Fingolimod Solinea

Leaflet accompanying the packaging: information for the user

FINGOLIMOD SOLINEA, 0.5 mg, hard capsules
Fingolimod

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

• You should keep this leaflet to be able to read it again if needed.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed to you by a doctor and is intended for your use only. Do not give it to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist (see section 4).

Table of contents of the leaflet

• 1. What is Fingolimod Solinea and what is it used for
• 2. Important information before taking Fingolimod Solinea
• 3. How to take Fingolimod Solinea
• 4. Possible side effects
• 5. How to store Fingolimod Solinea
• 6. Contents of the pack and other information

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

What is Fingolimod Solinea

The active substance of Fingolimod Solinea is fingolimod.

What is Fingolimod Solinea used for

Fingolimod Solinea is used in adults and children and adolescents (aged 10 years and older with a body weight of over 40 kg) to treat relapsing-remitting multiple sclerosis (MS), particularly in:

• patients who have not responded to MS treatment

or

• patients with rapidly evolving severe MS.

Fingolimod Solinea does not cure MS, but it helps reduce the number of relapses and slows down the progression of disability caused by MS.

What is multiple sclerosis

MS is a chronic disease of the central nervous system (CNS), consisting of the brain and spinal cord. In MS, the inflammatory process destroys the nerve sheath (called myelin) in the CNS, preventing it from functioning properly. This phenomenon is called demyelination.

The relapsing-remitting form of MS is characterized by recurring relapses (exacerbations) of neurological symptoms, reflecting the inflammatory process in the CNS. Symptoms vary among patients, but usually include walking difficulties, numbness, vision problems, or balance problems. Relapse symptoms may completely resolve, but some disturbances may persist.

How Fingolimod Solinea works

Fingolimod Solinea helps protect the CNS from immune system attacks by reducing the ability of certain white blood cells (lymphocytes) to move freely in the patient's body and preventing them from entering the brain and spinal cord. In this way, the medicine reduces nerve damage caused by MS. Fingolimod Solinea also weakens some immune responses of the body.

2. Important information before taking Fingolimod Solinea

When not to take Fingolimod Solinea

• if the patient has reduced immune response(due to immunodeficiency syndrome, disease, or taking immunosuppressive medications);
• if the patient has severe active infection or chronic active infection, such as hepatitis or tuberculosis;
• if the patient has active cancer;
• if the patient has severe liver disease;
• - if the patient has had a heart attack, angina pectoris, stroke, or symptoms of stroke within the last 6 months;
• if the patient has a certain type of irregular or abnormal heartbeat(arrhythmia), including patients who have had an electrocardiogram (ECG) showing a prolonged QT interval before starting treatment with Fingolimod Solinea;
• - if the patient is currently taking or has recently taken medications for irregular heartbeat,such as quinidine, disopyramide, amiodarone, or sotalol;
• if the patient is pregnant or breastfeeding or of childbearing age and not using effective contraception;
• if the patient has allergy to fingolimod or any of the other ingredients of this medicine(listed in section 6).

If any of these situations occur, you should tell your doctor and not take Fingolimod Solinea.

Warnings and precautions

Before starting treatment with Fingolimod Solinea, you should discuss the following with your doctor:

• - if you have severe breathing difficulties during sleep (sleep apnea);
• - if you have been informed that your ECG is abnormal;
• - if you have symptoms of slow heart rate (such as dizziness, nausea, or palpitations);
• - if you are taking or have recently taken medications that slow heart rate(such as beta blockers, verapamil, diltiazem, or ivabradine, digoxin, cholinesterase inhibitors, or pilocarpine);
• - if you have had sudden loss of consciousness or fainting spells in the past;
• if you plan to be vaccinated;
• - if you have never had chickenpox;
• - if you have or have had vision problemsor other symptoms of macular edema (such as blurred vision, blind spots, or flashes of light) or uveitis (inflammation or infection of the eye), or if you have diabetes,which may cause vision problems;
• - if you have liver disease;
• if you have high blood pressure that cannot be controlled with medication;
• if you have severe lung diseaseor a cough typical of smokers.

