Bonaxon: detailed information

Package leaflet: Information for the user

Bonaxon, 0.5 mg, hard capsules
Fingolimod
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for a specific patient. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

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

1. What Bonaxon is and what it is used for

What Bonaxon is
Bonaxon contains the active substance fingolimod.

What Bonaxon is used for
Bonaxon is used in adults 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 forms of MS.

Bonaxon 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 disturbances, or balance problems. Symptoms of relapses may resolve completely, although some deficits may persist.

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

2. Important information before taking Bonaxon

When not to take Bonaxon

if the patient has a weakened immune response (due to immunodeficiency syndrome, illness, 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 active severe 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 Bonaxon;
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 is 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 any of these situations apply, or the patient is unsure, the patient must inform the doctor
and must not take Bonaxon.
Warnings and precautions
Before starting Bonaxon, discuss the following with the doctor:

if the patient has severe breathing problems during sleep (sleep apnoea);
if the patient has been informed that their ECG reading 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 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 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 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 is unsure, the patient must inform the doctor
before taking Bonaxon.
Slow heart rate (bradycardia) and irregular heartbeat
At the beginning of treatment, Bonaxon slows the heart rate. As a result, the patient may experience dizziness, fatigue, palpitations, or low blood pressure.
If these symptoms are severe, the patient must inform the doctor, as immediate treatment may be required. Bonaxon may also cause an 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 generally 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 Bonaxon, with hourly monitoring of pulse and blood pressure, so that appropriate treatment can be administered if any adverse effects occur at the beginning of treatment. An ECG will be performed before the first dose of Bonaxon and again at the end of the 6-hour observation period. During this time, the doctor may perform continuous monitoring of 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, the patient may require longer monitoring (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 Bonaxon after a treatment interruption, depending on the duration of the interruption and how long the patient had previously taken Bonaxon before stopping treatment.
If the patient has an irregular or abnormal heartbeat, risk factors for such events, an abnormal ECG, heart disease, or heart failure, Bonaxon may not be suitable.
If the patient has previously experienced sudden loss of consciousness or slowed heart function, Bonaxon may not be suitable. A consultation with a cardiologist (a heart specialist) may be necessary to advise on how to start treatment with Bonaxon, including how to monitor the patient overnight.
If the patient is taking medicines that may reduce heart rate, Bonaxon may not be suitable. A consultation with a cardiologist may be necessary to determine whether the patient can switch to other medicines that do not reduce heart rate, to allow treatment with Bonaxon. If such a change in treatment is not possible, the cardiologist will advise the patient on how to start treatment with Bonaxon, including monitoring until the day after the first dose of Bonaxon.
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 treatment with Bonaxon. If this is the case, the doctor will delay the start of Bonaxon treatment by one month after completion of the full vaccination course.
Infections
Bonaxon reduces the number of white blood cells (especially lymphocytes). White blood cells fight infections. While taking Bonaxon (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 a headache accompanied by 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 must contact the doctor immediately, as this condition may be severe and life-threatening.
Infections with human papillomavirus (HPV) have been reported in patients treated with fingolimod, including cases of warts, dysplasia, and HPV-related malignant tumours. The doctor will consider whether the patient needs HPV vaccination before starting treatment. In women, the doctor will also recommend HPV screening tests.
PML
PML is a rare brain disorder caused by infection that may lead to severe disability or death. The treating doctor will order a magnetic resonance imaging (MRI) scan before starting and during treatment to monitor the risk of PML.
If the patient feels their condition is worsening or notices any new symptoms, such as changes in mood or behaviour, new weakness or worsening of existing weakness on one side of the body, changes in vision, confusion, temporary memory lapses, or difficulties with speech and communication, the patient must speak to the doctor immediately. 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, the condition can be treated, and treatment with Bonaxon will be stopped. In some patients, an inflammatory reaction may occur after discontinuation of Bonaxon. This reaction (called immune reconstitution inflammatory syndrome, IRIS) may lead to worsening of the patient's condition, including worsening of brain function.
Macular oedema
Before starting treatment with Bonaxon, 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, 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 Bonaxon.
The macula is a small area of the retina at the back of the eye that enables sharp, clear vision of shapes, colours, and fine details. Bonaxon may cause swelling of the macula, a condition called macular oedema. This swelling usually occurs within the first 4 months of treatment with Bonaxon.
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, the doctor must be informed before resuming treatment with Bonaxon.
Macular oedema may cause certain vision disturbances, similar to those during an MS attack (optic neuritis). In the early stages, symptoms may be absent. The patient must inform the doctor of any changes in vision. The doctor may refer the patient for ophthalmological examination, especially if:

