FINGOLIMOD 0.5 MG Hard capsule

Зміст інструкції

1. Fingolimod Medical Valley 0.5 mg hard capsules
   1. What is Fingolimod Medical Valley and what is it used for
   2. What you need to know before taking Fingolimod Medical Valley
   3. How to take Fingolimod Medical Valley
   4. Possible side effects
   5. How to store Fingolimod Medical Valley
   6. Contents of the pack and other information

Fingolimod Medical Valley 0.5 mg hard capsules

fingolimod

Generic medicine

Read 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Fingolimod Medical Valley is and what it is used for
• 2. What you need to know before you take Fingolimod Medical Valley
• 3. How to take Fingolimod Medical Valley
• 4. Possible side effects
• 5. How to store Fingolimod Medical Valley
• 6. Contents of the pack and other information

1. What is Fingolimod Medical Valley and what is it used for

What is Fingolimod Medical Valley
Fingolimod Medical Valley contains the active substance fingolimod.

What is Fingolimod Medical Valley used for
Fingolimod Medical Valley is used in adults and children and adolescents (from 10
years of age) for the treatment of relapsing-remitting multiple sclerosis (MS), in
particular in:

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

Fingolimod Medical Valley does not cure MS, but helps to reduce the number of relapses and to slow the
progression of physical disabilities 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 covers the nerves of the CNS and prevents the nerves from functioning properly. This process
is called demyelination.
Relapsing-remitting MS is characterized by repeated attacks (relapses) of neurological symptoms that
reflect an inflammatory state of the CNS. Symptoms vary from patient to patient, but typically
include difficulty walking, numbness, visual or balance disturbances. Symptoms
of a relapse may disappear completely when the relapse is over, but some disturbances
may persist.

How does Fingolimod Medical Valley work
Fingolimod Medical Valley helps to protect the central nervous system from attacks by the immune system by reducing the ability of some white blood cells (lymphocytes) to circulate freely in the
body and preventing them from reaching the brain and spinal cord. This limits the
nerve damage caused by MS. Fingolimod Medical Valley also reduces some of the
body's immune reactions.

2. What you need to know before taking Fingolimod Medical Valley

Do not take Fingolimod Medical Valley

• if you have a reduced immune response(due to an immunodeficiency syndrome, a disease or medications that suppress the immune system).
• if you have a severe ongoing infection or an ongoing chronic infectionsuch as hepatitis or tuberculosis.
• if you have active cancer.
• if you have severe liver problems.
• if, in the last 6 months, you have had a heart attack, angina, stroke or warning signs of astroke 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 treatment with Fingolimod Medical Valley.
• if you are taking or have recently taken medications for irregular heartbeatsuch as quinidine, disopyramide, amiodarone or sotalol.
• if you are pregnantor if you are a woman of childbearing potential who is not using effective contraceptive measures.
• if you are allergicto 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, tell your doctor before takingFingolimod Medical Valley.

Warnings and precautions
Consult your doctor before taking Fingolimod Medical Valley:

• if you have severe breathing problems during sleep (severe sleep apnea).
• if you have been told that you have an abnormal electrocardiogram.
• if you experience symptoms of a slow heart rate (for example, dizziness, nausea or palpitations).
• if you are taking or have recently taken medications that slow down the heartbeat(such as beta-blockers, verapamil, diltiazem or ivabradine, digoxin, anticholinesterase drugs or pilocarpine).
• if you have a history 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 disturbancesor other signs of swelling in the area of central vision (macula) in the back of the eye (a condition known as macular edema, see below), inflammation or infection of the eye (uveitis), or if you have diabetes(which can cause eye problems).
• if you suffer from liver problems.
• if you suffer from high blood pressure that cannot be controlled by medications.
• if you suffer from severe lung problemsor if you have a smoker's cough. If any of these apply to you, tell your doctor before takingFingolimod Medical Valley.

