FENOXA

Package leaflet: Information for the patient

Fenoxa, 0.5 mg, hard capsules
Fingolimod
Please read all of this leaflet carefully before taking this medicine, because 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 only. Do not pass it on to others. It may harm other people, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What Fenoxa is and what it is used for

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

• patients who have not responded to previous MS treatments, or
• patients with rapidly evolving, severe relapsing-remitting MS.

Fenoxa 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, inflammatory processes damage 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 disturbances, or balance problems. Symptoms of relapses may
resolve completely, although some deficits may persist.
How Fenoxa works
Fenoxa 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, Fenoxa limits nerve damage associated with MS. Fenoxa also modulates certain immune responses in the body.

2. Important information before taking Fenoxa

When not to take Fenoxa

• if the patient has reduced immune response (due to immunodeficiency syndrome, disease, or medications suppressing the immune system);
• 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 experienced myocardial infarction, angina pectoris, stroke, warning signs of stroke, or certain types of heart failure within the past 6 months;
• if the patient has a certain type of irregular or abnormal heartbeat (arrhythmia), including patients in whom electrocardiographic examination (ECG) showed QT interval prolongation before starting treatment with Fenoxa;
• 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 Fenoxa.

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

• if the patient has severe breathing disorders during sleep (sleep apnoea);
• if the patient has been informed that their ECG trace 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 be vaccinated;
• if the patient has never had chickenpox;
• if the patient has or has had vision disorders or other symptoms of swelling in the center 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-type cough. If any of these situations apply or the patient has any doubts, they should consult their doctor before taking Fenoxa.

Slow heart rate (bradycardia) and irregular heartbeat
At the beginning of treatment or after taking the first 0.5 mg dose in patients who previously
took a daily dose of 0.25 mg fingolimod, Fenoxa slows heart rate.
As a result, the patient may experience dizziness, fatigue, strong heartbeat, or low blood pressure.
If these symptoms are severe, the patient should inform their doctor, as immediate treatment may be required. Fenoxa 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 Fenoxa or after the first 0.5 mg dose when switching from a daily dose of 0.25 mg fingolimod, with hourly monitoring of pulse and blood pressure, so that appropriate treatment can be administered if adverse reactions occur at the beginning of treatment. An ECG will be performed before the first dose of Fenoxa 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 progressively decreasing heart rate, or if the ECG shows abnormalities, the patient may require longer monitoring (for at least 2 additional hours or possibly until the next day) until these symptoms resolve. The same procedure may be recommended if the patient resumes treatment with Fenoxa after a treatment interruption, depending on the duration of the interruption and how long the patient had previously taken Fenoxa.

If the patient has irregular or abnormal heartbeat or risk factors for such events, an abnormal ECG trace, heart disease, or heart failure, Fenoxa may not be suitable.
If the patient has previously experienced sudden loss of consciousness or slowed heart function, Fenoxa may not be suitable. A consultation with a cardiologist (a heart specialist) may be needed to advise on how to start treatment with Fenoxa, including how to monitor the patient overnight.
If the patient is taking medications that may reduce heart rate, Fenoxa may not be suitable. A consultation with a cardiologist may be necessary to determine whether the patient can switch to other medications that do not reduce heart rate, to allow treatment with Fenoxa. If such a medication change is not possible, the cardiologist will advise the patient on how to start treatment with Fenoxa, including monitoring until the day after the first dose of Fenoxa.

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 treatment with Fenoxa. If this is the case,
the doctor will delay the start of treatment with Fenoxa by one month after completing
the full vaccination cycle.

Infections
Fenoxa reduces the number of white blood cells (particularly lymphocytes). White blood cells fight infections. While taking Fenoxa (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 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 serious and life-threatening. If the patient feels their condition is worsening (e.g. weakness or vision disturbances) or notices any new symptoms, they should speak to their doctor immediately, as these may be symptoms of a rare brain disease caused by infection called progressive multifocal leukoencephalopathy (PML). PML is a serious condition that may lead to severe disability or death. The doctor will consider performing a magnetic resonance imaging (MRI) scan to assess the patient's condition and decide whether treatment with Fenoxa should be discontinued.
Infections with human papillomavirus (HPV) have been reported in patients treated with Fenoxa, 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 HPV screening tests.

