Lognif 0.25 mg hard capsules EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Lognif 0.25 mg hard capsules EFG

Lognif 0.50 mg hard capsules EFG

fingolimod

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

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

Leaflet contents

What Lognif is and what it is used for
What you need to know before taking Lognif
How to take Lognif
Possible side effects
How to store Lognif
Contents of the container and other information

1. What Lognif is and what it is used for

What Lognif is

The active substance of Lognif is fingolimod.

What Lognif is used for

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

patients who have not responded to treatment despite receiving therapy for MS.

patients who rapidly develop severe MS.

This medicine does not cure MS, but helps reduce the number of relapses and slows the progression of physical disability caused by MS.

What is multiple sclerosis

MS is a chronic disease affecting the central nervous system (CNS), which consists of the brain and spinal cord. In MS, inflammation destroys the protective sheath (called myelin) that surrounds the nerves in the CNS, impairing proper nerve function. This is known as demyelination.

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

How Lognif works

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

2. What you need to know before taking Lognif

Do not take Lognif

if you have a weakened immune response (due to an immunodeficiency syndrome, an illness, or medications that suppress the immune system)
if your doctor suspects you may have a rare brain infection called progressive multifocal leukoencephalopathy (PML), or if you have been diagnosed with PML
if you have a severe active infection or chronic active infection such as hepatitis or tuberculosis
if you have active cancer
if you have severe liver problems
if you have had a heart attack, angina, stroke (cerebrovascular accident), risk of stroke, or any type of heart failure within the last 6 months
if you have any type of irregular or abnormal heartbeat (arrhythmia), including patients whose electrocardiogram (ECG) shows QT interval prolongation before starting treatment with this medicine
if you are taking or have recently taken medications for irregular heartbeat such as quinidine, disopyramide, amiodarone, or sotalol
if you are pregnant or a woman of childbearing potential who is not using an effective contraceptive method
if you are allergic to fingolimod or any of the other ingredients of this medicine (listed in section 6)

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

Warnings and precautions

Talk to your doctor before starting Lognif:

if you have severe breathing problems while sleeping (severe sleep apnea)
if you have been told you have an abnormal electrocardiogram (ECG)
if you have symptoms of a slow heartbeat (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, ivabradine, digoxin, anticholinesterase agents, or pilocarpine)
if you have a history of sudden loss of consciousness or fainting (syncope)
if you are planning to get vaccinated
if you have never had chickenpox
if you have or have had visual disorders or other signs of inflammation in the central area of vision (macula) at the back of the eye (a condition known as macular edema, see below), eye inflammation or infection (uveitis), or if you have diabetes (which can cause eye problems)
if you have liver problems
if you have high blood pressure that cannot be controlled with medication
if you have severe lung problems or smoker’s cough

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

Slow heart rate (bradycardia) and irregular heartbeat

At the start of treatment or after taking the first 0.5 mg dose when switching from a daily dose of 0.25 mg, this medicine causes a temporary slowing of the heart rate. As a result, you may feel dizzy or tired, become aware of your heartbeat, or experience a drop in blood pressure. If these effects are severe, inform your doctor immediately, as you may need immediate treatment. This medicine can also cause irregular heartbeats, especially after the first dose. Irregular heartbeats usually return to normal within less than a day. The slow heart rate typically returns to normal within one month. During this time, clinically significant effects on heart rate are generally not expected.

Your doctor will ask you to remain at the clinic or hospital for at least 6 hours, with hourly pulse and blood pressure checks, after taking the first dose of this medicine or after taking the first 0.5 mg dose when switching from a daily dose of 0.25 mg, so that appropriate measures can be taken if adverse effects occur at the beginning of treatment. Before the first dose, you must have had an electrocardiogram (ECG), and another ECG after the 6-hour monitoring period. Your doctor may continuously monitor your ECG during this time. If, after the 6-hour period, you have a very slow or decreasing heart rate, or if your ECG shows abnormalities, you may need to be monitored for a longer period (at least 2 additional hours and possibly overnight) until the issue resolves. The same may apply if you are restarting this medicine after a treatment break, depending on the length of the break and how long you had been taking the medicine before the break.

