Patient Information Leaflet

Efigalo, 0.5 mg, hard capsules
fingolimod
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

Keep this leaflet, as 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 individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

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

1. What Efigalo is and what it is used for

What Efigalo is
Efigalo contains the active substance fingolimod.

What Efigalo is used for
Efigalo is used in adults, 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 previous MS treatments, or
patients with rapidly evolving, severe form of MS.

Efigalo 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, an inflammatory process damages the protective covering of nerves (called myelin) in the CNS, impairing their proper function. This phenomenon is known as demyelination. Relapsing-remitting MS is characterized by recurrent episodes (relapses) of neurological symptoms, reflecting inflammatory activity within the CNS. Symptoms vary among patients but typically include walking difficulties, numbness, vision problems, or balance disturbances. Symptoms of relapses may resolve completely, although some deficits may persist.

How Efigalo works
Efigalo 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, Efigalo limits nerve damage caused by MS. Efigalo also modulates certain immune responses in the body.

2. Important information before taking Efigalo

When not to take Efigalo

if the patient has reduced immune response (due to immunodeficiency syndrome, disease, or use of immunosuppressive drugs)
if the doctor suspects the patient has a rare brain infection called progressive multifocal leukoencephalopathy (PML) or if PML has already been diagnosed in the patient
if the patient has severe active infection or chronic active infection, such as hepatitis or tuberculosis
if the patient has active cancer
if the patient has severe liver disease
if the patient has had a heart attack, angina, stroke, or warning signs of stroke, or certain types of heart failure within the last 6 months
if the patient has a certain type of irregular or abnormal heartbeat (arrhythmia), including patients in whom electrocardiographic (ECG) testing has shown QT interval prolongation before starting treatment with Efigalo
if the patient is currently taking or has recently taken medications for irregular heartbeat, such as quinidine, disopyramide, amiodarone, or sotalol
if the patient is pregnant or of childbearing potential and not using effective contraception
if the patient is allergic to fingolimod or any of the other ingredients of this medicine (listed in section 6). If any of these situations apply or the patient has any doubts, they should consult their doctor before taking Efigalo.

Warnings and precautions
Before starting treatment with Efigalo, discuss the following with your doctor:

if the patient has severe breathing problems during sleep (severe sleep apnoea)
if the patient has been told that their ECG recording is abnormal
if the patient experiences symptoms of slow heart rate (e.g. dizziness, nausea, or palpitations)
if the patient is taking or has recently taken medications that slow heart rate (such as beta-blockers, verapamil, diltiazem, ivabradine, digoxin, cholinesterase inhibitors, or pilocarpine)
if the patient has previously experienced sudden loss of consciousness or fainting
if the patient plans to receive vaccination
if the patient has never had chickenpox
if the patient has or has had vision disorders or other symptoms of swelling in the central part of the 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 the patient has diabetes, which may cause vision problems
if the patient has liver disease
if the patient has high blood pressure that cannot be controlled with medication
if the patient has severe lung disease or a smoker's cough

If any of these situations apply or the patient has any doubts, they should consult their doctor before taking Efigalo.