Slow heartbeat (bradycardia) and irregular heartbeat
At the beginning of treatment or when switching from a daily dose of 0.25 mg to the
administration of 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 effects are severe, tell your
doctor, as immediate treatment may be necessary.Fingolimod can also
cause an irregular heartbeat, especially after the first dose. The irregular heartbeat usually
returns to normal in less than a day. The slow heart rate usually returns to
normal within a month. During this period, clinically significant effects on heart rate are usually not expected.
Your doctor will ask you to remain in the outpatient clinic or hospital for at least 6 hours after
the first dose of Fingolimod Medical Valley or when switching from a daily dose of 0.25
mg to the administration of the first 0.5 mg dose, during which your pulse and blood pressure will be measured hourly, so that appropriate measures can be taken in case of adverse effects that occur at the beginning of treatment. You must have an
electrocardiogram performed before the administration of the first dose of Fingolimod
Medical Valley and at the end of the 6 hours of monitoring. The doctor may continuously monitor
the electrocardiogram during this period. If after the 6-hour period you have a
very low or decreasing heart rate, or if your electrocardiogram shows abnormalities, you may need to remain under observation for a longer period (at least for another 2 hours
and possibly until the next morning) until these problems are resolved. The same
can happen if you are restarting Fingolimod Medical Valley after an interruption of treatment,
depending on how long the interruption was and how long you were taking Fingolimod
Medical Valley before the interruption.
If you have, or are at risk of, an irregular or abnormal heartbeat, if your electrocardiogram is
abnormal or if you have heart disease or heart failure, Fingolimod Medical Valley may
not be suitable for you.
If you have had episodes of sudden loss of consciousness or decreased heart rate in the past, Fingolimod Medical Valley may not be suitable for you. You will be visited by a cardiologist
(heart specialist) who will give you instructions on how to start treatment with Fingolimod
Medical Valley, including monitoring until the next morning.
If you are taking medications that can cause a decrease in heart rate,
Fingolimod Medical Valley may not be suitable for you. You will be visited by a cardiologist, who
will assess whether you can take, as an alternative, medications that do not decrease heart rate, in order to allow treatment with Fingolimod Medical Valley. If such a change of
therapy is not possible, the cardiologist will give you instructions on how to start treatment with
Fingolimod Medical Valley, including monitoring until the next morning.
If you have never had chickenpox
If you have never had chickenpox, your doctor will check your immunity to the virus that causes it
(varicella-zoster virus). If you are not protected against the virus, vaccination may be necessary before starting treatment with Fingolimod Medical Valley. In this case, the doctor
will postpone the start of treatment with Fingolimod Medical Valley until one month after
completion of the entire vaccination cycle.
Infections
Fingolimod reduces the number of white blood cells (especially lymphocytes). White blood cells
fight infections. While taking Fingolimod Medical Valley (and up to 2 months after
stopping treatment), you may be more likely to contract infections. Any existing infection may worsen. Infections can be serious and life-threatening. If
you think you have an infection, if you have a fever, if you have flu-like symptoms, if you have shingles or if you have a headache accompanied by stiffness of the neck, sensitivity to light, nausea, rash, and/or confusion or
convulsions (seizures) (these may be symptoms of meningitis and/or encephalitis caused by a fungal or viral infection with herpes), contact your doctor immediately, as this may be a serious and life-threatening problem.
If you believe that the MS is worsening (for example if you experience weakness or visual disturbances) or if
you notice any new symptoms, see your doctor immediately, as these may be the
symptoms of a rare brain disorder caused by an infection called progressive multifocal
leukoencephalopathy (PML). PML is a serious condition that can lead to severe disability or death. The
doctor will consider performing an MRI scan to assess this
condition and decide whether you should stop taking Fingolimod Medical Valley.
Human papillomavirus (HPV) infection has been reported in patients treated with fingolimod
including papillomas, dysplasia, condylomas and HPV-related cancer. The doctor will assess whether you
need an HPV vaccination before starting treatment. If you are a woman, the doctor
will also recommend that you undergo screening for HPV.
Macular edema
Before starting treatment with Fingolimod Medical Valley, if you have or have had visual disturbances or other
signs of swelling in the area of central vision (macula) in the back of the eye,
inflammation or infection of the eye (uveitis) or diabetes, the doctor may ask you to undergo an
eye examination.
The doctor may ask you to undergo an eye examination 3 or 4 months after starting treatment
with Fingolimod Medical Valley.
The macula is a small area of the retina in the back of the eye that allows you to see
shapes, colors and details clearly and sharply. Fingolimod Medical Valley can cause swelling
in the macula, a condition that is known as macular edema. Swelling usually occurs within the
first 4 months of treatment with Fingolimod Medical Valley.
The possibility of developing macular edema is greater if you suffer from diabetesor if you have had
an inflammation of the eye called uveitis. In these cases, your doctor will want to subject you to regular
eye examinations to diagnose macular edema.
If you have suffered from macular edema, talk to your doctor before resuming treatment with
Fingolimod Medical Valley.
Macular edema can cause some of the visual symptoms (optic neuritis) that occur in an MS attack.
There may be no symptoms in the early stages. Be sure to tell your doctor of
any changes in vision.
The doctor may ask you to undergo an eye examination, especially if:

