Ganexim

Italy
Brand name Ganexim
Form capsules, hard gelatin
Active substance / Dosage
FINGOLIMOD HYDROCHLORIDE
Prescription type Restricted prescription – dispensable on hospital or specialist prescription
ATC code
L04AA27
Registration number 048319
Manufacturer BAUSCH HEALTH IRELAND LIMITED

Table of Contents

Package leaflet: Information for the user

Gaxenim 0.5 mg hard capsules
Fingolimod
Equivalent medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
  • If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this 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
The active substance in Gaxenim is fingolimod.
What Gaxenim is used for
Gaxenim is used in adults and children and adolescents (aged 10 years and above) for the treatment of
relapsing-remitting multiple sclerosis (MS), particularly in:

  • patients who have not responded to therapy with a treatment for MS; or
  • patients with rapidly evolving severe MS.

Gaxenim does not cure MS, but helps to reduce the number of relapses and to slow down the progression of
physical disability caused by MS.
What is multiple sclerosis
MS is a chronic disease affecting the central nervous system (CNS), which includes the brain and spinal cord.
In MS, inflammation damages the protective covering (called myelin) that surrounds the nerves in the CNS,
preventing the nerves from functioning properly. This process is called demyelination.
Relapsing-remitting MS is characterized by recurrent attacks (relapses) of neurological symptoms reflecting
inflammatory activity in the central nervous system. Symptoms vary from person to person, but usually include
difficulty walking, numbness, vision or balance problems. Symptoms of a relapse may disappear completely
after the relapse ends, but some symptoms may persist.
How Gaxenim works
Gaxenim helps protect the nervous system from attacks by the immune system by reducing the ability of certain
white blood cells (lymphocytes) to circulate freely throughout the body, thereby preventing them from reaching
the brain and spinal cord. This limits nerve damage caused by MS.
Gaxenim also reduces some of the body's immune responses.

2. What you should know before taking Gaxenim

Do not take Gaxenim

  • if you have a reduced immune response (due to immunodeficiency syndrome, an illness, or medicines that suppress the immune system);
  • if you currently have a serious infection or a chronic ongoing infection, such as hepatitis or tuberculosis;
  • if you have active cancer;
  • if you have severe liver problems;
  • if you have had a heart attack, angina, stroke, or a warning sign of stroke, or certain types of heart failure within the last 6 months;
  • if you have certain types of irregular or abnormal heartbeat (arrhythmia), including patients in whom the electrocardiogram (ECG) shows a prolonged QT interval before starting treatment with Gaxenim;
  • if you are currently taking or have recently taken medicines for irregular heartbeat, such as quinidine, disopyramide, amiodarone, or sotalol;
  • if you are pregnant or are a woman of childbearing potential who is not using effective contraception;
  • if you are allergic to fingolimod or to any of the other ingredients of this medicine (listed in section 6). If any of these apply to you, inform your doctor before taking Gaxenim.

Warnings and precautions
Talk to your doctor before taking Gaxenim:

  • if you have severe breathing problems during sleep (severe sleep apnea);
  • if you have been told that you have an abnormal electrocardiogram (ECG);
  • if you experience symptoms of a slow heart rate (e.g., dizziness, nausea, or palpitations);
  • if you are currently taking or have recently taken medicines that slow the heartbeat (such as beta-blockers, verapamil, diltiazem, ivabradine, digoxin, anticholinesterase drugs, or pilocarpine);
  • if you have previously had episodes of sudden loss of consciousness or fainting (syncope);
  • if you plan to get vaccinated;
  • if you have never had chickenpox;
  • if you have or have had visual disorders or other signs of swelling in the central area of vision (macula) at the back of the eye (a condition known as macular edema, see below), if you have or have had inflammation or infection of the eye (uveitis), or if you have diabetes (which can cause eye problems);
  • if you have liver problems;
  • if you have high blood pressure that cannot be controlled by medication;
  • if you have severe lung problems or a smoker’s cough. If any of these apply to you, inform your doctor before taking Gaxenim.

