FINGOLIMOD COMBIX 0.5 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Fingolimod Combix 0.5 mg Hard Capsules EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

Contents of the Package Leaflet

1. What is Fingolimod Combix and what is it used for
2. What you need to know before taking Fingolimod Combix
3. How to take Fingolimod Combix
4. Possible side effects
5. Storage of Fingolimod Combix
6. Package Contents and Additional Information

1. What is Fingolimod Combix and what is it used for

What is Fingolimod Combix

Fingolimod Combix contains the active ingredient fingolimod.

What Fingolimod Combix is used for

Fingolimod is used in adults, children, and adolescents (10 years of age and older) to treat relapsing-remitting multiple sclerosis (MS) (with relapses), particularly in:

• Patient who do not respond to treatment despite MS treatment.

or

• Patient who rapidly develop severe MS.

Fingolimod does not cure MS, but it helps reduce the number of relapses and slow the progression of physical disabilities 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 sheath (called myelin) that covers the nerves in the CNS, preventing the nerves from functioning properly. This process is called demyelination.

Relapsing-remitting MS is characterized by repeated attacks (relapses) of neurological symptoms that reflect the inflammation occurring in the CNS. Symptoms vary from patient to patient but usually include difficulty walking, loss of sensation in some part of the body (numbness), vision problems, or balance disorders. The symptoms of a relapse may disappear completely when the relapse ends, but some problems may persist.

How Fingolimod Combix Works

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

2. What you need to know before starting to take Fingolimod Combix

Do not take Fingolimod Combix

• if you have a weakened immune system(due to an immunodeficiency syndrome, a disease, or medications that suppress the immune system).
• if you have a severe active or chronic infectionsuch as hepatitis or tuberculosis.
• if you have active cancer.
• if you have severe liver problems.
• if, in the last 6 months, you have had a heart attack, chest pain, stroke, or warning signs of a stroke, or any type of heart failure.
• if you have any type of irregular or abnormal heartbeat(arrhythmia), including patients in whom the electrocardiogram (ECG) shows a prolonged QT interval before starting treatment with Fingolimod Combix.
• if you are taking or have recently taken medications for irregular heartbeatsuch as quinidine, disopyramide, amiodarone, or sotalol.
• if you arepregnant orif you are a woman of childbearing age and do not use an effective contraceptive method .
• if you are allergicto fingolimod or to any of the other components of this medication (included in section 6).

If any of the above cases apply to you or if you are unsure, tell your doctor before taking Fingolimod Combix.

Warnings and precautions

Consult your doctor before starting to take Fingolimod Combix:

• if you have severe respiratory problems when sleeping (severe sleep apnea).
• if you have been told that you have an abnormal electrocardiogram.
• if you have symptoms of a slow heart rate (e.g., dizziness, nausea, or palpitations).
• if you are taking or have recently taken medications that slow your heart rate(such as beta-blockers, verapamil, diltiazem, or ivabradine, digoxin, anticholinesterase agents, or pilocarpine).
• if you have a history 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 disordersor other signs of inflammation in the central vision area (macula) of the eye (a condition known as macular edema), 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 with medication.
• if you have severe lung problemsor smoker's cough.

If any of the above cases apply to you or if you are unsure, tell your doctor before taking Fingolimod Combix.

Slow heart rate (bradycardia) and irregular heartbeats

At the start of treatment or after taking the first dose of 0.5 mg when changing from a daily dose of 0.25 mg, Fingolimod Combix 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 severe, tell your doctor as you may need immediate treatment.Fingolimod Combix may also cause your heartbeats to become irregular, especially after the first dose. Irregular heartbeats usually normalize in less than a day. The slow heart rate usually normalizes within a month. During this period, no clinically significant effect on heart rate is usually expected.

Your doctor will ask you to stay in the office or hospital for at least 6 hours, with pulse and blood pressure checks every hour, after taking the first dose of Fingolimod Combix or after taking the first dose of 0.5 mg, when changing from a daily dose of 0.25 mg, so that appropriate measures can be taken in case of adverse effects that appear at the start of treatment. You should have an electrocardiogram before the first dose of fingolimod and after the 6-hour monitoring period. Your doctor may continuously monitor your electrocardiogram during this time. If after the 6-hour period you have a very slow or decreasing heart rate, or if your electrocardiogram shows anomalies, you will need to be monitored for a longer period (at least 2 hours more and possibly overnight), until this is resolved. The same may apply if you are resuming Fingolimod Combix 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 or abnormal heartbeats, if your electrocardiogram is abnormal, or if you have heart disease or heart failure, Fingolimod may not be suitable for you.