If any of these situations occur, you should tell your doctor before taking
Fingolimod Solinea.
Slow heart rate (bradycardia) and irregular heartbeat
At the beginning of treatment or after taking the first dose of 0.5 mg in patients who have previously taken a daily dose of 0.25 mg using other fingolimod-containing medications with lower potency, fingolimod slows down the heart rate. As a result, the patient may experience dizziness, fatigue, palpitations, or low blood pressure. If these symptoms are very
severe, you should inform your doctor, as immediate treatment may be necessary.Fingolimod Solinea may also cause irregular heartbeat, especially after taking the first dose. Irregular heartbeat usually returns to normal within less than one day. Slow heart rate usually returns to normal within one month.
Your doctor will ask you to stay in the doctor's office or clinic for at least 6 hours after taking the first dose of Fingolimod Solinea or after the first dose of 0.5 mg in case of a change in treatment from a daily dose of 0.25 mg using other fingolimod-containing medications with lower potency, with hourly measurement of pulse and blood pressure, so that if any adverse reactions occur that happen at the beginning of treatment, appropriate treatment can be applied. Before the first dose of Fingolimod Solinea and after the end of the 6-hour observation, an ECG will be performed on the patient. During this time, the doctor may also perform continuous monitoring of the patient's heart activity using an electrocardiogram. If after 6 hours of observation, the patient has a very slow or decreasing heart rate or if the ECG shows abnormalities, there may be a need for longer monitoring of the patient's condition (for at least 2 hours longer or possibly until the next day), until these symptoms resolve. The same procedure may be recommended if the patient resumes treatment with Fingolimod Solinea after a break in treatment, depending on how long the break lasted and how long the patient took Fingolimod Solinea before the break.
If the patient has irregular or abnormal heartbeat, or risk factors for these events, or abnormal ECG or heart disease, or heart failure, Fingolimod Solinea may not be suitable for them.
If the patient has a history of sudden loss of consciousness or slow heart rate, Fingolimod Solinea may not be suitable for them. There may be a need for consultation with a cardiologist (a specialist who deals with the heart), who will advise on how to start treatment with Fingolimod Solinea, including how to monitor the patient at night.
If the patient is taking medications that can slow down the heart rate, Fingolimod Solinea may not be suitable. There may be a need for consultation with a cardiologist, who will check if the patient can switch to other medications that do not slow down the heart rate, to allow treatment with Fingolimod Solinea. If such a change in treatment is not possible, the cardiologist will advise the patient on how to start treatment with Fingolimod Solinea, taking into account monitoring until the next day after administration of the first dose of Fingolimod Solinea.
Patients who have never had chickenpox
If the patient has never had chickenpox, the doctor will check the patient's immunity to the varicella-zoster virus. If the patient is not protected against the virus, they may need to be vaccinated before starting treatment with Fingolimod Solinea. If this is the case, the doctor will delay the start of treatment with Fingolimod Solinea by one month after the full vaccination cycle.
Infections
Fingolimod Solinea reduces the number of white blood cells (especially lymphocytes). White blood cells fight infections. While taking Fingolimod Solinea (and up to 2 months after the end of treatment), the patient may be more susceptible to infections. Any existing infections may worsen. Infections can be severe and life-threatening. If the patient thinks they have an infection, have a fever, flu-like symptoms, shingles, or a headache accompanied by stiff neck, sensitivity to light, nausea, rash, and/or confusion or seizures (seizure attacks) (which may be symptoms of meningitis and/or brain infection caused by fungal or herpes virus infection), they should contact their doctor immediately, as this condition can be severe and life-threatening.
If the patient thinks their MS is getting worse (e.g., weakness or vision problems) or if the patient notices any new symptoms, they should talk to their doctor immediately, as these may be symptoms of a rare brain disease caused by infection and called progressive multifocal leukoencephalopathy (PML). PML is a serious disease that can lead to severe disability or death. The doctor will consider performing an MRI scan to assess the patient's condition and decide whether it is necessary to stop taking Fingolimod Solinea.
Patients treated with Fingolimod Solinea have reported infections with the human papillomavirus (HPV), including cases of warts, dysplasia, warts, and HPV-related cancer. The doctor will consider whether the patient needs to be vaccinated against HPV before starting treatment with Fingolimod Solinea. In women, the doctor will also recommend screening for HPV.
Macular edema
Before starting treatment with Fingolimod Solinea, the doctor may refer patients with existing or past vision problems or other symptoms of macular edema (such as blurred vision, blind spots, or flashes of light) or uveitis (inflammation or infection of the eye) or diabetes for ophthalmological examinations.
The doctor may also refer the patient for ophthalmological examinations after 3 to 4 months of starting treatment with Fingolimod Solinea.
The macula is a small area of the retina at the back of the eye that allows for sharp and detailed vision of shapes, colors, and other details. Fingolimod Solinea may cause macular edema, a condition called macular edema. This edema usually occurs within the first 4 months of treatment with Fingolimod Solinea.
The risk of macular edema is higher in patients with diabetesor with a history of uveitis. In such cases, the doctor will prescribe regular ophthalmological examinations to detect macular edema.
If the patient develops macular edema, they should inform their doctor before resuming treatment with Fingolimod Solinea.
Macular edema can cause vision problems similar to those experienced during an MS relapse (optic neuritis). In the early stages, symptoms may not appear at all.
The patient should inform their doctor about any changes in vision. The doctor may refer the patient for ophthalmological examinations, especially if:

• the center of the visual field becomes blurred or shaded;
• a defect appears in the center of the visual field;
• there are difficulties with color vision or fine details.

Liver function tests
Patients with severe liver disease should not take Fingolimod Solinea.
Fingolimod Solinea may affect liver function tests. The patient is unlikely to experience any symptoms, but if they notice yellowing of the skin or whites of the eyes (jaundice), dark urine (brown), pain in the right upper abdomen (abdomen), fatigue, decreased appetite, or unexplained nausea and vomiting, they should immediately tell their doctor.
If the patient experiences any of the above symptoms after starting treatment with Fingolimod Solinea, they should immediately tell their doctor.
Before, during, and after treatment, the doctor will prescribe blood tests to monitor liver function. If the test results indicate liver function disorders, treatment with Fingolimod Solinea may be discontinued.
High blood pressure
The doctor may regularly check blood pressure, as Fingolimod Solinea can cause a slight increase in blood pressure.
Lung diseases
Fingolimod Solinea has a minor effect on lung function. Patients with severe lung disease or a cough typical of smokers are at higher risk of adverse reactions.
Blood cell count
The expected effect of Fingolimod Solinea is a reduction in the number of white blood cells in the blood. Their number usually returns to normal within 2 months after the end of treatment.
If blood tests need to be performed, the patient should inform their doctor that they are taking Fingolimod Solinea. Otherwise, the doctor may not be able to interpret the results of the blood test, and in the case of certain tests, the doctor may prescribe a larger amount of blood than usual.
Before starting treatment with Fingolimod Solinea, the doctor will check if the patient has a sufficient number of white blood cells to start treatment and may prescribe regular repetition of blood tests.
In case of insufficient white blood cell count, it may be necessary to discontinue treatment with Fingolimod Solinea.
Posterior reversible encephalopathy syndrome (PRES)
In patients with MS treated with Fingolimod Solinea, there have been rare reports of a disease called posterior reversible encephalopathy syndrome (PRES). The symptoms of this disease may include severe headache with a sudden onset, confusion, seizures, and/or vision changes. If any of these symptoms occur during treatment with Fingolimod Solinea, the patient should immediately tell their doctor, as this condition can be severe.
Cancer
Patients with MS treated with Fingolimod Solinea have reported skin cancers.
If the patient notices any lumps on the skin (e.g., shiny lumps with a pearly color), spots, or open sores that do not heal within a few weeks, they should immediately tell their doctor. Symptoms of skin cancer may include abnormal growths or changes in skin tissue (e.g., new moles) that change color, shape, or size over time. Before starting treatment with Fingolimod Solinea, it is necessary to examine the skin for any lumps. The treating doctor will also perform regular skin checks during treatment with Fingolimod Solinea. If skin problems occur, the treating doctor may refer the patient to a dermatologist, who may decide on the need for regular visits after consultation.
Patients with MS treated with fingolimod have reported a type of lymphoma (a type of cancer affecting the lymphatic system).
Exposure to sunlight and protection from ultraviolet radiation
Fingolimod weakens the immune system. This condition increases the risk of developing cancers, especially skin cancers. The patient should limit exposure to sunlight and UV radiation by:

• wearing protective clothing;
• regularly applying sunscreen with a high degree of UV protection.

