Gaxenim

Package leaflet: Information for the patient

Gaxenim, 0.5 mg, hard capsules
Fingolimod
Please read the entire leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet for future reference.
• If you have any questions, please consult 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 as yours.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Gaxenim is and what it is used for

What Gaxenim is
Gaxenim contains the active substance fingolimod.

What Gaxenim is used for
Gaxenim 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 MS.

Gaxenim does not cure MS, but helps reduce the number of relapses and slows the progression of disability caused by MS.

What is multiple sclerosis
MS is a chronic disease of the central nervous system (CNS), which consists of the brain and spinal cord. In MS, the inflammatory process damages the protective covering of nerves (called myelin) within 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 disturbances, or problems with balance. Symptoms of relapses may completely resolve, although some impairments may persist.

How Gaxenim works
Gaxenim helps protect the CNS from immune system attacks by reducing the ability of certain white blood cells (lymphocytes) to move freely throughout the body and by preventing them from entering the brain and spinal cord. In this way, the medicine limits nerve damage associated with MS. Gaxenim also reduces certain immune responses in the body.

2. Important information before taking Gaxenim

When not to take Gaxenim

• if the patient has a weakened immune response (due to immunodeficiency syndrome, disease, or taking medicines that suppress the immune system); if the doctor suspects that the patient has a rare brain infection called progressive multifocal leukoencephalopathy (PML) or if PML has 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 showed QT interval prolongation before starting treatment with Gaxenim;
• if the patient is currently taking or has recently taken medicines for irregular heartbeat, such as quinidine, disopyramide, amiodarone, or sotalol;
• if the patient is pregnant or of childbearing age 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 this is the case or if the patient has any doubts, consult the doctor before taking Gaxenim.

Warnings and precautions
Before starting Gaxenim, discuss with your doctor:

• if the patient has severe breathing problems during sleep (sleep apnoea);
• if the patient has been told that their ECG recording is abnormal;
• if the patient experiences symptoms of a slow heartbeat (e.g. dizziness, nausea, or palpitations);
• if the patient is taking or has recently taken medicines that slow the heartbeat (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 be vaccinated;
• if the patient has never had chickenpox;
• if the patient has or has had vision problems or other symptoms of swelling in the centre 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 problems;
• if the patient has high blood pressure that cannot be controlled with medication;
• if the patient has severe lung disease or a smoker-type cough. If any of these situations apply or if the patient has any doubts, consult the doctor before taking Gaxenim.

Slow heart rate (bradycardia) and irregular heartbeat
At the beginning of treatment or after taking the first 0.5 mg dose in patients previously taking a 0.25 mg daily dose, Gaxenim slows the heart rate. As a result, the patient may experience dizziness, fatigue, strong heartbeat, or low blood pressure. If these symptoms are severe, inform the doctor immediately, as immediate treatment may be required. Gaxenim may also cause irregular heartbeat, especially after the first dose. Irregular heartbeat usually returns to normal within less than one day. Slow heart rate usually 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 Gaxenim or after 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 given if adverse effects occur at the beginning of treatment. An ECG will be performed before the first dose of Gaxenim and after the 6-hour observation period. During this time, the doctor may continuously monitor the patient's heart function using electrocardiography. If, after 6 hours of observation, the patient has a very slow or decreasing heart rate or if the ECG shows abnormalities, prolonged monitoring (at least 2 hours longer or possibly until the next day) may be required until these symptoms resolve. The same procedure may be recommended if the patient resumes Gaxenim treatment after a treatment interruption, depending on the duration of the interruption and how long the patient had previously taken Gaxenim before the interruption.
If the patient has irregular or abnormal heartbeat or risk factors for such events, abnormal ECG findings, heart disease, or heart failure, Gaxenim may not be suitable.
If the patient has a history of sudden loss of consciousness or slowed heart function, Gaxenim may not be suitable. A consultation with a cardiologist (a heart specialist) may be needed to advise on how to start Gaxenim treatment, including overnight monitoring.
If the patient is taking medicines that may reduce heart rate, Gaxenim may not be suitable. A consultation with a cardiologist may be required to determine whether the patient can switch to other medicines that do not reduce heart rate, to allow Gaxenim treatment. If such a change is not possible, the cardiologist will advise the patient on how to start Gaxenim 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 chickenpox virus (varicella zoster virus). If the patient is not protected against the virus, vaccination may be required before starting Gaxenim treatment. If this is the case, the doctor will delay the start of Gaxenim treatment by one month after completing the full vaccination course.

