Label: Information for the User

Fingolimod Glenmark 0.5 mg Hard Capsules EFG

Read this label carefully before you start taking this medicine, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

What is Fingolimod Glenmark

The active ingredient of this medication is fingolimod.

What is Fingolimod Glenmark used for

This medication is used in adults and in children and adolescents (10 years of age and older) with a weight of 40 kg or more to treat relapsing-remitting multiple sclerosis (that occurs with relapses) (MS), particularly in:

• Patients who do not respond to treatment despite treatment for MS or
• Patients who rapidly develop severe MS.

Fingolimod does not cure MS, but it helps to reduce the number of relapses and to reduce the speed of physical disability progression due to MS.

What is multiple sclerosis

MS is a chronic disease that affects the central nervous system (CNS), consisting of the brain and spinal cord. In MS, inflammation destroys the protective covering (called myelin) that surrounds the nerves in the CNS and prevents nerves from functioning correctly. This process is called demyelination.

Relapsing-remitting MS is characterized by repeated attacks (relapses) of CNS symptoms that are a reflection of the inflammation that occurs in the CNS. Symptoms vary from patient to patient, but generally consist of difficulties walking, numbness in some part of the body (numbness), vision problems, or balance disorders. Symptoms of a relapse may disappear completely when the relapse ends, but some problems may persist.

How Fingolimod Glenmark works

Fingolimod helps to combat the attacks of the immune system on the CNS by reducing the ability of some white blood cells (lymphocytes) to move freely within the body and by preventing them from reaching the brain and spinal cord. This limits nerve damage attributed to MS. Fingolimod also reduces some of the immune responses of your body.

Do not take Fingolimod Glenmark

• if you have aweakened immune response(due to immunodeficiency syndrome, a disease, or medications that suppress the immune system).
• if you have anactive severe infection or an active chronic infectionsuch as hepatitis or tuberculosis.
• if you have anactive cancer.
• if you havesevere liver problems.
• if, in the last 6 months, you have had a heart attack, angina, stroke, or transient ischemic attack or any type of heart failure.
• if you have any type ofirregular heartbeat or arrhythmia, including patients in whom the electrocardiogram (ECG) shows prolongation of the QT interval before starting treatment with fingolimod.
• if you are taking or have recently taken medications for irregular heartbeatsuch as quinidine, disopyramide, amiodarone, or sotalol.
• if you arepregnantorif you are a fertile woman and do not use an effective contraceptive method.
• if you are allergicto fingolimod or to any of the other components of this medication (including those in section 6).

If any of the above cases apply to you or you are unsure,inform your doctor before taking fingolimod.

Warnings and precautions

Consult your doctor before starting to take this medication:

If any of the above cases apply to you or you are unsure,inform your doctor before taking fingolimod.

Slow heart rate (bradycardia) and irregular heartbeats

At the start of treatment or after taking the first dose of 0.5 mg, in the case that you have been changed from a previous dose of 0.25 mg once a day, fingolimod causes a decrease in heart rate. As a result, you may feel dizzy or tired, be aware of your heartbeat, or your blood pressure may drop.If these effects are pronounced, inform your doctor as you may need immediate treatment.Fingolimod can also make your heartbeats irregular, especially after the first dose. Irregular heartbeats usually normalize within a day. Slow heart rate usually normalizes within a month. During this period, you can generally not expect any clinically significant heart rate effects.

Your doctor will ask you to stay in the consultation or hospital for at least 6 hours, with pulse and blood pressure checks every hour, after taking the first dose of fingolimod or after taking the first dose of 0.5 mg, in the case that you have been changed from a previous dose of 0.25 mg once a day, to take appropriate measures if adverse effects appear at the start of treatment. You will need to have an electrocardiogram before the first dose of fingolimod and after the 6-hour monitoring period. Your doctor may monitor your electrocardiogram continuously during this time. If, after the 6-hour period, you have a very slow or decreasing heart rate, or if your electrocardiogram shows abnormalities, you will need to be monitored for a longer period (at least 2 hours more and possibly throughout the night, until this is resolved). The same may apply if you are restarting fingolimod after a pause in treatment, depending on both the duration of the pause and how long you were taking fingolimod before the pause.