Unusual changes in the brain associated with MS relapse
Patients treated with Fingolimod Solinea have reported rare cases of unusually large changes in the brain associated with MS relapse. In case of a severe relapse, the doctor will consider performing an MRI scan to assess this condition and decide whether it is necessary to discontinue Fingolimod Solinea.
Switching to Fingolimod Solinea
The doctor may directly switch treatment from interferon beta, glatiramer acetate, or dimethyl fumarate to Fingolimod Solinea if there are no symptoms of abnormality caused by the previous treatment. The doctor may prescribe a blood test to rule out such abnormalities. After stopping treatment with natalizumab, it may be necessary to wait 2-3 months before starting treatment with Fingolimod Solinea. In case of switching treatment from teriflunomide, the doctor may recommend waiting for a certain period or undergoing an accelerated elimination procedure. If the patient has been treated with alemtuzumab, a thorough assessment and discussion with the doctor are necessary before deciding whether Fingolimod Solinea is suitable for the patient.
Women of childbearing age
Fingolimod Solinea should not be used during pregnancy, if the patient is trying to become pregnant, or in women of childbearing age who do not use effective contraception. If Fingolimod Solinea is used during pregnancy, there is a risk of harm to the unborn child. The incidence of congenital malformations observed in infants exposed to Fingolimod Solinea during pregnancy is about 2 times higher than in the general population (in which the incidence of congenital malformations is about 2-3%). The most commonly reported congenital malformations were heart, kidney, and musculoskeletal malformations.
Therefore, if the patient is of childbearing age:

• before starting treatment with Fingolimod Solinea, the doctor will inform the patient about the risk to the unborn child and ask for a pregnancy test to ensure that the patient is not pregnant, and
• to avoid becoming pregnant, the patient should use effective contraception during treatment with Fingolimod Solinea and for 2 months after the end of treatment. The patient should discuss effective contraception methods with their doctor.

The doctor will provide the patient with a card explaining why they should not become pregnant while taking Fingolimod Solinea.

If the patient becomes pregnant while taking Fingolimod Solinea, they should immediately

tell their doctor.The doctor will decide on discontinuing treatment (see "Discontinuing Fingolimod Solinea in section 3, as well as section 4, "Possible side effects").
The patient will also need to undergo prenatal check-ups.
Breastfeeding
Do not breastfeed while taking Fingolimod Solinea.Fingolimod Solinea may pass into breast milk, posing a risk of severe side effects in the child.

Driving and using machines

The doctor will inform the patient whether their condition allows them to drive vehicles safely, including cycling and operating machinery. It is not expected that Fingolimod Solinea will affect the ability to drive vehicles and operate machinery.
However, at the beginning of treatment, the patient must stay in the doctor's office or clinic for 6 hours after taking the first dose of Fingolimod Solinea. During this time and potentially after it, the ability to drive vehicles and operate machinery may be impaired.

3. How to take Fingolimod Solinea

Treatment with Fingolimod Solinea will be supervised by a doctor with experience in treating multiple sclerosis.
This medicine should always be taken exactly as prescribed by the doctor. If you are unsure, ask your doctor.
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 a body weight of 40 kg or less: one 0.25 mg fingolimod capsule per day. Fingolimod Solinea 0.5 mg hard capsules are not suitable for children and adolescents with a body weight of 40 kg or less. Other fingolimod-containing medications with lower potency (0.25 mg capsules) are available.
• Children and adolescents with a body weight over 40 kg: one 0.5 mg capsule per day. Children and adolescents starting treatment with one 0.25 mg fingolimod capsule per day and later achieving a stable body weight over 40 kg will be advised by their doctor to switch to one 0.5 mg capsule per day. In this case, it is recommended to repeat the observation period as after the first dose.