Infections
Gaxenim reduces the number of white blood cells (especially lymphocytes). White blood cells fight infections. While taking Gaxenim (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 an infection, has a fever, flu-like symptoms, shingles, or headache with neck stiffness, light sensitivity, nausea, rash, and/or confusion or seizures (which may be symptoms of meningitis and/or encephalitis caused by fungal or herpes virus infection), the patient should contact the doctor immediately, as this condition may be serious and life-threatening.
In patients treated with fingolimod, human papillomavirus (HPV) infection has been reported, including cases of warts, dysplasia, and HPV-related malignant tumours. The doctor may consider the need for HPV vaccination before starting treatment. In women, the doctor will also recommend screening 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) scans before and during treatment to monitor PML risk.
If the patient feels their multiple sclerosis (MS) 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, temporary memory lapses, or speech and communication difficulties, they should speak to the 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. Symptoms may occur that the patient is not aware of.
If PML occurs, it can be treated, and Gaxenim treatment will be stopped. In some patients, after removing Gaxenim from the body, an inflammatory reaction may occur. This reaction (called immune reconstitution inflammatory syndrome, IRIS) may worsen the patient's condition, including worsening brain function.

Macular oedema
Before starting Gaxenim treatment, the doctor may refer patients with current or past vision problems or other symptoms of swelling in the centre of the 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 Gaxenim 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 other details. Gaxenim may cause swelling of the macula, a condition called macular oedema. This swelling usually occurs within the first 4 months of Gaxenim 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, inform the doctor before resuming Gaxenim treatment.
Macular oedema may cause vision disturbances similar to MS relapse (optic neuritis). In the early stages, symptoms may not occur at all.
Inform the doctor of any vision changes. The doctor may refer the patient for ophthalmological examination, especially if:

• the centre of the visual field becomes blurry or shaded;
• a blind spot appears in the centre of the visual field;
• difficulty seeing colours or fine details occurs.

Liver function tests
Patients with severe liver disease should not take Gaxenim. Gaxenim 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, inform the doctor immediately.
If any of these symptoms occur after starting Gaxenim treatment, inform the doctor immediately.
Before, during, and after treatment, the doctor will order blood tests to monitor liver function. If test results indicate liver function disorders, Gaxenim treatment may be stopped.

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

Lung problems
Gaxenim has a minor effect on lung function. Patients with severe lung disease or smoker-type cough are at higher risk of adverse effects.

Blood cell count
A known effect of Gaxenim is a reduction in the number of white blood cells in the blood. Their number usually returns to normal within 2 months after stopping treatment. When blood tests are needed, inform the doctor about taking Gaxenim. Otherwise, the doctor may not be able to interpret blood test results, and for certain tests, the doctor may order a larger blood sample than usual.
Before starting Gaxenim, 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, Gaxenim treatment may need to be stopped.

Posterior reversible encephalopathy syndrome (PRES)
In patients with MS treated with fingolimod, a rare condition called posterior reversible encephalopathy syndrome (PRES) has been reported. Symptoms may include sudden severe headache, confusion, seizures, and vision changes. If any of these symptoms occur during Gaxenim treatment, inform the doctor immediately, as this condition may be serious.

Cancer
In patients with MS treated with fingolimod, skin cancers have been reported. If any lumps (e.g. shiny, pearly lumps), spots, or open sores that do not heal within a few weeks appear on the skin, inform the treating doctor immediately. Skin cancer symptoms may include abnormal growths or changes in skin tissue (e.g. new moles) that change colour, shape, or size over time. Before starting Gaxenim treatment, a skin examination must be performed to check for any skin lumps. The treating doctor will also perform regular skin checks during Gaxenim treatment. If skin problems occur, the treating doctor may refer the patient to a dermatologist, who may decide after consultation that regular visits are necessary.
In patients with MS treated with fingolimod, a certain type of lymphatic system cancer (lymphoma) has been reported.

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 exposure to sunlight and UV radiation by:

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

Unusual brain changes related to MS relapse
In patients treated with fingolimod, rare cases of unusually large brain changes related to MS relapse have been reported. In case of a severe MS relapse, the treating doctor may consider performing an MRI to assess this condition and decide whether to stop taking Gaxenim.

