.25 mg and 0.5 mg hard capsules
fingolimod

1. What Gilenya is and what it is used for

What Gilenya is

Gilenya contains the active substance fingolimod.

What Gilenya is used for

Gilenya is used in adults and in children and adolescents (aged 10 years and older) to treat relapsing multiple sclerosis (MS), more specifically in:

  • Patients who did not respond despite treatment with MS treatment.

or

  • Patients who have rapid development of severe MS.

Gilenya does not cure MS but helps to reduce the number of relapses and to slow down the development of physical disabilities due to MS.

What is multiple sclerosis?

MS is a chronic disease that affects the central nervous system ( CNS ), which consists of the brain and spinal cord. In MS, the protective sheath (called myelin) that surrounds the nerves in the CNS is destroyed due to inflammation, which means that the nerves do not function properly. This is called demyelination.

Relapsing-remitting MS is characterized by repeated attacks ( relapses ) of symptoms from the nervous system that reflect inflammation in the CNS. The symptoms vary from patient to patient, but the typical symptoms are difficulty walking, numbness, visual disturbances, or balance disorders. When the relapse is over, the symptoms may disappear completely, but some problems may also persist.

How Gilenya works

Gilenya helps protect against the immune system’s attacks on the CNS by reducing the ability of certain white blood cells (lymphocytes) to move freely in the body and by preventing those that cause inflammation from reaching the brain and spinal cord. This limits nerve damage caused by MS. Gilenya also lowers some of the body’s immune reactions.

2. What you need to know before taking Gilenya

Do not take Gilenya

  • if you have a reduced immune response (due to an immune deficiency syndrome, disease or drugs that inhibit the immune system).
  • if you have a severe, active infection or active, chronic infection such as hepatitis or tuberculosis .
  • if you have an active cancer .
  • if you have severe liver problems .
  • if you have had a heart attack, angina, stroke or warning of a stroke or certain types of heart failure in the last 6 months.
  • if you have certain types of irregular or abnormal heartbeat ( arrhythmia ), including patients in whom the electrocardiogram ( ECG ) shows a long QT interval before you start using Gilenya.
  • if you are taking or have recently taken medicines for irregular heartbeats, such as quinidine , disopyramide , amiodarone or sotalol.
  • if you are pregnant or a woman of childbearing potential not using effective contraception .
  • if you are allergic to fingolimod or any of the other ingredients of this medicine (listed in section 6).

If this applies to you or if you are not sure, talk to your doctor before taking Gilenya.

Warnings and cautions

Talk to your doctor before taking Gilenya:

  • if you have severe breathing problems during sleep (severe sleep apnea ).
  • if you have been told that you have an abnormal ECG .
  • if you have symptoms of a slow heart rate (eg dizziness, nausea or palpitations).
  • if you are taking or have recently taken medicines that lower your heart rate (such as beta-blockers , verapamil, diltiazem or ivabradine , digoxin , cholinesterase inhibitors or pilocarpine).
  • if you have previously had sudden unconsciousness or fainting ( syncope ).
  • if you are planning to get vaccinated.
  • if you have never had chickenpox.
  • if you have or have had visual disturbances or other signs of swelling in the central vision area ( yellow spot or macula ) located at the back of the eye (a condition called macular edema, see below), inflammation or infection in 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 with medication .
  • if you have severe lung problems or whooping cough.

If this applies to you or if you are not sure, talk to your doctor before taking Gilenya.

Slow heart rate ( bradycardia ) and irregular heartbeat

At the beginning of treatment or after taking the first dose of 0.5 mg when you change from a daily dose of 0.25 mg, Gilenya may cause your heart to beat more slowly. This can cause you to feel dizzy or tired or have a clear heartbeat, or your blood pressure to drop. If these effects are serious, tell your doctor as you may need immediate treatment. Gilenya can also cause irregular heartbeat, especially after the first dose. Irregular heartbeat usually returns to normal in less than a day. Slow heart rate usually returns to normal within a month. During this period, no clinically relevant effects on heart rate are usually expected.