Slow heart rate (bradycardia) and irregular heartbeat
At the beginning of treatment or after taking the first dose of 0.5 mg in patients previously receiving a daily dose of 0.25 mg, Efigalo slows heart rate. As a result, the patient may experience dizziness, fatigue, palpitations, or low blood pressure. If these symptoms are severe, the patient should inform their doctor immediately, as prompt treatment may be required. Efigalo may also cause irregular heartbeat, especially after the first dose. Irregular heartbeat usually returns to normal within less than one day. Slow heart rate typically returns to normal within one month. During this period, no clinically significant effect on heart rate is expected.
The doctor will ask the patient to remain in the doctor's office or clinic for at least 6 hours after taking the first dose of Efigalo or the first 0.5 mg dose when switching from a 0.25 mg daily dose, with hourly monitoring of pulse and blood pressure, so that appropriate treatment can be administered if adverse effects occur at the beginning of treatment. An ECG will be performed before the first dose of Efigalo and again after the 6-hour observation period. During this time, the doctor may perform continuous cardiac monitoring using electrocardiography. If after 6 hours of observation the patient has a very slow or progressively decreasing heart rate, or if the ECG shows abnormalities, prolonged monitoring (for at least 2 additional hours or possibly until the next day) may be required until these symptoms resolve. The same procedure may be recommended if the patient resumes Efigalo treatment after a treatment interruption, depending on the duration of the interruption and how long the patient had previously taken Efigalo.
If the patient has irregular or abnormal heartbeat, risk factors for such events, abnormal ECG findings, or heart disease or heart failure, Efigalo may not be suitable.
If the patient has a history of sudden loss of consciousness or slowed heart function, Efigalo may not be appropriate. A consultation with a cardiologist (a heart specialist) may be needed to advise on how to initiate Efigalo treatment, including overnight monitoring.
If the patient is taking medications that may reduce heart rate, Efigalo may not be appropriate. A cardiologist consultation may be required to determine whether the patient can switch to other medications that do not reduce heart rate, to allow Efigalo treatment. If such a switch is not possible, the cardiologist will advise on initiating Efigalo treatment, including monitoring until the day after the first dose.

Patients who have never had chickenpox
If the patient has never had chickenpox, the doctor will check the patient's immunity to the varicella zoster virus. If the patient is not protected against the virus, vaccination may be required before starting Efigalo treatment. If this is the case, the doctor will delay the start of Efigalo treatment by one month after completion of the full vaccination course.

Infections
Efigalo reduces the number of white blood cells (particularly lymphocytes). White blood cells fight infections. While taking Efigalo (and for up to 2 months after stopping treatment), the patient may be more susceptible to infections. Existing infections may worsen. Infections may be severe and life-threatening. If the patient suspects they have an infection, has a fever, flu-like symptoms, shingles, or headache accompanied by neck stiffness, photophobia, nausea, rash, and/or confusion or seizures (which may be symptoms of meningitis and/or encephalitis caused by fungal or herpes virus infection), they should contact their doctor immediately, as this condition may be severe and life-threatening.
Human papillomavirus (HPV) infection, including cases of warts, dysplasia, and HPV-related malignant tumours, has been reported in patients treated with Efigalo.
The doctor will consider the need for HPV vaccination before starting treatment. In women, the doctor will also recommend screening tests for HPV.

PML
PML is a rare brain disorder caused by infection that may lead to severe disability or death. The treating doctor will order magnetic resonance imaging (MRI) before starting and during treatment to monitor PML risk.
If the patient feels their multiple sclerosis is worsening or if they notice new symptoms, such as mood or behavioural changes, new weakness or worsening of existing weakness on one side of the body, vision changes, confusion, transient memory lapses, or speech and communication difficulties, they should speak to their doctor as soon as possible. These may be symptoms of PML. The patient should also talk to their partner or caregivers and inform them about the treatment being used. Symptoms may occur that the patient is not aware of.
If PML occurs, it can be treated, and Efigalo treatment will be stopped.
In some patients, after removal of Efigalo from the body, an inflammatory reaction may occur. This reaction (called immune reconstitution inflammatory syndrome, IRIS) may lead to worsening of the patient's condition, including worsening brain function.

Macular oedema
Before starting Efigalo treatment, the doctor may refer patients with current or past vision disorders or other symptoms of swelling in the central visual field (macula) at the back of the eye, eye inflammation or infection (uveitis), or diabetes for ophthalmological examination.
The doctor may refer the patient for ophthalmological examination 3 to 4 months after starting Efigalo treatment.
The macula is a small area of the retina at the back of the eye that enables clear and sharp vision of shapes, colours, and fine details. Efigalo may cause swelling of the macula, a condition called macular oedema. This swelling usually occurs within the first 4 months of Efigalo treatment.
The risk of macular oedema is higher in patients with diabetes or a history of uveitis. In such cases, the doctor will order regular ophthalmological examinations to detect macular oedema.
If macular oedema occurs, the patient should inform their doctor before resuming Efigalo treatment.
Macular oedema may cause visual disturbances similar to those in MS attacks (optic neuritis). In early stages, symptoms may be absent. The patient should inform their doctor of any changes in vision. The doctor may refer the patient for ophthalmological examination, especially if:

the centre of the visual field becomes blurred or shadowed,
a blind spot appears in the centre of the visual field,
there are difficulties with colour vision or seeing fine details.