Do not exceed the recommended dose.
Fingolimod Solinea is intended for oral use.
Fingolimod Solinea should be taken once a day, with a glass of water. Fingolimod Solinea should always be swallowed whole, without opening the capsules. Fingolimod Solinea can be taken with or without food.
Taking Fingolimod Solinea at the same time every day will help you remember to take your medicine.
If you are unsure how long to take Fingolimod Solinea, ask your doctor or pharmacist.

Taking a higher dose of Fingolimod Solinea than recommended

If you take a higher dose of Fingolimod Solinea than recommended, contact your doctor immediately.

Missing a dose of Fingolimod Solinea

If you take Fingolimod Solinea for less than 1 month and forget to take 1 dose for the whole day, contact your doctor before taking the next dose. The doctor may decide to keep you under observation during the administration of the next dose.
If you take Fingolimod Solinea for at least 1 month and forget to take the medicine for more than 2 weeks, contact your doctor before taking the next dose. The doctor may decide to keep you under observation during the administration of the next dose. However, if you forget to take the medicine for up to 2 weeks, you can take the next dose as planned.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Fingolimod Solinea

Do not stop taking Fingolimod Solinea or change the dose without consulting your doctor first.
Fingolimod Solinea stays in the body for 2 months after stopping treatment.
During this time, the number of white blood cells (lymphocytes) may also be reduced, and side effects described in this leaflet may still occur. After stopping treatment with Fingolimod Solinea, wait 6-8 weeks before starting new MS treatment.
In patients resuming treatment with Fingolimod Solinea after more than 2 weeks of stopping the medicine, the effect on heart rate may occur again, which is usually observed after starting treatment for the first time, and monitoring of the patient's condition in the doctor's office or clinic will be necessary due to the resumption of treatment. Do not resume treatment with Fingolimod Solinea after a break of more than 2 weeks without consulting your doctor.
The treating doctor will decide how to monitor the patient after stopping treatment with Fingolimod Solinea. If the patient thinks their MS is getting worse after stopping treatment with Fingolimod Solinea, they should immediately tell their doctor. This situation may be serious.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Fingolimod Solinea can cause side effects, although not everybody gets them.
Some side effects may be or may become serious:
Very common(may affect up to 1 in 10 people):

• Cough with expectoration, unspecified unpleasant feeling in the chest, fever (symptoms of respiratory disorders).
• Herpesvirus infections (shingles or herpes) with symptoms such as blisters, burning, itching, or pain of the skin, usually above the upper body or face. Other symptoms may include fever and weakness at the early stage of infection, followed by numbness, itching, or red spots with severe pain.
• Slow heart rate (bradycardia), irregular heartbeat.
• A type of skin cancer called basal cell carcinoma (BCC), which often appears as a pearly nodule, although it may have a different appearance.
• Depression and anxiety are more common in the MS population and have also been reported in children and adolescents treated with Fingolimod Solinea.
• Weight loss.

Common(may affect up to 1 in 100 people):

• Pneumonia with symptoms such as fever, cough, difficulty breathing.
• Macular edema (swelling in the center of the visual field in the retina, at the back of the eye) with symptoms such as shadows or defects in the center of the visual field, blurred vision, difficulty seeing colors and details.
• Reduced platelet count, which increases the risk of bleeding or bruising
• Malignant melanoma (a type of skin cancer that usually develops from an abnormal mole). Possible symptoms of melanoma include moles whose size, shape, elevation, or color changes over time or the appearance of new moles. Moles may itch, bleed, or ulcerate.
• Seizures, epileptic seizures (more common in children and adolescents than in adults).

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

• A condition called posterior reversible encephalopathy syndrome (PRES). Symptoms may include sudden, severe headache, confusion, seizures, and/or vision changes.
• Lymphoma (a type of cancer affecting the lymphatic system).
• Squamous cell carcinoma: a type of skin cancer that may appear as a hard, red nodule, an ulcer covered with a scab, or a fresh ulcer in the place of an existing scar.

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

• Abnormalities in the ECG recording (inversion of the T wave).
• A tumor associated with human herpesvirus 8 infection (Kaposi's sarcoma).

