Fingolimod Medical Valley: detailed information

Package leaflet: Information for the user

Fingolimod Medical Valley 0.5 mg hard capsules

fingolimod
Equivalent medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Fingolimod Medical Valley is and what it is used for

What Fingolimod Medical Valley is
Fingolimod Medical Valley contains the active substance fingolimod.
What Fingolimod Medical Valley is used for
Fingolimod Medical Valley is used in adults and children and adolescents (from 10 years of age onwards) for the treatment of relapsing-remitting multiple sclerosis (MS), particularly in:

Patients who have not responded to therapy with a treatment for MS, or
Patients with severe, rapidly evolving MS.

Fingolimod Medical Valley does not cure MS, but helps reduce the number of relapses and slows the progression of physical disability caused by MS.
What is multiple sclerosis
MS is a chronic disease affecting the central nervous system (CNS), which includes the brain and spinal cord. In MS, inflammation destroys the protective covering (called myelin) that surrounds the nerves of the CNS, impairing the nerves' ability to function properly. This process is known as demyelination.
Relapsing-remitting MS is characterized by repeated attacks (relapses) of neurological symptoms reflecting an inflammatory state of the CNS. Symptoms vary from patient to patient, but typically include difficulty walking, numbness, visual disturbances, or balance problems. Symptoms of a relapse may completely disappear once the relapse ends, but some impairments may persist.
How Fingolimod Medical Valley works
Fingolimod Medical Valley helps protect the central nervous system from attacks by the immune system by reducing the ability of certain white blood cells (lymphocytes) to circulate freely throughout the body, thereby preventing them from reaching the brain and spinal cord. This limits nerve damage caused by MS. Fingolimod Medical Valley also reduces some of the body's immune responses.

2. What you need to know before taking Fingolimod Medical Valley

Do not take Fingolimod Medical Valley

if you have a reduced immune response (due to immunodeficiency syndrome, an illness, or medicines that suppress the immune system).
if you currently have a severe infection or a chronic ongoing infection such as hepatitis or tuberculosis.
if you have active cancer.
if you have severe liver problems.
if you have had a heart attack, angina, stroke, or transient ischaemic attack (TIA), or certain types of heart failure within the last 6 months.
if you have certain types of irregular or abnormal heartbeat (arrhythmia), including patients whose electrocardiogram (ECG) shows a prolonged QT interval before starting treatment with Fingolimod Medical Valley.
if you are currently taking or have recently taken medicines for irregular heartbeat such as quinidine, disopyramide, amiodarone, or sotalol.
if you are pregnant or if you are a woman of childbearing potential who is not using effective contraception.
if you are allergic to fingolimod or any of the other ingredients of this medicine (listed in section 6). If any of these apply to you or you are unsure, inform your doctor before taking Fingolimod Medical Valley.

Warnings and precautions
Talk to your doctor before taking Fingolimod Medical Valley:

if you have severe breathing problems during sleep (severe sleep apnoea).
if you have been told you have an abnormal electrocardiogram.
if you experience symptoms of slow heart rate (e.g. dizziness, nausea, or palpitations).
if you are currently taking or have recently taken medicines that slow your heart rate (such as beta-blockers, verapamil, diltiazem, ivabradine, digoxin, anticholinesterase agents, or pilocarpine).
if you have a history of sudden loss of consciousness or fainting (syncope).
if you plan to be vaccinated.
if you have never had chickenpox.
if you have or have had visual disturbances or other signs of swelling in the central area of vision (macula) at the back of the eye (a condition known as macular oedema, see below), eye inflammation or infection (uveitis), or if you have diabetes (which can cause eye problems).
if you have liver problems.
if you have high blood pressure that cannot be controlled with medication.
if you have severe lung problems or a smoker's cough. If any of these apply to you, inform your doctor before taking Fingolimod Medical Valley.