If you have or are at risk of having irregular or abnormal heartbeats, if your ECG is abnormal, or if you have heart disease or heart failure, this medicine may not be suitable for you.

If you have a history of sudden loss of consciousness (fainting) or slow heart rate, this medicine may not be suitable for you. You will be evaluated by a cardiologist (heart specialist) who will advise on how to start treatment with this medicine, including overnight monitoring.

If you are taking medications that can slow your heart rate, this medicine 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 medicine that does not slow the heart rate to allow treatment with this medicine. If such a switch is not possible, the cardiologist will advise on how to start treatment with this medicine, including overnight monitoring.

If you have never had chickenpox

If you have never 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 to be vaccinated before starting treatment with this medicine. If so, your doctor will delay the start of treatment with this medicine by one month after completing the vaccination series.

Infections

Fingolimod reduces the number of white blood cells (especially lymphocytes). White blood cells fight infections. During treatment with this medicine (and for up to two months after stopping treatment), you may be more susceptible to infections. An existing infection may also worsen. Infections may be serious and potentially fatal. If you think you have an infection, have a fever, flu-like symptoms, herpes (shingles), or have a headache accompanied by neck stiffness, light sensitivity, nausea, rash, and/or confusion or seizures (fits) (which may be due to a fungal infection and could be symptoms of fungal meningitis and/or encephalitis or herpes virus infection), contact your doctor immediately, as this could be serious and life-threatening. If you think your MS is worsening (e.g., weakness or vision changes) or notice any new symptoms, inform your doctor immediately, as they may be signs of a rare brain disorder caused by infection called progressive multifocal leukoencephalopathy (PML). PML is a serious condition that can lead to severe disability or death. Your doctor will assess whether you need a magnetic resonance imaging (MRI) scan to evaluate your condition and decide whether you need to stop taking this medicine.

Human papillomavirus (HPV) infections, including warts, dysplasia, and HPV-related cancers, have been reported in patients treated with fingolimod. Your doctor will assess whether you need HPV vaccination before starting treatment. If you are a woman, your doctor will also recommend regular HPV screening.

PML

PML is a rare brain disorder caused by infection that can lead to severe disability or death. Your doctor will perform magnetic resonance imaging (MRI) scans before and during treatment to monitor the risk of PML.

If you think your MS is worsening or notice any new symptoms, such as changes in mood or behavior, worsening or new weakness on one side of the body, vision changes, confusion, memory problems, or difficulty speaking or communicating, inform your doctor as soon as possible. These may be symptoms of PML. In addition, talk to your family members or caregivers about your treatment, as symptoms may appear without your awareness.

If you develop PML, it can be treated and your treatment with Lognif will be stopped. Some people experience an inflammatory reaction when Lognif is cleared from the body. This reaction (known as immune reconstitution inflammatory syndrome or IRIS) may worsen your condition, including worsening brain function.

Macular edema

Before starting treatment with this medicine, 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) at the back of the eye, eye inflammation or infection (uveitis), or diabetes.

After starting treatment with this medicine, your doctor may request an eye examination 3 to 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 sharply. This medicine can cause inflammation of the macula, a condition known as macular edema. Inflammation usually occurs within the first 4 months of treatment with this medicine.

If you have diabetes or have had eye inflammation called uveitis, you are at higher risk of developing macular edema. In these cases, your doctor will recommend regular eye examinations to detect macular edema.

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

Macular edema can cause some of the same visual symptoms as an MS attack (optic neuritis). Initially, you may not have symptoms. You must report any changes in your vision to your doctor.

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 difficulty seeing colors or small details.

