Package leaflet: Information for the user

Fingolimod Olpha, 0.5 mg, hard capsules
Fingolimodum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.
Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are similar.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

What Fingolimod Olpha is and what it is used for
Important information before taking Fingolimod Olpha
How to take Fingolimod Olpha
Possible side effects
How to store Fingolimod Olpha
Contents of the pack and other information

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

What Fingolimod Olpha is
Fingolimod Olpha contains the active substance fingolimod.

What Fingolimod Olpha is used for
Fingolimod Olpha is used in adults, children and adolescents (aged 10 years and older) for the treatment of relapsing-remitting multiple sclerosis (MS, Latin: Sclerosis multiplex), particularly in:
patients who have not responded to previous MS treatments,
or
patients with rapidly evolving, severe forms of MS.
Fingolimod Olpha does not cure MS, but helps reduce the number of relapses and slows the progression of disability caused by MS.

What is multiple sclerosis
MS is a chronic disease of the central nervous system (CNS), which consists of the brain and spinal cord. In MS, an inflammatory process damages the protective covering of nerves (called myelin) in the CNS, impairing their proper function. This phenomenon is known as demyelination.
Relapsing-remitting MS is characterized by recurrent episodes (relapses) of neurological symptoms reflecting inflammatory activity within the CNS. Symptoms vary among patients but typically include walking difficulties, numbness, vision disturbances, or balance problems. Symptoms of relapses may resolve completely, although some deficits may persist.

How Fingolimod Olpha works
Fingolimod Olpha helps protect the CNS from immune system attacks by reducing the ability of certain white blood cells (lymphocytes) to move freely throughout the body and by preventing them from entering the brain and spinal cord. This way, the medicine limits nerve damage caused by MS. Fingolimod Olpha also reduces certain immune responses in the body.

2. Important Information Before Taking Fingolimod Olpha

When not to take Fingolimod Olpha

if the patient has a weakened immune response (due to immunodeficiency syndrome, disease, or use of medicines that suppress the immune system);
if the doctor suspects that the patient has a rare brain infection called progressive multifocal leukoencephalopathy (PML) or if PML has been diagnosed in the patient;
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, stroke, or stroke warning signs, or certain types of heart failure within the last 6 months;
if the patient has a certain type of irregular or abnormal heartbeat (arrhythmia), including patients in whom an electrocardiogram (ECG) showed QT interval prolongation before starting treatment with Fingolimod Olpha;
if the patient is currently taking or has recently taken medicines for irregular heartbeat, such as quinidine, disopyramide, amiodarone, or sotalol;
if the patient is pregnant or is of childbearing age and not using effective contraception;
if the patient is allergic to fingolimod or any of the other ingredients of this medicine (listed in section 6).

If any of these situations apply or the patient has any doubts, consult the doctor before taking Fingolimod Olpha.

Warnings and precautions

Before starting treatment with Fingolimod Olpha, discuss the following with the doctor:

if the patient has severe breathing problems during sleep (sleep apnoea);
if the patient has been told that their ECG tracing is abnormal;
if the patient experiences symptoms of a slow heart rate (e.g. dizziness, nausea, or palpitations);
if the patient is taking or has recently taken medicines that slow heart rate (such as beta-blockers, verapamil, diltiazem, ivabradine, digoxin, cholinesterase inhibitors, or pilocarpine);
if the patient has previously experienced sudden loss of consciousness or fainting;
if the patient plans to be vaccinated;
if the patient has never had chickenpox;
if the patient has or has had vision problems or other symptoms of swelling in the centre of the visual field (macula) at the back of the eye (a condition called macular oedema, see below), inflammation or infection of the eye (uveitis), or if the patient has diabetes, which may cause vision problems;
if the patient has liver problems;
if the patient has high blood pressure that cannot be controlled with medication;
if the patient has severe lung disease or a cough typical of smokers.

If any of these situations apply or the patient has any doubts, consult the doctor before taking Fingolimod Olpha.