Slow heart rate (bradycardia) and irregular heartbeat
At the start of treatment or when switching from the 0.25 mg daily dose to the first 0.5 mg dose, fingolimod causes a slowing of the heart rate. As a result, you may experience dizziness or fatigue, awareness of your heartbeat, or a drop in blood pressure. If these effects are severe, inform your doctor, as immediate treatment may be necessary. Fingolimod may also cause an irregular heartbeat, especially after the first dose. Irregular heartbeat usually returns to normal within less than a day. Slow heart rate usually returns to normal within one month. During this time, clinically significant effects on heart rate are generally not expected.
Your doctor will ask you to remain in the clinic or hospital for at least 6 hours after the first dose of Fingolimod Medical Valley or when switching from the 0.25 mg daily dose to the first 0.5 mg dose. During this time, your pulse and blood pressure will be monitored hourly so that appropriate measures can be taken if adverse effects occur at the beginning of treatment. You must have an electrocardiogram performed before the first dose of Fingolimod Medical Valley and again at the end of the 6-hour monitoring period. Your doctor may continuously monitor your ECG during this time. If, after the 6-hour period, you have a very low or decreasing heart rate, or if your ECG shows abnormalities, you may need to remain under observation for a longer period (at least an additional 2 hours and possibly until the next morning) until these issues resolve. The same may apply if you are restarting Fingolimod Medical Valley after a treatment interruption, depending on how long the interruption was and how long you had been taking Fingolimod Medical Valley before the interruption.

If you have, or are at risk of, an irregular or abnormal heartbeat, if your electrocardiogram is abnormal, or if you have heart disease or heart failure, Fingolimod Medical Valley may not be suitable for you.
If you have previously experienced episodes of sudden loss of consciousness or reduced heart rate, Fingolimod Medical Valley may not be suitable for you. You will be evaluated by a cardiologist (a heart specialist) who will advise you on how to start treatment with Fingolimod Medical Valley, including monitoring until the next morning.
If you are taking medicines that can reduce heart rate, Fingolimod Medical Valley may not be suitable for you. You will be evaluated by a cardiologist, who will assess whether you can switch to alternative medicines that do not reduce heart rate, to allow treatment with Fingolimod Medical Valley. If such a change in therapy is not possible, the cardiologist will advise you on how to start treatment with Fingolimod Medical Valley, including monitoring until the next morning.

If you have never had chickenpox
If you have never had chickenpox, your doctor will check your immunity against the virus that causes it (varicella zoster virus). If you are not protected against the virus, vaccination may be required before starting treatment with Fingolimod Medical Valley. In this case, your doctor will delay the start of treatment with Fingolimod Medical Valley until one month after completion of the full vaccination course.

Infections
Fingolimod reduces the number of white blood cells (particularly lymphocytes). White blood cells fight infections. While taking Fingolimod Medical Valley (and up to 2 months after stopping treatment), you may be more susceptible to infections. Any existing infection may worsen. Infections can be serious and life-threatening. If you suspect you have an infection, if you have a fever, flu-like symptoms, shingles, or a headache accompanied by neck stiffness, light sensitivity, nausea, rash, and/or confusion or seizures (these may be symptoms of meningitis and/or encephalitis caused by a fungal or viral herpes infection), contact your doctor immediately, as this could be a serious and life-threatening condition.
If you think your multiple sclerosis (MS) is worsening (e.g. if you experience weakness or vision problems) or if you notice any new symptoms, contact your doctor immediately, as these could be symptoms of a rare brain disorder caused by infection called progressive multifocal leukoencephalopathy (PML). PML is a serious condition that can lead to severe disability or death. Your doctor will consider performing a magnetic resonance imaging (MRI) scan to evaluate this condition and will decide whether you should stop taking Fingolimod Medical Valley.
Human papillomavirus (HPV) infection has been reported in patients treated with fingolimod, including papillomas, dysplasia, condylomas, and HPV-related cancers. Your doctor will assess whether you need HPV vaccination before starting treatment. If you are a woman, your doctor will also recommend HPV screening.

Macular oedema
Before starting treatment with Fingolimod Medical Valley, if you have or have had visual disturbances or other signs of swelling in the central area of vision (macula) at the back of the eye, eye inflammation or infection (uveitis), or diabetes, your doctor may ask you to undergo an eye examination.
Your doctor may ask you to have an eye examination 3 to 4 months after starting treatment with Fingolimod Medical Valley.
The macula is a small area of the retina at the back of the eye that allows you to see shapes, colours, and fine details clearly and sharply. Fingolimod Medical Valley can cause swelling in the macula, a condition known as macular oedema. Swelling usually occurs within the first 4 months of treatment with Fingolimod Medical Valley.
The risk of developing macular oedema is higher if you have diabetes or if you have had eye inflammation called uveitis. In these cases, your doctor may recommend regular eye examinations to detect macular oedema.
If you have previously had macular oedema, talk to your doctor before restarting treatment with Fingolimod Medical Valley.
Macular oedema can cause some of the visual symptoms (optic neuritis) that occur during an MS relapse. In the early stages, there may be no symptoms. Be sure to inform your doctor of any changes in vision.
Your doctor may ask you to have an eye examination, especially if:

the central area of vision is blurred or has shadows;
a blind spot develops in the central area of vision;
you have difficulty distinguishing colours or fine details.

