LOGNIF 0.25 mg HARD CAPSULES

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 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 Lognif and what is it used for
2. What you need to know before taking Lognif
3. How to take Lognif
4. Possible side effects
5. Storage of Lognif

1. Contents of the pack and further information

1. What is Lognif and what is it used for

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 (aged 10 years and above) to treat relapsing-remitting multiple sclerosis (MS), particularly in:

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

or

• patients who rapidly develop severe MS.

This medication does not cure MS, but it helps reduce the number of relapses and slow down the progression of physical disabilities due to MS.

What is multiple sclerosis

MS is a chronic disease that affects the central nervous system (CNS), which consists of the brain and spinal cord. In MS, inflammation destroys the protective sheath (called myelin) that covers the nerves in the CNS, preventing the nerves from functioning properly. This is called demyelination.

Relapsing-remitting MS is characterized by repeated attacks (relapses) of neurological symptoms that reflect inflammation in the CNS. Symptoms vary from patient to patient but usually include difficulties with 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 Lognif works

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

2. What you need to know before starting to take Lognif

Do not takeLognif

• 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 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 this medication.
• such as quinidine, disopyramide, amiodarone, or sotalol
• if you are pregnantor if you are a woman of childbearing age who is not using an effective contraceptive method
• to 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 this medication.

Warnings and precautions

Consult your doctor before starting to take Lognif:

• (such as beta blockers, verapamil, diltiazem, or ivabradine, digoxin, anticholinesterase agents, or pilocarpine)
• or other signs of inflammation in the central vision area (macula) of the eye, inflammation or infection in the eye (uveitis), or if you have diabetes(which can cause eye 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 this medication.

Slow heart rate (bradycardia) and irregular heartbeat

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 can cause a decrease in heart rate. As a result, you may feel dizzy or tired, or be aware of your heartbeats, or your blood pressure may drop. If these effects are severe, tell your doctor as you may need immediate treatment. This medication can 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 in a month. During this period, it is generally not expected to have any clinically significant effect on the heart rate.

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 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 appropriate measures in case of adverse effects that appear at the start of treatment. Before the first dose of this medication, you should have had an electrocardiogram and after the 6-hour monitoring period. Your doctor may want to 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 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 resuming 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 heartbeats, if your electrocardiogram is abnormal, or if you have 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 slow heart rate, 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 rate, 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 the heart rate to allow treatment with this medication. If this change 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 the start of treatment with this medication for one month after completing the vaccination cycle.

Infections

Fingolimod reduces the number of white blood cells (especially the number of lymphocytes). White blood cells fight infections. During treatment with this medication (and up to two months after stopping treatment), you may be more likely to get infections. You may even get worse if you already have an infection. Infections can be serious and potentially life-threatening. If you think you have an infection, have a fever, have flu-like symptoms, have herpes (shingles), or have a headache accompanied by stiffness in the neck, sensitivity to light, nausea, vomiting, 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 life-threatening. If you think your MS is getting worse (e.g., weakness or vision problems) 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 scan to evaluate your condition and decide if you need to stop taking this medication.

Human papillomavirus (HPV) infection, including papilloma, dysplasia, warts, and HPV-associated cancer, has 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 regular HPV checks.

Macular edema

Before starting treatment with this medication, 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 in the eye (uveitis), or diabetes.

After starting treatment with this medication, 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. This medication can cause inflammation of the macula, a disease known as macular edema. Inflammation usually occurs within the first 4 months of treatment with this medication.

If you have diabetesor have had inflammation in the eye called 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 resuming treatment with this medication.

Macular edema can cause some of the same visual symptoms as those produced by an MS attack (optic neuritis). At first, you may not have symptoms. It is essential that you 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 field of vision becomes blurry or has shadows;
• a blind spot appears in the center of your field of vision;
• you have trouble seeing colors or small details.

Liver function tests

If you have severe liver problems, you should not take this medication. 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 this medication, tell your doctor immediately.

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

High blood pressure

Since this medication can cause a slight increase in blood pressure, your doctor will want you to have your blood pressure checked regularly.

Lung problems

This medication 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 medication is to reduce the number of white blood cells in your blood. This effect usually normalizes within 2 months after stopping treatment. If you need to have blood tests, inform your doctor that you are taking this medication. If you do not, it may not be possible for your doctor to understand the test results, and for certain types of blood tests, your doctor may need 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 checks regularly. If you do not have enough white blood cells, you may need to stop treatment with this medication.

Posterior reversible encephalopathy syndrome (PRES)

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

Cancer

Skin cancer has been reported in patients with MS treated with fingolimod. Tell your doctor immediately if you notice any nodules on the skin (e.g., shiny nodules), 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 this medication, a skin examination is required 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 if it is essential to see you regularly.

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 the sun and UV rays by:

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

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 the need for an MRI scan to evaluate your condition and decide if you need to stop treatment with this medication.

Switching from another treatment to Lognif

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

Women of childbearing age

If this medication 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 have 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 this medication. 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 "Pregnancy and breastfeeding" section).