Slow heart rate (bradycardia) and irregular heartbeat

At the beginning of treatment or after taking the first 0.5 mg dose in patients previously taking a 0.25 mg daily dose, Fingolimod Olpha slows heart rate. As a result, the patient may feel dizzy, fatigued, have a pounding heartbeat, or experience low blood pressure. If these symptoms are severe, inform the doctor immediately, as immediate treatment may be necessary. Fingolimod Olpha may also cause irregular heartbeat, especially after the first dose. Irregular heartbeat usually returns to normal within less than one day. Slow heart rate usually returns to normal within one month. During this period, no clinically significant effect on heart rate is generally expected.

The doctor will ask the patient to remain in the doctor's office or clinic for at least 6 hours after taking the first dose of Fingolimod Olpha or the first 0.5 mg dose when switching from a 0.25 mg daily dose, with hourly monitoring of pulse and blood pressure, so that appropriate treatment can be given if any adverse effects occur at the beginning of treatment. An ECG will be performed before the first dose of Fingolimod Olpha and again after the 6-hour observation period. During this time, the doctor may continuously monitor the patient's heart function with an electrocardiogram. If, after 6 hours of observation, the patient has a very slow or decreasing heart rate or if the ECG shows abnormalities, longer monitoring (for at least 2 additional hours or possibly until the next day) may be required until symptoms resolve. The same procedure may be recommended if the patient resumes treatment with Fingolimod Olpha after a treatment interruption, depending on the duration of the interruption and how long the patient had previously taken Fingolimod Olpha before the interruption.

If the patient has irregular or abnormal heartbeat, risk factors for such events, abnormal ECG findings, heart disease, or heart failure, Fingolimod Olpha may not be suitable.

If the patient has a history of sudden loss of consciousness or slowed heart function, Fingolimod Olpha may not be suitable. Consultation with a cardiologist (a heart specialist) may be needed to advise on how to start treatment with Fingolimod Olpha, including overnight monitoring.

If the patient is taking medicines that may slow heart rate, Fingolimod Olpha may not be suitable. Consultation with a cardiologist may be necessary to determine whether the patient can switch to other medicines that do not slow heart rate, to allow treatment with Fingolimod Olpha. If such a change is not possible, the cardiologist will advise on how to start treatment with Fingolimod Olpha, including monitoring until the day after the first dose.

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, vaccination may be required before starting treatment with Fingolimod Olpha. If this is the case, the doctor will delay the start of treatment with Fingolimod Olpha by one month after completion of the full vaccination course.

Infections

Fingolimod Olpha reduces the number of white blood cells (especially lymphocytes). White blood cells fight infections. While taking Fingolimod Olpha (and for up to 2 months after stopping treatment), the patient may be more susceptible to infections. Existing infections may worsen. Infections may be severe and life-threatening. If the patient suspects an infection, has a fever, flu-like symptoms, shingles, or a headache accompanied by neck stiffness, light sensitivity, nausea, rash, and/or confusion or seizures (symptoms of meningitis and/or encephalitis caused by fungal or herpes virus infections), contact the doctor immediately, as this condition may be serious and life-threatening.

In patients treated with Fingolimod Olpha, human papillomavirus (HPV) infections have been reported, including cases of warts, dysplasia, and HPV-related malignant tumours. The doctor will consider whether the patient needs HPV vaccination before starting treatment. In women, the doctor will also recommend screening tests for HPV.

PML

PML is a rare brain disorder caused by infection that may lead to severe disability or death. The treating doctor will order a magnetic resonance imaging (MRI) scan before starting and during treatment to monitor PML risk.

If the patient feels their multiple sclerosis is worsening or notices new symptoms such as mood or behavioural changes, new weakness or worsening of existing weakness on one side of the body, vision changes, confusion, temporary memory lapses, or speech and communication difficulties, contact the doctor immediately. These may be symptoms of PML. Discuss the treatment with a partner or caregiver and inform them, as symptoms may occur that the patient is not aware of.

