NAEGOTI 0.25 MG Hard capsule

Зміст інструкції

1. Naegoti 0.25 mg hard capsules, 0.5 mg hard capsules
   1. What is Naegoti and what is it used for
   2. What you need to know before taking Naegoti
   3. How to take Naegoti
   4. Possible side effects
   5. How to store Naegoti
   6. Package Contents and Other Information

Naegoti 0.25 mg hard capsules, 0.5 mg hard capsules

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

1. What is Naegoti and what is it used for

What is Naegoti
The active substance of Naegoti is fingolimod.

What is Naegoti used for
Naegoti is used in adults and children and adolescents (10 years of age and older) for the treatment
of relapsing-remitting multiple sclerosis (MS), particularly in:

• Patients who have not responded to therapy with an MS treatment.

or

• Patients with rapidly evolving severe MS.

Naegoti does not cure MS, but helps to reduce the number of relapses and to slow the progression of
physical disability caused by MS.

What is multiple sclerosis
MS is a chronic disease that affects the central nervous system (CNS), which includes the
brain and spinal cord. In MS, inflammation destroys the protective sheath (called
myelin) that coats the nerves in the CNS and prevents the nerves from functioning properly. This
process is called demyelination.
Relapsing-remitting MS is characterized by relapsing attacks (relapses) of neurological symptoms
that reflect an inflammatory state of the central nervous system. Symptoms vary from patient to
patient, but usually involve difficulty walking, numbness, visual disturbances or
balance problems. The symptoms of a relapse may disappear completely when the relapse is
over, but some disturbances may persist.

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

2. What you need to know before taking Naegoti

Do not take Naegoti

• if you have a reduced immune response(due to an immunodeficiency syndrome, illness or medications that suppress the immune system).
• if you have a severe ongoing infection or a chronic ongoing infectionsuch as hepatitis or tuberculosis.
• if you have active cancer.
• if you suffer from severe liver problems.
• if, in the last 6 months, you have had a heart attack, angina, stroke or warning signs of a stroke orcertain types of heart failure.
• if you have certain types of irregular or abnormal heartbeat(arrhythmia), including patients in whom the electrocardiogram (ECG) shows a prolonged QT interval before starting treatment with Naegoti.
• if you are taking or have recently taken medications for irregular heartbeatsuch as quinidine, disopyramide, amiodarone or sotalol.
• if you are pregnantor 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 not sure, talk to your doctor before takingNaegoti.

Warnings and precautions
Talk to your doctor before taking Naegoti:

• 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 (e.g., dizziness, nausea, or palpitations).
• if you are taking or have recently taken medicines that slow down the heartbeat(such as beta-blockers, verapamil, diltiazem or ivabradine, digoxin, anticholinesterase drugs or pilocarpine).
• if you have had episodes of sudden loss of consciousness or fainting(syncope) in the past.
• if you intend to get vaccinated.
• if you have never had chickenpox.
• if you have or have had vision problemsor 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), if you have or have had inflammation or infection of the eye (uveitis), or ifyou suffer from diabetes(which can cause eye problems).
• if you suffer from liver problems.
• if you suffer from high blood pressure that cannot be controlled by medication.
• if you suffer from severe lung problemsor if you have a smoker's cough. If any of these apply to you or you are not sure, talk to your doctor before takingNaegoti. 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 dose of 0.5 mg, Naegoti causes a slowing of the heart rate. As a result, you may experience dizziness or fatigue, awareness of your heartbeat, or a drop in blood pressure. If these effects are severe, contact yourdoctor, as immediate treatment may be necessary. Naegoti can also cause an irregular heartbeat, especially after the first dose. The irregular heartbeat usually returns to normal within a day. The slow heart rate usually returns to normal within