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

Liver function tests
If you have severe liver problems, you should not take Fingolimod Medical Valley. Fingolimod
Medical Valley can affect your liver function. You probably won't notice any symptoms,
but if you notice yellowing of the skin or the whites of your eyes, an abnormal dark
color of your urine (brown in color), pain on the right side of your stomach area (abdomen), fatigue,
a feeling of unusual loss of appetite or unexplained nausea and vomiting, tell your
doctor immediately.
If you experience any of these symptoms after starting treatment with Fingolimod Medical Valley, tell
your doctor immediately.
Before, during and after treatment, the doctor will ask you for blood tests to monitor
liver function. If the test results indicate a liver problem, it may be
necessary to stop treatment with Fingolimod Medical Valley.
High blood pressure
Because Fingolimod Medical Valley causes a slight increase in blood pressure, the doctor may decide to
subject you to regular blood pressure checks.
Lung problems
Fingolimod Medical Valley has a weak effect on lung function. Adverse effects may occur more easily in patients with severe
lung problems or with a smoker's cough.
Blood count
The desired effect of treatment with Fingolimod Medical Valley is to reduce the amount of
white blood cells in the blood. These usually return to normal values within 2 months of
stopping treatment. If you need to undergo blood tests, tell your doctor that
you are taking Fingolimod Medical Valley. Otherwise, the doctor may not be able to
correctly assess the test results, and for some types of tests the doctor may need to
draw more blood than usual.
Before starting treatment with Fingolimod Medical Valley, the doctor will confirm whether the number of
white blood cells in the blood is sufficient, and may ask you to repeat the count periodically.
If you do not have enough white blood cells, it may be necessary to stop the
treatment with Fingolimod Medical Valley.
Posterior reversible encephalopathy syndrome (PRES)
A condition called posterior reversible encephalopathy syndrome (PRES) has been reported
rarely in patients with multiple sclerosis (MS) treated with fingolimod. Symptoms may include
the sudden onset of a severe headache, confusion, seizures, and changes in vision. Tell
your doctor immediately if you experience any of these symptoms while taking Fingolimod Medical
Valley, as it may be serious.
Cancer
Skin tumors have been reported in patients with MS treated with fingolimod. Contact
your doctor immediately if you notice the appearance of any skin nodules (e.g. pearly, shiny nodules), spots or open sores that do not heal within a few weeks. Symptoms of skin cancer may include abnormal growths or changes in skin tissue (e.g. moles
with a change in color, shape or size over time). Before starting treatment
with Fingolimod Medical Valley, a skin check should be performed to check for skin nodules.
The doctor will also perform periodic skin checks during treatment with
Fingolimod Medical Valley. If you develop skin problems, your doctor may refer you to a
dermatologist who, after consultation, can establish the need for periodic visits.
A type of cancer of the lymphatic system (lymphoma) has been reported in patients with MS treated with
fingolimod.
Sun exposure and sun protection
Fingolimod weakens your immune system. This increases the risk of developing cancer, in
particular skin cancer. You should limit exposure to the sun and UV rays:

• by wearing appropriate protective clothing.
• by regularly applying a sunscreen with a high degree of UV protection.

Unusual brain lesions associated with MS relapse
Rare cases of unusually extensive brain lesions associated with an MS relapse have been reported in
patients treated with fingolimod. In case of a severe relapse, the doctor will assess whether to perform an MRI scan to assess this condition and decide whether to stop taking
Fingolimod Medical Valley.
Switching from other treatments to Fingolimod Medical Valley
The doctor may switch you directly from treatment with interferon-beta, glatiramer acetate or
dimethyl fumarate to that with Fingolimod Medical Valley if there are no signs of abnormalities caused by
the previous treatment. The doctor may ask you to undergo a blood test to rule out such
anomalies. After stopping natalizumab, it may be necessary to wait 2-3 months before
starting treatment with Fingolimod Medical Valley. For switching from teriflunomide, your doctor
may advise you to wait for a certain time or to proceed with an accelerated elimination
procedure. If you have undergone treatment with alemtuzumab, careful assessment and a
discussion with the doctor are necessary to decide whether Fingolimod Medical Valley is suitable for you.
Women of childbearing potential

