause swelling of the macula, a condition
called macular oedema. This usually occurs within the first 4 months of Fingolimod Teva treatment.
The risk of macular oedema is higher in patients with diabetes or a history of uveitis. In such
cases, your doctor will order regular ophthalmological examinations to detect macular oedema.
If you have had macular oedema, tell your doctor before restarting Fingolimod Teva treatment.
Macular oedema may cause vision disturbances similar to those during an MS attack (optic
neuritis). In early stages, symptoms may be absent. Report any vision changes to your doctor. Your
doctor may refer you for ophthalmological examination, especially if:

the centre of your visual field becomes blurry or shadowed;
a gap appears in the centre of your visual field;
you have difficulty seeing colours or fine details.

Liver function tests
Patients with severe liver disease should not take Fingolimod Teva. Fingolimod Teva may affect
liver function test results. You may not feel any symptoms, but if you develop yellowing of the skin
or whites of the eyes, abnormal (brown) urine colour, pain in the right side of the abdomen, fatigue,
reduced appetite, or unexplained nausea and vomiting, tell your doctor immediately.
If any of these symptoms occur after starting Fingolimod Teva treatment, tell your doctor immediately.
Before, during, and after treatment, your doctor will order blood tests to monitor liver function. If
test results indicate liver function abnormalities, treatment with Fingolimod Teva may be stopped.
High blood pressure
Your doctor may regularly check your blood pressure, as Fingolimod Teva causes a slight increase
in blood pressure.
Lung problems
Fingolimod Teva has a minor effect on lung function. Patients with severe lung disease or a
smoker's cough are at higher risk of side effects.
Blood cell count
A known effect of Fingolimod Teva is a reduction in white blood cells in the blood. Their number
usually returns to normal within 2 months after stopping treatment. For blood tests, inform your
doctor that you are taking Fingolimod Teva. Otherwise, your doctor may not interpret blood test
results correctly, and for certain tests, your doctor may order a larger blood sample than usual.
Before starting Fingolimod Teva, your doctor will confirm that your white blood cell count is
appropriate to start treatment and may order regular repeat tests. If there are not enough white blood
cells, treatment with Fingolimod Teva 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 MS patients treated with Fingolimod Teva. Symptoms may include sudden severe
headache, confusion, seizures, and vision changes. If you experience any of these symptoms during
Fingolimod Teva treatment, tell your doctor immediately, as this condition may be serious.
Cancer
Skin cancers have been reported in MS patients treated with Fingolimod Teva. If you notice any
lumps on your skin (e.g. shiny, pearly lumps), spots, or open sores that do not heal within a few
weeks, tell your doctor immediately. Skin cancer symptoms may include abnormal growths or
changes in skin tissue (e.g. new moles) that change in colour, shape, or size over time. Before
starting Fingolimod Teva treatment, a skin examination should be performed to check for any
lumps on the skin. Your doctor will also perform regular skin checks during Fingolimod Teva
treatment. If skin problems occur, your doctor may refer you to a dermatologist, who may decide,
after consultation, that regular visits are needed.
Cases of a certain type of lymphatic system cancer (lymphoma) have been reported in MS patients
treated with fingolimod.
Sun exposure and sun protection
Fingolimod weakens the immune system. This increases the risk of malignant tumours, especially
skin cancers. You should limit sun and UV radiation exposure by:

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

Unusual brain changes associated with MS relapse
Rare cases of unusually large brain lesions associated with MS relapse have been reported in
patients treated with fingolimod. In case of a severe MS relapse, your doctor may consider an MRI
scan to assess this condition and decide whether to discontinue Fingolimod Teva.
Switching from other medicines to Fingolimod Teva
Your doctor may switch treatment directly from interferon-beta, glatiramer acetate, or dimethyl
fumarate to Fingolimod Teva if there are no signs of abnormalities caused by previous treatment.
Your doctor may order blood tests to rule out such abnormalities. After stopping natalizumab, a 2-
to 3-month waiting period may be needed before starting Fingolimod Teva. When switching from
teriflunomide, your doctor may advise waiting a certain time or undergoing an accelerated drug
elimination procedure. Patients previously treated with alemtuzumab require careful assessment and
discussion with their doctor before deciding whether Fingolimod Teva is suitable.
Women of childbearing potential
If Fingolimod Teva is used during pregnancy, it may harm the unborn child. Before starting
Fingolimod Teva treatment, your doctor will explain the risks and ask you to take a pregnancy test
to rule out pregnancy.
Your doctor will give you a card explaining why you should not become pregnant while taking
Fingolimod Teva. The card also contains information on how to avoid pregnancy while taking
Fingolimod Teva. 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 Teva treatment
Do not stop taking Fingolimod Teva or change the dose without first consulting your doctor.
Tell your doctor immediately if you feel your MS is worsening after stopping Fingolimod Teva
treatment. This situation may be serious (see "Stopping Fingolimod Teva" in section 3 and section 4
"Possible side effects").
Elderly patients
Experience with fingolimod in elderly patients (over 65 years) is limited. If in doubt, consult your
doctor.
Children and adolescents
Fingolimod Teva 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. Particularly
important information for children and adolescents and their caregivers includes:

Before starting Fingolimod Teva treatment, your doctor will check your vaccination status. If you have not received certain vaccinations, vaccination may be needed before starting Fingolimod Teva.
During the first dose of Fingolimod Teva or when changing the daily dose from 0.25 mg to 0.5 mg, your doctor will monitor your heart rate and pulse (see "Slow heartbeat (bradycardia) and irregular heartbeat" above).
If you have seizures or epileptic fits before or during Fingolimod Teva treatment, tell your doctor.
If you develop depression or anxiety, or feel low mood or anxiety during Fingolimod Teva treatment, tell your doctor. You may need closer monitoring.

Fingolimod Teva with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken,
and any you plan to take:
Tell your doctor if you are taking the following medicines:

Medicines that suppress or modulate the immune system, including other medicines used to treat MS, such as interferon beta, glatiramer acetate, natalizumab, mitoxantrone, teriflunomide, dimethyl fumarate, or alemtuzumab. Do not take Fingolimod Teva with these medicines, as this could intensify effects on the immune system (see also "Do not take Fingolimod Teva").
Corticosteroids, due to possible additive effects on the immune system.
Vaccines. If you need vaccination, consult your doctor first. During and for 2 months after Fingolimod Teva treatment, patients should not receive certain types of vaccines (live attenuated vaccines), as they could cause the infection they are meant to prevent. Other vaccines may also be ineffective if given during this period.
Medicines that slow heart function (e.g. beta-blockers such as atenolol). Taking Fingolimod Teva with these medicines could intensify effects on heart function in the first days of Fingolimod Teva treatment.
Medicines for irregular heartbeat, such as quinidine, disopyramide, amiodarone, or sotalol. Do not take Fingolimod Teva if you are taking these medicines, as it could intensify effects on irregular heartbeat (see also "Do not take Fingolimod Teva").
Other medicines: o protease inhibitors, antiviral medicines such as ketoconazole, azole antifungals, clarithromycin, or telithromycin. o carbamazepine, rifampicin, phenobarbital, phenytoin, efavirenz, or St John's wort products (possible risk of reduced Fingolimod Teva effectiveness).

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your
doctor before taking this medicine.
Pregnancy
Fingolimod Teva should not be used during pregnancy, if you are trying to become pregnant, or if
you may become pregnant and are not using effective contraception. If Fingolimod Teva is used
during pregnancy, there is a risk of harm to the unborn child. The rate of congenital malformations
observed in children exposed to Fingolimod Teva during pregnancy is about twice that observed in
the general population (where the rate of congenital malformations is about 2-3%). Most commonly
reported congenital malformations include heart, kidney, and musculoskeletal system developmental
abnormalities.
Therefore, if you are of childbearing age:

before starting Fingolimod Teva treatment, your doctor will inform you of the risk to the unborn child and ask you to take a pregnancy test to confirm you are not pregnant

and

you must use effective contraception during Fingolimod Teva treatment and for two months after stopping treatment to avoid pregnancy. Discuss effective contraceptive methods with your doctor.

Your doctor will give you a card explaining why you should not become pregnant while taking
Fingolimod Teva.
If you become pregnant while taking Fingolimod Teva, tell your doctor immediately. Your
doctor will decide whether to stop treatment (see "Stopping Fingolimod Teva" in section 3 and
section 4 "Possible side effects"). You will also need to attend prenatal check-ups.
Breastfeeding
Do not breastfeed while taking Fingolimod Teva. Fingolimod Teva may pass into breast milk,
posing a risk of serious side effects to the child.
Driving and using machines
Your doctor will inform you whether your condition allows you to drive safely, including cycling,
and operate machinery. Fingolimod Teva is not expected to affect your ability to drive and operate
machinery.
However, at the beginning of treatment, you must remain in the doctor's office or clinic for 6 hours
after taking the first dose of Fingolimod Teva. During this time and potentially afterwards, your
ability to drive and operate machinery may be impaired.
Fingolimod Teva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is
considered "sodium-free".

3. How to take Fingolimod Teva

Treatment with Fingolimod Teva will be supervised by a doctor experienced in the treatment of multiple sclerosis.
This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor.