If PML occurs, treatment may be required and treatment with Fingolimod Olpha will be stopped. In some patients, after removal of Fingolimod Olpha from the body, an inflammatory reaction may occur. This reaction (called immune reconstitution inflammatory syndrome, IRIS) may lead to worsening of the patient's condition, including worsening brain function.

Macular oedema

Before starting treatment with Fingolimod Olpha, the doctor may refer patients with current or past vision problems or other symptoms of swelling in the centre of the visual field (macula) at the back of the eye, eye inflammation or infection (uveitis), or diabetes for ophthalmological examination.

The doctor may refer the patient for ophthalmological examination 3 to 4 months after starting treatment with Fingolimod Olpha.

The macula is a small area of the retina at the back of the eye that enables clear, sharp vision of shapes, colours, and fine details. Fingolimod Olpha may cause swelling of the macula, a condition called macular oedema. This swelling usually occurs within the first 4 months of treatment with Fingolimod Olpha.

The risk of macular oedema is higher in patients with diabetes or a history of uveitis. In such cases, the doctor will order regular ophthalmological examinations to detect macular oedema.

If macular oedema occurs, inform the doctor before resuming treatment with Fingolimod Olpha.

Macular oedema may cause visual disturbances similar to those seen in MS attacks (optic neuritis). In early stages, symptoms may be absent. Report any changes in vision to the doctor.

The doctor may refer the patient for ophthalmological examination, especially if: - the centre of the visual field becomes blurry or shadowed; - a blind spot appears in the centre of the visual field; - difficulty seeing colours or fine details occurs.

Liver function tests

Patients with severe liver disease should not take Fingolimod Olpha. Fingolimod Olpha may affect liver function test results. The patient may not experience any symptoms, but if yellowing of the skin or whites of the eyes, abnormally dark (brown) urine, pain in the right side of the abdomen, fatigue, reduced appetite, or unexplained nausea and vomiting occur, contact the doctor immediately.

If any of these symptoms occur after starting treatment with Fingolimod Olpha, contact the doctor immediately.

Before, during, and after treatment, the doctor will order blood tests to monitor liver function. If test results indicate liver dysfunction, treatment with Fingolimod Olpha may be stopped.

High blood pressure

The doctor may regularly check blood pressure, as Fingolimod Olpha causes a slight increase in blood pressure.

Lung problems

Fingolimod Olpha has a minor effect on lung function. Patients with severe lung disease or a smoker's cough are at higher risk of adverse effects.

Blood cell count

A known effect of Fingolimod Olpha is a reduction in white blood cells (especially lymphocytes). Their number usually returns to normal within 2 months after stopping treatment. If blood tests are needed, inform the doctor about taking Fingolimod Olpha. Otherwise, the doctor may not be able to interpret blood test results correctly, and for certain tests, the doctor may order a larger blood sample than usual.

Before starting Fingolimod Olpha, the doctor will confirm that the white blood cell count is adequate to begin treatment and may order regular repeat tests. If white blood cell count is insufficient, treatment with Fingolimod Olpha may need to be stopped.

Posterior reversible encephalopathy syndrome (PRES)

Rarely, patients with MS treated with Fingolimod Olpha have reported a condition called posterior reversible encephalopathy syndrome (PRES). Symptoms may include sudden severe headache, confusion, seizures, and vision changes. If any of these symptoms occur during treatment with Fingolimod Olpha, contact the doctor immediately, as this condition may be serious.

Cancer

Skin cancers have been reported in patients with MS treated with Fingolimod Olpha. If any lumps (e.g. shiny, pearly lumps), spots, or open sores that do not heal within several weeks appear on the skin, contact the doctor immediately. Skin cancer symptoms may include abnormal growths or changes in skin tissue (e.g. new moles) that change in colour, shape, or size over time. A skin examination for any lumps should be performed before starting treatment with Fingolimod Olpha. The treating doctor will also perform regular skin checks during treatment with Fingolimod Olpha. If skin problems occur, the doctor may refer the patient to a dermatologist, who may recommend regular visits after consultation.