r/>If used during pregnancy, Fingolimod Medical Valley may harm the unborn child. Before
starting treatment with Fingolimod Medical Valley, your doctor will explain the risk and ask you to
undergo a pregnancy test to ensure that you are not pregnant. Your doctor will
give you a card explaining why you should not become pregnant while taking
Fingolimod Medical Valley. They will also explain what you need to do to avoid pregnancy while taking
Fingolimod Medical Valley. You must use effective contraceptive measures during treatment and for 2 months
after stopping treatment (see the paragraph "Pregnancy and breastfeeding").
Worsening of MS after stopping treatment with Fingolimod Medical Valley
Do not stop taking Fingolimod Medical Valley or change your dose without first
talking to your doctor.
Tell your doctor immediately if you think your multiple sclerosis is getting worse after stopping
treatment with Fingolimod Medical Valley. This could be serious (see "If you stop taking Fingolimod Medical Valley" in paragraph 3, and also paragraph 4, "Possible side
effects").

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 Medical Valley 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 and adolescents and for people
who care for them:

• Before starting treatment with Fingolimod Medical Valley, your doctor will check your vaccination status. If you have not had certain vaccinations, you may need to be given them before starting treatment with Fingolimod Medical Valley.
• The first time you take Fingolimod Medical Valley or when you switch from a daily dose of 0.25 mg to a daily dose of 0.5 mg, your doctor will check your heart rate and heartbeat (see above “Low heart rate (bradycardia) and irregular heartbeat”).
• If you experience seizures or convulsions before or during treatment with Fingolimod Medical Valley, tell your doctor.
• If you suffer from depression or anxiety or become depressed or anxious while taking Fingolimod Medical Valley, tell your doctor. You may need to be monitored more closely.

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

• Medicines that suppress or modulate the immune system, including other medicinesused for the treatment of MS, such as interferon beta, glatiramer acetate, natalizumab, mitoxantrone, teriflunomide, dimethyl fumarate or alemtuzumab. You should not use Fingolimod Medical Valley together with such medicines because it could intensify the effect on the immune system (see also “Do not take Fingolimod Medical Valley”).
• Corticosteroids, due to the possible additive effect on the immune system.
• Vaccines.If you need to be vaccinated, ask your doctor for advice first. During and up to 2 months after treatment with Fingolimod Medical Valley, you should not receive certain types of vaccine (live attenuated vaccines) as they could trigger the infection they were intended to prevent. Other vaccines may not work as well as usual if given during this period.
• Medicines that slow down the heartbeat(for example beta-blockers, such as atenolol). Concomitant use of Fingolimod Medical Valley with such medicines could intensify the effect on the heartbeat in the first few days of treatment with Fingolimod Medical Valley.
• Medicines for irregular heartbeat, such as quinidine, disopyramide, amiodarone or sotalol. You should not use Fingolimod Medical Valley if you are taking these medicines because they could intensify the effect on irregular heartbeat (see also “Do not take Fingolimod Medical Valley”).
• Other medicines:or 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 efficacy of Fingolimod Medical Valley).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding,
ask your doctor for advice before taking this medicine.
Pregnancy
Do not use Fingolimod Medical Valley if you are pregnant, planning a pregnancy, or are a
woman of childbearing potential and are not using effective contraceptive measures. If Fingolimod Medical Valley 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 during pregnancy is approximately 2 times the rate observed in
the general population (in which the rate of congenital malformations is approximately 2-3%). The malformations
most frequently reported include heart, kidney and musculoskeletal malformations.
Therefore, if you are a woman of childbearing potential:
risk to the unborn child and ask you to undergo a pregnancy test to ensure that you are not
pregnant
and

• you must use effective contraceptive measures during treatment with Fingolimod Medical Valley and for two months after stopping treatment to avoid pregnancy. Talk to your doctor about reliable methods of contraception.