Liver function tests
If you have severe liver problems, you must not take Fingolimod Medical Valley. Fingolimod Medical Valley can affect your liver function. You may not notice any symptoms, but if you notice yellowing of the skin or whites of the eyes, abnormally dark urine (brown-coloured), pain in the right side of the stomach area (abdomen), fatigue, unusual loss of appetite, or unexplained nausea and vomiting, inform your doctor immediately.
If you experience any of these symptoms after starting treatment with Fingolimod Medical Valley, inform your doctor immediately.
Before, during, and after treatment, your doctor will request blood tests to monitor liver function. If test results indicate a liver problem, treatment with Fingolimod Medical Valley may need to be discontinued.

High blood pressure
Since Fingolimod Medical Valley causes a slight increase in blood pressure, your doctor may decide to perform regular blood pressure checks.

Lung problems
Fingolimod Medical Valley has a mild effect on lung function. Undesirable effects may occur more easily in patients with severe lung problems or smoker's cough.

Blood count
The intended effect of treatment with Fingolimod Medical Valley is to reduce the number of white blood cells in the blood. These usually return to normal levels within 2 months after stopping treatment. If you need blood tests, inform your doctor that you are taking Fingolimod Medical Valley. Otherwise, your doctor may not be able to correctly interpret the test results, and for certain types of tests, your doctor may need to draw more blood than usual.
Before starting treatment with Fingolimod Medical Valley, your doctor will confirm that your white blood cell count is sufficient and may ask you to have it checked periodically.
If your white blood cell count is too low, treatment with Fingolimod Medical Valley may need to be discontinued.

Posterior reversible encephalopathy syndrome (PRES)
A condition called posterior reversible encephalopathy syndrome (PRES) has been rarely reported in patients with multiple sclerosis (MS) treated with fingolimod. Symptoms may include sudden, severe headache, confusion, seizures, and vision changes. Inform your doctor immediately if any of these symptoms occur during treatment with Fingolimod Medical Valley, as they may be serious.

Cancer
Skin tumours have been reported in patients with MS treated with fingolimod. Contact your doctor immediately if you notice the appearance of any skin nodules (e.g. shiny, pearly nodules), spots, or open sores that do not heal within a few weeks. Symptoms of skin cancer may include unusual growths or changes in the skin tissue (e.g. unusual moles) with changes in colour, shape, or size over time. Before starting treatment with Fingolimod Medical Valley, a skin examination is required to check for skin nodules. Your doctor will also perform periodic skin checks during treatment with Fingolimod Medical Valley. If you develop skin problems, your doctor may refer you to a dermatologist who, after consultation, may recommend periodic examinations.
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 tumours, particularly skin tumours. You should limit exposure to sunlight and UV radiation:

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

Unusual brain lesions associated with MS relapse
Rare cases of unusually large brain lesions associated with an MS relapse have been reported in patients treated with fingolimod. In case of a severe relapse, your doctor will evaluate whether to perform a magnetic resonance imaging (MRI) scan to assess this condition and decide whether Fingolimod Medical Valley should be discontinued.

Switching from other treatments to Fingolimod Medical Valley
Your doctor may switch you directly from treatment with interferon-beta, glatiramer acetate, or dimethyl fumarate to Fingolimod Medical Valley if there are no signs of abnormalities caused by the previous treatment. Your doctor may perform a blood test to rule out such abnormalities. After stopping natalizumab, you may need to wait 2–3 months before starting treatment with Fingolimod Medical Valley. For switching 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, careful evaluation and discussion with your doctor are necessary to determine whether Fingolimod Medical Valley is suitable for you.

Women of childbearing potential
Fingolimod Medical Valley may harm the unborn child if used during pregnancy. Before starting treatment with Fingolimod Medical Valley, your doctor will explain the risks and ask you to take a pregnancy test to ensure you are not pregnant. Your doctor will give you a card explaining why you must not become pregnant while taking Fingolimod Medical Valley. It also explains what you should do to avoid pregnancy while taking Fingolimod Medical Valley. You must use effective contraception during treatment and for 2 months after stopping treatment (see section "Pregnancy and breastfeeding").