Macular oedema
Before starting treatment with Fenoxa, the doctor may refer patients with current or previous vision disorders or other symptoms of swelling in the center of the visual field (macula) at the back of the eye, inflammation or infection of the eye (uveitis), or diabetes for ophthalmological examination.
The doctor may refer the patient for ophthalmological examination 3 to 4 months after starting treatment with Fenoxa.
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. Fenoxa may cause swelling of the macula, a condition called macular oedema. This swelling usually occurs within the first 4 months of treatment with Fenoxa.
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 the patient develops macular oedema, they should inform their doctor before resuming treatment with Fenoxa.
Macular oedema may cause certain vision disturbances, similar to those in an MS attack (optic neuritis). In the 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 center of the visual field becomes blurry or shaded;
• a blind spot appears in the center of the visual field;
• difficulty seeing colours or fine details occurs.

Liver function tests
Patients with severe liver disease should not take Fenoxa. Fenoxa 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 treatment with Fenoxa, 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 dysfunction, treatment with Fenoxa may be discontinued.

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

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

Blood cell count
A known effect of Fenoxa 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. If blood tests are needed, the patient should inform their doctor about taking Fenoxa. 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 treatment with Fenoxa, the doctor will confirm that the white blood cell count is appropriate to start treatment and may order regular repeat tests. If there are insufficient white blood cells, treatment with Fenoxa may need to be discontinued.

Posterior reversible encephalopathy syndrome (PRES)
Rare cases of a condition called posterior reversible encephalopathy syndrome (PRES) have been reported in MS patients treated with Fenoxa. Symptoms may include sudden severe headache, confusion, seizures, and vision changes. If any of these symptoms occur during treatment with Fenoxa, the patient should inform their doctor immediately, as this condition may be serious.

Cancer
Skin cancers have been reported in MS patients treated with Fenoxa. If any nodules (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. Symptoms of skin cancer may include abnormal growths or changes in skin tissue (e.g. atypical moles) that change in colour, shape, or size over time.
Before starting treatment with Fenoxa, a skin examination should be performed to detect any skin nodules. The doctor will also perform regular skin checks during treatment with Fenoxa. If skin problems occur, the doctor may refer the patient to a dermatologist, who may recommend regular visits after consultation.
Cases of a certain type of lymphatic system tumour (lymphoma) have been reported in MS patients treated with fingolimod.

Sun exposure and protection from solar radiation
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 protective clothing.
• regularly applying sunscreen with high UV protection factor.

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

Switching from other medications to Fenoxa
The doctor may switch treatment directly from interferon-beta, glatiramer acetate, or dimethyl fumarate to Fenoxa if there are no symptoms of abnormalities caused by previous treatment. The doctor may order a blood test to rule out such abnormalities.
After stopping natalizumab treatment, a waiting period of 2 to 3 months may be necessary before starting Fenoxa. 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 with their doctor before deciding whether Fenoxa is suitable.

Women of childbearing potential
If Fenoxa is used during pregnancy, it may have harmful effects on the unborn child. Before starting treatment with Fenoxa, 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 treatment with Fenoxa. The card also contains information on how to avoid pregnancy while taking Fenoxa.
Patients must use effective contraception during treatment and for 2 months after stopping treatment (see section "Pregnancy and breastfeeding").

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

Elderly patients
Experience with the use of Fenoxa in elderly patients (over 65 years) is limited. In case of doubts, consult your doctor.

Children and adolescents
Fenoxa 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 and adolescents and their caregivers:

• Before starting treatment with Fenoxa, the doctor will check the patient's vaccination status. If the patient has not received certain vaccinations, vaccination may be necessary before starting treatment with Fenoxa.
• During the first dose of Fenoxa or when changing the daily dose from 0.25 mg fingolimod 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 treatment with Fenoxa, they should inform their doctor.
• If the patient develops depression or anxiety, or feels low mood or distress during treatment with Fenoxa, they should inform their doctor. Closer monitoring may be required.