Your doctor will ask you to stay at the doctor’s or clinic for at least 6 hours, with heart rate and blood pressure measurements every hour, after taking the first dose of Gilenya or after taking the first dose of 0.5 mg. when switching from a daily dose of 0.25 mg, so that appropriate action can be taken in the event of side effects occurring at the beginning of treatment. You should have an ECG measurement performed before the first dose of Gilenya and after the 6-hour monitoring period. Your doctor can monitor your ECGcontinuously during that time. If after this 6-hour period you have a very slow or decreasing heart rate, or if your ECG shows abnormalities, you may need to be monitored for a longer period (for at least 2 more hours and possibly overnight), until these have disappeared. The same can apply if you resume treatment with Gilenya after a break in treatment, depending on both how long the break was and how long you had taken Gilenya before the break.

If you have or are at risk for abnormal or irregular heartbeat, if your ECG is abnormal or if you have heart disease or heart failure, Gilenya may not be suitable for you.

If you have a history of sudden unconsciousness or decreased heart rate, Gilenya may not be suitable for you. You will be evaluated by a cardiologist (cardiologist) who will advise on how to start treatment with Gilenya, including overnight monitoring.

If you are taking medicines that may cause your heart rate to drop, Gilenya may not be suitable for you. You will need to be evaluated by a cardiologist, who will check if you can switch to another medicine that does not reduce your heart rate so that you can start treatment with Gilenya. If such a change is impossible, your cardiologist will advise you on how to start treatment with Gilenya, including overnight monitoring.

If you have never had chickenpox

If you have never had chickenpox, your doctor will check if you are immune to the virus that causes the disease (varicella-zoster virus). If you have no virus protection, you may need to get vaccinated before starting treatment with Gilenya. If this is the case, your doctor will postpone the start of treatment with Gilenya for one month after the end of the full vaccination program.

Infection is

Gilenya reduces the number of white blood cells (especially the lymphocyte count). White blood cells fight infection with you. While you are taking Gilenya (and up to 2 months after you stop taking the medicine) you may find it easier to get an infection. If you already have an infection, it can get worse. Infection can be serious and life-threatening. Contact your doctor immediately, as it can be serious and life-threatening if you think you have an infection, have a fever, feel like you have the flu, have shingles or headache accompanied by a stiff neck, sensitivity to light, nausea, rash, and/or confusion or convulsions (seizures) (these may be symptoms of meningitis ( meningitis ), and/or brain inflammation ( encephalitis ) caused by a fungal or herpes infection).

If you think your MS is getting worse (eg weakness or vision changes) or if you notice any new symptoms, talk to your doctor immediately, as this may be a symptom of a rare brain disease caused by infection. This rare brain disease is called progressive multifocal leukoencephalopathy (PML). PML is a serious condition that can lead to severe disability or death. Your doctor will consider performing an MRI scan to evaluate this condition and will decide if you need to stop taking Gilenya.

Infection with human papillomavirus (HPV), including papillomas, dysplasia, warts, and HPV-related cancers have been reported in patients treated with Gilenya. Your doctor will consider whether you need to be vaccinated against HPV before starting treatment. If you are a woman, your doctor will also recommend HPV screening.

Macular edema

If you have or have had visual disturbances or other signs of swelling in the macula ( macula ) at the back of the eye, inflammation or infection of the eye ( uveitis ), or diabetes, your doctor may want you to undergo an eye examination before starting Gilenya.

Your doctor may want you to have an eye examination 3 to 4 months after you start treatment with Gilenya.

The macula ( macula ) is a small area on the retina at the back of the eye that allows you to see shapes, colors, and details clearly and sharply. Gilenya can cause swelling in the macula, a condition called macular edema. The swelling usually occurs within the first 4 months of Gilenya treatment.

The risk of developing macular edema is higher if you have diabetes or have had an inflammation of the eye called uveitis. In such cases, your doctor will want you to have regular eye examinations to detect macular edema.

If you have had macular edema, talk to your doctor before resuming treatment with Gilenya.

Macular edema can cause the same visual symptoms as an MS relapse ( optic neuritis ). In the early course, the condition can cause symptoms or be asymptomatic. If your vision changes, be sure to tell your doctor. Your doctor may want you to have an eye exam, especially if:

  • the center of the field of view becomes blurred or has shadows;
  • you develop a blind spot in the middle of the field of vision;
  • you have difficulty seeing colors or small details.