Worsening of MS after stopping treatment with Fingolimod Medical Valley
Do not stop taking Fingolimod Medical Valley or change your dose without first discussing it with your doctor.
Inform your doctor immediately if you think your multiple sclerosis is worsening after stopping treatment with Fingolimod Medical Valley. This could be serious (see "If you stop taking Fingolimod Medical Valley" in section 3, and also section 4, "Possible side effects").

Elderly
Experience with fingolimod in elderly patients (over 65 years) is limited. If you have any doubts, consult your doctor.

Children and adolescents
Fingolimod Medical Valley is not intended for use in children under 10 years of age, as it has not been studied in patients with MS in this age group.
The warnings and precautions listed above also apply to children and adolescents. The following information is particularly important for children and adolescents and for those who care for them:

Before starting treatment with Fingolimod Medical Valley, your doctor will check your vaccination status. If you have not received certain vaccinations, they may need to be administered before starting treatment with Fingolimod Medical Valley.
The first time you take Fingolimod Medical Valley or when switching from the 0.25 mg daily dose to the 0.5 mg daily dose, your doctor will monitor your heart rate and heartbeat (see above “Slow heart rate (bradycardia) and irregular heartbeat”).
If you experience seizures or epileptic fits before or during treatment with Fingolimod Medical Valley, inform your doctor.
If you suffer from depression or anxiety, or if you become depressed or anxious while taking Fingolimod Medical Valley, inform your doctor. You may need closer monitoring.

Other medicines and Fingolimod Medical Valley
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Inform your doctor if you are taking any of the following medicines:

Medicines that suppress or modulate the immune system, including other medicines used to treat MS, such as interferon beta, glatiramer acetate, natalizumab, mitoxantrone, teriflunomide, dimethyl fumarate, or alemtuzumab. You must not use Fingolimod Medical Valley together with these medicines, as this could intensify the effect on the immune system (see also “Do not take Fingolimod Medical Valley”).
Corticosteroids, due to a possible additive effect on the immune system.
Vaccines. If you need to be vaccinated, consult your doctor first. During and up to 2 months after treatment with Fingolimod Medical Valley, you should not receive certain types of vaccines (live attenuated vaccines), as they could trigger the infection they are meant to prevent. Other vaccines may not work as well as usual if administered during this period.
Medicines that slow the heart rate (e.g. beta-blockers such as atenolol). Concomitant use of Fingolimod Medical Valley with such medicines may intensify the effect on heart rate in the first days of treatment with Fingolimod Medical Valley.
Medicines for irregular heartbeat, such as quinidine, disopyramide, amiodarone, or sotalol. You must not use Fingolimod Medical Valley if you are taking these medicines, as they could intensify the effect on irregular heartbeat (see also “Do not take Fingolimod Medical Valley”).
Other medicines: protease inhibitors, anti-infectives such as ketoconazole, azole antifungals, clarithromycin or telithromycin; or carbamazepine, rifampicin, phenobarbital, phenytoin, efavirenz, or St John's wort (potential risk of reduced effectiveness of Fingolimod Medical Valley).

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

Pregnancy
Do not use Fingolimod Medical Valley during pregnancy, if you are planning a pregnancy, or if you are a woman of childbearing potential and not using effective contraception. If Fingolimod Medical Valley is used during pregnancy, there is a risk of harm to the unborn child. The rate of congenital malformations observed in infants exposed to fingolimod during pregnancy is approximately twice the rate observed in the general population (in which the rate of congenital malformations is about 2–3%). The most frequently reported malformations include cardiac, renal, and musculoskeletal abnormalities.
Therefore, if you are a woman of childbearing potential:

before starting treatment with Fingolimod Medical Valley, your doctor will inform you of the risk to the unborn child and ask you to take a pregnancy test to ensure you are not pregnant, and
you must use effective contraception during treatment with Fingolimod Medical Valley and for two months after stopping treatment to avoid pregnancy. Discuss reliable contraceptive methods with your doctor.

Your doctor will give you a card explaining why you must not become pregnant while taking Fingolimod Medical Valley.
If you become pregnant while taking Fingolimod Medical Valley, inform your doctor immediately. Your doctor will decide whether to stop treatment (see "If you stop taking Fingolimod Medical Valley" in section 3 and also section 4, "Possible side effects"). You will also need specialized prenatal monitoring.