a month. During this period, no clinically significant effects on heart rate are usually expected.
The doctor will ask you to remain in the outpatient clinic or hospital for at least 6 hours after
administration of the first dose of Naegoti or, when switching from a daily dose of 0.25
mg to the administration of the first dose of 0.5 mg, during which pulse and blood pressure will be measured hourly.
In this way, 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 Naegoti and at the end
of the 6 hours of monitoring. The doctor may continuously monitor your electrocardiogram
during this period. If after 6 hours your heart rate is very low or is decreasing, or if your
electrocardiogram shows abnormalities, it may be necessary
that you remain under observation for a longer period (at least for another 2 hours and
possibly until the next morning), until these problems have resolved. The same may
happen if you resume Naegoti after an interruption of treatment, depending on how long the
interruption has been and how long you have been taking Naegoti before the interruption.
If you have or are at risk of having an irregular or abnormal heartbeat, if your
electrocardiogram is abnormal, or if you have heart problems or heart failure, Naegoti may not be suitable for you.
If you have had episodes of sudden loss of consciousness or reduced heart rate in the past,
Naegoti may not be suitable for you. You will be examined by a cardiologist (heart specialist) who will give you
instructions on how to start treatment with Naegoti, including monitoring until the next morning.
If you are taking medicines that can cause a decrease in heart rate, Naegoti
may not be suitable for you. You will be examined by a cardiologist who will evaluate whether you can take, as
an alternative, medicines that do not decrease the heart rate and allow you to start
treatment with Naegoti. If this change in therapy is not possible, the cardiologist will give you
instructions on how to start treatment with Naegoti, 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 Naegoti. If this situation occurs, your doctor will postpone the start of
treatment with Naegoti 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 Naegoti (and up to 2 months after stopping the
treatment), you may be more likely to get 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, shingles, or headache
accompanied by stiff 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 it may be serious and life-threatening. If you believe that MS is worsening (e.g. if you experience weakness or vision disturbances) or if you notice any new symptoms, contact your doctor immediately as these
may be 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 to assess
this condition and decide whether you need to stop taking Naegoti.
Human papillomavirus (HPV) infection has been reported in patients treated with Naegoti,
including papilloma, dysplasia, genital warts and HPV-related cancer. The doctor will assess whether you need
vaccination against HPV before starting treatment. If you are a woman, your doctor will
also recommend that you undergo screening for HPV.
Macular edema
Before starting treatment with Naegoti, if you have or have had vision problems or other signs of swelling
in the area of central vision (macula) in the back of the eye, if you have or have had
inflammation or infection of the eye (uveitis) or if you suffer from diabetes, your doctor may ask you
to undergo an eye examination.
The doctor may ask you to undergo an eye examination 3-4 months after starting treatment
with Naegoti.
The macula is a small area of the retina located in the back of the eye that allows you to
see shapes, colors and details clearly. Naegoti can cause swelling of the macula, a
condition that is known as macular edema. The swelling usually occurs within the first 4 months of
treatment with Naegoti.
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, the doctor will want to subject you to
regular checks to detect the first signs of macular edema.
If you have suffered from macular edema, tell your doctor before resuming treatment with Naegoti.
Macular edema can cause some of the visual symptoms (optic neuritis) that occur during
MS attacks. In the early stages, there may be no symptoms. Be sure to inform your doctor
of any changes in vision. The doctor may ask you to undergo an eye examination,
especially if:

• the central area of vision is blurred or has shadows;
• a blind spot develops in the central area of vision;
• you have trouble distinguishing colors or fine details. Liver function tests If you have severe liver problems, you should not take Naegoti. Treatment with Naegoti 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 coloration of your urine (brown in color), pain on the right side of your stomach area (abdomen), fatigue, an unusual feeling of loss of appetite, or unexplained nausea and vomiting, tell your doctor immediately. If you experience any of these symptoms after starting treatment with Naegoti, tell yourdoctor immediately.