Switching from other medicines to Gaxenim
The doctor may switch treatment directly from interferon-beta, glatiramer acetate, or dimethyl fumarate to Gaxenim if there are no signs of abnormalities caused by previous treatment. The doctor may order blood tests to rule out these abnormalities. After stopping natalizumab treatment, it may be necessary to wait 2 to 3 months before starting Gaxenim treatment. When switching from teriflunomide, the doctor may advise the patient to wait a certain time or undergo an accelerated elimination procedure. Patients previously treated with alemtuzumab require careful assessment and discussion of their situation with the doctor before deciding whether Gaxenim is suitable.

Women of childbearing age
If Gaxenim is used during pregnancy, it may harm the unborn child. Before starting Gaxenim treatment, the doctor will explain the risks to the patient and request a pregnancy test to rule out pregnancy. The doctor will provide the patient with an information card explaining why pregnancy should be avoided during Gaxenim treatment. The card also contains information on how to avoid pregnancy during Gaxenim 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 Gaxenim treatment
Do not stop taking Gaxenim or change the dose without first consulting the doctor.
Inform the doctor immediately if the patient feels their MS is worsening after stopping Gaxenim treatment. This situation may be serious (see "Stopping Gaxenim treatment" in section 3 and section 4 "Possible side effects").

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

Children and adolescents
Gaxenim is not intended for use in children under 10 years of age, as it has not been studied in MS patients in this age group.
The warnings and precautions listed above also apply to children and adolescents. The following information is particularly important for children, adolescents, and their caregivers:

• Before starting Gaxenim treatment, the doctor will check the patient's vaccination status. If the patient has not received certain vaccinations, vaccination may be necessary before starting Gaxenim treatment.
• During the first dose of Gaxenim 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 Gaxenim treatment, inform the doctor.
• If the patient develops depression or anxiety or feels low mood or anxiety during Gaxenim treatment, inform the doctor. The patient may require closer monitoring.

Gaxenim and other medicines
Inform the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take:

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

Pregnancy
Gaxenim should not be used during pregnancy, if the patient is trying to become pregnant, or if the patient may become pregnant and is not using effective contraception. If Gaxenim is used during pregnancy, there is a risk of harm to the unborn child. The rate of congenital malformations observed in children exposed to fingolimod during pregnancy is about twice that observed in the general population (where the rate of congenital malformations is about 2-3%). The 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 Gaxenim treatment, the doctor will inform the patient of the risk to the unborn child and request a pregnancy test to confirm that the patient is not pregnant;
• effective contraception must be used during Gaxenim treatment and for two months after stopping treatment to avoid pregnancy. Discuss effective contraceptive methods with the doctor.

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

Breastfeeding
Do not breastfeed while taking Gaxenim. Gaxenim may pass into breast milk, posing a risk of serious adverse effects in the child.

Driving and operating machinery
The doctor will inform the patient whether their condition allows them to drive safely, including cycling, and operate machinery. Gaxenim 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 Gaxenim. During this time and potentially afterwards, the ability to drive and operate machinery may be impaired.
The medicine contains less than 1 mmol (23 mg) of sodium per hard capsule, meaning the medicine is considered "sodium-free".

3. How to take Gaxenim

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

Recommended dose:
Adults:
One 0.5 mg capsule once daily.

Children and adolescents (aged 10 years and older):
Dose depends on body weight:

• Children and adolescents with body weight less than or equal to 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.

Since the 0.5 mg hard capsules are not suitable for children weighing ≤ 40 kg, alternative fingolimod-containing medicines with lower strength (in the form of 0.25 mg capsules) are available.
Children and adolescents who start treatment with one 0.25 mg capsule once daily and subsequently achieve a stable body weight above 40 kg will receive instructions from their doctor to switch to one 0.5 mg capsule once daily. In such cases, repeat observation monitoring as after the first dose is recommended.

Do not exceed the recommended dose.

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

Taking Gaxenim at the same time each day will help remember to take the medicine.

For any questions regarding the duration of treatment with Gaxenim, consult the doctor or pharmacist.

Overdose of Gaxenim
If a patient has taken more than the recommended dose, they should contact their doctor immediately.

Missed dose of Gaxenim
If a patient has been taking Gaxenim for less than 1 month and forgets to take one dose for a full day, they should contact their doctor before taking the next dose. The doctor may decide to observe the patient when administering the next dose.