Breastfeeding
Do not breastfeed during treatment with Fingolimod Medical Valley.
Fingolimod is excreted in breast milk and may cause serious adverse effects in the newborn.

Driving and using machines
Your doctor will advise you whether your condition allows you to safely drive vehicles, including bicycles, and use machinery. Fingolimod Medical Valley should not affect your ability to drive or use machinery.
However, at the start of treatment, you must remain in your doctor's office or hospital for 6 hours after taking the first dose of Fingolimod Medical Valley. Your ability to drive and use machinery may be impaired during this time and potentially also afterwards.

3. How to take Fingolimod Medical Valley

Treatment with Fingolimod Medical Valley must be supervised by a physician experienced in the treatment of multiple sclerosis.
Always take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor.

Recommended dose:
Adults:
The dose is one 0.5 mg capsule once daily.
Children and adolescents (from 10 years of age onwards):
The dose is based on body weight:

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

Children and adolescents who start treatment with one 0.25 mg capsule daily and later achieve a stable body weight above 40 kg will be instructed by the doctor to switch to one 0.5 mg capsule daily. In this case, repeat the first-dose observation period is recommended.

Do not exceed the recommended dose.
Fingolimod Medical Valley is for oral use.
Take Fingolimod Medical Valley once daily with a glass of water. The capsules of Fingolimod Medical Valley must always be swallowed whole, without opening them.
Fingolimod Medical Valley may be taken with or without food.
Taking Fingolimod Medical Valley at the same time each day will help you remember when to take the medicine.
If you have any doubts about the duration of treatment with Fingolimod Medical Valley, consult your doctor or pharmacist.

If you take more Fingolimod Medical Valley than you should
If you have taken an excessive amount of Fingolimod Medical Valley, inform your doctor immediately.

If you forget to take Fingolimod Medical Valley
If you have been taking Fingolimod Medical Valley for less than 1 month and miss one dose for a full day, contact your doctor before taking the next dose. Your doctor may decide to monitor you when you take the next dose.

If you have been taking Fingolimod Medical Valley for at least 1 month and have missed taking the medicine for more than 2 weeks, contact your doctor before taking the next dose. Your doctor may decide to monitor you when you take the next dose. However, if you have missed taking the medicine for 2 weeks or less, you may take the next dose as scheduled.
Never take a double dose to make up for a missed dose.

If you stop taking Fingolimod Medical Valley
Do not stop taking Fingolimod Medical Valley or change the dose without first discussing it with your doctor.
Fingolimod Medical Valley 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 period, and the side effects described in this leaflet may still occur. After stopping treatment with Fingolimod Medical Valley, you may need to wait 6–8 weeks before starting a new treatment for multiple sclerosis.

If you restart taking Fingolimod Medical Valley after an interruption of more than 2 weeks, the effect on heart rate normally observed at the beginning of treatment may reoccur: therefore, restarting treatment will require monitoring in an outpatient clinic or hospital setting. Do not restart treatment with Fingolimod Medical Valley after an interruption of more than two weeks without first consulting your doctor.

Your doctor will decide whether and how you need to be monitored after stopping treatment with Fingolimod Medical Valley. Inform your doctor immediately if you feel that your multiple sclerosis is worsening after stopping treatment with Fingolimod Medical Valley. This could be serious.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects could be or become serious.

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

Cough with phlegm, chest discomfort, fever (signs of lung disorders)
Herpes virus infection (cold sores or shingles) with symptoms such as blisters, burning, itching or pain on the skin, typically on the upper body or face. Other symptoms may include fever and weakness in the early stages of infection, followed by numbness, itching or red patches with severe pain
Slow heartbeat (bradycardia), irregular heart rhythm
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 people with MS and have also been reported in pediatric patients treated with fingolimod.
Weight loss.