If you have, or are at risk of having, irregular heartbeats or arrhythmias, if your electrocardiogram is abnormal, or if you have a heart disease or heart failure, fingolimod may not be suitable for you.

If you have had sudden fainting spells in the past or decreased heart rate, fingolimod may not be appropriate for you. You will be evaluated by a cardiologist (heart specialist) who will advise you on how to start treatment with fingolimod, including monitoring during the night.

If you are taking other medications that can slow your heart rate, fingolimod may not be suitable for you. It is necessary for a cardiologist to evaluate you, and it is they who will decide if you can switch to alternative medications that do not slow your heart rate to allow treatment with fingolimod. If this change is impossible, the cardiologist will advise you on how to start treatment with fingolimod, including monitoring during the night.

If you have never had chickenpox

If you have not had chickenpox, your doctor will check your immunity to the virus that causes it (varicella-zoster virus). If you are not protected against the virus, your doctor will probably delay starting treatment with fingolimod for a month after completing the vaccination cycle.

Infections

Fingolimod reduces the number of white blood cells in your blood (especially the number of lymphocytes). White blood cells fight infections. During treatment with fingolimod (and for up to 2 months after you stop treatment), you may be more susceptible to infections. You may even have a worsening of an existing infection. Infections can be severe and potentially life-threatening.

If you think you have contracted an infection, have a fever, have symptoms similar to the flu, have herpes (cold sore) or have a headache accompanied by neck stiffness, sensitivity to light, nausea, rash, and/or confusion or seizures (which can be symptoms of meningitis and/or encephalitis caused by a fungal infection or herpes virus, contact your doctor immediately as it can be severe and life-threatening. If you think your MS is worsening (e.g. weakness or changes in vision) or if you notice any new symptoms, inform your doctor immediately, as they may be symptoms of a rare brain disorder caused by an infection called progressive multifocal leukoencephalopathy (PML). PML is a serious disease that can cause severe disability or death. Your doctor will evaluate the need for a magnetic resonance imaging (MRI) scan to assess your condition and decide if you need to stop taking fingolimod.

There have been reports of human papillomavirus (HPV) infection, including papilloma, dysplasia, warts, and cancer associated with HPV, in patients treated with fingolimod. Your doctor will evaluate if you need to be vaccinated against HPV before starting treatment. If you are a woman, your doctor will also recommend regular HPV checks.

Macular edema

Before starting treatment with fingolimod, your doctor may ask you to have an eye examination if you have or have had eye problems or other signs of inflammation in the central vision area (macula) of the back of the eye, an eye inflammation or infection (uveitis), or diabetes.

After starting treatment with fingolimod, your doctor may ask you to have an eye examination 3 or 4 months after starting treatment.

The macula is a small area of the retina located at the back of the eye that allows you to see shapes, colors, and details clearly and clearly. Fingolimod can cause inflammation of the macula, and this condition is known as macular edema. Inflammation usually occurs within the first four months of treatment with fingolimod.

If you havediabetesor have had an eye inflammation known as uveitis, you are more likely to develop macular edema. In these cases, your doctor will want to have regular eye checks to detect macular edema.

If you have had macular edema, consult your doctor before continuing treatment with fingolimod.

Macular edema can cause the same visual symptoms as an MS attack (optic neuritis). At first, you may not have any symptoms. It is necessary to inform your doctor of any changes you notice in your vision. Your doctor may want to have an eye examination, especially if:

• The center of your visual field becomes blurry or contains shadows;
• A blind spot appears in the center of your visual field;
• You have trouble seeing colors or small details.

Liver function tests

If you have severe liver problems, you should not take fingolimod. Fingolimod can affect liver function. You may not notice any symptoms, but if you notice a yellowish tint to your skin or the white part of your eyes, abnormally dark urine (brown), abdominal pain on the right side, fatigue, loss of appetite, nausea, or vomiting without apparent cause,inform your doctor immediately.

If you have any of these symptoms after starting treatment with fingolimod,inform your doctor immediately.

Before, during, and after treatment, your doctor will ask you to have blood tests to monitor your liver function. You may need to stop treatment if the results of your blood tests indicate a liver problem.

High blood pressure

As fingolimod causes a slight increase in blood pressure, your doctor will want to monitor your blood pressure regularly.

Lung problems

Fingolimod has a mild effect on lung function. Patients with severe lung problems or "smoker's cough" are more likely to develop adverse effects.