Slow heartbeat (bradycardia) and irregular heartbeat
At the beginning of treatment or when switching from the daily dose of 0.25 mg to the first dose of 0.5 mg, Gaxenim causes a slowing of the heart rate. As a result, you may experience dizziness or fatigue, awareness of your heartbeat, or a drop in blood pressure. If these effects are pronounced, contact your doctor, as immediate treatment may be necessary. Gaxenim may also cause an irregular heartbeat, especially after the first dose. Irregular heartbeat usually returns to normal within less than a day. Slow heart rate typically returns to normal within one month. During this time, clinically significant effects on heart rate are generally not expected.
Your doctor will ask you to remain in the clinic or hospital for at least 6 hours after taking the first dose of Gaxenim or when switching from the daily dose of 0.25 mg to the first dose of 0.5 mg. During this time, your pulse and blood pressure will be monitored hourly so that appropriate measures can be taken if any adverse effects occur at the beginning of treatment. You must have an electrocardiogram (ECG) performed before the first dose of Gaxenim and again at the end of the 6-hour monitoring period. Your doctor may continuously monitor your ECG during this time. If after 6 hours your heart rate is very low or continues to decrease, or if your ECG shows abnormalities, you may need to remain under observation for a longer period (at least an additional 2 hours, and possibly until the next morning) until these issues resolve.
The same may occur if you restart Gaxenim after an interruption in treatment, depending on how long the interruption was and how long you had been taking Gaxenim before the interruption.
If you have or are at risk of having an irregular or abnormal heartbeat, if your ECG is abnormal, or if you have heart disorders or heart failure, Gaxenim may not be suitable for you.
If you have previously experienced episodes of sudden loss of consciousness or reduced heart rate, Gaxenim may not be suitable for you. You will be evaluated by a cardiologist (a heart specialist) who will advise you on how to start treatment with Gaxenim, including monitoring until the next morning.
If you are taking medicines that may reduce heart rate, Gaxenim may not be suitable for you. You will be evaluated by a cardiologist who will assess whether you can switch to alternative medicines that do not reduce heart rate, allowing you to start treatment with Gaxenim. If such a change in therapy is not possible, the cardiologist will advise you on how to start treatment with Gaxenim, including monitoring until the next morning.

If you have never had chickenpox
If you have never had chickenpox, your doctor will check your immunity against the virus that causes it (varicella zoster virus). If you are not protected against the virus, vaccination may be required before starting treatment with Gaxenim. If this is the case, your doctor will delay the start of Gaxenim treatment until one month after completing the full vaccination course.

Infections
Gaxenim reduces the number of white blood cells (particularly lymphocytes). White blood cells fight infections. While taking Gaxenim (and up to 2 months after stopping treatment), you may be more susceptible to infections. Any existing infection may worsen. Infections may be severe and life-threatening. If you think you have an infection, if you have a fever, flu-like symptoms, or a headache accompanied by neck stiffness, sensitivity to light, nausea, and/or confusion (which may be caused by a fungal infection and could be symptoms of meningitis), contact your doctor immediately, as this may be serious and life-threatening. If you believe your MS is worsening (e.g., you experience weakness or vision problems) or if you notice any new symptoms, contact your doctor immediately, as these may be symptoms of a rare brain disorder caused by infection called progressive multifocal leukoencephalopathy (PML). PML is a serious condition that may lead to severe disability or death. Your doctor will consider performing an MRI to evaluate this condition and decide whether you should stop taking Gaxenim.
In patients treated with Gaxenim, human papillomavirus (HPV) infection has been reported, including warts, dysplasia, condylomas, and HPV-related cancers. Your doctor will assess whether you need HPV vaccination before starting treatment. If you are a woman, your doctor will also recommend HPV screening.