Liver function tests

If you have severe liver problems, do not take Gilenya. Gilenya may affect your liver function. You will probably not notice any symptoms, but if the skin or whites of the eyes turn yellow, if the urine is abnormally dark (brown), pain on the right side of the stomach (abdomen), fatigue, feeling less appetite than usual, or if you feel sick or vomit for no reason, tell your doctor immediately.

If you experience any of these symptoms after starting Gilenya, tell your doctor immediately.

Before, during, and after treatment, your doctor will want to take blood samples to check your liver function. If the test results show problems with the liver, you may need to stop treatment with Gilenya.

High blood pressure

Because Gilenya causes a slight increase in blood pressure, your doctor may want to check your blood pressure at regular intervals.

Pulmonary problems

Gilenya has a small effect on lung function. Patients with severe lung problems or whooping cough may be at higher risk of developing side effects.

Blood cell count

The effect you want Gilenya to have is to reduce the number of white blood cells in the blood. This usually returns to normal within 2 months of stopping treatment. If you need to take blood samples, tell your doctor that you are taking Gilenya. Otherwise, the results of the test may be difficult to interpret and for some types of blood tests, your doctor may need to take more blood than normal.

Before starting Gilenya, your doctor will confirm if you have enough white blood cells in your blood and may want to repeat a check-up at regular intervals. If you do not have enough white blood cells, you may need to stop taking Gilenya.

Posterior reversible encephalopathy syndrome (PRES)

A condition called posterior reversible encephalopathy syndrome (PRES) has been reported rarely in MS patients treated with Gilenya. The symptoms may be sudden onset of severe headache, confusion, seizures, and changes in vision. Tell your doctor immediately if you experience any of these symptoms during treatment with Gilenya, as it may be serious.

Cancer

Skin cancer has been reported in MS patients treated with Gilenya. Talk to your doctor immediately if you notice any skin nodules (eg shiny, pearlescent nodules), spots, or open wounds that do not heal within a few weeks. Symptoms of skin cancer may include abnormal growth or changes in skin tissue (such as unusual liver spots) with a change in color, shape, or size over time. Before you start taking Gilenya, a skin examination is necessary to check if you have any skin lumps. Your doctor will also perform regular skin examinations during treatment with Gilenya. If you have skin problems, your doctor may refer you to a dermatologist, who may decide after the examination that it is important for you to be examined at regular intervals.

One type of cancer of the lymphatic system ( lymphoma ) has been reported in MS patients treated with Gilenya.

Exposure to the sun and protection from the sun

Fingolimod weakens your immune system. This increases the risk of developing cancer, especially skin cancer. You should limit your exposure to the sun and UV rays by:

  • wear appropriate protective clothing.
  • regularly apply sunscreen with a high degree of UV protection.

Rare disease activity in isolated areas of the brain associated with MS relapses

Rare cases of unusually high disease activity in isolated areas of the brain associated with MS relapses have been reported in patients treated with Gilenya. In case of severe relapse, your doctor will consider performing a magnetic resonance imaging (MRI) scan to evaluate this condition and determine if you need to stop taking Gilenya.

Switching from other treatments to Gilenya

Your doctor may change your treatment directly from beta-interferon, glatiramer acetate, or dimethyl fumarate to Gilenya if there are no signs of abnormalities caused by your previous treatment. Your doctor may need to take a blood test to rule out such abnormalities. After stopping treatment with natalizumab, you may need to wait 2-3 months before treatment with Gilenya. To switch from teriflunomide, your doctor may advise you to wait a certain amount of time or to undergo an accelerated elimination procedure. If you have been treated with alemtuzumab, a thorough evaluation and discussion with your doctor are required to determine if Gilenya is suitable for you.

Women of childbearing age

If used during pregnancy, Gilenya may harm the unborn baby. Before starting treatment with Gilenya, your doctor will explain the risk to you and ask you to take a pregnancy test to make sure you are not pregnant. Your doctor will give you a card explaining why you should not get pregnant while taking Gilenya. It also explains what to do to avoid getting pregnant while taking Gilenya. You must use an effective method of contraception during treatment and for 2 months after stopping treatment (see section “Pregnancy and breastfeeding”).