Blood count

The expected effect of treatment with fingolimod is to reduce the number of white blood cells in your blood. This effect usually normalizes within 2 months after stopping treatment. If you need to have blood tests, inform your doctor that you are taking fingolimod, as if you do not, the doctor may not understand the results of the blood tests. For certain blood tests, your doctor may need to take more blood than usual.

Before starting treatment with fingolimod, your doctor will confirm if you have enough white blood cells in your blood and may want to repeat the checks regularly. If you do not have enough white blood cells, you may need to stop treatment with fingolimod.

Reversible posterior leukoencephalopathy syndrome (RPLS)

Rarely, a condition called reversible posterior leukoencephalopathy syndrome (RPLS) has been described in patients with MS treated with fingolimod. Symptoms may include sudden and intense headache, confusion, seizures, and changes in vision. Inform your doctor immediately if you experience any of these symptoms during treatment with fingolimod, as it can be severe.

Cancer

In patients with MS who have been treated with fingolimod, cases of skin cancer have been reported. Inform your doctor immediately if you notice any new skin nodules (e.g. shiny nodules that look like pearls), moles, or open sores that do not heal within weeks. Symptoms of skin cancer may include abnormal growth or changes in skin tissue (e.g. unusual moles) that change color, shape, or size over time. Before starting treatment with fingolimod, you will need to have a skin examination to check for any skin nodules. Your doctor will also want to have regular skin checks during treatment with fingolimod. If you notice any skin problems, your doctor may refer you to a dermatologist, who may decide if you need regular check-ups.

In patients with MS who have been treated with fingolimod, a type of lymphoma has been reported.

Sun exposure and sun protection

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

Unusual brain lesions associated with MS relapses

Rare cases of large and unusual brain lesions associated with MS relapses have been reported in patients treated with fingolimod. In the case of severe relapses, your doctor will evaluate the need for an MRI scan to assess your condition and decide if you need to stop taking fingolimod.

Switching from other treatments to Fingolimod Glenmark

Your doctor may switch you directly from interferon beta, glatiramer acetate, or dimethyl fumarate to Fingolimod Glenmark if there are no signs of abnormalities caused by previous treatment. Your doctor may need to have a blood test to rule out these abnormalities. After stopping natalizumab, you may need to wait 2-3 months before starting treatment with Fingolimod Glenmark. To switch from teriflunomide, your doctor may advise you to wait or undergo accelerated elimination. If you have been treated with alemtuzumab, you will need a thorough evaluation and discuss it with your doctor to decide if Fingolimod Glenmark is suitable for you.

Women of childbearing age

If fingolimod is used during pregnancy, it may be harmful to the fetus. Before starting treatment with fingolimod, your doctor will explain the risks and ask you to have a pregnancy test to ensure you are not pregnant.

Your doctor will give you a card explaining why you should not become pregnant while taking fingolimod. They will also explain what you should do to avoid becoming pregnant while taking fingolimod. During treatment and for 2 months after stopping treatment, you must use an effective contraceptive method to avoid becoming pregnant. Talk to your doctor about reliable contraceptive methods.

Worsening of MS after stopping treatment with Fingolimod Glenmark

Do not stop taking Fingolimod Glenmark or change the dose your doctor has prescribed without discussing it with your doctor first.

Inform your doctor immediately if you think your MS is worsening after stopping treatment with fingolimod, as it can be severe (see section 3 "If you stop treatment with Fingolimod Glenmark" and also section 4 "Possible side effects").

Older adults

The experience with fingolimod in patients over 65 years old is limited. If you have any doubts, consult your doctor.

Children and adolescents

Fingolimod should not be administered to children under 10 years of age as it has not been studied in patients with MS in this age group.

The warnings and precautions mentioned above also apply to children and adolescents. The following information is especially important for children and adolescents and their caregivers:

• Before starting treatment with fingolimod, your doctor will check your vaccination status. If you have not been vaccinated, you may need to have the vaccinations before starting treatment with fingolimod.
• The first time you take fingolimod, or when you change from a daily dose of 0.25 mg to a daily dose of 0.5 mg, your doctor will monitor your heart rate and heartbeats (see the previous section "Slow heart rate (bradycardia) and irregular heartbeats").
• If you have seizures or seizures before taking or while taking fingolimod, inform your doctor.
• If you experience depression or anxiety or feel depressed or anxious during treatment with fingolimod, inform your doctor. You may need closer monitoring.