Before, during and after treatment, your doctor will ask you to have blood tests to
check your liver function. If the results indicate a liver problem, it may
be necessary to stop treatment with Naegoti.
High blood pressure
Because Naegoti causes a slight increase in blood pressure, your doctor may subject you to regular
checks of blood pressure.
Lung problems
Naegoti has a weak effect on lung function. In patients with severe lung problems
or with smoker's cough, adverse effects may occur more easily.
Blood count
The desired effect of treatment with Naegoti is to reduce the number of white blood cells in
the blood. These usually return to normal values within 2 months after the end of treatment. If
you need to undergo blood tests, tell your doctor that you are taking Naegoti. Otherwise, it may not be possible for the doctor 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 Naegoti, the doctor will confirm whether your number of white
blood cells is sufficient, and may ask you to repeat the count regularly. If you do not have
enough white blood cells, it may be necessary to stop treatment with Naegoti.
Reversible posterior encephalopathy syndrome (PRES)
A syndrome called reversible posterior encephalopathy (PRES) has been rarely reported in patients with multiple sclerosis treated with fingolimod. Symptoms may include sudden onset of severe headache, confusion, seizures, and visual disturbances. Tell
your doctor immediately if you experience any of these symptoms during treatment with Naegoti because
it may be serious.
Cancer
Skin cancers have been reported in patients with MS treated with fingolimod. Contact
your doctor immediately if you notice the appearance of any skin nodule (e.g. shiny, pearly nodule),
spot or open sore that does not heal within a few weeks. Symptoms of skin cancer
may include abnormal growths or changes in skin tissue (e.g. unusual moles) with
changing color, thickness or size over time. Before starting treatment with Naegoti
a skin check is necessary to verify the presence of skin nodules. The doctor will also perform
periodic skin checks during treatment with Naegoti. If skin problems occur, the doctor may refer you to a dermatologist who, after the visit, may decide that it is
important for you to be visited regularly.
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 must limit exposure to the sun and UV rays:

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

Unusual brain lesions associated with an 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
to assess this condition and decide whether you need to stop taking Naegoti.
Switching from other treatments to Naegoti
The doctor may switch you directly from treatment with interferon-beta, glatiramer acetate or
dimethyl fumarate to Naegoti if there are no signs of abnormalities caused by the previous
treatment. The doctor may have you undergo a blood test to rule out such abnormalities. After stopping
natalizumab, it may be necessary to wait 2-3 months before
starting treatment with Naegoti. For switching from teriflunomide, the doctor may advise you to
wait for a certain period of time or to proceed with an accelerated elimination
procedure. If you have been treated with alemtuzumab, a careful assessment and
discussion with the doctor is necessary to decide whether Naegoti is suitable for you.
Women of childbearing potential
If used during pregnancy, Naegoti can harm the unborn child. Before starting
treatment with Naegoti, the doctor will explain the risk to you and ask you to undergo a pregnancy test to make sure you are not pregnant. The doctor will give you a
reminder explaining why you should not become pregnant while taking Naegoti. It also explains
what you need to do to avoid pregnancy while taking Naegoti. You must use effective contraceptive
measures during treatment and for 2 months after stopping treatment (see section
“Pregnancy and breastfeeding")

”).
Worsening of MS after stopping treatment with Naegoti
Do not stop taking Naegoti 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 Naegoti. This may be serious (see “If you stop taking Naegoti” in section 3 and also 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, ask your doctor.

Children and adolescents
Fingolimod 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 those who care for them:

• Before starting treatment with Naegoti, 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 Naegoti.
• The first time you take Naegoti 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 “slow heart rate (bradycardia) and irregular heartbeat”).
• If you have seizures or convulsions before taking or while taking Naegoti, tell your doctor.
• If you suffer from depression or anxiety or become depressed or anxious during treatment with Naegoti, tell your doctor. You may need to be monitored more closely.