Fenoxa and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan 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. Fenoxa must not be used together with these medicines, as this could intensify the effect on the immune system (see also "When not to take Fenoxa").
• Corticosteroids, due to possible additive effects on the immune system.
• Vaccines. If the patient requires vaccination, they should first consult their doctor. During and for 2 months after treatment with Fenoxa, 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 function (e.g. beta-blockers such as atenolol). Using Fenoxa together with these medicines could intensify the effect on heart function in the first days of treatment with Fenoxa.
• Medicines for irregular heartbeat, such as quinidine, disopyramide, amiodarone, or sotalol. Fenoxa must not be used in patients taking these medicines, as it could intensify the effect on irregular heartbeat (see also "When not to take Fenoxa").
• Other medicines: protease inhibitors, medicines used in infections, such as ketoconazole, azole antifungals, clarithromycin, or telithromycin; carbamazepine, rifampicin, phenobarbital, phenytoin, efavirenz, or St John's wort preparations (possible risk of reduced effectiveness of Fenoxa).

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
Fenoxa 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 Fenoxa is used during pregnancy, there is a risk of harmful effects on the unborn child. The rate of congenital malformations observed in children exposed to Fenoxa during pregnancy is about twice that observed in the general population (where the rate of congenital malformations is about 2-3%). The most frequently reported congenital malformations include developmental defects of the heart, kidneys, and musculoskeletal system.
Therefore, if the patient is of childbearing age:

• before starting treatment with Fenoxa, the doctor will inform the patient of the risks to the unborn child and request a pregnancy test to confirm that the patient is not pregnant, and
• effective contraception must be used during treatment with Fenoxa 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 treatment with Fenoxa.
If the patient becomes pregnant while taking Fenoxa, she should inform her doctor immediately.
The doctor will decide whether to discontinue treatment (see "Discontinuation of Fenoxa" in section 3 and section 4 "Possible side effects"). The patient will also need to attend regular prenatal check-ups.
Breastfeeding
Breastfeeding should not be used during treatment with Fenoxa. Fenoxa 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 safely drive vehicles, including cycling, and operate machinery. Fenoxa is not expected to affect the ability to drive vehicles and 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 Fenoxa. During this time and potentially afterwards, the ability to drive vehicles and operate machinery may be impaired.

3. How to take Fenoxa

Treatment with Fenoxa will be supervised by a physician experienced in the management of multiple sclerosis.
This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor.
The recommended dose is:
Adults:
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 of 40 kg or less: one 0.25 mg capsule of fingolimod once daily. Other medicines containing fingolimod are available in a lower dose (0.25 mg capsules) marketed by other pharmaceutical companies.
• Children and adolescents with body weight above 40 kg: one 0.5 mg capsule once daily.

Children and adolescents who start treatment with one 0.25 mg fingolimod capsule daily and later 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, it is recommended to repeat the monitoring period as after the first dose of the medicine.

Do not exceed the recommended dose.
Fenoxa is intended for oral use.
Fenoxa should be taken once daily with a glass of water. Fenoxa capsules should always be swallowed whole, without opening. Fenoxa may be taken with or without food.
Taking Fenoxa at the same time each day will help you remember to take your medicine.
If you have any doubts about how long treatment with Fenoxa should continue, consult your doctor or pharmacist.

Taking more Fenoxa than you should
If a patient has taken too much Fenoxa, they should contact their doctor immediately.

Missing a dose of Fenoxa
If a patient has been taking Fenoxa for less than 1 month and misses one dose for a full 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 Fenoxa 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 Fenoxa
Do not stop taking Fenoxa or change the dose without first consulting your doctor.
Fenoxa may remain in the body for up to 2 months after stopping treatment.
During this time, the number of white blood cells (lymphocyte count) may still be reduced, and adverse effects described in this leaflet may continue to occur. After stopping treatment with Fenoxa, wait 6–8 weeks before starting a new treatment for multiple sclerosis.