Macular edema
Before starting treatment with Gaxenim, if you have or have had visual disorders or other signs of swelling in the central area of vision (macula) at the back of the eye, if you have or have had inflammation or infection of the eye (uveitis), or if you have diabetes, your doctor may ask you to undergo an eye examination.
Your doctor may also ask you to have an eye examination 3–4 months after starting treatment with Gaxenim.
The macula is a small area of the retina located at the back of the eye that allows you to see shapes, colors, and fine details clearly. Gaxenim may cause swelling of the macula, a condition known as macular edema. Swelling usually occurs within the first 4 months of treatment with Gaxenim.
The risk of macular edema is higher if you have diabetes or have had eye inflammation called uveitis. In these cases, your doctor will want to perform regular checks to detect early signs of macular edema.
If you have previously had macular edema, discuss this with your doctor before restarting treatment with Gaxenim.
Macular edema may cause some of the visual symptoms (optic neuritis) that occur during MS attacks. In early stages, there may be no symptoms. Be sure to inform your doctor of any changes in vision. Your doctor may ask you to undergo an eye examination, especially if:

  • the central area of vision is blurred or has shadows;
  • a blind spot develops in the central area of vision;
  • you have difficulty distinguishing colors or fine details.

Liver function tests
Do not take Gaxenim if you have severe liver problems. Treatment with Gaxenim may affect your liver function. You may not notice any symptoms, but if you notice yellowing of the skin or whites of the eyes, abnormally dark urine, or unexplained nausea and vomiting, contact your doctor immediately. If you experience any of these symptoms after starting treatment with Gaxenim, inform your doctor immediately. During the first twelve months of treatment, your doctor will ask you to have blood tests to monitor liver function. If results indicate a liver problem, treatment with Gaxenim may need to be stopped.

High blood pressure
Since Gaxenim causes a slight increase in blood pressure, your doctor may perform regular blood pressure checks.

Lung problems
Gaxenim has a mild effect on lung function. Undesirable effects may occur more easily in patients with severe lung problems or a smoker’s cough.

Blood count
The intended effect of Gaxenim treatment is to reduce the number of white blood cells in the blood. These usually return to normal levels within 2 months after stopping treatment. If you need blood tests, inform your doctor that you are taking Gaxenim. Otherwise, your doctor may not be able to correctly interpret test results, and for certain types of tests, your doctor may need to collect more blood than usual.
Before starting treatment with Gaxenim, your doctor will confirm whether your white blood cell count is sufficient and may ask you to have it checked regularly. If your white blood cell count is too low, treatment with Gaxenim may need to be stopped.

Posterior reversible encephalopathy syndrome (PRES)
Posterior reversible encephalopathy syndrome (PRES) has been rarely reported in patients with multiple sclerosis treated with fingolimod. Symptoms may include sudden severe headache, confusion, seizures, and vision changes. Inform your doctor immediately if you experience any of these symptoms during treatment with Gaxenim, as this may be serious.

Cancer
Skin tumors have been reported in patients with MS treated with fingolimod. Contact your doctor immediately if you notice the appearance of any skin nodules (e.g., shiny, pearly nodules), spots, or open sores that do not heal within a few weeks. Symptoms of skin cancer may include unusual growths or changes in the skin (e.g., unusual moles) with changes in color, thickness, or size over time. A skin examination is required before starting treatment with Gaxenim to check for skin nodules. Your doctor will also perform periodic skin checks during treatment with Gaxenim. If skin problems occur, your doctor may refer you to a dermatologist who, after evaluation, may recommend regular monitoring.
A type of cancer of the lymphatic system (lymphoma) has been reported in patients with MS treated with Gaxenim.

Sun exposure and sun protection
Fingolimod weakens your immune system. This increases the risk of developing tumors, particularly skin tumors. You should limit exposure to sunlight and UV rays:

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

Unusual brain lesions associated with an MS relapse
Rare cases of unusually large brain lesions associated with an MS relapse have been reported in patients treated with fingolimod. In case of a severe relapse, your doctor will evaluate whether an MRI should be performed to assess this condition and decide whether you should stop taking Gaxenim.

Switching from other treatments to Gaxenim
Your doctor may switch you directly from treatment with interferon-beta, glatiramer acetate, or dimethyl fumarate to Gaxenim if there are no signs of abnormalities caused by the previous treatment. Your doctor may perform a blood test to rule out such abnormalities. After stopping natalizumab, you may need to wait 2–3 months before starting treatment with Gaxenim. For switching from teriflunomide, your doctor may advise waiting for a certain period or performing an accelerated elimination procedure. If you have been treated with alemtuzumab, careful evaluation and discussion with your doctor are needed to determine whether Gaxenim is suitable for you.