Lymphoma, a type of lymphatic system cancer, has been reported in patients with MS treated with Fingolimod Olpha.

Sun exposure and sun protection

Fingolimod suppresses the immune system. This increases the risk of malignancies, especially skin cancers. The patient should limit exposure to sunlight and UV radiation by:

wearing protective clothing;
regularly applying sunscreen with high UV protection.

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 Olpha. In case of a severe MS relapse, the treating doctor may consider an MRI scan to assess the condition and decide whether to discontinue Fingolimod Olpha.

Switching from other medicines to Fingolimod Olpha

The doctor may switch treatment directly from interferon-beta, glatiramer acetate, or dimethyl fumarate to Fingolimod Olpha if there are no signs of abnormalities caused by previous treatment. The doctor may order blood tests to rule out such abnormalities. After stopping natalizumab, a waiting period of 2 to 3 months may be required before starting Fingolimod Olpha. When switching from teriflunomide, the doctor may advise waiting a certain time or undergoing an accelerated elimination procedure. Patients previously treated with alemtuzumab require careful evaluation and discussion with the doctor to determine whether Fingolimod Olpha is suitable.

Women of childbearing age

If Fingolimod Olpha is used during pregnancy, it may harm the unborn child. Before starting treatment with Fingolimod Olpha, the doctor will explain the risks and request a pregnancy test to exclude pregnancy. The doctor will provide the patient with a card explaining why pregnancy should be avoided while taking Fingolimod Olpha. The card also contains information on how to avoid pregnancy while taking Fingolimod Olpha. Patients must use effective contraception during treatment and for 2 months after stopping treatment (see section "Pregnancy and breastfeeding").

If the patient becomes pregnant while taking Fingolimod Olpha, contact the doctor immediately. The doctor will decide whether to discontinue treatment (see "Discontinuation of Fingolimod Olpha" in section 3 and section 4 "Possible side effects"). The patient will also need to attend prenatal check-ups.

Breast-feeding

Do not breast-feed while taking Fingolimod Olpha. Fingolimod Olpha may pass into breast milk, posing a risk of serious adverse effects in the infant.

Driving and using machines

The doctor will inform the patient whether their condition allows safe driving, including cycling, and operating machinery. Fingolimod Olpha is not expected to affect the ability to drive or operate machinery.

However, at the beginning of treatment, the patient must remain in the doctor's office or clinic for 6 hours after taking the first dose of Fingolimod Olpha. During this time and potentially afterwards, the ability to drive and operate machinery may be impaired.

This medicine contains less than 1 mmol (23 mg) of sodium per hard capsule, i.e. the medicine is considered "sodium-free".

3. How to take Fingolimod Olpha

Treatment with Fingolimod Olpha will be supervised by a physician experienced in the treatment of multiple sclerosis.
This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor.
Recommended dose:
Adults:
Dosage is one 0.5 mg capsule once daily.
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 once daily.
Children and adolescents with body weight above 40 kg: one 0.5 mg capsule once daily.