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

If you become pregnant while taking Fingolimod Medical Valley, tell your
doctor immediately.The doctor will decide to stop treatment (see "If you stop taking Fingolimod Medical Valley" in paragraph 3 and also paragraph 4, "Possible side
effects"). You will also need to have specialized prenatal check-ups.
Breastfeeding

Do not breastfeed while taking Fingolimod Medical Valley.
Fingolimod is excreted in breast milk with the risk of serious side effects for the newborn.

Driving and using machines
Your doctor will tell you if your illness allows you to drive vehicles, including bicycles, and use
machines safely. Fingolimod Medical Valley should not affect your ability to
drive vehicles and use machines.
However, at the beginning of treatment you must remain in the doctor's office or in hospital for 6
hours after taking the first dose of Fingolimod Medical Valley. The ability to drive vehicles and
use machines may be impaired during this time and potentially also
afterwards.

3. How to take Fingolimod Medical Valley

Treatment with Fingolimod Medical Valley will be supervised by a doctor experienced in the treatment
of multiple sclerosis.
Take this medicine following exactly the instructions of your doctor. If you have any doubts
consult your doctor.
The recommended dose is:

Adults:
The dose is one 0.5 mg capsule once a day.
Children and adolescents (from 10 years of age and over):
The dose depends on body weight:

• Children and adolescents with a body weight equal to or less than 40 kg: one 0.25 mg capsule per day.
• Children and adolescents with a body weight greater than 40 kg: one 0.5 mg capsule per day. Children and adolescents who start treatment with a 0.25 mg capsule per day and subsequently reach a stable body weight greater than 40 kg will be instructed by the doctor to switch to treatment with a 0.5 mg capsule per day. In this case, it is recommended to repeat the first-dose observation period.

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

If you take more Fingolimod Medical Valley than you should
If you have taken an excessive amount of Fingolimod Medical Valley, inform your doctor immediately.

If you forget to take Fingolimod Medical Valley
If you have been taking Fingolimod Medical Valley for less than 1 month and you forget to take 1 dose for
an entire day, consult your doctor before taking the next dose. The doctor may decide to
keep you under observation when you take the next dose.
If you have been taking Fingolimod Medical Valley for at least 1 month and you have forgotten to take the
medicine for more than 2 weeks, consult your doctor before taking the next dose. The doctor
may decide to keep you under observation when you take the next dose. However, if you have
forgotten to take the medicine for 2 weeks or less, you can take the next dose as
planned.
Never take a double dose to make up for a missed dose.

If you stop taking Fingolimod Medical Valley
Do not stop taking Fingolimod Medical Valley or change the dose without first talking
to your doctor.
Fingolimod Medical Valley will remain in the body for up to 2 months after stopping treatment.
The number of white blood cells (lymphocyte count) may also remain low during this period and
the undesirable effects described in this leaflet may still occur. After stopping treatment with
Fingolimod Medical Valley, you may need to wait 6-8 weeks before
starting a new treatment for multiple sclerosis.
If you need to restart taking Fingolimod Medical Valley after more than 2 weeks of
stopping treatment, the effect on heart rate normally observed at the start of
treatment may reappear: to restart treatment, you will therefore need to stay in
an outpatient clinic or hospital under observation. Do not restart treatment with Fingolimod Medical
Valley after interrupting it for more than two weeks without consulting your doctor.
The doctor will decide whether and how you need to be monitored after stopping treatment with
Fingolimod Medical Valley. Inform your doctor immediately if you think your multiple sclerosis
is getting worse after stopping treatment with Fingolimod Medical Valley. It could be
serious.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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

• Cough with mucus, chest discomfort, fever (signs of lung problems)
• Herpes virus infection (shingles or herpes zoster) with symptoms such as blisters, burning, itching or skin pain, typically on the upper part of the body or on the face. Other symptoms may include fever and weakness in the early stages of the infection, followed by numbness, itching or red patches with severe pain
• Slow heartbeat (bradycardia), irregular heartbeat
• A type of skin cancer called basal cell carcinoma (BCC) which often appears as a pearly nodule, although it can also take on other appearances
• Depression and anxiety are known to occur more frequently in the population affected by MS and have also been reported in pediatric 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 edema (swelling in the area of central vision of the retina at the back of the eye) with symptoms such as shadows or a blind spot in the center of vision, blurred vision, problems distinguishing colors or details
• Reduced platelets in the blood which increases the risk of bleeding or bruising
• Malignant melanoma (a type of skin cancer that usually develops from an unusual mole). Possible signs of melanoma include moles that may change in size, shape, thickness or color over time, or new moles. Moles may itch, bleed or ulcerate
• Convulsions, seizures (more frequent in children and adolescents than in adults)

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

• A syndrome 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 red, hard nodule, an ulcer with a crust, or a new ulcer on a pre-existing scar.