Liver function tests
Patients with severe liver disease should not take Efigalo. Efigalo may affect liver function test results. The patient may not experience any symptoms, but if yellowing of the skin or whites of the eyes, abnormally dark (brown) urine, pain in the right side of the abdomen, fatigue, reduced appetite, or unexplained nausea and vomiting occur, the patient should inform their doctor immediately.
If any of these symptoms occur after starting Efigalo treatment, the patient should inform their doctor immediately.
Before, during, and after treatment, the doctor will order blood tests to monitor liver function. If test results indicate liver function abnormalities, Efigalo treatment may be discontinued.

High blood pressure
The doctor may regularly check blood pressure, as Efigalo causes a slight increase in blood pressure.

Lung diseases
Efigalo has a minor effect on lung function. Patients with severe lung disease or smoker's cough are at higher risk of adverse effects.

Blood cell count
A decrease in white blood cells in the blood is an expected effect of Efigalo. Their number usually returns to normal within 2 months after stopping treatment. If blood tests are needed, the patient should inform their doctor about taking Efigalo. Otherwise, the doctor may not be able to interpret blood test results correctly, and for certain tests, the doctor may order a larger blood sample than usual.
Before starting Efigalo, the doctor will confirm that the white blood cell count is appropriate to begin treatment and may order regular repeat tests. If there are insufficient white blood cells, Efigalo treatment may need to be discontinued.

Posterior reversible encephalopathy syndrome (PRES)
PRES, a rare condition, has been reported in MS patients treated with Efigalo. Symptoms may include sudden severe headache, confusion, seizures, and vision changes. If the patient experiences any of these symptoms during Efigalo treatment, they should inform their doctor immediately, as this condition may be serious.

Cancer
Skin cancers have been reported in MS patients treated with Efigalo. If any lumps (e.g. shiny, pearly nodules), spots, or open sores that do not heal within a few weeks are noticed on the skin, the patient should inform their 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. A skin examination must be performed before starting Efigalo treatment to detect any skin lumps. The treating doctor will also perform regular skin checks during Efigalo treatment. If skin problems occur, the treating doctor may refer the patient to a dermatologist, who may recommend regular visits after consultation.

Lymphoma, a type of lymphatic system cancer, has been reported in MS patients treated with Efigalo.

Sun exposure and sun protection
Fingolimod weakens the immune system. This condition increases the risk of malignant tumours, especially skin cancers. The patient should limit sun and UV radiation exposure by:

wearing protective clothing
regularly applying sunscreen with high UV protection factor

Unusual brain changes related to MS relapse
Rare cases of unusually large brain lesions related to MS relapse have been reported in patients treated with Efigalo. In case of severe MS relapse, the treating doctor may consider performing an MRI to assess this condition and decide whether Efigalo treatment should be discontinued.

Switching from other medications to Efigalo
The doctor may switch treatment directly from interferon-beta, glatiramer acetate, or dimethyl fumarate to Efigalo if there are no signs of abnormalities caused by previous treatment. The doctor may order blood tests to rule out such abnormalities. After stopping natalizumab, a 2- to 3-month waiting period may be required before starting Efigalo. When switching from teriflunomide, the doctor may advise waiting a certain time or undergoing an accelerated elimination procedure. Patients previously treated with alemtuzumab require careful evaluation and discussion with their doctor before deciding whether Efigalo is suitable.

Women of childbearing potential
If Efigalo is used during pregnancy, it may harm the unborn child. Before starting Efigalo treatment, the doctor will explain the risks to the patient and request a pregnancy test to exclude pregnancy. The doctor will provide the patient with an information card explaining why pregnancy should be avoided during Efigalo treatment. The card also contains information on how to avoid pregnancy during Efigalo treatment.
Patients must use effective contraception during treatment and for 2 months after stopping treatment (see section "Pregnancy and breastfeeding").