Exacerbation of MS after discontinuation of Gilenya

Do not stop taking Gilenya or change the dose without talking to your doctor first.

Tell your doctor immediately if you think your MS is getting worse after stopping treatment with Gilenya. This can be serious (see “If you stop taking Gilenya” in section 3 and also section 4, “Possible side effects”).

Older

Experience with Gilenya in elderly patients (over 65 years of age) is limited. Talk to your doctor if you have any questions.

Children and young people

Gilenya 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 you start taking Gilenya, your doctor will check your vaccination status. If you have not been given any vaccinations, it may be necessary for you to get them before starting treatment with Gilenya.
  • The first time you take Gilenya, or when you switch from a daily dose of 0.25 mg to a daily dose of 0.5 mg, your doctor will monitor your heart rate and heart rate (see “Slow heart rate ( bradycardia ) and irregular heartbeat ” ). ”Above).
  • If you experience seizures or seizures before or while taking Gilenya, talk to your doctor.
  • If you suffer from depression or anxiety, or if you become depressed or anxious while taking Gilenya, talk to your doctor. You may need to be monitored more closely.

Other medicines and Gilenya

Tell your doctor or pharmacist if you have recently taken or might take any other medicines. Tell your doctor if you are taking any of the following medicines:

  • Drugs that inhibit or modulate the immune system, including other medicines used to treat MS, such as beta- interferon , glatiramer acetate, natalizumab, mitoxantrone, teriflunomide, dimethylfumarate or alemtuzumab. You must not use Gilenya at the same time as such medicines as this may increase the effect on the immune system (see also “Do not take Gilenya”).
  • Corticosteroid is , due to a possible additional effect on the immune system.
  • Vaccines . If you need to be vaccinated, ask your doctor’s advice first. During and up to 2 months after treatment with Gilenya, you should not receive certain types of vaccines (live attenuated vaccines) as they may trigger the infection that they are intended to prevent. Other vaccines may not be as effective as normal if given during this period.
  • Drugs that lower the heart rate (eg beta-blockers , such as atenolol). Using Gilenya with such medicines may increase the effect on your heart rate during the first days of treatment with Gilenya.
  • Drugs for irregular heartbeat , such as quinidine , disopyramide , amiodarone or sotalol. You must not use Gilenya if you are taking such a medicine as it may increase the effect on irregular heartbeat (see also “Do not take Gilenya”).
  • Other medicines:
    • protease inhibitors , anti- infective agents such as ketoconazole , azole antifungals, clarithromycin or telithromycin.
    • carbamazepine, rifampicin, phenobarbital, phenytoin , efavirenz or St. John’s wort (possible risk of reduced effect of Gilenya).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.

Pregnancy

Do not use Gilenya during pregnancy, if you are trying to conceive or if you are a woman who may become pregnant and you are not using an effective method of contraception. If Gilenya is used during pregnancy, there is a risk of harm to the unborn baby. The incidence of congenital malformations observed in infants exposed to Gilenya during pregnancy is approximately 2 times the frequency observed in the general population (in which the incidence of congenital malformations is approximately 2-3%). The most commonly reported malformations include heart, kidney, and musculoskeletal malformations.

Therefore, if you are a woman of childbearing age:

  • Before starting treatment with Gilenya, your doctor will inform you about the risk of an unborn baby and ask you to take a pregnancy test to make sure you are not pregnant.

and,

  • you must use an effective method of contraception while taking Gilenya and for 2 months after you stop taking it to avoid getting pregnant. Talk to your doctor about reliable contraceptive methods.

Your doctor will give you a card explaining why you should not get pregnant while taking Gilenya.

If you become pregnant while taking Gilenya, tell your doctor immediately. Your doctor will decide to stop your treatment (see “If you stop taking Gilenya” in section 3 and also section 4, “Possible side effects”). Specialized pregnancy tests will be performed.

Breast-feeding

You should not breastfeed while taking Gilenya. Gilenya can pass into breast milk and there is a risk of serious side effects in the baby.