Other medications and Fingolimod Glenmark

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. Inform your doctor if you are taking any of the following medications:

• Medications that suppress or modulate the immune system, includingother medications used to treat MS, such as interferon beta, glatiramer acetate, natalizumab, mitoxantrone, teriflunomide, dimethyl fumarate, or alemtuzumab. You should not use fingolimod with these medications because this could intensify the effect on the immune system (see also "Do not take Fingolimod Glenmark").
• Corticosteroidsdue to an additional effect on the immune system.
• Vaccines.If you need a vaccine, inform your doctor first. During treatment with fingolimod and for up to 2 months after stopping treatment, you should not be given certain types of vaccines (vaccines made with live, attenuated viruses) as they may cause the infections that these vaccines are intended to prevent. It is possible that other vaccines may not have the desired effect if given during this period of time.
• Medications that slow heart rate(e.g. beta-blockers such as atenolol). The use of fingolimod with these medications may intensify the effect on heart rate during the first few days after starting treatment with fingolimod.
• Medications for irregular heartbeat, such as quinidine, disopyramide, amiodarone, or sotalol. If you are taking any of these medications, you should not use fingolimod, as this could intensify the effect on irregular heartbeat (see also the section "Do not take Fingolimod Glenmark").
• Other medications:

• protease inhibitors, antifungals such as ketoconazole, azole antifungals, clarithromycin, or telithromycin.
• carbamazepine, rifampicin, phenobarbital, phenytoin, efavirenz, or St. John's Wort (potential risk of reduced fingolimod efficacy).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor before using this medication.

Pregnancy

Do not use fingolimod during pregnancy, or if you are planning to become pregnant, or if you are a woman who may become pregnant and do not use an effective contraceptive method. If fingolimod is used during pregnancy, there is a risk of harming the fetus. The rate of congenital malformations observed in babies exposed to fingolimod during pregnancy is approximately 2 times higher than that observed in the general population (where the rate of congenital malformations is approximately 2-3%). The most frequently reported malformations included heart, kidney, and musculoskeletal malformations.

Therefore, if you are a fertile woman:

• before starting treatment with fingolimod, your doctor will inform you about the risk to the fetus and ask you to have a pregnancy test to ensure you are not pregnant,

and,

• during treatment with fingolimod and for 2 months after stopping treatment, you must use an effective contraceptive method to avoid becoming pregnant. Talk to your doctor about reliable contraceptive methods.

Card given to you by your doctor

If you become pregnant while taking Fingolimod Glenmark, inform your doctor immediately.Your doctor will decide to stop treatment (see section 3 "If you stop treatment with Fingolimod Glenmark" and also section 4 "Possible side effects"). You will have a specific prenatal follow-up.

Breastfeeding

During treatment with Fingolimod Glenmark, you should not breastfeed.Fingolimod passes into breast milk, and there is a risk of severe adverse effects in the baby.

Driving and operating machinery

Your doctor will inform you if your disease allows you to drive vehicles, including bicycles, and use machines safely. Fingolimod is not expected to affect your ability to drive and use machines.

However, after taking the first dose of fingolimod, you will need to stay in the consultation or hospital for at least 6 hours. During this period and possibly afterwards, your ability to drive and use machines may be impaired.

The treatment with fingolimod will be monitored by a doctor with experience in treating multiple sclerosis.

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor again.

The recommended dose is:

Adults:

The dose is one capsule of 0.5 mg per day.

Children and adolescents (10 years of age and older) with a weight of more than 40 kg:

The dose is one capsule of 0.5 mg per day:

Children and adolescents who start with a capsule of 0.25 mg per day and later reach a stable weight of more than 40 kg, the doctor will instruct them to change to a capsule of 0.5 mg per day. In this case, it is recommended to repeat the observation period of the first dose.

Do not exceed the recommended dose. Fingolimod is used orally.

Take fingolimod once a day with a glass of water. Fingolimod capsules must always be swallowed whole, without opening them. You can take fingolimod with or without food.