Recommended dose:
Adults:
The recommended 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 weighing less than or equal to 40 kg: one 0.25 mg capsule once daily.
Children and adolescents weighing more than 40 kg: one 0.5 mg capsule once daily.

Children and adolescents who start treatment with one 0.25 mg capsule once daily and later achieve a stable body weight above 40 kg will receive instructions from their doctor to change the dose to one 0.5 mg capsule once daily. In such cases, repeat observation after the first dose is recommended.

Do not exceed the recommended dose.

Fingolimod Teva is intended for oral use.
Take Fingolimod Teva once daily, with a glass of water. Fingolimod Teva capsules should always be swallowed whole, without opening. Fingolimod Teva can be taken with or without food.

Taking Fingolimod Teva at the same time each day will help you remember to take your dose.

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

Taking more Fingolimod Teva than prescribed
If you have taken more than the prescribed dose, contact your doctor immediately.

Missing a dose of Fingolimod Teva
If you have been taking Fingolimod Teva for less than 1 month and miss one 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 Teva for at least 1 month and have missed doses 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 doses for up to 2 weeks, you may take the next dose as scheduled.

Do not take a double dose to make up for a missed dose.

Stopping Fingolimod Teva
Do not stop treatment with Fingolimod Teva or change the dose without first consulting your doctor.

Fingolimod Teva remains in the body for up to 2 months after stopping treatment. During this time, the number of white blood cells (lymphocyte count) may still be reduced, and adverse effects described in this leaflet may continue to occur. After stopping Fingolimod Teva, wait 6–8 weeks before starting a new multiple sclerosis treatment.

In patients restarting Fingolimod Teva after a treatment interruption of more than 2 weeks, effects on heart rate similar to those observed when starting treatment for the first time may reoccur, and monitoring in a doctor's office or clinic will be necessary upon restarting treatment. Do not restart Fingolimod Teva after a treatment break lasting more than two weeks without consulting your treating doctor.

Your treating doctor will decide whether and how you should be monitored after stopping Fingolimod Teva. Inform your doctor immediately if you feel your multiple sclerosis is worsening after stopping Fingolimod Teva. This situation may be serious.

If you have any further questions about how to use 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 may become serious.

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

Cough with phlegm, unspecified discomfort in the chest, fever (symptoms of lung disorders)
Herpesvirus infection (shingles or herpes simplex) with symptoms such as blisters, burning sensation, itching or skin pain, usually above the upper part of the body or face. Other symptoms may include fever and weakness in the early stage of infection, followed by numbness, itching, red spots and severe pain
Slow heart rate (bradycardia), irregular heartbeat
A type of skin cancer called basal cell carcinoma (BCC), which often appears as a pearly lump, although it may also look different
Depression and anxiety are known to occur more frequently in patients with MS and have also been reported in children and adolescents treated with fingolimod
Weight loss

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

Pneumonia with symptoms such as fever, cough, difficulty breathing
Macular edema (swelling in the center of the retina at the back of the eye) with symptoms such as shadows or blind spots in the center of vision, blurred vision, difficulty perceiving colors and details
Decreased platelet count, which increases the risk of bleeding or bruising
Malignant melanoma (a type of skin cancer that usually develops from an atypical mole). Possible signs of melanoma include moles that change in size, shape, elevation or color over time, or new moles appearing. Moles may itch, bleed or ulcerate
Seizures, epileptic seizures (more common in children and adolescents than in adults)

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

A condition called posterior reversible encephalopathy syndrome (PRES). Symptoms may include sudden, severe headache, confusion, seizures and (or) visual disturbances
Lymphoma (a type of cancer affecting the lymphatic system)
Squamous cell carcinoma: a type of skin cancer that may appear as a hard, red nodule, an ulcer covered with a scab, or a new ulcer developing at the site of an existing scar

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

Abnormalities in ECG test results (T-wave inversion)
Tumor associated with human herpesvirus 8 infection (Kaposi’s sarcoma)

Frequency unknown (frequency cannot be estimated from available data):

Allergic reactions, including rash or itchy hives, swelling of lips, tongue or face, which are more likely to occur on the day of starting treatment with Fingolimod Teva
Symptoms 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 abdomen, dark (brown) urine, reduced appetite, fatigue and abnormal liver function tests. In very rare cases, liver failure may lead to liver transplantation
Risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). Symptoms of PML may resemble an MS relapse. Other symptoms may not be noticeable to the patient, such as changes in mood or behavior, temporary memory lapses, difficulty speaking and communicating, which should be evaluated by a doctor to rule out PML. Therefore, if the patient feels that their MS is worsening or if the patient or their family notice any new or unusual symptoms, it is very important to inform the doctor immediately
Inflammatory disorders after stopping treatment with Fingolimod Teva (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 a painless, flesh-colored or bluish-red nodule, often located on the face, head or neck. Merkel cell carcinoma may also appear as a firm, painless nodule or mass. Long-term sun exposure and weakened immune system may influence the risk of developing Merkel cell carcinoma
After stopping treatment with Fingolimod Teva, MS symptoms may return and worsen compared to the period before and during treatment
Autoimmune form of anemia (reduced number of red blood cells), in which red blood cells are destroyed (autoimmune hemolytic anemia)

If any of these side effects occur in the patient, you should tell the doctor immediately.