Driving and using machines

Your doctor will tell you if you can drive, cycle or use machines safely with your illness. Gilenya is not expected to affect your ability to drive or use machines.

However, when starting treatment, you must stay at the doctor’s office or clinic for 6 hours after taking the first dose of Gilenya. Your driving ability and used machines may deteriorate during and possibly after this time period.

How to take Gilenya

Treatment with Gilenya will be supervised by a doctor who has experience in the treatment of multiple sclerosis.

Always take this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.

Recommended dose:

Adults:

Dose one is one capsule 0.5 mg a day.

Children and adolescents (aged 10 years and older):

Dose one depends on body weight:

  • Children and adolescents with body weight equal to or less than 40 kg: one 0.25 mg capsule per day.
  • Children and adolescents with body weight over 40 kg: one 0.5 mg capsule per day.

Children and adolescents starting on a 0.25 mg capsule per day and later reaching a stable body weight over 40 kg will be instructed by their doctor to switch to a 0.5 mg capsule per day. In this case, it is recommended to repeat the observation time for the first dose.

Do not take more than the recommended dose.

Gilenya is for oral use.

Take Gilenya once a day with a glass of water. Gilenya capsules should always be swallowed whole, without opening them. Gilenya can be taken with or without food.

Taking Gilenya at the same time each day will make it easier to remember when to take the medicine.

If you have any further questions on the use of Gilenya, ask your doctor or pharmacist.

If you take more Gilenya than you should

If you take more Gilenya than you should, contact your doctor immediately.

If you forget to take Gilenya

If you have been taking Gilenya for less than 1 month and you forget to take 1 dose for a whole day, consult your doctor before taking the next dose. Your doctor may decide to keep you under observation when you take the next dose.

If you have been taking Gilenya for at least 1 month and have forgotten to take your treatment for more than 2 weeks, consult your doctor before taking the next dose. Your doctor may decide to keep you under observation when you take the next dose. However, if you have forgotten to take your treatment for a maximum of 2 weeks, you can take the next dose as planned.

Never take a double dose to make up for a forgotten dose.

If you stop taking Gilenya

Do not stop taking Gilenya and do not change your dose without talking to your doctor first.

Gilenya stays in the body for up to 2 months after stopping treatment. The number of white blood cells (lymphocyte count) may also remain low during this time and the side effects described in this leaflet may still occur. After you stop taking Gilenya, you may have to wait 6-8 weeks before starting a new MS treatment.

If you need to resume medication with Gilenya more than 2 weeks after you stopped taking it, the effect on your heart rate that is normally seen at the start of treatment may reappear and you will need to be monitored at a doctor’s office or clinic to resume treatment. You should not start treatment with Gilenya, if it was stopped more than 2 weeks ago, without seeking advice from your doctor.

Your doctor will decide if and how you need to be monitored after you stop taking Gilenya.

Tell your doctor immediately if you think your MS has worsened after stopping treatment with Gilenya. It can be serious.

If you have any further questions on the use of this product, ask 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 maybe serious

Common (may affect up to 1 in 10 people)

  • Cough with mucus, chest discomfort, fever (signs of lung disease)
  • Herpes virus infection ( shingles or herpes zoster) with symptoms such as blisters, burning, itching or pain in the skin, usually on the upper body or face. Other symptoms may include fever and weakness in the early stages of the infection, followed by numbness, itching or red spots with severe pain
  • Slow heartbeat ( bradycardia ), irregular heartbeat
  • A type of skin cancer called basal cell carcinoma (BCC) that often appears as a pearlescent nodule, but it can also take other forms.
  • Depression and anxiety have occurred with increasing frequency in the MS population and have also been reported in pediatric patients treated with Gilenya
  • Weight loss

Uncommon (may affect up to 1 in 100 people)

  • Pneumonia with symptoms such as fever, cough, difficulty breathing
  • Macular edema (swelling of the yellow spot on the retina at the back of the eye) with symptoms such as shadows or a blind spot in the middle of the visual field , blurred vision, difficulty seeing colors or details
  • Reduction in the number of platelets , which increases the risk of bleeding or bruising
  • Malignant melanoma (a type of skin cancer that usually develops from an unusual liver spot). Possible signs of melanoma include liver spots that can change size, shape, height or color over time or new liver spots. Liver spots may itch, bleed or become sore
  • Seizures, seizures (more common in children and adolescents than in adults)