Other medicines and Naegoti
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 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 should not use Naegoti with these medicines as it may intensify the effect on the immune system (see also “Do not take Naegoti”).
• 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 Naegoti, you should not receive certain types of vaccines (live attenuated vaccines) as they may 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(such as beta-blockers, such as atenolol). Concomitant use of Naegoti with these medicines may intensify the effect on the heartbeat in the first few days of treatment with Naegoti.
• Medicines for irregular heartbeat, such as quinidine, disopyramide, amiodarone or sotalol. You should not use Naegoti if you are taking these medicines because they can intensify the effect on irregular heartbeat (see also ‘Do not take Naegoti).
• 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 Naegoti).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor for advice before taking this medicine.
Pregnancy
Do not use Naegoti during pregnancy, if you are planning a pregnancy or if you are a woman of childbearing potential and are not using effective contraception. If Naegoti is used during pregnancy, there is a risk of harm to the unborn child. The rate of congenital malformations observed in newborns exposed to Naegoti 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 most frequently reported malformations include heart, kidney and musculoskeletal malformations.
Therefore, if you are a woman of childbearing potential:

• before starting treatment with Naegoti, your doctor will inform you about the 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 contraception during treatment with Naegoti 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 reminder document explaining why you should not become pregnant while taking Naegoti.

If you become pregnant during treatment with Naegoti, tell your doctor immediately.
The doctor will decide to stop treatment (see “If you stop taking Naegoti” in section 3 and also section 4, “Possible side effects”). You will also need to have specialized prenatal check-ups.
Breastfeeding

Do not breastfeed during treatment with Naegoti. Fingolimod can pass into 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. Naegoti should not affect your ability to drive vehicles and use machines.
However, at the beginning of treatment, you should remain at the doctor's office or in hospital for 6 hours after taking the first dose of Naegoti. The ability to drive vehicles and use machines may be impaired during this time and potentially also afterwards.

Naegoti contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially ‘sodium-free’.

3. How to take Naegoti

Treatment with Naegoti will be supervised by a doctor experienced in the treatment of multiple
sclerosis.
Take this medicine following the doctor's instructions exactly. 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 (10 years of age and older):
The dose depends on body weight:

• Children and adolescents with a body weight equal to or less than 40 kg: one 0.25 mg capsuleper day.
• Children and adolescents with a body weight greater than 40 kg: one 0.5 mg capsule perday.

Children and adolescents who start treatment with a 0.25 mg capsule per day and
subsequently reach a stable body weight above 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
observation period of the first dose.
Do not exceed the recommended dose.
Naegoti is for oral use.
Take Naegoti once a day with a glass of water. The Naegoti capsules must always be
swallowed whole, without opening them. Naegoti can be taken with or without food.
Taking Naegoti 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 Naegoti, contact your doctor or pharmacist.

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

If you forget to take Naegoti
If you have been taking Naegoti for less than 1 month and forget to take 1 dose for an entire day, contact
your doctor before taking the next dose. The doctor may decide to observe you when you take the next
dose.
If you have been taking Naegoti for at least 1 month and have forgotten to take the medicine for more than 2
weeks, contact your doctor before taking the next dose. The doctor may decide to observe you 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 Naegoti
Do not stop taking Naegoti and do not change the dose without first contacting your doctor.
Fingolimod will remain in the body for up to 2 months after stopping treatment. The number of
white blood cells (lymphocytes) may remain low during this period and the undesirable effects described in
this leaflet may still occur. After stopping treatment with Naegoti, you may need to wait 6-8 weeks before
starting a new treatment for multiple sclerosis.
If it is necessary to restart taking Naegoti after more than 2 weeks of interruption of
treatment, the effect on heart rate that normally occurs at the beginning of treatment
may occur again: to restart treatment it will therefore be necessary to stay in
the outpatient clinic or hospital under observation. Do not restart treatment with Naegoti after having
interrupted 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
Naegoti. Immediately inform your doctor if you think there is a worsening of multiple
sclerosis after stopping treatment with Naegoti. This may 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 phlegm, chest discomfort, fever (signs of lung problems)
• Herpes virus infection (shingles or herpes zoster), with symptoms such as blisters, burning, itching or pain on the skin, usually 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 spots 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
• It is known that depression and anxiety occur with increased frequency in the population affected by MS and have 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 blind spots 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 1000):
• A syndrome called reversible posterior encephalopathy syndrome. Symptoms may include sudden onset of severe headache, confusion, seizures and/or visual disturbances
• Lymphoma (a type of cancer that affects the lymphatic system)
• Squamous cell carcinoma: a type of skin cancer that may appear as a hard-textured red nodule, a crusted ulceration, or a new ulceration on a pre-existing scar Very rare(may affect up to 1 in 10,000):
• Abnormality on the electrocardiogram (T wave inversion)
• Tumor related 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 Naegoti.
• 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 upper right part of the stomach (abdomen), dark urine (brown in color), unusual feeling of loss of appetite,

