Prospect: Information for the User

Lognif 0.25 mg Hard Capsules EFG

Lognif 0.50 mg Hard Capsules EFG

fingolimod

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

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

6. Contents of the pack and additional information

What is Lognif

The active ingredient of Lognif is fingolimod.

What is Lognif used for

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

• patients who have not responded to treatment despite treatment for MS.

or

• patients who rapidly develop severe MS.

This medication does not cure MS, but helps to reduce the number of relapses and decrease the rate 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 sheath (called myelin) that covers the nerves in the CNS, preventing nerves from functioning properly. This is called demyelination.

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

How Lognif works

This medication 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 nerve damage caused by MS. This medication also reduces some of the body's immune responses.

Do not takeLognif

• if you have a weakened immune response (due to immunodeficiency syndrome, a disease, or medications that suppress the immune system)
• if you have an active severe infection or an active chronic infection, such as hepatitis or tuberculosis
• if you have an active cancer
• if you have severe liver problems
• if, in the last 6 months, you have had a heart attack, angina, stroke (cerebral hemorrhage), or risk of stroke or any type of heart failure
• if you have any type of irregular or abnormal heart rhythm (arrhythmia), including patients in whom the electrocardiogram (ECG) shows prolongation of the QT interval before starting treatment with this medication
• if you are taking or have recently taken medications for irregular heart rhythm (such as quinidine, disopyramide, amiodarone, or sotalol)
• if you are pregnant or if you are a fertile woman who is not using an effective contraceptive method
• if you are allergic to fingolimod or to any of the other components of this medication (including those listed in section 6)

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

Warnings and precautions

Consult your doctor before starting to takeLognif:

• if you have severe sleep apnea
• if you have been told you have an abnormal electrocardiogram
• if you have symptoms of slow heart rhythm (e.g., dizziness, nausea, or palpitations)
• if you are taking or have recently taken medications that slow your heart rhythm (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 be vaccinated
• if you have never had chickenpox
• if you have or have had visual disturbances or other signs of inflammation in the central vision area (macula) of the back of the eye (a condition known as 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 uncontrolled high blood pressure
• if you have severe lung problems or smoker's cough

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

Slow heart rhythm (bradycardia) and irregular heart rhythm

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, this medication causes a decrease in heart rhythm. As a result, you may feel dizzy or tired, or be aware of your heartbeats, or that your blood pressure may drop.If these effects are severe, inform your doctor as you may need immediate treatment.This medication can also make your heartbeats irregular, especially after the first dose. The irregular heartbeats usually normalize within a day. The slow heart rhythm usually normalizes within a month.During this period, you can generally not expect any clinically significant heart rhythm 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 this medication or after taking the first dose of 0.5 mg when changing from a daily dose of 0.25 mg, so that they can take the necessary measures if you experience adverse effects that appear at the start of treatment. Before the first dose of this medication, you will have had to have an electrocardiogram and after the 6-hour monitoring period. Your doctor can continuously monitor your electrocardiogram during this time. If, after the 6-hour period, you have a very slow or decreasing heart rhythm, or if your electrocardiogram shows abnormalities, you may 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 this medication after a pause in treatment, depending on both the duration of the pause and how long you have been taking this medication before the pause.

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

If you have a history of sudden loss of consciousness (fainting) or decreased heart rhythm, this medication 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 this medication, including monitoring during the night.

If you are taking medications that can slow your heart rhythm, this medication may not be suitable for you. You will need to be evaluated by a cardiologist who will assess whether you can switch to an alternative medication that does not slow your heart rhythm to allow treatment with this medication. If this is not possible, the cardiologist will advise you on how to start treatment with this medication, 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, you may need a vaccine before starting treatment with this medication. If so, your doctor will delay starting treatment with this medication for a month after completing the vaccination cycle.

Infections

Fingolimod reduces the number of white blood cells (especially lymphocytes). White blood cells fight infections. During treatment with this medication (and for up to 2 months after stopping treatment), you may be more susceptible to infections. You may even exacerbate 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, hives, and/or confusion or seizures (which may be due to a fungal infection and may be symptoms of meningitis and/or encephalitis caused by a fungal infection or the herpes virus), contact your doctor immediately, as it may be severe and life-threatening. If you think your EM is worsening (e.g., weakness or visual disturbances) 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 leucoencephalopathy multifocal progressive (LMP). LMP 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 whether you need to stop taking this medication.