the centre of the visual field becomes blurry or shadowed;
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 Bonaxon. Bonaxon 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 urine (brown-coloured), pain in the right side of the abdomen, fatigue, reduced appetite, or unexplained nausea and vomiting occur, the patient must inform the doctor immediately.
If any of the above symptoms occur after starting treatment with Bonaxon, the patient must inform the 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 Bonaxon may be discontinued.
High blood pressure
The doctor may regularly check blood pressure, as Bonaxon causes a slight increase in blood pressure.
Lung diseases
Bonaxon has a minor effect on lung function. Patients with severe lung disease or a smoker-type cough are at higher risk of adverse effects.
Blood cell count
A known effect of Bonaxon is a reduction in the number of white blood cells in the blood. The count usually returns to normal within 2 months after stopping treatment. If blood tests are required, the patient must inform the doctor about taking Bonaxon. Otherwise, the doctor may not be able to interpret the blood test results correctly, and for certain tests, the doctor may order a larger blood sample than usual.
Before starting Bonaxon, the doctor will confirm that the white blood cell count is appropriate to begin treatment and may order regular repeat testing. If there are insufficient white blood cells, treatment with Bonaxon may need to be discontinued.
Posterior reversible encephalopathy syndrome (PRES)
Posterior reversible encephalopathy syndrome (PRES) has been rarely reported in patients with MS treated with fingolimod. Symptoms may include sudden severe headache, confusion, seizures, and vision changes. If any of these symptoms occur during treatment with Bonaxon, the patient must inform the doctor immediately, as this condition may be severe.
Cancer
Skin cancers have been reported in patients with MS treated with fingolimod. If any lumps (e.g. shiny, pearly lumps), spots, or open sores that do not heal within a few weeks are noticed on the skin, the patient must inform the doctor immediately. Symptoms of skin cancer may include unusual growths or changes in the skin tissue (e.g. atypical moles) that change in colour, shape, or size over time. A skin examination must be performed before starting treatment with fingolimod to detect any skin lumps. The treating doctor will also perform regular skin checks during treatment with fingolimod. If skin problems occur, the treating doctor may refer the patient to a dermatologist, who may decide on the need for regular visits after consultation.
Lymphoma, a type of lymphatic system cancer, has been reported in patients with MS 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 appropriate protective clothing,
regularly applying sunscreen with a 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 Bonaxon. In case of a severe MS relapse, the treating doctor may consider performing an MRI scan to assess this condition and decide whether discontinuation of Bonaxon is necessary.
Switching from other medicines to Bonaxon
The doctor may switch treatment directly from interferon-beta, glatiramer acetate, or dimethyl fumarate to Bonaxon if there are no symptoms of abnormalities caused by previous treatment. The doctor may order blood tests to rule out such abnormalities. After stopping natalizumab treatment, a waiting period of 2 to 3 months may be necessary before starting Bonaxon. 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 evaluation and discussion with the doctor before deciding whether Bonaxon is suitable.
Women of childbearing age
If Bonaxon is used during pregnancy, it may have harmful effects on the unborn child. Before starting treatment with Bonaxon, 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 treatment with Bonaxon. The card also contains information on how to avoid pregnancy while taking Bonaxon.
Patients must use effective contraception during treatment and for 2 months after stopping treatment (see section "Pregnancy and breastfeeding" below).
Worsening of MS after stopping Bonaxon treatment
Do not stop taking Bonaxon or change the dose without first consulting the doctor.
The patient must inform the doctor immediately if they feel their MS is worsening after stopping Bonaxon treatment. This situation may be serious (see section 3 "Discontinuation of Bonaxon treatment" and section 4 "Possible side effects").
Elderly patients
Experience with the use of fingolimod in elderly patients (over 65 years) is limited. If in doubt, consult the doctor.
Children and adolescents
Bonaxon must not be used in children and adolescents under 18 years of age.
Bonaxon and other medicines
The patient must inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for future use:

Medicines that suppress or modulate the immune system, including other medicines used in the treatment of MS, such as interferon beta, glatiramer acetate, natalizumab, mitoxantrone, teriflunomide, dimethyl fumarate, or alemtuzumab. Bonaxon must not be used together with these medicines, as this could intensify the effect on the immune system (see also "When not to take Bonaxon").
Corticosteroids, due to a possible additive effect on the immune system.
Vaccines. If the patient requires vaccination, they should consult the doctor first. During and for 2 months after treatment with Bonaxon, patients should not receive certain types of vaccines (live attenuated vaccines), as they could cause the infection they are intended 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 Bonaxon together with these medicines could intensify the effect on heart function in the first days of Bonaxon treatment.
Medicines for irregular heartbeat, such as quinidine, disopyramide, amiodarone, or sotalol. Bonaxon must not be used in patients taking these medicines, as it could intensify the effect on irregular heartbeat (see also "When not to take Bonaxon" above).
Other medicines:
- protease inhibitors, medicines used in infections, such as ketoconazole, azole antifungal medicines, clarithromycin, or telithromycin;
- carbamazepine, rifampicin, phenobarbital, phenytoin, efavirenz, or St John's wort preparations (possible risk of reduced effectiveness of Bonaxon).

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
Bonaxon must 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 Bonaxon 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 fingolimod during pregnancy is about twice that observed in the general population (in whom the rate of congenital malformations is approximately 2-3%).
The most commonly reported congenital malformations include heart, kidney, and musculoskeletal system developmental defects.
Therefore, if the patient is of childbearing age:

before starting treatment with Bonaxon, 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 Bonaxon and for two months after stopping treatment to avoid pregnancy. The patient should discuss effective contraceptive methods with the doctor. The doctor will provide the patient with an information card explaining why pregnancy should be avoided during treatment with Bonaxon.