Other side effects

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

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

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

Fungal skin infections (dermatophytosis) (pityriasis versicolor)
Dizziness
Severe headache, often accompanied by nausea, vomiting and light sensitivity (migraine symptoms)
Low white blood cell count (lymphocytes, leukocytes)
Weakness
Itchy, red, burning rash (rash)
Itching
Increased blood lipid (triglyceride) levels
Hair loss
Shortness of breath
Depression
Blurred vision (see also section on macular edema under “Some side effects may be or may become serious”)
Hypertension (Fingolimod Teva may cause a mild increase in blood pressure)
Muscle pain
Joint pain

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

Low white blood cell count (neutrophils)
Depressed mood
Nausea

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

Lymphatic system cancer (lymphoma)

Frequency unknown (frequency cannot be estimated from available data):

Peripheral edema

If any of these symptoms are severe, you should tell the doctor.

Reporting of side effects

If any adverse effects occur, including any adverse effects not listed in this leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Fingolimod Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and
blister pack following “Expiry date (EXP)”/“EXP”. The expiry date refers to the last day of the stated month.
No special storage conditions apply for this medicine.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Fingolimod Teva contains

The active substance is fingolimod.
Fingolimod Teva 0.25 mg hard capsules: Each capsule contains 0.25 mg of fingolimod (as hydrochloride).
Fingolimod Teva 0.5 mg hard capsules: Each capsule contains 0.5 mg of fingolimod (as hydrochloride).
The other ingredients are:
Capsule contents: Gelatinised starch (maize), sodium lauryl sulphate.
Fingolimod Teva 0.25 mg hard capsules
Capsule shell: Titanium dioxide (E 171), gelatin.
Fingolimod Teva 0.5 mg hard capsules
Capsule shell: Iron oxide yellow (E 172), titanium dioxide (E 171), gelatin.
Printing ink: Shellac, propylene glycol, concentrated ammonia solution, iron oxide black (E 172), potassium hydroxide.

What Fingolimod Teva looks like and contents of the pack
Fingolimod Teva 0.25 mg: A gelatin capsule approximately 14 mm in size, with a black print “TV 3654” on the white opaque cap and “TV 3654” on the white opaque body of the capsule.
Fingolimod Teva 0.5 mg: A gelatin capsule approximately 14 mm in size, with a black print “TV 7820” on the yellow cap and “TV 7820” on the white opaque body of the capsule.
Fingolimod Teva is available in packs containing 7 x 1 hard capsules or 28 x 1 hard capsules in single-dose perforated blisters.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00–113 Warsaw
tel.: (022) 345 93 00

Manufacturers/Importers:
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.
2600 Dupnitsa, Bulgaria
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Kraków, Poland
Teva Nederland B.V.
Swensweg 5
2031GA Haarlem, The Netherlands
Merckle GmbH
Ludwig-Merckle-Strasse 3
89143 Blaubeuren, Germany

This medicinal product is authorised in the European Economic Area under the following names:
Germany: Fingolimod-ratiopharm 0.25 mg Hartkapseln; Fingolimod-ratiopharm 0.5 mg Hartkapseln
Denmark, Estonia, Iceland, Norway, Poland, Portugal, Sweden: Fingolimod Teva
Finland: Fingolimod ratiopharm 0.5 mg kapseli, kova
France: FINGOLIMOD TEVA 0.25 mg, gélule; FINGOLIMOD TEVA 0.5 mg, gélule
Croatia: Fingolimod Teva 0.5 mg tvrde kapsule
Ireland: Fingolimod Teva 0.5 mg Hard Capsules
Lithuania: Fingolimod Teva 0.5 mg kietosios kapsulės
Luxembourg: Fingolimod Teva 0.25 mg gélules; Fingolimod Teva 0.5 mg gélules
Latvia: Fingolimod Teva 0.5 mg cietās kapsulas
The Netherlands: Fingolimod Teva 0.5 mg, harde capsules
Slovenia: Fingolimod Teva 0.25 mg trde kapsule; Fingolimod Teva 0.50 mg trde kapsule
United Kingdom (Northern Ireland): Fingolimod Teva 0.25 mg & 0.5 mg Capsule, Hard