In patients restarting Fenoxa after more than 2 weeks since stopping the medicine, the effect on heart rate observed usually after starting treatment for the first time may reoccur, and monitoring in a doctor's office or clinic will be required when restarting treatment. Do not restart Fenoxa after a break lasting more than two weeks without consulting your treating physician.

Your treating physician will decide whether and how monitoring should be carried out after stopping treatment with Fenoxa. Inform your doctor immediately if you feel your multiple sclerosis is worsening after stopping Fenoxa. This situation may be serious.

If you have any further questions about the use of this medicine, consult your 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 (occur in no more than 1 in 10 patients):

• Cough with sputum production, non-specific discomfort in the chest, fever (symptoms of lung disorders)
• Herpes virus infection (shingles or cold sores) 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 fatigue 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 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 Fenoxa.
• Weight loss

Uncommon (occur in no more than 1 in 100 patients):

• Lung inflammation 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 the visual field, blurred vision, difficulty perceiving colors and details
• Decreased number of blood platelets, which increases the risk of bleeding or bruising
• Malignant melanoma (a type of skin cancer that usually develops from an atypical mole). Possible symptoms of melanoma include moles that change in size, shape, elevation, or color over time, or new moles appearing. Moles may itch, bleed, or ulcerate.
• Seizures, epileptic fits (more common in children and adolescents than in adults)

Rare (occur in no more than 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 tumor 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 (occur in no more than 1 in 10,000 patients):

• Abnormalities in ECG test results (T-wave inversion)
• Tumor 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 Fenoxa is started
• 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 an MS relapse. There may also be symptoms the patient is not aware of, such as mood or behavioral changes, temporary memory lapses, difficulty speaking and communicating, which should be evaluated by a doctor to rule out PML. Therefore, if the patient feels 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
• 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 appear as a firm, painless nodule or mass. Long-term sun exposure and weakened immune system may influence the risk of developing Merkel cell carcinoma.
• After discontinuation of Fenoxa treatment, MS symptoms may recur 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 adverse reactions occur, the patient should immediately inform their doctor.

Other adverse reactions

Very common (occur in more than 1 in 10 patients):

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

Common (occur in no more than 1 in 10 patients):

• Fungal skin infections (dermatophytosis) (pityriasis versicolor)
• Dizziness
• Severe headache, often accompanied by nausea, vomiting, and light sensitivity (migraine symptoms)
• Low number of white blood cells (lymphocytes, leukocytes)
• Fatigue
• Itchy, red, burning rash (rash)
• Itching
• Increased levels of blood lipids (triglycerides)
• 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 (Fenoxa may cause a mild increase in blood pressure)
• Muscle pain
• Joint pain

Uncommon (occur in no more than 1 in 100 patients):

• Low number of white blood cells (neutrophils)
• Depressive mood
• Nausea

Rare (occur in no more than 1 in 1,000 patients):

• Lymphatic system tumor (lymphoma)

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

• Peripheral edema

If any of these symptoms occur severely, the patient should inform their doctor.

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, the patient should inform their doctor or pharmacist. 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.

By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Fenoxa

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after: EXP.
The expiry date refers to the last day of the stated month.
The marking on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation LOT indicates the batch number.
Do not store above 30°C.
Store in the original packaging to protect from moisture. Do not use medicines from packages that are damaged or show signs of tampering.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Fenoxa contains

• The active substance is fingolimod.
• The other ingredients are:
• Capsule fill: monohydrate potassium citrate, colloidal anhydrous silica, magnesium stearate. Capsule shell: gelatin, titanium dioxide (E171). Cap: gelatin, titanium dioxide (E171), yellow iron oxide (E172).

What Fenoxa looks like and contents of the pack
Fenoxa is a 16 mm hard gelatin capsule (size 3) with an opaque white body and an opaque yellow cap.
Fenoxa is available in packs containing 7, 28 and 98 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01
Manufacturer
Synthon Hispania S.L.
C/ astelló 1
Sant Boi De Llobregat
08830 Barcelona
Spain
Synthon BV
Microweg 22
6545 CM Nijmegen
The Netherlands