Worsening of MS after stopping Efigalo
Do not stop taking Efigalo or change the dose without first consulting a doctor.
The patient should inform their doctor immediately if they feel their MS is worsening after stopping Efigalo. This situation may be serious (see "Stopping Efigalo" in section 3 and section 4 "Possible side effects").

Elderly patients
Experience with Efigalo in elderly patients (over 65 years) is limited. If in doubt, consult a doctor.

Children and adolescents
Efigalo 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, adolescents, and their caregivers includes:

Before starting Efigalo treatment, the doctor will check the patient's vaccination status. If the patient has not received certain vaccinations, vaccination may be required before starting Efigalo.
During the first dose of Efigalo or when changing the daily dose from 0.25 mg to 0.5 mg, the doctor will monitor heart rate and pulse (see "Slow heart rate (bradycardia) and irregular heartbeat" above).
If the patient experiences seizures or epileptic fits before or during Efigalo treatment, they should inform their doctor.
If the patient develops depression or anxiety, or feels low mood or distress during Efigalo treatment, they should inform their doctor. Close monitoring may be required.

Efigalo and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take:

Immunosuppressive or immunomodulatory drugs, including other MS treatments such as interferon beta, glatiramer acetate, natalizumab, mitoxantrone, teriflunomide, dimethyl fumarate, or alemtuzumab. Efigalo must not be used with these drugs, as this could intensify the effect on the immune system (see also "When not to take Efigalo").
Corticosteroids, due to the potential for additive effects on the immune system.
Vaccines. If the patient requires vaccination, they should consult their doctor first. During and for 2 months after Efigalo treatment, patients should not receive certain vaccines (live attenuated vaccines), as they could cause the infection they are meant to prevent. Other vaccines may also be ineffective if administered during this period.
Medications that slow heart rate (e.g. beta-blockers such as atenolol). Using Efigalo with these drugs could intensify the effect on heart function in the first days of Efigalo treatment.
Medications for irregular heartbeat, such as quinidine, disopyramide, amiodarone, or sotalol. Efigalo must not be used in patients taking these drugs, as it could intensify the effect on irregular heartbeat (see also "When not to take Efigalo").
Other medicines:
protease inhibitors, antiviral drugs such as ketoconazole, azole antifungals, clarithromycin, or telithromycin,
carbamazepine, rifampicin, phenobarbital, phenytoin, efavirenz, or St. John's wort preparations (possible risk of reduced Efigalo effectiveness).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor before using this medicine.

Pregnancy
Efigalo should not be used: during pregnancy, when the patient is trying to become pregnant or may become pregnant and is not using effective contraception. If Efigalo is used during pregnancy, there is a risk of harm to the unborn child. The rate of congenital malformations observed in children exposed to Efigalo during pregnancy is about twice that observed in the general population (in whom the rate of congenital malformations is approximately 2-3%). Most commonly reported congenital malformations include developmental defects of the heart, kidneys, and musculoskeletal system.
Therefore, if the patient is of childbearing age:

before starting Efigalo treatment, the doctor will inform the patient about the risk to the unborn child and request a pregnancy test to confirm the patient is not pregnant, and
effective contraception must be used during Efigalo treatment and for two months after stopping treatment to avoid pregnancy. The patient should discuss effective contraceptive methods with their doctor.

The doctor will provide the patient with an information card explaining why pregnancy should be avoided during Efigalo treatment.
If the patient becomes pregnant while taking Efigalo, she must inform her doctor immediately. The doctor will decide whether to discontinue treatment (see "Stopping Efigalo" in section 3 and section 4 "Possible side effects"). The patient will also need to attend follow-up prenatal examinations.

Breastfeeding
Breastfeeding should not be used during Efigalo treatment. Efigalo may pass into breast milk, posing a risk of serious adverse effects in the infant.