If you have suffered from sudden fainting in the past or clinically significant slow heart rate, Fingolimod Combix may not be suitable for you. You will be evaluated by a cardiologist (heart specialist) who will advise you on how to start treatment with fingolimod, including overnight monitoring.

If you are taking other medications that can slow your heart rate, fingolimod may not be suitable for you. You need to be evaluated by a cardiologist, who will assess whether you can switch to alternative medications that do not slow the heart rate to allow treatment with fingolimod. If such a change is not possible, the cardiologist will advise you on how to start treatment with fingolimod, including overnight monitoring.

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, you will likely need to be vaccinated before starting treatment with Fingolimod Combix. If so, your doctor will delay the start of treatment with fingolimod for a month after completing the vaccination cycle.

Infections

Fingolimod Combix reduces the number of white blood cells in your blood (especially the number of lymphocytes). White blood cells fight infections. During treatment with Fingolimod Combix (and up to 2 months after stopping treatment), you may be more likely to get infections. You may even have a worsening of an infection you already have. Infections can be serious and potentially life-threatening. If you think you have an infection, have a fever, have flu-like symptoms, have shingles, or have a headache accompanied by stiffness in the neck, 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 the herpes virus), contact your doctor immediately because it can be serious and potentially life-threatening. If you think your MS is getting worse (e.g., weakness or vision changes) or if you notice any new symptoms, tell your doctor immediately, as they can 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 assess the need for an MRI to evaluate your condition and decide if you need to stop taking Fingolimod Combix.

Cases of human papillomavirus (HPV) infection, including papilloma, dysplasia, warts, and HPV-associated cancer, have been reported in patients treated with fingolimod. Your doctor will assess whether you need to be vaccinated against HPV before starting treatment. If you are a woman, your doctor will also recommend that you have HPV screenings.

Macular edema

Before starting treatment with Fingolimod Combix, your doctor may request an eye examination if you have or have had visual disorders or other signs of inflammation in the central vision area (macula) of the eye, inflammation or infection of the eye (uveitis), or diabetes.

After starting treatment with fingolimod, your doctor may request an eye examination after 3 or 4 months of 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 sharply. Fingolimod Combix can cause inflammation of the macula, and this condition is known as macular edema. Inflammation usually occurs within the first 4 months of treatment with fingolimod.

If you have diabetes or have had an eye inflammation known as uveitis, you are more likely to develop macular edema. In these cases, your doctor will want you 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 those produced by an MS attack (optic neuritis). At first, you may not have symptoms. You should tell your doctor about any changes you notice in your vision. Your doctor may want to perform an eye examination, especially if:

• the center of your field of vision becomes blurry or contains shadows;
• a blind spot appears in the center of your field of vision;
• you have problems seeing colors or small details.

Liver function tests

If you have severe liver problems, you should not take Fingolimod Combix. This medication can affect liver function. You may not notice any symptoms, but if you notice a yellowish tone to your skin or the white part of your eyes, unusually dark urine (brown color), pain in your right side of the stomach (abdomen), fatigue, loss of appetite, or nausea and vomiting without apparent cause, tell your doctor immediately.

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

Before, during, and after treatment, your doctor will request blood tests to check your liver function. You may need to stop treatment with Fingolimod Combix if the results of your blood tests indicate a problem with your liver.

High blood pressure

Since fingolimod causes a slight increase in blood pressure, your doctor will want you to have your blood pressure checked 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 Combix 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, tell your doctor that you are taking fingolimod, as your doctor may not understand the results of the tests otherwise, and for certain blood tests, your doctor may need more blood than usual.

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

Posterior reversible encephalopathy syndrome (PRES)

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

Cancer

Cases of skin cancer have been reported in MS patients treated with fingolimod. Tell your doctor immediately if you notice any nodules on your skin (e.g., shiny nodules with a pearl-like appearance), spots, or open sores that do not heal within weeks. Symptoms of skin cancer can 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, a skin examination is required to check if you have any nodules on your skin. Your doctor will also perform regular skin checks during treatment with fingolimod. If any skin problems appear, your doctor may refer you to a dermatologist, who may decide if it is important to visit you regularly.

Cases of a type of cancer of the lymphatic system (lymphoma) have been reported in MS patients treated with fingolimod.

Sun exposure and sun protection

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

• wearing suitable protective clothing.
• regularly applying a sunscreen with a high UV protection index.

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 assess the need for an MRI to evaluate your condition and decide if you need to stop taking Fingolimod Combix.

Switching from other treatments to Fingolimod Combix

Your doctor may switch you directly from interferon beta, glatiramer acetate, or dimethyl fumarate to fingolimod if there are no signs of treatment-related anomalies. Your doctor may want to perform a blood test to rule out such anomalies. After stopping natalizumab, you may need to wait for 2-3 months before starting treatment with fingolimod. To switch from teriflunomide, your doctor may advise you to wait for a period of time or undergo an accelerated elimination procedure. If you have been treated with alemtuzumab, a thorough evaluation is necessary, and you should discuss it with your doctor to decide if Fingolimod Combix is suitable for you.