Liver function tests

If you have severe liver problems, you must not take this medicine. This medicine can affect liver function. You may not notice any symptoms, but if you notice yellowing of the skin or whites of the eyes, abnormally dark urine (brown-colored), pain in the right side of your abdomen, fatigue, loss of appetite, or nausea and vomiting without an apparent cause, inform your doctor immediately.

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

Before, during, and after treatment, your doctor will order blood tests to monitor your liver function. If results indicate a liver problem, you may need to stop treatment with this medicine.

High blood pressure

As this medicine causes a slight increase in blood pressure, your doctor will want you to have your blood pressure monitored regularly.

Lung problems

This medicine 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 this medicine is to reduce the number of white blood cells in your blood. This effect usually returns to normal within 2 months after stopping treatment. If you need blood tests, inform your doctor that you are taking this medicine. If you do not, your doctor may not be able to interpret the test results correctly, and for certain blood tests, your doctor may need more blood than usual.

Before starting treatment with this medicine, your doctor will confirm that you have an adequate number of white blood cells in your blood and may want to repeat blood tests regularly. If you do not have enough white blood cells, you may need to stop treatment with this medicine.

Posterior reversible encephalopathy syndrome (PRES)

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

Cancer

Skin cancer has been reported in patients with MS treated with fingolimod. Inform your doctor immediately if you notice any skin nodules (e.g., shiny, pearl-like nodules), spots, or open sores that do not heal for weeks. Symptoms of skin cancer may include abnormal growth or changes in skin tissue (e.g., unusual moles) that change in color, shape, or size over time. Before starting treatment with this medicine, a skin examination is required to check for any skin nodules. Your doctor will also perform periodic skin checks during treatment with this medicine. If any skin problems occur, your doctor may refer you to a dermatologist, who may decide that regular follow-up is necessary.

A type of cancer of the lymphatic system (lymphoma) has been reported in patients with MS 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 sunlight and UV rays by:

wearing appropriate protective clothing
regularly applying sunscreen with a high UV protection factor

Unusual brain lesions associated with MS relapses

Rare cases of unusually large brain lesions associated with MS relapses have been reported in patients treated with fingolimod. In the case of severe relapses, your doctor will assess whether you need a magnetic resonance imaging (MRI) scan to evaluate your condition and decide whether you need to stop treatment with this medicine.

Switching from other treatments to Lognif

Your doctor may switch your treatment directly from interferon beta, glatiramer acetate, or dimethyl fumarate to this medicine if there are no signs of abnormalities from your previous treatment. Your doctor may need to perform a blood test to rule out such abnormalities. After stopping natalizumab, you may need to wait 2–3 months before starting treatment with this medicine. When switching from teriflunomide, your doctor may advise waiting a certain time or undergoing an accelerated elimination procedure. If you have been treated with alemtuzumab, a thorough evaluation and discussion with your doctor is necessary to determine whether this medicine is appropriate for you.

Women of childbearing potential

If this medicine is used during pregnancy, it may harm the fetus. Before starting treatment, your doctor will explain the risks and ask you to take a pregnancy test to confirm you are not pregnant. Your doctor will give you a card explaining why you must not become pregnant while taking this medicine and what you should do to avoid pregnancy. 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 Lognif treatment

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

Inform your doctor immediately if you think your MS is worsening after stopping treatment with this medicine. This may be serious (see “If you stop taking Lognif” in section 3 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 must not be given 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 particularly important for children, adolescents, and their caregivers:

before starting treatment with this medicine, your doctor will check your vaccination status. If you have not received certain vaccines, you may need to be vaccinated before starting treatment.
The first time you take this medicine or when switching from a daily dose of 0.25 mg to a daily dose of 0.5 mg, your doctor will monitor your heart rate and rhythm (see “Slow heart rate (bradycardia) and irregular heartbeat” above).
If you experience seizures or fits before or while taking this medicine, inform your doctor.
If you have depression or anxiety, or if you feel depressed or anxious during treatment with this medicine, inform your doctor. You may need closer monitoring.