Women of childbearing potential
If used during pregnancy, Gaxenim may harm the unborn baby. Before starting treatment with Gaxenim, your doctor will explain the risks and ask you to take a pregnancy test to ensure you are not pregnant. Your doctor will give you a reminder card explaining why you should not become pregnant while taking Gaxenim and what you should do to avoid pregnancy. You must use effective contraception during treatment and for 2 months after stopping treatment (see section “Pregnancy and breastfeeding”).

Worsening of MS after stopping treatment with Gaxenim
Do not stop taking Gaxenim or change your dose without first talking to your doctor. Inform your doctor immediately if you think your multiple sclerosis is worsening after stopping treatment with Gaxenim. This may be serious (see “If you stop taking Gaxenim” in section 3 and also section 4, “Possible side effects”).

Use in the elderly
Experience with fingolimod in elderly patients (over 65 years of age) is limited. If you have any concerns, talk to your doctor.

Children and adolescents
Gaxenim is not intended for use in children under 10 years of age, as it has not been studied in pediatric patients with MS in this age group.
The warnings and precautions listed above also apply to children and adolescents. The following information is of particular importance for children, adolescents, and those caring for them:

  • before starting treatment with Gaxenim, your doctor will check your vaccination status. If you have not received certain vaccinations, they may need to be administered before starting treatment with Gaxenim;
  • the first time you take Gaxenim or when switching from the daily dose of 0.25 mg to the daily dose of 0.5 mg, your doctor will monitor your heart rate and heartbeat (see above “slow heart rate (bradycardia) and irregular heartbeat”);
  • if you experience seizures or epileptic fits before or while taking Gaxenim, inform your doctor;
  • if you suffer from depression or anxiety or become depressed or anxious during treatment with Gaxenim, inform your doctor. You may need closer monitoring.

Other medicines and Gaxenim
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Inform your doctor if you are taking any of the following medicines:

  • 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. You must not use Gaxenim with these medicines, as this may intensify the effect on the immune system (see also “Do not take Gaxenim”).
  • Corticosteroids, due to possible additive effects on the immune system.
  • Vaccines. If you need to be vaccinated, consult your doctor first. During and up to 2 months after treatment with Gaxenim, you must not receive certain types of vaccines (live attenuated vaccines), as they may trigger the infection they are meant to prevent. Other vaccines may not work as well as usual if given during this period.
  • Medicines that slow the heartbeat (such as beta-blockers, e.g., atenolol). Concomitant use of Gaxenim with these medicines may intensify the effect on heart rate in the first days of treatment with Gaxenim.
  • Medicines for irregular heartbeat, such as quinidine, disopyramide, amiodarone, or sotalol. You must not use Gaxenim if you are taking these medicines, as they may intensify the effect on irregular heartbeat (see also “Do not take Gaxenim”).
  • Other medicines: protease inhibitors, anti-infectives such as ketoconazole, azole antifungals, clarithromycin, or telithromycin; or carbamazepine, rifampicin, phenobarbital, phenytoin, efavirenz, or St. John’s wort (potential risk of reduced effectiveness of Gaxenim).

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you suspect you are pregnant, or if you are planning a pregnancy, consult your doctor before taking this medicine.

Pregnancy
Do not use Gaxenim during pregnancy, if you are planning a pregnancy, or if you are a woman of childbearing potential and not using effective contraception. If Gaxenim is used during pregnancy, there is a risk of harm to the unborn baby. The rate of congenital malformations observed in newborns exposed to fingolimod during pregnancy is about twice the rate observed in the general population (in which the rate of congenital malformations is about 2–3%). The most frequently reported malformations include cardiac, renal, and musculoskeletal malformations.
Therefore, if you are a woman of childbearing potential:

  • before starting treatment with Gaxenim, your doctor will inform you of the risks to the unborn baby and ask you to take a pregnancy test to ensure you are not pregnant, and
  • you must use effective contraception during treatment with Gaxenim and for two months after stopping treatment to avoid pregnancy. Discuss reliable contraceptive methods with your doctor. Your doctor will give you a reminder document explaining why you should not become pregnant while taking Gaxenim.