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 assess 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

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

After starting treatment with this medication, your doctor may request an eye examination 3 or 4 months after 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 distinctly.This medicationcan cause inflammation of the macula, a condition known as macular edema. The inflammation usually occurs within the first 4 months of treatment with this medication.

If you have diabetes or have had uveitis, you will have a higher risk of developing macular edema. In these cases, your doctor will want to perform regular eye checks to detect macular edema.

If you have had macular edema, consult your doctor before restarting treatment with this medication.

Macular edema can cause some of the same visual symptoms as an EM attack (optic neuritis). At first, you may not have any symptoms. You need to inform your doctor of any changes you notice in your vision.

Your doctor may want to perform 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 this medication.This medicationcan 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), pain in your right side of the abdomen, fatigue, decreased appetite, nausea, and vomiting without apparent cause,inform your doctor immediately.

If you notice any of these symptoms after starting treatment with this medication,inform your doctor immediately.

Before, during, and after treatment, your doctor will request blood tests to monitor your liver function. If the results indicate a liver problem, you may need to stop taking this medication.

High blood pressure

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

Lung problems

This medicationhas a mild effect on lung function. Patients with severe lung problems or smoker's cough have a higher risk of developing adverse effects.

Blood count

The expected effect of treatment with this medicationis 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 this medication.If you do not inform your doctor, it may not be possible for your doctor to understand the test results, and for certain types of blood tests, your doctor may need to take more blood than usual.

Before starting treatment with this medication, your doctor will confirm that you have a sufficient number of 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 taking this medication.

Posterior reversible encephalopathy syndrome (PRES)

Rarely, a condition called posterior reversible encephalopathy syndrome (PRES) has been reported in patients with EM treated with fingolimod. Symptoms may include sudden onset of severe headache, confusion, seizures, and visual disturbances. Inform your doctor immediately if you experience any of these symptoms during treatment with this medication, as they may be severe.

Cancer

There have been reports of skin cancer in patients with EM treated with fingolimod. Inform your doctor immediately if you notice any new skin nodules (e.g., shiny nodules with a pearl-like appearance), skin lesions, 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 this medication, a skin examination will be performed to check for any skin nodules. Your doctor will also perform regular skin checks during treatment with this medication. If any skin problems appear, your doctor may refer you to a dermatologist, who may decide whether you need regular follow-up appointments.

There have been reports of a type of lymphatic system cancer (lymphoma) in patients with EM treated with fingolimod.

Sun exposure and sun protection

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

• wearing protective clothing.
• regularly applying a high-protection sunscreen.

Unusual brain lesions associated with EM relapses

Rare cases of unusual brain lesions associated with EM 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 whether you need to stop taking this medication.

Switching from another treatment to Lognif

Your doctor may switch you directly from interferon beta, glatiramer acetate, or dimethyl fumarate to this medicationif there are no signs of abnormalities caused by your previous treatment. Your doctor may need to perform a blood test to rule out these abnormalities. After stopping natalizumab, you may need to wait 2-3 months before starting treatment with this medication. To switch from teriflunomide, your doctor may advise you to wait a certain time 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 whether this medication is suitable for you.

Women of childbearing age

If you take this medication during pregnancy, it may harm the fetus. Before starting treatment with this medication, 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 this medication. They will also explain 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 EM after stopping Lognif treatment

Do not stop taking this medication or change your dose without first talking to your doctor.

Inform your doctor immediately if you think your EM is worsening after stopping treatment with this medication.

Older patients

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

Children and adolescents

Fingolimod should not be administered to children under 10 years old, as it has not been studied in patients with EM 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 this medication, your doctor will check your vaccination status. If you have not been vaccinated, you may need to have the vaccinations before starting treatment with this medication.
• The first time you take this medication or when changing from a daily dose of 0.25 mg to a dose of 0.5 mg per day, your doctor will monitor your heart rhythm and heart rate (see “Slow heart rhythm (bradycardia) and irregular heart rhythm” above).
• If you experience seizures or attacks before or while taking this medication, inform your doctor.
• If you have depression or anxiety or if you feel depressed or anxious while taking this medication, inform your doctor. You may need closer monitoring.