Children and adolescents who start treatment with one 0.25 mg capsule once daily and later achieve a stable body weight above 40 kg will receive instructions from their doctor to change the dose to one 0.5 mg capsule once daily. In this case, a repeat observation period, similar to that after the first dose, is recommended.
Do not exceed the recommended dose.
Fingolimod Olpha is intended for oral administration.
Fingolimod Olpha should be taken once daily, with a glass of water. Fingolimod Olpha capsules must always be swallowed whole, without opening. Fingolimod Olpha may be taken with or without food.
Taking Fingolimod Olpha at the same time each day will help you remember to take your dose.
If you have any questions about the duration of treatment with Fingolimod Olpha, consult your doctor or pharmacist.
Taking more than the recommended dose of Fingolimod Olpha
If a patient takes more than the recommended dose, they should contact their doctor immediately.
Missing a dose of Fingolimod Olpha
If a patient has been taking Fingolimod Olpha for less than 1 month and misses one dose for a full day, they should contact their doctor before taking the next dose. The doctor may decide to keep the patient under observation when administering the next dose.
If a patient has been taking Fingolimod Olpha for at least 1 month and has missed doses for more than 2 weeks, they should contact their doctor before taking the next dose. The doctor may decide to keep the patient under observation when administering the next dose. However, if a patient has missed doses for up to 2 weeks, they may take the next dose as scheduled.
Do not take a double dose to make up for a missed dose.
Stopping treatment with Fingolimod Olpha
Do not stop treatment with Fingolimod Olpha or change the dosage without first consulting your doctor.
Fingolimod Olpha may remain in the body for up to 2 months after stopping treatment. During this time, white blood cell count (lymphocyte count) may still be reduced and adverse effects described in this leaflet may continue to occur. After discontinuation of Fingolimod Olpha, wait 6–8 weeks before starting a new treatment for MS.
In patients restarting treatment with Fingolimod Olpha after a break of more than 2 weeks, the effect on heart rate observed typically after starting treatment for the first time may reoccur, and monitoring of the patient’s condition will be necessary in a doctor’s office or clinic upon resuming treatment. Do not restart treatment with Fingolimod Olpha after a break of more than two weeks without consulting the treating physician.
The treating physician will decide whether and how monitoring of the patient is required after stopping treatment with Fingolimod Olpha. Inform your doctor immediately if you feel that your MS symptoms are worsening after stopping Fingolimod Olpha. This situation may be serious.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Some adverse reactions may be or may become serious.

Common (may affect less than 1 in 10 patients):

Productive cough, unspecified discomfort in the chest, fever (symptoms of lung disorders).
Herpesvirus infection (shingles or herpes simplex) with symptoms such as blisters, burning sensation, itching or pain in the skin, usually above the upper part of the body or face. Other symptoms may include fever and malaise in 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 also have other appearances.
Depression and anxiety are known to occur more frequently in patients with MS and have also been reported in children and adolescents treated with Fingolimod Olpha.
Weight loss.

Uncommon (may affect less than 1 in 100 patients):

Pneumonia with symptoms such as fever, cough, difficulty breathing.
Macular edema (swelling in the central part of the retina at the back of the eye) with symptoms such as shadows or blind spots in the center of the visual field, blurred vision, difficulty perceiving colors and details.
Decreased platelet count, increasing the risk of bleeding or bruising.
Malignant melanoma (a type of skin cancer that usually develops from an atypical mole). Possible signs of melanoma include moles that change in size, shape, elevation or pigmentation over time, or new moles appearing. Moles may itch, bleed or ulcerate.
Seizures, epileptic fits (more frequently in children and adolescents than in adults).

Rare (may affect less than 1 in 1,000 patients):

A condition called posterior reversible encephalopathy syndrome (PRES). Symptoms may include sudden, 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 hard, red nodule, an ulcer covered with a scab or a new ulcer developing at the site of an existing scar.

Very rare (may affect less than 1 in 10,000 patients):

Abnormalities in the ECG test result (T-wave inversion).
Tumor associated with human herpesvirus 8 infection (Kaposi's sarcoma).

Unknown frequency (frequency cannot be estimated from available data):

Allergic reactions, including rash or itchy hives, swelling of the lips, tongue or face, which are more likely to occur on the day of initiation of treatment with Fingolimod Olpha.
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 side of the abdomen, dark (brown) urine, reduced appetite, fatigue, and abnormal liver function tests. In very rare cases, liver failure may lead to the need for liver transplantation.
Risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). Symptoms of PML may resemble an MS relapse. Other symptoms may also occur that the patient may not be aware of, such as changes in mood or behavior, temporary memory lapses, difficulty speaking and communicating, which should be evaluated by a physician to rule out PML. Therefore, if the patient feels that their MS is worsening, or if the patient or their family members notice any new or unusual symptoms, it is very important to inform the treating physician as soon as possible.
Inflammatory disorders after discontinuation of Fingolimod Olpha treatment (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, light sensitivity, nausea and (or) confusion.
Merkel cell carcinoma (a type of skin cancer). Possible signs of Merkel cell carcinoma include the presence of a painless, raw meat-colored or blue-red nodule, often located on the face, head or neck. Merkel cell carcinoma may also appear as a firm, painless nodule or mass. Long-term sun exposure and weakened immune system may influence the risk of developing Merkel cell carcinoma.
After stopping treatment with Fingolimod Olpha, MS symptoms may return and worsen compared to the period before and during treatment.
Autoimmune form of anemia (reduced number of red blood cells), in which red blood cells are destroyed (autoimmune hemolytic anemia).