If you become pregnant while taking Gaxenim, inform your doctor immediately. Your doctor will decide whether to stop treatment (see “If you stop taking Gaxenim” in section 3 and also section 4, “Possible side effects”). You will also need specialized prenatal monitoring.

Breastfeeding
Do not breastfeed during treatment with Gaxenim. Gaxenim is excreted in breast milk and may cause serious adverse effects in the newborn.

Driving and using machines
Your doctor will advise you whether your condition allows you to safely drive vehicles, including bicycles, and use machinery. Gaxenim should not affect your ability to drive or use machinery.
However, at the beginning of treatment, you must remain at your doctor’s office or in the hospital for 6 hours after taking the first dose of Gaxenim. Your ability to drive or use machinery may be impaired during this time and potentially afterward.

This medicine contains less than 1 mmol of sodium (23 mg) per hard capsule, i.e., it is essentially “sodium-free”.

3. How to take Gaxenim

Treatment with Gaxenim will be supervised by a physician experienced in the management of multiple sclerosis.
Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor.

Recommended dose:
Adults:
One 0.5 mg capsule once daily.
Children and adolescents (aged 10 years and older):
Dose is based on body weight:

  • Children and adolescents with body weight equal to or less than 40 kg: one 0.25 mg capsule once daily.
  • Children and adolescents with body weight greater than 40 kg: one 0.5 mg capsule once daily.

Since the 0.5 mg hard capsules are not suitable for children with body weight ≤40 kg, other medicinal products containing fingolimod are available at a lower dosage (such as 0.25 mg capsules).
Children and adolescents who start treatment with a 0.25 mg capsule once daily and subsequently achieve a stable body weight above 40 kg will be instructed by their doctor to switch to treatment with a 0.5 mg capsule once daily. In this case, repeating the first-dose observation period is recommended.

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

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

If you forget to take Gaxenim
If you have been taking Gaxenim for less than 1 month and you miss a dose for a full day, consult your doctor before taking the next dose. Your doctor may decide to observe you when you take the next dose.
If you have been taking Gaxenim for at least 1 month and you have missed taking the medicine for more than 2 weeks, consult your doctor before taking the next dose. Your doctor may decide to observe you when you take the next dose. However, if you have missed taking the medicine for 2 weeks or less, you may take the next dose as planned.
Never take a double dose to make up for a forgotten dose.

If you stop taking Gaxenim
Do not stop taking Gaxenim or change your dose without first consulting your doctor.
Gaxenim will remain in your body for up to 2 months after stopping treatment. Your white blood cell count (lymphocyte count) may remain low during this time, and the adverse effects described in this leaflet may still occur. After stopping Gaxenim, you may need to wait 6–8 weeks before starting another treatment for MS.
If you need to restart Gaxenim after a treatment interruption of more than 2 weeks, the effect on heart rate that normally occurs at the beginning of treatment may reoccur: therefore, restarting treatment will require you to remain under observation in an outpatient clinic or hospital setting. Do not restart Gaxenim after an interruption of more than two weeks without first consulting your doctor.
Your doctor will decide whether and how you need to be monitored after stopping treatment with Gaxenim. Inform your doctor immediately if you think your MS is worsening after stopping Gaxenim. This could be serious.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

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

  • Cough with phlegm, chest discomfort, fever (signs of lung disorders).
  • Herpes virus infection (cold sores or shingles), with symptoms such as blisters, burning, itching, or pain on the skin, usually on the upper body or face. Other symptoms may include fever and weakness in the early stages of infection, followed by numbness, itching, or red patches with severe pain.
  • Slow heart rate (bradycardia), irregular heart rhythm.
  • 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 with increased frequency in the population affected by MS and have been reported in paediatric patients treated with fingolimod.
  • Weight loss.

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

  • Pneumonia with symptoms such as fever, cough, difficulty breathing.
  • Macular oedema (swelling in the central vision area of the retina, at the back of the eye) with symptoms such as shadows or blind spots in the centre of vision, blurred vision, problems distinguishing colours or details.
  • Reduction in blood platelets, increasing the risk of bleeding or bruising.
  • Malignant melanoma (a type of skin cancer that usually develops from an unusual mole). Possible signs of melanoma include moles that may change in size, shape, thickness, or colour over time, or new moles. Moles may itch, bleed, or ulcerate.
  • Seizures, epileptic fits (more frequent in children and adolescents than in adults).