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

• Electrocardiogram abnormality (T-wave inversion)
• Tumor linked to human herpesvirus 8 infection (Kaposi's sarcoma)

Not known(frequency cannot be estimated based on available data):

• Allergic reactions, including symptoms of skin rash or hives, swelling of the lips, tongue or face, which is more likely to occur on the first day of treatment with Fingolimod Medical Valley.
• Signs of liver disease (including liver failure), such as yellowing of the skin or whites of the eyes (jaundice), nausea or vomiting, pain on the right side of the stomach area (abdomen), dark urine (brown in color), a feeling of 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 a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML symptoms may be similar to those of an MS relapse. Symptoms that you may not be personally aware of may also occur, such as changes in mood or behavior, memory gaps, difficulty with speech and communication, which may require further medical evaluation to rule out the risk of PML. Therefore, if you feel that your MS is worsening or if you or someone close to you notices new or unusual symptoms, it is very important to contact your doctor as soon as possible
• Cryptococcal infections (a type of fungal infection), including cryptococcal meningitis with symptoms such as headache accompanied by stiff neck, sensitivity to light, 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 on the face, head or neck. Merkel cell carcinoma can also appear as a hard, painless nodule or a mass. Long-term exposure to the sun and a weakened immune system can affect the risk of developing Merkel cell carcinoma
• After stopping treatment with Fingolimod Medical Valley, the symptoms of MS may reappear and may worsen compared to how they were before or during treatment.
• Autoimmune form of anemia (decrease in the number of red blood cells) in which red blood cells are destroyed (autoimmune hemolytic anemia).

If any of these side effects occur, tell 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 (tinea versicolor)
• Dizziness
• Severe headache often accompanied by nausea, vomiting and sensitivity to light (migraine)
• Low levels of white blood cells (lymphocytes, leukocytes)
• Weakness
• Skin rash with itching, redness and burning (eczema)
• Itching
• Increased levels of fats in the blood (triglycerides)
• Hair loss
• Shortness of breath
• Depression
• Blurred vision (see also the paragraph regarding macular edema in the section "Some side effects may be or become serious")
• High blood pressure (Fingolimod Medical Valley can cause a slight increase in blood pressure)
• Muscle pain
• Joint pain

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

• Low levels of some white blood cells (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 based on available data):

• Peripheral edema

If any of these side effects occur severely, tell your doctor.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through 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 Medical Valley

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 package and on the blister after
"Exp.". The expiry date refers to the last day of that month.
Do not store at a temperature above 25ºC.
Do not use this medicine if you notice that the packaging is damaged or shows signs of
tampering.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Fingolimod Medical Valley contains

• The active ingredient is fingolimod.
• Each capsule contains 0.5 mg of fingolimod (as hydrochloride).
• The other ingredients are: Capsule content:Microcrystalline cellulose, Colloidal silicon dioxide, Magnesium stearate Capsule shell:Titanium dioxide (E171), Yellow iron oxide (E17)2, Gelatin.

Description of the appearance of Fingolimod Medical Valley and contents of the pack
The 0.5 mg hard capsule of Fingolimod Medical Valley has an opaque yellow cap and an opaque white
body.
Fingolimod Medical Valley 0.5 mg capsules are available in packs of 7, 28, 84 (3
packs of 28 capsules) or 98 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Medical Valley Invest AB
Brädgårdsvägen 28
236 32 Höllviken
Sweden

Manufacturer
Haupt Pharma Amareg GmbH
Donaustaufr Str. 378 – 93055 Regensburg
Germany
Laboratorios Liconsa, S.A.
Avda. Miralcampo, nº 7.
Polígono Industrial Miralcampo.
19200 Azuqueca de Henares
Guadalajara
Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Germany: Fingolimod Liconsa 0.5 mg hard capsules
France: Fingolimod Laboratorios Liconsa 0.5 mg capsules
Italy: Fingolimod Medical Valley