Women of childbearing age

If Fingolimod Combix is used during pregnancy, it may harm the fetus. Before starting treatment with this medication, 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 card that explains why you should not become pregnant while taking fingolimod. It also explains what you should do to avoid becoming pregnant while taking this medication. During treatment and for 2 months after stopping treatment, you must use an effective contraceptive method (see section "Pregnancy and breastfeeding").

Worsening of MS after stopping treatment with Fingolimod Combix

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

Tell your doctor immediately if you think your MS is getting worse after stopping treatment with fingolimod. It could be serious (see section 3 "If you stop taking Fingolimod Combix" and also section 4 "Possible side effects").

Elderly patients

Experience with fingolimod in elderly patients (over 65 years) is limited. If in doubt, 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 received certain vaccinations, you may need to receive them before you can start treatment with fingolimod.
• The first time you take this medication, or when changing from a daily dose of 0.25 mg using other medications that contain fingolimod, which are available in lower doses, 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 attacks before taking or while taking fingolimod, tell your doctor.
• If you suffer from depression or anxiety or if during treatment with this medication you feel depressed or anxious, tell your doctor. You may need closer monitoring.

Other medications and Fingolimod Combix

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication. Tell 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 Combix with these medications because it could enhance the effect on the immune system (see also "Do not take Fingolimod Combix").
• Corticosteroidsdue to an added effect on the immune system.
• Vaccines. If you need a vaccine, tell your doctor first. During treatment with fingolimod and up to 2 months after stopping treatment, you should not receive certain types of vaccines (vaccines made with live attenuated viruses) because they can cause the infections they are intended to prevent. Other vaccines may not have the desired effect if administered during this period.
• Medications that slow the heart rate(e.g., beta-blockers such as atenolol). The use of fingolimod with these medications can enhance the effect on the heart rate during the first days after starting treatment with Fingolimod Combix.
• Medications to treat irregular heartbeats, such as quinine, disopyramide, amiodarone, or sotalol. If you take any of these medications, you should not take Fingolimod Combix.

3. How to take Fingolimod Combix

Treatment with fingolimod will be supervised by a doctor with experience in treating multiple sclerosis.

Follow the administration instructions for this medication exactly as indicated by your doctor. If in doubt, consult your doctor again.

The recommended dose is:

Adults:

The dose is one 0.5 mg capsule per day.

Children and adolescents (10 years of age and older):

The dose depends on body weight:

• Children and adolescents with a weight of 40 kg or less: one 0.25 mg capsule per day.

Fingolimod Combix 0.5 mg hard capsules are not suitable for pediatric patients with a body weight of ≤40 kg. Other medications containing fingolimod are available in lower doses (such as 0.25 mg capsules).

• Children and adolescents with a weight over 40 kg: one 0.5 mg capsule per day.

For children and adolescents who start with a 0.25 mg capsule per day using other medications containing fingolimod, which are available in lower doses, and later reach a stable weight over 40 kg, the doctor will indicate that they switch to a 0.5 mg capsule per day. In this case, it is recommended to repeat the first-dose observation period.

Do not exceed the recommended dose.

Fingolimod Combix is taken orally

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

Taking Fingolimod Combix 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 Combix, consult your doctor or pharmacist.

If you take more Fingolimod Combix 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, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Fingolimod Combix

If you have been taking Fingolimod Combix for less than 1 month and forget to take 1 dose during a whole day, talk to 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 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 when 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 make up for forgotten doses.

If you stop treatment with Fingolimod Combix

Do not stop taking fingolimod or change the dose to be taken without discussing it with your doctor first.

Fingolimod will remain in your body for up to 2 months after stopping treatment. The number of white blood cells in the blood (lymphocyte count) may remain low during this period, and it is possible that the side effects described in this leaflet may still occur. After stopping treatment with fingolimod, you may have to wait for 6-8 weeks before starting a new treatment for MS.

If you need to restart treatment with fingolimod after a pause of more than 2 weeks, the effect on heart rate that may occur at the start of treatment may repeat, and you will need to be monitored in the doctor's office to restart treatment. Do not restart treatment with fingolimod after interrupting it for more than two weeks without consulting your doctor.