Other medicines and Lognif

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Tell your doctor if you are taking any of the following medicines:

Medicines that suppress or modulate the immune system, including other medicines used to treat MS, such as interferon beta, glatiramer acetate, natalizumab, mitoxantrone, teriflunomide, dimethyl fumarate, or alemtuzumab. You must not use this medicine together with these medicines, as this could 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, inform your doctor first. During treatment with this medicine and for up to 2 months after stopping, you must not receive certain types of vaccines (live attenuated vaccines), as they could cause the infections they are meant to prevent. Other vaccines may not work as well if given during this time.
Medicines that slow the heart rate (e.g., beta-blockers such as atenolol). Using this medicine together with these medicines may intensify the effect on heart rate during the first few days after starting treatment.
Medicines to treat irregular heartbeat, such as quinidine, disopyramide, amiodarone, or sotalol. If you are taking any of these medicines, you must not use this medicine, as they could intensify the effect on irregular heartbeat (see also “Do not take Lognif”).
Other medicines:
- Protease inhibitors, 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 medicine).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Do not take this medicine during pregnancy, if you plan to become pregnant, or if you are a woman who could become pregnant and are not using an effective contraceptive method. If you take this medicine during pregnancy, there is a risk of harm to 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 potential:

Before starting treatment with this medicine, your doctor will inform you of the risk to the fetus and request a pregnancy test to confirm you are not pregnant,

and

During treatment with this medicine and for 2 months after stopping treatment, you must use an effective contraceptive method to avoid pregnancy. Discuss reliable contraceptive methods with your doctor.

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

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

Breastfeeding

You must not breastfeed while taking this medicine. Fingolimod passes into breast milk and there is a risk of serious adverse effects for the baby.

Driving and using machines

Your doctor will advise you whether your condition allows you to drive vehicles, including bicycles, and operate machinery safely. This medicine is not expected to affect your ability to drive or operate machinery.

However, at the start of treatment, you will need to remain at your doctor’s office or in the hospital for 6 hours after taking the first dose of this medicine. During this time and possibly afterward, your ability to drive and operate machinery may be impaired.

Lognif contains sodium

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

3. How to take Lognif

Treatment with this medicine will be supervised by a doctor experienced in the treatment of multiple sclerosis.

Always follow exactly the instructions for administration of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults:

The dose is one 0.5 mg capsule per day.

Children and adolescents (aged 10 years and older):

The dose depends on body weight:

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

Children and adolescents who start with a 0.25 mg capsule per day and subsequently reach a stable body weight above 40 kg may be switched by their doctor to a 0.5 mg capsule per day. In these cases, repeating the first-dose observation period is recommended.

Do not exceed the recommended dose.

Lognif is for oral use.

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

Taking this medicine at the same time each day may help you remember when to take it.

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

If you take more Lognif than you should

If you have taken too much medicine, contact your doctor immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Lognif

If you have been taking this medicine for less than 1 month and you miss a dose for a full day, inform 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 this medicine for at least 1 month and you miss your treatment for more than 2 weeks, inform 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 missed treatment for up to two weeks, you may take the next dose as planned.

Never take a double dose to make up for missed doses.

If you stop taking Lognif

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

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

If you need to restart treatment with this medicine after a break of more than 2 weeks, the effect on heart rate that may occur at the beginning of treatment could reappear, and you will need to be monitored in a doctor's office or hospital when restarting treatment. Do not restart treatment with this medicine after stopping it for more than two weeks without seeking advice from your doctor.

Your doctor will decide whether and how you need follow-up after stopping treatment with this medicine. Inform your doctor immediately if you think your MS is worsening after stopping fingolimod. This could be serious.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Some adverse effects may be serious or potentially serious.