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

Pneumonia with symptoms such as fever, cough, difficulty breathing
Macular edema (swelling in the central vision area of the retina at the back of the eye) with symptoms such as shadows or blind spot in the center of vision, blurred vision, problems distinguishing colors or details
Reduction in blood platelets, increasing the risk of bleeding or bruising
Malignant melanoma (a type of skin cancer that usually develops from an unusual mole). Possible signs of melanoma include moles that may change in size, shape, thickness or color over time, or new moles. Moles may itch, bleed or ulcerate
Seizures, epileptic fits (more frequent in children and adolescents than in adults)

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

A condition called reversible posterior encephalopathy syndrome (PRES). Symptoms may include sudden onset of severe headache, confusion, seizures and/or visual disturbances
Lymphoma (a type of cancer affecting the lymphatic system)
Squamous cell carcinoma: a type of skin cancer that may appear as a red, hard nodule, an ulcerated lesion with a crust, or a new ulceration on a pre-existing scar.

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

Abnormal electrocardiogram (ECG) finding (T-wave inversion)
Tumour associated with human herpesvirus 8 infection (Kaposi’s sarcoma)

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

Allergic reactions, including symptoms such as skin rash or hives, swelling of the lips, tongue or face, which are more likely to occur on the first day of treatment with Fingolimod Medical Valley.
Signs of liver disease (including liver failure), such as yellowing of the skin or whites of the eyes (jaundice), nausea or vomiting, pain on the right side of the stomach area (abdomen), dark (brown-colored) urine, unusual loss of appetite, fatigue, and abnormal liver function tests. In a very small number of cases, liver failure could lead to liver transplantation.
Risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). Symptoms of PML may resemble those of an MS relapse. Other symptoms may occur that you or those close to you may not notice, such as changes in mood or behavior, memory lapses, or difficulties with language and communication, which may require further medical evaluation to rule out PML. Therefore, if you think your MS is worsening, or if you or someone close to you notices new or unusual symptoms, it is very important to contact your doctor as soon as possible.
Infections caused by cryptococcus (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 a painless flesh-colored or red-blue nodule, often on the face, head or neck. Merkel cell carcinoma may also appear as a hard, painless nodule or mass. Long-term sun exposure and a weakened immune system may influence the risk of developing Merkel cell carcinoma.
After stopping treatment with Fingolimod Medical Valley, MS symptoms may return and may worsen compared to before or during treatment.
Autoimmune form of anemia (decrease in red blood cells) in which red blood cells are destroyed (autoimmune hemolytic anemia).

If you experience any of these side effects, contact 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
Feeling of pressure or pain in the cheeks and forehead (sinusitis)
Headache
Diarrhea
Back pain
Blood tests showing higher levels of liver enzymes
Cough

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

Tinea versicolor, a fungal skin infection (tinea versicolor)
Dizziness
Severe headache often accompanied by nausea, vomiting and sensitivity to light (migraine)
Low levels of white blood cells (lymphocytes, leukocytes)
Weakness
Skin rash with itching, redness and burning (eczema)
Itching
Increased levels of fats in the blood (triglycerides)
Hair loss
Shortness of breath
Depression
Blurred vision (see also the section "Some side effects could be or become serious" regarding macular edema)
Hypertension (Fingolimod Medical Valley may cause a slight 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)

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

Peripheral swelling

If any of these side effects become severe, contact your doctor.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fingolimod Medical Valley

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp.". The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Fingolimod Medical Valley contains

The active substance is fingolimod.
Each capsule contains 0.5 mg of fingolimod (as hydrochloride).
The other components are: Capsule contents: Microcrystalline cellulose, Colloidal silicon dioxide, Magnesium stearate. Capsule shell: Titanium dioxide (E171), Yellow iron oxide (E172), Gelatin.

Description of the appearance of Fingolimod Medical Valley and package contents
The 0.5 mg hard capsule of Fingolimod Medical Valley has an opaque yellow cap and an opaque white body.
Fingolimod Medical Valley 0.5 mg capsules are available in packs of 7, 28, 84 (3 packs of 28 capsules) or 98 capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Medical Valley Invest AB
Brädgårdsvägen 28
236 32 Höllviken
Sweden

Manufacturer
Haupt Pharma Amareg GmbH
Donaustaufstr. 378 – 93055 Regensburg
Germany
Laboratorios Liconsa, S.A.
Avda. Miralcampo, nº 7.
Polígono Industrial Miralcampo.
19200 Azuqueca de Henares
Guadalajara
Spain

This medicinal product is authorized in the European Economic Area countries under the following names:
Germany: Fingolimod Liconsa 0.5 mg Hartkapseln
France: Fingolimod Laboratorios Liconsa 0.5 mg gélules
Italy: Fingolimod Medical Valley