Taking fingolimod every day at the same time will help you remember when to take the medication. If you have doubts about the duration of treatment with fingolimod, consult your doctor or pharmacist.

If you take more Fingolimod Glenmark than you should

If you have taken more fingolimod than you should, inform your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 915 620 420, indicating the medication and the amount ingested.

If you forgot to take Fingolimod Glenmark

If you have been taking fingolimod for less than 1 month and forget to take 1 dose for an entire day, talk to your doctor before taking the next dose. Your doctor may decide to keep you under observation at the time you take the next dose.

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

Never take a double dose to compensate for the missed doses.

If you interrupt the treatment with Fingolimod Glenmark

Do not stop taking fingolimod or change the dose that should be taken without consulting your doctor first.

Fingolimod will remain in your body for up to two months after treatment interruption. The number of white blood cells in the blood (lymphocyte count) may remain low during this period and it is possible that the adverse effects described in this leaflet will still occur. After interrupting treatment with fingolimod, you may need to wait 6-8 weeks before starting a new treatment with EM.

If you need to resume treatment with fingolimod after a pause of more than two weeks, the effect on heart rhythm that may occur at the beginning of treatment may repeat and you will need to be monitored in the medical consultation to resume treatment. Do not restart treatment with fingolimod after interrupting it for more than two weeks without consulting your doctor.

Your doctor will decide if you need to be followed up after interrupting treatment with fingolimod and how. Inform your doctor immediately if you think your MS is worsening after interrupting treatment with fingolimod, as it could be serious.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Some side effects can be serious or potentially serious

Frequent(may affect up to 1 in 10 patients):

• Cough with mucus production (sputum), chest discomfort, fever (signs of respiratory changes)
• Herpes virus infection (cold sore or shingles) with symptoms such as blisters, itching, prickling, or skin pain, especially on the upper body or face. Other symptoms you may experience are fever and weakness in the early stages of the infection, followed by numbness, itching, or red spots with intense pain
• Slow heart rate (bradycardia), irregular heart rhythm
• A type of skin cancer known as basal cell carcinoma (BCC) that often presents as a pearl-like nodule, although it can also have other forms
• It is known that the population with multiple sclerosis has depression and anxiety more frequently, and it has also been reported in pediatric patients treated with fingolimod.
• Weight loss.

Less frequent(may affect up to 1 in 100 patients):

• Pneumonia, with symptoms such as fever, cough, difficulty breathing
• Macular edema (inflammation in the central vision area of the retina in the back of the eye) with symptoms such as shadows or a blind spot or loss of vision in the central visual field, blurred vision, problems seeing colors or details
• Decreased platelet count, which increases the risk of bleeding or hematomas
• Malignant melanoma (a type of skin cancer that usually develops from an unusual mole). Possible signs of melanoma include moles that over time can change in size, shape, thickness, or color, or the formation of new moles. Moles can cause itching, bleeding, or ulceration
• Seizures, attacks (more frequent in children and adolescents than in adults)

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

• A disease called posterior reversible encephalopathy syndrome (PRES). Symptoms may include the sudden and intense onset of 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 present as a firm, red nodule, a sore with a crust, or a new sore over an existing scar

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

• Electrocardiogram anomaly (T wave inversion)
• Tumor related to human herpesvirus 8 infection (Kaposi's sarcoma)

Frequency unknown(cannot be estimated from available data):

• Allergic reactions, including symptoms such as rash or urticaria with itching, swelling of lips, tongue, or face, which is more likely to appear on the day treatment with fingolimod begins.
• Signs of liver disease (including liver failure), such as yellowing of the skin or the white part of the eyes (jaundice), nausea or vomiting, pain on the right side of the stomach (abdomen), dark urine (brown), less appetite than usual, fatigue, and abnormal liver function test results. In a small number of cases, liver failure could lead to liver transplantation.
• Risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). Symptoms of PML may be similar to those of MS. You may also experience symptoms that you may not notice yourself, such as changes in mood or behavior, memory loss, difficulty speaking and communicating, which your doctor may need to investigate further to rule out PML. Therefore, if you think your MS is getting worse or if you or people close to you notice any new or unusual symptoms, it is very important to inform 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, sensitivity to light, nausea, and/or confusion
• Merkel cell carcinoma (a type of skin cancer). Possible signs of Merkel cell carcinoma include the formation of a painless, flesh-colored or red-blue nodule, usually on the face, head, or neck. Merkel cell carcinoma can also present as a firm or painless nodule or mass. Long-term exposure to sunlight and a weakened immune system may affect the risk of developing Merkel cell carcinoma.
• After stopping treatment with fingolimod, MS symptoms may reappear and may be worse than they were before or during treatment.
• Autoimmune form of anemia (decrease in the number of red blood cells) in which red blood cells are destroyed (autoimmune hemolytic anemia).