If a patient has been taking Gaxenim for at least 1 month and has missed taking the medicine for more than 2 weeks, they should contact their doctor before taking the next dose. The doctor may decide to observe the patient when administering the next dose. However, if the patient has missed taking the medicine 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 Gaxenim
Do not stop treatment with Gaxenim or change the dose without first consulting the doctor.

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

In patients restarting Gaxenim more than 2 weeks after stopping treatment, the effect on heart rate observed usually after first starting treatment may reoccur, and monitoring of the patient in a doctor's office or clinic will be necessary due to treatment reinitiation. Do not restart treatment with Gaxenim after a break lasting more than two weeks without consulting the treating doctor.

The treating doctor will decide whether and how to monitor the patient after stopping treatment with Gaxenim. Inform the doctor immediately if the patient feels their multiple sclerosis is worsening after stopping Gaxenim. This situation may be serious.

If there are any further doubts about using this medicine, consult the doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Some adverse reactions may be or may become serious
Common (may affect less than 1 in 10 people):

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

Uncommon (may affect less than 1 in 100 people):

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

Rare (may affect less than 1 in 1,000 people):

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

Very rare (may affect less than 1 in 10,000 people):

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

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 of starting treatment with Gaxenim
• Symptoms of liver disease (including liver failure), such as yellowing of the skin or whites of the eyes (jaundice), nausea or vomiting, pain in the right side of the abdomen, dark (brown) urine, reduced appetite, fatigue and abnormal liver function 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 a relapse of MS. Other symptoms, which the patient may not be aware of, may also occur, such as changes in mood or behavior, temporary memory lapses, difficulties in speaking and communicating, which should be evaluated by a doctor to rule out PML. Therefore, if the patient feels that their MS is worsening or if the patient or their family notice any new or unusual symptoms, it is very important to inform the treating doctor as soon as possible.
• Inflammatory disorders after discontinuation of Gaxenim treatment (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 symptoms of Merkel cell carcinoma include the presence of a painless, flesh-colored or bluish-red nodule, often located on the face, head or neck. Merkel cell carcinoma may also present as a firm, painless nodule or mass. Long-term sun exposure and weakened immune system may influence the risk of developing Merkel cell carcinoma.
• After stopping treatment with Gaxenim, MS symptoms may return and worsen compared to the period before and during treatment.
• Autoimmune form of anemia (reduced number of red blood cells), in which red blood cells are destroyed (autoimmune hemolytic anemia)

If any of these reactions occur in the patient, the doctor should be informed immediately.
Other adverse reactions
Very common (may affect more than 1 in 10 people):

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

Common (may affect less than 1 in 10 people):

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

Uncommon (may affect less than 1 in 100 people):

• Low white blood cell count (neutrophils)
• Depressive mood
• Nausea

Rare (may affect less than 1 in 1,000 people):

• Lymphatic system cancer (lymphoma)

Not known (frequency cannot be estimated from available data):

• Peripheral edema

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

5. How to store Gaxenim

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard packaging and on the blister
after "EXP". The expiry date refers to the last day of the stated month.
PVC/PVDC/Aluminium blisters: Do not store above 30°C.
PVC/PE/PVDC/Aluminium blisters: No special storage precautions for the medicine.
Do not use this medicine if you notice that the packaging is damaged or shows signs of having been opened.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Gaxenim contains
The active substance is fingolimod.
Each hard capsule contains fingolimod hydrochloride equivalent to 0.5 mg of fingolimod.
The other ingredients are:
Capsule filling: calcium hydrogen phosphate dihydrate, sodium croscarmellose,
hydroxypropylcellulose, magnesium stearate
Capsule shell – body: gelatin, titanium dioxide (E 171)
Capsule shell – cap: gelatin, titanium dioxide (E 171), iron oxide yellow (E 172)
Printing ink: shellac (E 904), propylene glycol, iron oxide black (E 172), potassium hydroxide (E 525)

What Gaxenim looks like and contents of the pack
Gaxenim 0.5 mg hard capsules are 15.9 mm long, with a yellow cap and an opaque white body, printed in black ink with "FD 0.5 mg" on the cap.
Gaxenim 0.5 mg hard capsules are available in packs of 28 or 98 capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer
Genepharm S.A
18th km Marathonos Avenue
153 51 Pallini Attiki
Greece

Bausch Health Poland sp. z o.o.
ul. Kosztowska 21
41-409 Mysłowice
Poland