If the patient becomes pregnant while taking Bonaxon, she must inform the doctor immediately. The doctor will decide whether to discontinue treatment (see section 3 "Discontinuation of Bonaxon treatment" and section 4 "Possible side effects"). The patient will also need to attend regular prenatal check-ups.
Breastfeeding
Breastfeeding must not be used during treatment with Bonaxon. Bonaxon 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 drive vehicles, including cycling, and operate machinery safely. No effect of Bonaxon on the ability to drive and operate machinery is expected.
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 Bonaxon. During this time and potentially afterwards, the ability to drive and operate machinery may be impaired.

3. How to take Bonaxon

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

Recommended dose:
Adults:
The recommended dose is one 0.5 mg hard capsule once daily.
Do not exceed the recommended dose.

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

Taking more Bonaxon than recommended
If a patient has taken too high a dose of the medicine, they should contact their doctor immediately.

Missing a dose of Bonaxon
If a patient has been taking Bonaxon for less than 1 month and has forgotten to take a 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 taking the next dose.
If a patient has been taking Bonaxon 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 keep the patient under observation when taking the next dose.
However, if a 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 treatment with Bonaxon
Do not stop taking Bonaxon or change the dose without first consulting your doctor.
Bonaxon remains 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 reactions described in this leaflet may continue to occur. After stopping treatment with Bonaxon, a waiting period of 6–8 weeks is required before starting a new treatment for MS.

In patients restarting Bonaxon after a treatment interruption of more than 2 weeks, the effect on heart rate observed usually after starting treatment for the first time may reoccur, and monitoring of the patient in a doctor's office or clinic will be necessary when resuming treatment. Do not restart treatment with Bonaxon after a treatment break lasting more than two weeks without consulting the treating physician.

The treating physician will decide whether and how to monitor the patient after stopping treatment with Bonaxon. Inform the doctor immediately if the patient feels that their MS is worsening after stopping treatment with Bonaxon. This situation could be serious.

If there are any further doubts about the use of 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 up to 1 in 10 people):

Cough with sputum production, feeling of 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 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.
Weight loss.

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

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, or new moles appearing. Moles may itch, bleed or ulcerate.
Seizures, epileptic fits.

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

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

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 Bonaxon 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 on the right side of the abdomen, dark urine (brown), decreased 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. There may also be symptoms the patient is not aware of, 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 relatives notice any new or unusual symptoms, it is very important to inform the treating doctor as soon as possible.
Inflammatory disorders after discontinuation of Bonaxon 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 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 stopping treatment with Bonaxon, 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, you should immediately tell your doctor.

Other adverse reactions

Very common (may affect more than 1 in 10 people):

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

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

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).
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 (Bonaxon may cause a mild increase in blood pressure).
Muscle pain.
Joint pain.

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

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

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

Lymphatic system tumor (lymphoma).

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

Peripheral edema.

If any of these symptoms occur severely, you should tell your doctor.

Reporting of adverse reactions

If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse reactions can also 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
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 provide more information on the safety of the medicine.

5. How to store the medicine Bonaxon

The medicine should be stored in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and
blister pack following “Expiry date (EXP)” / “EXP”. The expiry date refers to the last day of the stated month.
There are no special storage instructions for this medicine.
Do not use medicines from packaging that is damaged or shows signs of having been opened.
Medicines should 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 Bonaxon contains

The active substance is fingolimod. Each hard capsule contains 0.5 mg of fingolimod (in the form of fingolimod hydrochloride).
The other ingredients are: calcium hydrogen phosphate, stearic acid. Capsule shell: gelatin, titanium dioxide (E 171), yellow iron oxide (E 172). Printing ink: shellac, black iron oxide (E 172).

What Bonaxon looks like and contents of the pack
Bonaxon 0.5 mg hard capsules contain a white or almost white powder in a size 3 hard gelatin capsule, 15.9 mm ± 0.3 mm in length, composed of a yellow, opaque cap and a white, opaque body, with the marking "0.5 mg" printed in black ink on the cap.
Bonaxon 0.5 mg hard capsules are packed in a cardboard box containing a suitable number of PVC/PE/PVDC/Aluminium foil blisters with the appropriate number of capsules and an instruction leaflet.
Pack sizes:
Cardboard box containing 28 hard capsules.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Egis Pharmaceuticals PLC
Keresztúri út 30-38
1106 Budapest
Hungary

Manufacturer
Pharmathen International S.A
Industrial Park Sapes
Rodopi Prefecture
Block No 5
69300 Rodopi
Greece
PHARMATHEN S.A.
Dervenakion 6
15351 Pallini
Attiki
Greece

This medicinal product is authorised in the European Economic Area countries under the following names:
Denmark, Bulgaria, Czech Republic, Hungary, Poland, Slovakia: Bonaxon