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

Other side effects

Very frequent(may affect more than 1 in 10 patients):

• Influenza virus infection with symptoms such as fatigue, chills, sore throat, joint or muscle pain, fever
• Sensation of pressure or pain in the cheeks and forehead (sinusitis)
• Headache
• Diarrhea
• Back pain
• Blood test with alterations in liver enzyme levels
• Cough

Frequent(may affect up to 1 in 10 patients):

• Pityriasis versicolor (fungal infection of the skin)
• Dizziness
• Severe headache, usually accompanied by nausea, vomiting, and sensitivity to light (migraine)
• Low white blood cell count (lymphocytes, leukocytes)
• Weakness
• Itching
• Increased levels of certain lipids in the blood (triglycerides)
• Hair loss
• Difficulty breathing
• Depression
• Blurred vision (see also the section on macular edema under the title "Some side effects can be serious or potentially serious")
• Hypertension (fingolimod may cause a slight increase in blood pressure)
• Muscle pain
• Joint pain

Less frequent(may affect up to 1 in 100 patients):

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

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

• Lymphoma (a type of cancer that affects the lymphatic system)

Frequency unknown(cannot be estimated from available data):

• Peripheral inflammation

If you consider that any of the side effects you are experiencing are serious,inform your doctor.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging and on the aluminum blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Do not use any packaging that is damaged or shows signs of having been manipulated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Fingolimod Glenmark

• Each capsule contains 0.5 mg of the active ingredient, fingolimod (as hydrochloride).
• The other components are:

Capule content: calcium phosphate, stearic acid.

Capule coating: gelatin, titanium dioxide (E171), iron oxide yellow (E172).

Printing ink: shellac (E904), iron oxide black (E172).

Appearance of the product and contents of the package

Fingolimod Glenmark 0.5 mg hard capsules EFG are presented in hard gelatin capsules with an opaque yellow cap and an opaque white body; with a length of 15.9 ± 0.3 mm, with "0.5 mg" printed on the cap with black ink.

Fingolimod Glenmark 0.5 mg hard capsules EFG are packaged in carton boxes containing the appropriate number of PVC/PE/PVDC/aluminum foil or perforated single-dose PVC/PE/PVDC/aluminum foil blisters with the appropriate number of capsules and the package insert.

Packaging sizes:

Carton packages containing 7, 7x1, 28, 28x1, 98, or 98x1 capsules or multi-packages containing 84 capsules (3 packages of 28 capsules).

Only some packaging sizes may be commercially available.

Marketing authorization holder and manufacturer

Marketing authorization holder

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer

Pharmathen International, S.A

Industrial Park Sapes, Rodopi Prefecture,Block No 5

Rodopi 69300

Greece

Pharmathen S.A.

Dervenakion 6

Pallini Attiki, 15351

Greece

Glenmark Pharmaceuticals S.R.O

Fibichova 143

Vysoke Mýto 566 17

Czech Republic

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Viso Farmacéutica, S.L.U

c/ Retama 7, 7ª Planta

28045 Madrid

Spain

This medicinal product is authorized in the Member States of the EEA with the following names:

Denmark:Fingolimod Glenmark

Czech Republic:Fingolimod Glenmark

Germany:Fingolimod Glenmark 0.5 mg Hartkapseln

Netherlands:Fingolimod Glenmark 0.5 mg harde capsules

Poland:Fingolimod Glenmark

Slovakia:Fingolimod Glenmark 0.5 mg tvrdé kapsuly

Spain:Fingolimod Glenmark 0.5 mg cápsulas duras EFG

Sweden:Fingolimod Glenmark

United Kingdom:Fingolimod Glenmark 0.5 mg hard capsules

Last revision date of this leaflet: January 2021

For detailed and updated information about this medicinal product, please visit the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)