Other medications and Lognif

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 EM, such as interferon beta, glatiramer acetate, natalizumab, mitoxantrone, teriflunomide, dimethyl fumarate, or alemtuzumab. You should not use this medication with these medications, as it may intensify the effect on the immune system (see also “Do not take Lognif”).
• Corticosteroids, due to a possible additive effect on the immune system.
• Vaccines. If you need a vaccine, first inform your doctor. During treatment with this medication and for up to 2 months after stopping treatment, you should not be given certain types of vaccines (live attenuated vaccines) 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 rhythm(e.g., beta blockers, such as atenolol). The use of this medication with these medications may intensify the effect on heart rhythm during the first few days after starting treatment with this medication.
• Medications for irregular heart rhythm, such as quinidine, disopyramide, amiodarone, or sotalol. If you are taking any of these medications, you should not use this medication, as it may intensify the effect on irregular heart rhythm (see also “Do not take Lognif”).
• Other medications:
• • Inhibitors of protease, anti-infectives such as ketoconazole, azole antifungals, clarithromycin, or telithromycin.
  • Carbamazepine, rifampicin, phenobarbital, phenytoin, efavirenz, or St. John's Wort (potential risk of reducing the effectiveness of this medication).

Pregnancy and breastfeeding

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

Pregnancy

Do not take this medication during pregnancy, if you plan to become pregnant, or if you are a woman who may become pregnant and is not using an effective contraceptive method. If you take this medication 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 the rate observed in the general population (where the rate of congenital malformations is approximately 2-3%). The most frequently reported malformations included cardiac, renal, and musculoskeletal malformations.

Therefore, if you are a woman of childbearing age:

• Before starting treatment with this medication, your doctor will inform you of the risk to the fetus and ask you to have a pregnancy test to ensure you are not pregnant,

and

• During treatment with this medication and for 2 months after stopping treatment, you must use an effective contraceptive method to avoid becoming pregnant. Discuss effective contraceptive methods with your doctor.

Your doctor will give you a card explaining why you should not become pregnant while taking this medication.

If you become pregnant while taking this medication, inform your doctor immediately.Your doctor will decide whether to stop treatment (see “If you stop taking Lognif” in section 3 and also section 4, “Possible side effects”). You will have a specific prenatal follow-up.

Breastfeeding

You should not breastfeed while taking this medication.Fingolimod passes into breast milk, and there is a risk of severe adverse effects for 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. This medicationis not expected to affect your ability to drive and use machines.

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

Lognif contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per capsule; this is essentially “sodium-free”.

The treatment with this medication will be supervised 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 or pharmacist 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):

The dose depends on body weight:

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

Children and adolescents who start with one capsule of 0.25 mg per day and then reach a stable body weight greater than 40 kg, their doctor may change them to one capsule of 0.5 mg per day. In these cases, it is recommended to repeat the observation period of the first dose.

Do not exceed the recommended dose.

Lognif is for oral use.

Take this medication once a day with a glass of water. The capsules of this medication must always be swallowed whole, without opening. This medication can be taken with or without food.

Taking this medication always at the same time each day may help you remember when to take your medication.

If you have doubts about the duration of treatment with this medication, consult your doctor or pharmacist.

If you take more Lognif than you should

If you have taken too much medication, consult your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Lognif

If you have been taking this medication for less than 1 month and forget to take a dose for an entire day, inform 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 this medication for at least a month and forget to take your treatment for more than 2 weeks, inform 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 forget to take the treatment for a period of up to two 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 Lognif

Do not stop taking this medication or change your dose without talking to your doctor first.

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

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

Your doctor will decide if and how you need to be followed up after interrupting treatment with this medication. Inform your doctor immediately if you think your MS is worsening after interrupting treatment with fingolimod. This 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 people)

• Cough with mucus (phlegm), chest discomfort, fever (signs of lung changes)
• Herpes virus infection (cold sore or shingles) with symptoms such as blisters, itching, burning, and pain in the skin, especially in 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 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 EM population has depression and anxiety more frequently, and it has also been reported in pediatric patients treated with fingolimod.
• Weight loss.

Frequent (may affect up to 1 in 10 people)

• Pneumonia, with symptoms such as fever, cough, and 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 in the center of vision, blurred vision, problems seeing colors or details.
• Decreased platelet count, 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 over time can change in size, shape, thickness, or color, or the formation of new moles. Moles can itch, bleed, or ulcerate.
• Seizures, attacks (more common in children and adolescents than in adults).