MS worsening after stopping treatment with Lognif

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

Tell your doctor immediately if you think your MS is getting worse after stopping treatment with this medication. This can 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 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 this medication, your doctor will check your vaccination status. If you have not received certain vaccines, it may be necessary to administer them before starting treatment with this medication.
• The first time you take this medication or when you switch from a daily dose of 0.25 mg to a dose of 0.5 mg per day, your doctor will check your heart rate and rhythm (see "Slow heart rate (bradycardia) and irregular heartbeat" in the previous section).
• If you experience seizures or attacks before or while taking this medication, tell your doctor.
• If you have 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 Lognif

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, including other medications used to treat MS, such as interferon beta, glatiramer acetate, natalizumab, mitoxantrone, teriflunomide, dimethyl fumarate, or alemtuzumab. You should not use this medication with these medications, as it could intensify the effect on the immune system (see also "Do not take Lognif").
• Corticosteroids, due to a possible additional effect on the immune system.
• Vaccines. If you need a vaccine, first tell your doctor. During treatment with this medication and up to 2 months after stopping it, you should not receive certain types of vaccines (live attenuated vaccines), as they could cause the infections they are supposed 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). Using this medication with these medications can intensify the effect on the heart rate during the first days after starting treatment with this medication.
• Medications for treating irregular heartbeat, such as quinidine, disopyramide, amiodarone, or sotalol. If you are taking any of these medications, you should not use this medication because they could intensify the effect on the heart.

3. How to take Lognif

Treatment with this medication 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 or pharmacist 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 body weight of 40 kg or less:one 0.25 mg capsule per day
• Children and adolescents with a body weight over 40 kg:one 0.5 mg capsule per day.

Children and adolescents who start with a 0.25 mg capsule per day and later reach a stable body weight over 40 kg may have their doctor switch them to a 0.5 mg capsule per day. In these cases, it is recommended to repeat the first-dose observation period.

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 should always be swallowed whole, without opening them. This medication can be taken with or without food.

Taking this medication at the same time every day can help you remember 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Lognif

If you have been taking this medication for less than 1 month and forget to take a dose for a whole 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 medication for at least 1 month and have forgotten 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 when you take the next dose. However, if you have forgotten 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 make up for missed doses.

If you stop 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 stopping treatment. The number of white blood cells (lymphocyte count) may also remain low during this time, and it is possible that side effects may still occur. After stopping treatment with this medication, you may need to wait for 6-8 weeks before starting a new treatment for MS.

If you need to restart treatment with this medication after a pause of more than 2 weeks, the effect on heart rate that may occur at the start of treatment may recur, 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 stopping it for more than two weeks without consulting your doctor.

Your doctor will decide if and how you need to be monitored after stopping treatment with this medication. Inform your doctor immediately if you think your MS is getting worse after stopping treatment with fingolimod. This could be serious.

If you have any other questions about using 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 may be serious or potentially serious.

Common(may affect up to 1 in 10 people)

• Cough with expectoration (phlegm), chest discomfort, fever (signs of lung changes)
• Herpes virus infection (shingles or herpes zoster) with symptoms such as blisters, itching, burning, and pain on the skin, especially on the upper body or face. Other symptoms may include fever and weakness in the initial stages of the infection, followed by numbness, itching, or red spots with severe 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 it has 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 (inflammation in the central vision area of the retina in the eye) with symptoms such as shadows or a blind spot in the center of vision, blurred vision, problems seeing colors or details.
• Decreased number of 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 itch, 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 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 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)

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

• Allergic reactions, including symptoms such as rash or hives with itching, swelling of lips, tongue, or face, which is more likely to occur on the day you start treatment with this medication
• 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), decreased appetite, 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 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 nodules of flesh-colored or blue-red color, usually on the face, head, or neck. Merkel cell carcinoma can also appear as a firm, painless nodule or mass. Prolonged sun exposure and a weakened immune system can affect the risk of developing Merkel cell carcinoma.
• After stopping treatment with this medication, 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 tests showing high levels of liver enzymes
• Cough

Common(may affect up to 1 in 10 people)

• 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
• Rash with itching, redness, and burning of the skin (eczema)
• Itching
• Increased levels of certain lipids (triglycerides) in the blood
• Hair loss
• Difficulty breathing
• Depression
• Blurred vision (see also the section on macular edema in "Some side effects may be serious or potentially serious").
• Hypertension (this medication 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 that any of the side effects you are experiencing is serious, inform your doctor.

Reporting side effects

If you experience any side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Lognif

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging and on the 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 down the drain or into the trash. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

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:

Capsule content: pregelatinized corn 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.

Appearance of the product and package contents

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

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

Lognif is available in packages containing 7, 10, 28, 30, and 98 hard capsules in blisters or in packages 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.

Not all 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, 1ª planta,

Alcobendas 28108

Madrid (Spain)

Manufacturer

Balkanpharma-Dupnitsa AD

3 Samokovsko Shosse Str.

Dupnitsa 2600

Bulgaria

This medication is authorized in the Member States of the European Economic Area 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 cápsulas duras EFG; Lognif 0.50 mg cápsulas duras EFG

Hungary: Lognif 0.25 mg kemény kapszula;

Italy: LOGNIF

Greece: Lognif 0.5 mg σκληρ? καψ?κια

Date of last revision of this leaflet:August 2021

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