If any of these reactions occur in the patient, you should immediately inform the
physician.

Other adverse reactions

Very common (may affect more than 1 in 10 patients):

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.
Increased liver enzyme activity in blood tests.
Cough.

Common (may affect less than 1 in 10 patients):

Fungal skin infections (dermatophytosis) (pityriasis versicolor).
Dizziness.
Severe headache, often accompanied by nausea, vomiting and light sensitivity (migraine symptoms).
Low number of white blood cells (lymphocytes, leukocytes).
Weakness.
Itchy, red, burning rash (rash).
Itching.
Increased blood levels of fats (triglycerides).
Hair loss.
Shortness of breath.
Depression.
Blurred vision (see also the section on macular edema under "Some adverse reactions may be or may become serious").
Hypertension (Fingolimod Olpha may cause a mild increase in blood pressure).
Muscle pain.
Joint pain.

Uncommon (may affect less than 1 in 100 patients):

Low number of white blood cells (neutrophils).
Depressed mood.
Nausea.

Rare (may affect less than 1 in 1,000 patients):

Cancer of the lymphatic system (lymphoma).

Unknown frequency (frequency cannot be estimated from available data):

Peripheral edema.

If any of these symptoms are severe, you should inform the
physician.

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, you should inform your physician or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Fingolimod Olpha

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and
blister after "EXP". The expiry date refers to the last day of the stated month.
PVC/PVDC/aluminium blisters
Store below 30°C.
PVC/PE/PVDC/aluminium blisters
No special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help
protect the environment.

6. Contents of the pack and other information

What Fingolimod Olpha contains

The active substance is fingolimod. Each capsule contains 0.5 mg of fingolimod (as hydrochloride).
The other ingredients are: Capsule filling: calcium hydrogen phosphate dihydrate; sodium croscarmellose; hydroxypropylcellulose; magnesium stearate. Capsule shell: gelatin; titanium dioxide (E171); iron oxide yellow (E172); printing ink (contains: shellac (E904); propylene glycol; concentrated ammonium hydroxide; iron oxide black (E172); potassium hydroxide).

What Fingolimod Olpha looks like and contents of the pack
Fingolimod Olpha 0.5 mg hard capsules contain a white or almost white granular powder in a hard gelatin capsule with a yellow cap and a white, opaque body, 15.9 mm nominal length (size 3), printed in black with "FD 0.5 mg" on the cap.
The blisters made of PVC/PVDC/aluminium and (or) PVC/PE/PVDC/aluminium contain 14 capsules (1 blister), 28 capsules (2 blisters), or 98 capsules (7 blisters) in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Olpha AS,
Rupnicu iela 5,
Olaine, Olaines novads, LV-2114,
Latvia
E-mail: [email protected]

Manufacturer
Genepharm S.A.
18th km Marathonos Avenue
Pallini, 153 51
Greece

This medicinal product is authorised in the European Economic Area countries under the following names:
Denmark, Czech Republic, Estonia, Italy, Poland, Slovakia: Fingolimod Olpha
Germany: Fingolimod Olpha 0.5 mg Hartkapseln
Spain: Fingolimod Olpha 0.5 mg cápsulas duras EFG
France: FINGOLIMOD OLPHA 0.5 mg, gélule
Lithuania: Fingolimod Olpha 0.5 mg kietosios kapsulės
Latvia: Fingolimod Olpha 0.5 mg cietās kapsulas

Fingolimod olpha