fatigue and abnormal liver function tests. In a very limited number of cases,
liver failure may lead to liver transplantation

• Risk of developing a rare brain infection called progressive multifocal leukoencephalopathy (PML). Symptoms of PML may be similar to an MS relapse. Symptoms that you may not be personally aware of may also occur, such as changes in mood or behavior, memory lapses, 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 any new or unusual symptoms, it is very important that you see 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 painless flesh-colored or bluish-red nodules, often on the face, head or neck. Merkel cell carcinoma can also appear as a painless hard nodule or a mass. Long-term sun exposure and a weakened immune system can affect the risk of developing Merkel cell carcinoma.
• After stopping treatment with Naegoti, the symptoms of MS may reappear and possibly worsen compared to how they were before or during treatment.
• Autoimmune form of anemia (decrease in red blood cells) where 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):

• Tinea, a fungal skin infection (pityriasis versicolor)
• Dizziness
• Severe headache often accompanied by nausea, vomiting and sensitivity to light (migraine)
• Low levels of white blood cells in the blood (lymphocytes, leukocytes)
• Weakness
• Skin rash with itching, redness and burning (eczema)
• Itching
• Increased levels of fats (triglycerides) in the blood
• Hair loss
• Shortness of breath
• Depression
• Blurred vision (see also the paragraph regarding macular edema “Some side effects may be or become serious”)
• High blood pressure (Naegoti can 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 1000):
• Cancer of the lymphatic system (lymphoma)

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

• Peripheral edema

If any of these 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 Naegoti

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.
This medicine does not require any particular storage conditions.
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. Package Contents and Other Information

What Naegoti contains

• The active ingredient is fingolimod. Naegoti 0.25 mg hard capsules Each capsule contains 0.25 mg of fingolimod (as hydrochloride). Naegoti 0.5 mg hard capsules Each capsule contains 0.5 mg of fingolimod (as hydrochloride).
• Other ingredients are: Capsule contents: Pregelatinized starch (corn), Sodium lauryl sulfate. Naegoti 0.25 mg hard capsules Capsule shell: Titanium dioxide (E171), gelatin. Naegoti 0.5 mg hard capsules Capsule shell: Yellow iron oxide (E172), titanium dioxide (E171), gelatin. Printing ink: Lacquer, propylene glycol (E1520), ammonia solution, concentrated, black iron oxide (E172), potassium hydroxide

Description of Naegoti and package contents
Naegoti 0.25 mg hard capsules: gelatin capsules of approximately 14 mm inscribed in black, with “TV 3654” on the
opaque white capsule cap and “TV 3654” on the opaque white capsule body.
Naegoti 0.5 mg hard capsules: gelatin capsules of approximately 14 mm inscribed in black, with “TV 7820” on the
yellow capsule cap and “TV 7820” on the opaque white capsule body.
Naegoti is available in boxes of 7 and 84 hard capsules in blisters or 28x1 hard capsules in blisters
divisible for single doses.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
medac pharma s.r.l
Via Viggiano 90,
00178 Rome, Italy

and manufacturers
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.
2600 Dupnitsa, Bulgaria
Actavis Ltd
BLB015-016 Bulebel Industrial Estate
3000 Zejtun, Malta

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Germany: Naegoti 0.25mg hard capsules, Naegoti 0.5mg hard capsules
Italy: Naegoti