Driving and operating machinery
The doctor will inform the patient whether their condition allows them to safely drive vehicles, including bicycles, and operate machinery. Efigalo is not expected to affect the ability to drive or operate machinery.
However, at the beginning of treatment, the patient must remain in the doctor's office or clinic for 6 hours after taking the first dose of Efigalo. During this time and potentially afterwards, the ability to drive and operate machinery may be impaired.

3. How to take Efigalo

Treatment with Efigalo will be supervised by a physician experienced in the management of multiple sclerosis.
This medicine should always be taken exactly as prescribed by the physician. 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 with body weight equal to or less than 40 kg: one 0.25 mg capsule once daily.
Children and adolescents with body weight above 40 kg: one 0.5 mg capsule once daily.
Children and adolescents who initiate treatment with one 0.25 mg capsule once daily and subsequently achieve a stable body weight above 40 kg will receive instructions from their physician to switch to one 0.5 mg capsule once daily. In this case, repeat observation period as after the first dose is recommended.

Efigalo is not available in a 0.25 mg strength. For this dose, other available fingolimod-containing medicines should be used. Please consult your doctor or pharmacist.
Do not exceed the recommended dose.

Efigalo is intended for oral administration.
Efigalo should be taken once daily with a glass of water. Efigalo capsules should always be swallowed whole, without opening them. Efigalo may be taken with or without food.
Taking Efigalo at the same time each day will help remember to take the medicine.
For any questions regarding the duration of treatment with Efigalo, consult your doctor or pharmacist.

Taking more Efigalo than recommended
If a patient takes more Efigalo than prescribed, they should contact their doctor immediately.

Missed dose of Efigalo
If a patient has been taking Efigalo for less than 1 month and misses one dose for the entire day, they should contact their doctor before taking the next dose. The doctor may decide to keep the patient under observation when administering the next dose.
If a patient has been taking Efigalo for at least 1 month and has missed doses for more than 2 weeks, they should contact their doctor before taking the next dose. The doctor may decide to keep the patient under observation when administering the next dose.
However, if a patient has missed doses for up to 2 weeks, they may take the next dose as scheduled.
Do not take a double dose to make up for a missed dose.

Stopping Efigalo
Do not stop treatment with Efigalo or change the dose without first consulting your doctor.
Efigalo may remain in the body for up to 2 months after stopping treatment. During this time, white blood cell count (lymphocyte count) may still be reduced and adverse reactions described in this leaflet may continue to occur. After stopping Efigalo, wait 6–8 weeks before starting a new multiple sclerosis treatment.

In patients restarting Efigalo after a break of more than 2 weeks, the effect on heart rate observed usually after the first initiation of treatment may reoccur, and monitoring of the patient in a doctor’s office or clinic will be necessary upon resuming treatment. Do not restart treatment with Efigalo after a break of more than two weeks without consulting the treating physician.

The treating physician will decide whether and how monitoring should be performed after stopping Efigalo. Inform your doctor immediately if you feel your multiple sclerosis is worsening after stopping Efigalo. This situation may be serious.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Common (occurring in up to 1 in 10 patients)

Productive cough, 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, 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 lump, although it may also have a different appearance.
Depression and anxiety are known to occur more frequently in patients with MS and have also been reported in children and adolescents treated with Efigalo.
Weight loss.

Uncommon (occurring in up to 1 in 100 patients)

Pneumonia with symptoms such as fever, cough, difficulty breathing.
Macular oedema (swelling in the central part of the retina at the back of the eye) with symptoms such as shadows or gaps in the centre of vision, blurred vision, difficulty perceiving colours 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, thickness, or colour over time, or new moles appearing. Moles may itch, bleed, or ulcerate.
Seizures, epileptic fits (more common in children and adolescents than in adults).

Rare (occurring in 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 tumour involving 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 (occurring in up to 1 in 10,000 patients)

Abnormalities in ECG recordings (T-wave inversion).
Tumour associated with human herpesvirus type 8 infection (Kaposi’s sarcoma).