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

• A disease called reversible posterior leukoencephalopathy syndrome (RPLS). Symptoms may include sudden onset of intense 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 red, firm nodule, a crusty sore, or a new sore in an existing scar.

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

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

Unknown frequency(frequency 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 the treatment with this medicine starts
• Signs of liver disease (including liver failure), such as yellowing of the skin or white part of the eyes (jaundice), nausea or vomiting, pain in 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 transplant.
• Risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). Symptoms of PML may be similar to those of EM. Other symptoms may also appear 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 EM is getting worse or if you or those around you notice any new or unusual symptoms, it is very important to talk to 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 painless, flesh-colored or red-blue nodules, usually on the face, head, or neck. Merkel cell carcinoma can also present as a firm, painless nodule or mass. Prolonged sun exposure and a weakened immune system may affect the risk of developing Merkel cell carcinoma.
• After stopping treatment with this medicine, the symptoms of EM may reappear and may be worse than 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 have any of these symptoms,inform your doctor immediately.

Other side effects

Very frequent(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 showing high levels of liver enzymes
• Cough

Frequent(may affect up to 1 in 10 people)

• Tinea, a fungal infection of the skin (tinea versicolor)
• Dizziness
• Intense headache, often accompanied by nausea, vomiting, and sensitivity to light (migraine)
• Low white blood cell count (lymphocytes, leukocytes)
• Weakness
• Rash with itching, redness, and burning of the skin (eczema)
• Itching
• Increased levels of certain blood lipids (triglycerides)
• Hair loss
• Difficulty breathing
• Depression
• Blurred vision (see also the section on macular edema in “Some side effects can be serious or potentially serious”).
• Hypertension (this medicine may cause a moderate increase in blood pressure)
• Muscle pain
• Joint pain

Poorly frequent(may affect up to 1 in 100 people):

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

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

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

Unknown frequency(frequencycannot 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 prospectus. You can also report them directly through the Spanish System for the Vigilance 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 blister after CAD/EXP. The expiration date refers to the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be thrown into the drains or trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of 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 ofLognif

• The active substance is fingolimod.

Lognif 0.25 mg hard capsules EFG

Each capsule contains 0.25 mg of fingolimod (as hydrochloride).

Lognif 0.50 mg hard capsules EFG

Each capsule contains 0.50 mg of fingolimod (as hydrochloride).

• The other ingredients are:

Capule content: maize pregelatinized starch, sodium lauryl sulfate

Lognif 0.25 mg hard capsules EFG

Capsule coating: titanium dioxide (E171), gelatin.

Lognif 0.50 mg hard capsules EFG

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

Printing ink: shellac, propylene glycol, strong ammonia solution, iron oxide black (E172), potassium hydroxide.

Appearance of the product and contents of the pack

Lognif 0.25 mg hard capsules EFG: gelatin capsule of approximately 14 mm, printed in black with “TV 3654” on the opaque white cap of the capsule and “TV 3654” on the opaque white body of the capsule.

Lognif 0.50 mg hard capsules EFG: gelatin capsule of approximately 14 mm, printed in black with “TV 7820” on the yellow cap of the capsule and “TV 7820” on the opaque white body of the capsule.

Lognif is available in packs containing 7, 10, 28, 30 and 98 hard capsules in blister or in packs containing 7 x 1.10 x 1, 28 x 1, 30 x 1, 98 x 1 and 100 x 1 hard capsules in perforated unit dose blisters.

Only some pack sizes may be marketed.

Marketing authorization holder and responsible person for manufacturing

Marketing authorization holder

Teva Pharma, S.L.U

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor,

Alcobendas 28108

Madrid (Spain)

Responsible person for manufacturing

Balkanpharma-Dupnitsa AD

3 Samokovsko Shosse Str.

Dupnitsa 2600

Bulgaria

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Germany:LOGNIF

Bulgaria:Lognif 0.5 mg hard capsules

Cyprus:Lognif 0,5mg σκληρ? καψ?κια

Czech Republic:Lognif

Slovakia:LOGNIF 0,5 mg tvrdé kapsuly

Spain:Lognif 0,25 mg hard capsules EFG; Lognif 0,50 mg hard capsules EFG

Hungary:Lognif 0,25 mg kemény kapszula;

Italy:LOGNIF

Greece:Lognif 0,5 mg σκληρ? καψ?κια

Revision date of this leaflet:August 2021

The detailed information on this medicinal product is available on the website of theSpanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es