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

  • A condition called posterior reversible encephalopathy syndrome (PRES). Symptoms may include sudden onset of severe headache, confusion, seizures and / or visual disturbances
  • Lymphoma (a type of cancer that affects the lymphatic system )
  • Squamous cell carcinoma: a type of skin cancer that can be shaped like a firm, small, red lump, a wound with a crust or a new wound on an existing scar

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

  • Abnormal ECG (T-wave inversion)
  • The tumor associated with infection by the human herpesvirus 8 ( Kaposi’s sarcoma )

No known frequency (can not be calculated from the available data)

  • Allergic reactions, including symptoms of skin rash or itchy hives , swelling of the lips, tongue or face, which are more likely to occur on the day you start treatment with Gilenya.
  • Signs 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 (abdomen), dark urine (brown), feeling less appetite than usual, fatigue and abnormal liver function values. In a very small number of cases, liver failure can lead to liver transplantation.
  • Risk of a rare brain infection, called progressive multifocal leukoencephalopathy (PML). The symptoms of PML may be similar to an MS relapse . Symptoms may also occur that you may not be aware of yourself, such as changes in mood or behavior, memory problems, speech and communication difficulties, which your doctor may need to investigate further to rule out PML. Therefore, if you think that your MS is getting worse or if you or your relatives notice any new or unusual symptoms, it is very important that you talk to your doctor as soon as possible.
  • Cryptococcal infections (a type of fungal infection), including meningitis ( cryptococcal meningitis ) with symptoms such as headache accompanied by stiff neck, photosensitivity, nausea and / or confusion.
  • Merkel cell carcinoma (a type of skin cancer). Possible signs of Merkel cell carcinoma include flesh-colored or bluish-red, painless lump, often on the face, head or neck. Merkel cell carcinoma can also be designed as a firm, painless lump or mass. Prolonged exposure to the sun and a weak immune system can affect the risk of developing Merkel cell carcinoma.
  • After discontinuation of treatment with Gilenya, symptoms of MS may return and become worse than before or during treatment.
  • Autoimmune form of anemia (decreased amount of red blood cells ) where red blood cells are destroyed ( autoimmune hemolytic anemia ).

If you experience any of these symptoms, tell your doctor immediately.

Other side effects are

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

  • Infection caused by influenza virus with symptoms such as fatigue, chills, sore throat, joint or muscle aches, fever
  • Feeling of pressure or pain in the cheeks and forehead (sinusitis)
  • Headache
  • Diarrhea
  • Back pain
  • Blood tests show higher levels of liver enzymes
  • Cough

Common (may affect up to 1 in 10 people)

  • Ringworm , a fungal infection of the skin ( tinea versicolor)
  • Dizziness
  • Severe headache often accompanied by nausea, vomiting and photosensitivity ( migraine )
  • Low white blood cell count ( lymphocytes , leukocytes )
  • Impotence
  • Itchy, red, itchy rash ( eczema )
  • Itching
  • Increase in blood fat level ( triglycerides )
  • Hair loss
  • Shortness of breath
  • Depression
  • Blurred vision (see also the section on macular edema under “Some side effects may be or may be serious”)
  • Hypertension (Gilenya may cause a slight increase in blood pressure )
  • Muscle aches
  • Joint pain

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

  • Low levels of certain white blood cells ( neutrophils )
  • Depression
  • Nausea

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

  • Cancer of the lymphatic system ( lymphoma )

No known frequency (can not be calculated from the available data)

  • Peripheral swelling

If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store Gilenya

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”. The expiration date is the last day of the specified month.

Do not store above 25 ° C.

Store in the original package. Moisture sensitive.

Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is fingolimod.

Gilenya 0.25 mg hard capsules

  • Each capsule contains 0.25 mg of fingolimod (as hydrochloride).
  • Other ingredients are:Capsule contents:  mannitol; hydroxypropylcellulose; hydroxypropyl betadex; magnesium stearate.Capsule shell: gelatin; titanium dioxide (E171); yellow iron oxide (E172).Printing ink: shellac (E904); black iron oxide (E172); propylene glycol (E1520); ammonia solution, concentrated (E527).