Frequency not known (frequency cannot be estimated from available data)

Allergic reactions, including rash or itchy hives, swelling of the lips, tongue, or face, which are more likely to occur on the day treatment with Efigalo is started.
Signs of liver disease (including liver failure), such as yellowing of the skin or whites of the eyes (jaundice), nausea or vomiting, pain in the right side of the abdomen, dark (brown) urine, reduced appetite, fatigue, and abnormal liver function test results. 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, which the patient may not be aware of, may also occur, such as changes in mood or behaviour, temporary memory lapses, difficulty speaking and communicating, which should be evaluated by a doctor to rule out PML. Therefore, if a 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 their doctor as soon as possible.
Inflammatory disorders after stopping treatment with Efigalo (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-coloured or blue-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 a weakened immune system may influence the risk of developing Merkel cell carcinoma.
After discontinuation of treatment with Efigalo, MS symptoms may return and worsen compared to the period before and during treatment.
Autoimmune form of anaemia (reduced number of red blood cells), in which red blood cells are destroyed (autoimmune haemolytic anaemia).

If any of these side effects occur, inform your doctor immediately.

Other side effects

Very common (occurring in more than 1 in 10 patients)

Viral influenza 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
Diarrhoea
Back pain
Increased liver enzyme activity in blood tests
Cough

Common (occurring in up to 1 in 10 patients)

Fungal skin infections (dermatophyte-induced fungal infection) (pityriasis versicolor)
Dizziness
Severe headache, often accompanied by nausea, vomiting, and light sensitivity (migraine symptoms)
Low number of white blood cells (lymphocytes, leukocytes)
Weakness
Itchy, red, burning rash (rash)
Itching
Increased levels of fats (triglycerides) in the blood
Hair loss
Shortness of breath
Depression
Blurred vision (see also section on macular oedema under “Some side effects may be or may become serious”)
Hypertension (Efigalo may cause a mild increase in blood pressure)
Muscle pain
Joint pain

Uncommon (occurring in up to 1 in 100 patients)

Low number of white blood cells (neutrophils)
Depressed mood
Nausea

Rare (occurring in up to 1 in 1,000 patients)

Lymphatic system tumour (lymphoma)

Frequency not known (frequency cannot be estimated from available data)

Peripheral oedema

If any of these symptoms occur severely, inform your doctor.

Reporting of side effects

If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting side effects helps to provide more information on the safety of this medicine.

5. How to store Efigalo medicine

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Blister packs:
Do not store above 25℃.
Store in the original packaging to protect from moisture.
Container:
Do not store above 25℃.
Keep the container tightly closed to protect from moisture.
Medicines must not be disposed of via wastewater 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 Efigalo contains

The active substance is fingolimod. Each hard capsule contains fingolimod hydrochloride equivalent to 0.5 mg of fingolimod.
The other ingredients are: microcrystalline cellulose (E 460), povidone K30, magnesium stearate. Capsule shell – body: titanium dioxide (E 171), carrageenan, potassium chloride, hypromellose. Capsule shell – cap: titanium dioxide (E 171), iron oxide, yellow (E 172), carrageenan, potassium chloride, hypromellose. Printing ink: shellac, iron oxide, black (E 172).

What Efigalo looks like and contents of the pack
The capsule cap is brown-yellow with a black inscription "F 0.5 mg" and a black company logo. The body of the capsule is white. The capsule contents are white or almost white powder. Capsule length: 15–17 mm.
Efigalo is available in packs containing:

7, 14, 28, 30, 56, 60, 90, 98 and 100 hard capsules in blister packs.
30 x 1, 60 x 1, 90 x 1 and 100 x 1 hard capsules in perforated blister strips, divided into single doses.
calendar pack: 7 x 1, 14 x 1, 28 x 1, 56 x 1 and 98 x 1 hard capsules in perforated blister strips, divided into single doses.

Efigalo is also available in containers containing 30 hard capsules, in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Krka, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Manufacturer
Krka, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Ardena Pamplona S.L., Poligono Mocholi, C/Noain, n°1 de Noain, 31110 Navarra, Spain
For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw, Poland
Tel. 22 57 37 500