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

  • A condition known as reversible posterior encephalopathy syndrome. Symptoms may include sudden onset of 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 ulcerated lesion with a crust, or a new ulceration on a pre-existing scar.

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

  • Abnormality on electrocardiogram (ECG) (T-wave inversion).
  • Tumour associated with human herpes virus 8 infection (Kaposi’s sarcoma).

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

  • Allergic reactions, including symptoms such as rash or hives, swelling of the lips, tongue, or face, which are more likely to occur on the first day of treatment with Gaxenim.
  • Risk of developing a rare brain infection called progressive multifocal leukoencephalopathy (PML). Symptoms of PML may resemble an MS relapse. Other symptoms may also occur that you may not personally notice, such as changes in mood or behaviour, memory lapses, language and communication difficulties, which may require further medical evaluation to rule out the risk of PML. Therefore, if you think your MS is worsening, or if you or someone close to you notices any new or unusual symptoms, it is very important that you contact your 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 signs of Merkel cell carcinoma include painless flesh-coloured or bluish-red nodules, often on the face, head, or neck. Merkel cell carcinoma may also appear as a firm, painless nodule or mass. Long-term sun exposure and a weakened immune system may influence the risk of developing Merkel cell carcinoma.
  • After stopping treatment with Gaxenim, MS symptoms may reappear and may even worsen compared to before or during treatment.
  • Autoimmune form of anaemia (reduction in red blood cells) in which red blood cells are destroyed (autoimmune haemolytic anaemia).

If you experience any of these side effects, contact your doctor immediately.

Other side effects

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

  • Influenza virus infection with symptoms such as fatigue, chills, sore throat, joint or muscle pain, fever.
  • Feeling of pressure or pain in the cheeks and forehead (sinusitis).
  • Headache.
  • Diarrhoea.
  • Back pain.
  • Blood tests showing higher than normal levels of liver enzymes.
  • Cough.

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

  • Tinea versicolor, a fungal skin infection (tinea).
  • Dizziness.
  • Severe headache often accompanied by nausea, vomiting, and light sensitivity (migraine).
  • Low levels of white blood cells in the blood (lymphocytes, leucocytes).
  • Weakness.
  • Skin rash with itching, redness, and burning (eczema).
  • Itching.
  • Increased blood levels of fats (triglycerides).
  • Hair loss.
  • Shortness of breath.
  • Depression.
  • Blurred vision (see also the section on macular oedema under “Some side effects may be or become serious”).
  • Hypertension (Gaxenim may cause a slight increase in blood pressure).
  • Muscle pain.
  • Joint pain.

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

  • Low levels of certain white blood cells in the blood (neutrophils).
  • Depressed mood.
  • Nausea.

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

  • Cancer of the lymphatic system (lymphoma).

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

  • Peripheral swelling.

If any of these side effects become severe, inform your doctor.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Gaxenim

Keep this medicine out of the 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 that month.
PVC/PVDC/Aluminium blisters: Do not store above 30°C.
PVC/PE/PVDC/Aluminium blisters: This medicine does not require any special storage conditions.
Do not use packages that are damaged or show signs of tampering.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Gaxenim contains
The active substance is fingolimod.
Each hard capsule contains fingolimod hydrochloride equivalent to 0.5 mg of fingolimod.
The other components are:
Capsule contents: dibasic calcium phosphate dihydrate, sodium croscarmellose, hydroxypropylcellulose (E463), magnesium stearate (E470b).
Capsule shell – body: gelatin, titanium dioxide (E171).
Capsule shell – cap: gelatin, titanium dioxide (E171), yellow iron oxide (E172).
Printing ink: shellac (E904), propylene glycol (E1520), black iron oxide (E172), potassium hydroxide (E525).

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

Marketing Authorization Holder and Manufacturer
Marketing Authorization 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 Palleni Attica
Greece