Your doctor will decide if it is necessary to monitor you after stopping treatment with fingolimod and how to do it. Inform your doctor immediately if you think your MS is getting worse after stopping treatment with fingolimod. It could be serious.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Some side effects can be serious or potentially serious

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

• Cough with phlegm, chest discomfort, fever (signs of pulmonary disorders)
• Herpes virus infection (shingles or herpes zoster) with symptoms such as blisters, itching, burning, or skin pain, especially on the upper body or face. Other symptoms you may have are fever and weakness in the early stage 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 appears as a pearl-like nodule, although it can also have other forms
• It is known that the MS population has depression and anxiety more frequently, and they have also been reported in pediatric 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 edema (inflammation in the central vision area of the retina in the eye) with symptoms such as shadows or a blind spot or no vision in the field of vision, blurred vision, problems seeing colors or details
• Decreased number of blood platelets, which increases the risk of bleeding or bruising
• Malignant melanoma (a type of skin cancer that usually develops from an unusual mole). Possible signs of melanoma include moles that change in size, shape, thickness, or color over time, or the formation of new moles. Moles can be itchy, bleed, or ulcerate
• Seizures, attacks (more frequent in children and adolescents than in adults).

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

• A disease called posterior reversible encephalopathy syndrome (PRES). Symptoms may include sudden and 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 appear as a firm red nodule, an ulcer with a crust, or a new ulcer on an existing scar.

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

• Abnormality in the electrocardiogram (T-wave inversion)
• Tumor related to human herpesvirus 8 infection (Kaposi's sarcoma).

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

• Allergic reactions, including symptoms of rash or hives with itching, swelling of lips, tongue, or face, which is more likely to occur on the day treatment with Fingolimod Combix 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 in the right side of the abdominal area, dark urine (brown color), less appetite than usual, fatigue, and abnormal liver function test results. In a small number of cases, liver failure could lead to a liver transplant
• Risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). The symptoms of PML may be similar to those of an MS relapse. You may also experience symptoms that you may not notice yourself, such as mood or behavior changes, memory loss, speech or communication difficulties, 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 those close to you notice any new or unusual symptoms, it is very important that you 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 nodule of flesh-colored or blue-red color, usually on the face, head, or neck. Merkel cell carcinoma can also appear as a firm and painless nodule or mass. Long-term sun exposure and a weakened immune system can affect the risk of developing Merkel cell carcinoma
• After stopping treatment with Fingolimod, MS symptoms may recur 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 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
• Sensation of pressure or pain in the cheeks and forehead (sinusitis)
• Headache
• Diarrhea
• Back pain
• Blood test with abnormal liver enzyme levels
• Cough.

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

• Fungal skin infection (tinea versicolor)
• Dizziness
• Severe headache, usually accompanied by nausea, vomiting, and sensitivity to light (migraine)
• Low white blood cell count (lymphocytes, leukocytes)
• Weakness
• Rash with itching, redness of the skin, and burning (eczema)
• Itching
• Increased blood levels of certain lipids (triglycerides)
• Hair loss
• Breathing difficulties
• Depression
• Blurred vision (see also the section on macular edema under the heading "Some side effects can be serious or potentially serious")
• Hypertension (Fingolimod Combix 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 (neutrophils)
• Depressive mood
• Nausea.

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

• Cancer of the lymphatic system (lymphoma).

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

• Peripheral inflammation.

If you consider any of the side effects you are experiencing to be 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 is not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Fingolimod Combix

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

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

Do not store above 30°C.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Fingolimod Combix

• The active ingredient is fingolimod. Each hard capsule contains 0.5 mg of fingolimod (as hydrochloride).
• Other components are:

Capsule content: powdered cellulose (E460), titanium dioxide (E171), magnesium stearate (E470b).

Capsule shell: gelatin (E441), yellow iron oxide (E172), titanium dioxide (E171), sodium lauryl sulfate (E487).

Black printing ink: shellac gum (E904), propylene glycol (E1520), black iron oxide (E172), potassium hydroxide (E525).

Blue printing ink: shellac gum (E904), propylene glycol (E1520), indigo carmine (E132).

Appearance of the product and package contents

Fingolimod Combix 0.5 mg hard capsules have a bright yellow cap and a white opaque body. The cap is printed with "H" in black ink and "F7" on the body with blue ink.

Fingolimod Combix 0.5 mg hard capsules are available in blister packs containing 7, 28, or 98 capsules, in single-dose blister packs containing 7x1 hard capsules, or in multiple packs containing 84 capsules (3 packs of 28 capsules).

Not all pack sizes may be marketed.

Marketing authorization holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Pharmadox Healthcare Limited

KW20A Kordin Industrial Park, Paola,

PLA 3000; Malta

This medication is authorized in the following EEA member states under the names:

France: Fingolimod Zydus 0.5 mg, capsule

Spain: Fingolimod Combix 0.5 mg hard capsules EFG

Date of last revision of this leaflet: September 2024

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/