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

• Allergic reactions, including symptoms such as rash or itchy hives, swelling of the lips, tongue, or face, which are more likely to occur on the day of starting treatment with Fingolimod Solinea.
• Symptoms of liver disease (including liver failure), such as yellowing of the skin or whites of the eyes (jaundice), nausea or vomiting, pain in the right upper abdomen (abdomen), fatigue, decreased appetite, or unexplained nausea and vomiting. In very rare cases, liver failure may lead to liver transplantation. The patient should immediately tell their doctor if they experience any of these symptoms.
• Risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). Symptoms of PML may be similar to those of an MS relapse. They may also include symptoms that the patient is not aware of, such as changes in mood or behavior, transient memory lapses, difficulty speaking or communicating, which the doctor should assess to rule out PML. It is very important that if the patient thinks their MS is getting worse or if the patient or their relatives notice any new or unusual symptoms, they should immediately tell their doctor.
• Cryptococcal infections (a type of fungal infection), including cryptococcal meningitis with symptoms such as headache, stiff neck, sensitivity to light, nausea, and/or confusion.
• Merkel cell carcinoma (a type of skin cancer). Possible symptoms of Merkel cell carcinoma include a painless lump with a fleshy color, usually located on the face, head, or neck. Merkel cell carcinoma can also appear as a hard, painless lump or mass. Long-term sun exposure and weakened immune system may increase the risk of Merkel cell carcinoma.
• After stopping treatment with Fingolimod Solinea, MS symptoms may relapse and worsen compared to the period before treatment and during treatment.
• Autoimmune hemolytic anemia (a condition in which red blood cells are destroyed).

If you experience any of these side effects, tell your doctor immediately.
Other side effects
Very common(may affect more than 1 in 10 people):

• Influenza 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
• Increased liver enzyme activity in blood tests
• Cough

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

• Fungal skin infections (dermatophytosis) (ringworm)
• Dizziness
• Severe headache, usually accompanied by nausea, vomiting, and sensitivity to light (migraine symptoms)
• Low white blood cell count (lymphocytes, leukocytes)
• Weakness
• Itchy, red, burning rash (rash)
• Itching
• Increased triglyceride levels in the blood
• Hair loss
• Shortness of breath
• Depression
• Blurred vision (see also the section on macular edema under "Some side effects may be or may become serious")
• Hypertension (Fingolimod Solinea may cause a mild increase in blood pressure)
• Muscle pain
• Joint pain

Uncommon(may affect up to 1 in 100 people):

• Low neutrophil count
• Depressed mood
• Nausea

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

• Lymphoma (a type of cancer affecting the lymphatic system)

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

• Peripheral edema

If any of these symptoms occur with high severity, tell your doctor.

5. How to store Fingolimod Solinea

The medicinal product should be stored out of the reach and sight of children. Do not use this medicinal product after the expiry date stated on the packaging after "Expiry date (EXP)". The expiry date refers to the last day of the given month. Do not store above 25°C. Store in the original packaging to protect from moisture. Do not use medicinal products from packaging that is damaged or shows signs of opening. Medicines should not be disposed of via wastewater or household waste containers. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Fingolimod Solinea contains

• The active substance is fingolimod. Each capsule contains 0.5 mg of fingolimod (as fingolimod hydrochloride).
• The other ingredients are: microcrystalline cellulose, talc, gelatin, titanium dioxide (E171), iron oxide, yellow (E172), shellac, propylene glycol, ammonia, concentrated, potassium hydroxide, iron oxide, black (E172).

What Fingolimod Solinea looks like and contents of the pack

Fingolimod Solinea is a capsule, size 3, consisting of a yellow cap and a white, opaque body, with "FGM 0.5 mg" printed in black ink on the cap. Fingolimod Solinea is available in OPA/Aluminium/PVC/Aluminium or OPA/Aluminium/PE and desiccant/Aluminium blisters containing 28 hard capsules, in a cardboard box.

Marketing authorization holder

Solinea Sp. z o.o. Sp. K., Elizówka 65, Hala I, 21-003 Ciecierzyn, Poland

Manufacturer

Bluepharma - Indústria Farmacêutica, S.A.

• S. Martinho do Bispo 3045-016 Coimbra Portugal

Date of last revision of the leaflet:

26-06-2023