Gilenya 0.5 mg hard capsules

  • Each capsule contains 0.5 mg of fingolimod (as hydrochloride).
  • Other ingredients are:Capsule contents: mannitol; magnesium stearate.Capsule shell: gelatin; titanium dioxide (E171); yellow iron oxide (E172).Printing ink:  shellac (E904); ethanol , anhydrous; isopropyl alcohol; butyl alcohol; propylene glycol (E1520); purified water; ammonia solution, concentrated (E527); potassium hydroxide; black iron oxide (E172); yellow iron oxide (E172); titanium dioxide (E171); dimethicone.

What the medicine looks like and contents of the pack

Gilenya 0.25 mg hard capsules have an ivory-colored, opaque top and bottom. “FTY0.25 mg” is printed on the upper part with black color and a stripe is printed on the lower part with black color.

Gilenya 0.5 mg hard capsules have a white opaque base and a clear yellow opaque top. “FTY0.5 mg” is printed on the upper part with black color and two stripes are printed on the lower part with yellow color.

Gilenya 0.25 mg capsules are supplied in packs containing 7 or 28 capsules. Not all pack sizes may be marketed in your country.

Gilenya 0.5 mg capsules are supplied in packs containing 7, 28 or 98 capsules or in multipacks containing 84 capsules (3 packs of 28 capsules). Not all pack sizes may be marketed in your country.

Marketing Authorization Holder and Manufacturer

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

Novartis Pharma GmbH

Roonstrasse 25

90429 Nuremberg

Germany

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgique / BelgienNovartis Pharma NVTel: +32 2 246 16 11 LithuaniaSIA Novartis Baltics Lithuanian branchesTel: +370 5 269 16 50
BulgariaNovartis Bulgaria EOODTel .: +359 2 489 98 28 Luxembourg / LuxemburgNovartis Pharma NVTel: +32 2 246 16 11
Czech RepublicNovartis sroTel: +420 225 775 111 HungaryNovartis Hungary Kft.Tel .: +36 1 457 65 00
DenmarkNovartis Healthcare A / STel: +45 39 16 84 00 MaltaNovartis Pharma Services Inc.Tel: +356 2122 2872
GermanyNovartis Pharma GmbHTel: +49 911 273 0 The NetherlandsNovartis Pharma BVTel: +31 88 04 52 111
EestiSIA Novartis Baltics Eesti subsidiaryTel: +372 66 30 810 NorwayNovartis Norge ASTel: +47 23 05 20 00
GreeceNovartis (Hellas) AEBE:Ηλ: +30 210 281 17 12 AustriaNovartis Pharma GmbHTel: +43 1 86 6570
SpainNovartis Pharmacéutica, SATel: +34 93 306 42 00 PolandNovartis Poland Sp. z ooTel .: +48 22 375 4888
FranceNovartis Pharma SASTel: +33 1 55 47 66 00 PortugalNovartis Pharma-Pharmaceutical Products, SATel: +351 21 000 8600
CroatiaNovartis Hrvatska dooTel. +385 1 6274220 RomaniaNovartis Pharma Services Romania SRLTel: +40 21 31299 01
IrelandNovartis Ireland LimitedTel: +353 1 260 12 55 SloveniaNovartis Pharma Services Inc.Tel: +386 1 300 75 50
IcelandVistor hf.Phone: +354 535 7000 Slovak RepublicNovartis Slovakia sroTel: +421 2 5542 5439
ItalyNovartis Farma SpATel: +39 02 96 54 1 Finland / FinlandNovartis Finland OyPuh / Tel: +358 (0) 10 6133 200
ΚύπροςNovartis Pharma Services Inc.:Ηλ: +357 22 690 690 SwedenNovartis Sverige ABTel: +46 8 732 32 00
LatviaSIA Novartis BalticsTel: +371 67 887 070 United Kingdom (Northern Ireland)Novartis Ireland LimitedTel: +44 1276 698370

Muhammad Nadeem

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