Frequent (may affect up to 1 in 10 people)

Cough with sputum (phlegm), chest discomfort, fever (signs of lung disorders)
Herpes virus infection (shingles or herpes zoster) with symptoms such as blisters, stinging, itching, and pain on the skin, especially on the upper part of the body or face. Other symptoms may include fever and weakness in the early stages of infection, followed by numbness, itching, or red spots with intense pain.
Slow heartbeat (bradycardia), irregular heart rhythm.
A type of skin cancer known as basal cell carcinoma (BCC), which often appears as a pearly nodule, although it may also have other forms.
Depression and anxiety are known to occur more frequently in patients with MS, and 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, and difficulty breathing
Macular edema (swelling in the central vision area of the retina at 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.
Decrease in 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 may change over time in size, shape, thickness, or color, or the development of new moles. Moles may itch, bleed, or ulcerate.
Seizures, fits (more common in children and adolescents than in adults).

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

A condition called posterior reversible encephalopathy syndrome (PRES). Symptoms may include sudden onset of severe headache, confusion, seizures, and/or visual disturbances.
Lymphoma (a type of cancer affecting the lymphatic system)
Squamous cell carcinoma: a type of skin cancer that may appear as a firm red nodule, a crusted 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 associated with 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 are more likely to occur on the day treatment with this medicine is started
Signs of liver disease (including liver failure), such as yellowing of the skin or whites of the eyes (jaundice), nausea or vomiting, pain on the right side of the stomach area (abdomen), dark (brown-colored) urine, loss of appetite, tiredness, and abnormal results in liver function tests. In a small number of cases, liver failure could require a liver transplant.
Risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). Symptoms of PML may be similar to an MS relapse. Other symptoms may go unnoticed by you, such as changes in mood or behavior, memory loss, or difficulties with speech and communication, which your doctor may need to investigate further to rule out PML. Therefore, if you think your MS is worsening, or if you or people close to you notice any new or unusual symptoms, it is very important to speak to your doctor as soon as possible.
Inflammatory disorder after stopping treatment with this medicine (known as immune reconstitution inflammatory syndrome or IRIS).
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 bluish-red nodules, usually on the face, head, or neck. Merkel cell carcinoma may also appear 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, MS symptoms may reappear and may be worse than before or during treatment.
Autoimmune form of anemia (decrease in red blood cells) in which red blood cells are destroyed (autoimmune hemolytic anemia).

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

Other adverse effects

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

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

Frequent (may affect up to 1 in 10 people)

Tinea, a fungal skin infection (tinea versicolor)
Dizziness
Severe headache, often accompanied by nausea, vomiting, and sensitivity to light (migraine)
Low levels of white blood cells (lymphocytes, leukocytes)
Weakness
Itchy rash, redness, and burning of the skin (eczema)
Itching
Increased blood levels of certain lipids (triglycerides)
Hair loss
Difficulty breathing
Depression
Blurred vision (see also the section on macular edema in “Some adverse effects may be serious or potentially serious”).
Hypertension (this medicine may cause a moderate 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)
Depressed 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 adverse effects you experience to be severe, inform your doctor.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lognif

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

Do not use this medicine after the expiry date stated on the packaging and blister after CAD/EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lognif

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:

Capsule contents: pregelatinized maize starch, sodium lauryl sulfate

Lognif 0.25 mg hard capsules EFG

Capsule shell: titanium dioxide (E171), gelatin

Lognif 0.50 mg hard capsules EFG

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

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

Nature and contents of the container

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

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

Lognif is available in packs containing 7, 10, 28, 30 and 98 hard capsules in blister packs, 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 single-dose perforated blisters.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U
C/ Anabel Segura, 11, Edificio Albatros B, 1st floor,
Alcobendas 28108
Madrid (Spain)

Manufacturer

Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria

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

Germany: LOGNIF
Bulgaria: Lognif 0.5 mg hard capsules
Cyprus: Lognif 0.5 mg 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
Greece: Lognif 0.5 mg σκληρ? καψ?κια

Date of the most recent revision of this leaflet: December 2025

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es