Package leaflet: Information for the user

Fingolimod Reddy, 0.5 mg, hard capsules
Fingolimodum
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

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

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

What Fingolimod Reddy is
Fingolimod Reddy contains the active substance fingolimod.
What Fingolimod Reddy is used for
Fingolimod Reddy is used in adults, and in 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 Reddy 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, inflammatory processes damage the protective covering of nerves (called myelin) within the CNS, impairing their proper function. This process is known as demyelination.
Relapsing-remitting MS is characterized by recurrent episodes (relapses) of neurological symptoms reflecting inflammatory activity within the CNS. Symptoms vary between patients but typically include walking difficulties, numbness, vision problems, or balance disturbances. Symptoms of relapses may completely resolve, although some deficits may persist.
How Fingolimod Reddy works
Fingolimod 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. In this way, the medicine reduces nerve damage associated with MS. Fingolimod also modulates certain immune responses in the body.

2. Important information before taking Fingolimod Reddy

When not to take Fingolimod Reddy

if the patient is allergic to fingolimod or to any of the other ingredients of this medicine (listed in section 6);
if the patient has reduced immune response (due to immunodeficiency syndrome, disease, or taking medicines that suppress the immune system);
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 warning signs of stroke, 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 whose electrocardiogram (ECG) showed QT interval prolongation before starting fingolimod treatment;
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 of childbearing age and not using effective contraception. If this is the case or the patient has any doubts, consult a doctor before taking Fingolimod Reddy.

Warnings and precautions
Before starting Fingolimod Reddy, discuss with your 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 has symptoms of 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), eye inflammation or infection (uveitis), or if the patient has diabetes, which may cause vision problems;
if the patient has liver disease;
if the patient has high blood pressure that cannot be controlled with medication;
if the patient has severe lung disease or a smoker-type cough. If any of these situations apply or the patient has any doubts, consult a doctor before taking Fingolimod Reddy.

Slow heart rate (bradycardia) and irregular heartbeat
At the beginning of treatment or after taking the first 0.5 mg dose in patients who previously took a 0.25 mg daily dose, fingolimod slows heart rate. As a result, the patient may experience dizziness, fatigue, strong heartbeats, or low blood pressure. If these symptoms are severe, inform the doctor immediately, as immediate treatment may be necessary.
Fingolimod 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 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 and after the 6-hour observation period. During this time, the doctor may continuously monitor the patient's heart function using electrocardiography. If, after 6 hours of observation, the patient has a very slow or decreasing heart rate or if the ECG shows abnormalities, longer monitoring of the patient (at least 2 hours longer or possibly until the next day) may be required until these symptoms resolve. The same approach may be recommended if the patient resumes fingolimod treatment after a treatment interruption, depending on how long the interruption lasted and how long the patient had previously taken fingolimod.
If the patient has irregular or abnormal heartbeat, risk factors for such events, abnormal ECG findings, or heart disease or heart failure, fingolimod may not be suitable.
If the patient has a history of sudden loss of consciousness or slowed heart function, fingolimod may not be appropriate. A consultation with a cardiologist (a heart specialist) may be needed to advise on how to start fingolimod treatment, including how to monitor the patient overnight.
If the patient is taking medicines that may reduce heart rate, fingolimod may not be appropriate. A consultation with a cardiologist may be necessary to determine whether the patient can switch to other medicines that do not reduce heart rate, to allow treatment with Fingolimod Reddy. If such a change is not possible, the cardiologist will advise the patient on how to start fingolimod treatment, including monitoring until the day after the first dose of fingolimod.

Patients who have never had chickenpox
If the patient has never had chickenpox, the doctor will check the patient's immunity to the chickenpox virus (varicella zoster virus). If the patient is not protected against the virus, vaccination may be required before starting fingolimod treatment. If this is the case, the doctor will delay starting Fingolimod Reddy treatment by one month after completing the full vaccination course.

Infections
Fingolimod reduces the number of white blood cells (particularly lymphocytes). White blood cells fight infections. While taking fingolimod (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 headache accompanied by neck stiffness, light sensitivity, nausea, rash, and/or confusion or seizures (which may be symptoms of meningitis and/or encephalitis caused by fungal or herpes virus infection), the patient should contact the doctor immediately, as this condition may be serious and life-threatening. If the patient feels their condition is worsening (e.g. weakness or vision problems) or notices any new symptoms, they should immediately speak to the doctor, as these may be symptoms of a rare brain disease caused by infection called progressive multifocal leukoencephalopathy (PML). PML is a serious condition that may lead to severe disability or death. The doctor will consider performing a magnetic resonance imaging (MRI) scan to assess the patient's condition and decide whether fingolimod treatment should be discontinued.
Infections with human papillomavirus (HPV) have been reported in patients treated with fingolimod, including cases of warts, dysplasia, and HPV-related malignant tumours. The doctor will consider the need for HPV vaccination before starting treatment. In women, the doctor will also recommend HPV screening tests.

Macular oedema
Before starting fingolimod treatment, 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 fingolimod treatment.
The macula is a small area of the retina at the back of the eye that enables clear and sharp vision of shapes, colours, and other details. Fingolimod may cause swelling of the macula, a condition called macular oedema. This swelling usually occurs within the first 4 months of fingolimod treatment.
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 the patient develops macular oedema, they should inform the doctor before resuming fingolimod treatment.
Macular oedema may cause certain vision problems, similar to those in MS relapses (optic neuritis). In the early stages, symptoms may be absent. Any changes in vision should be reported 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;
there are difficulties seeing colours or fine details.

Liver function tests
Patients with severe liver disease should not take fingolimod. Fingolimod 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, the doctor should be informed immediately.
If any of these symptoms occur after starting fingolimod treatment, the doctor should be informed immediately.
Before, during, and after treatment, the doctor will order blood tests to monitor liver function. If test results indicate liver function abnormalities, fingolimod treatment may be discontinued.

High blood pressure
The doctor may regularly check blood pressure, as fingolimod causes a slight increase in blood pressure.

Lung diseases
Fingolimod has a minor effect on lung function. Patients with severe lung disease or smoker-type cough are at higher risk of adverse effects.

Blood cell count
A known effect of fingolimod is a reduction in the number of white blood cells in the blood. Their number usually returns to normal within 2 months after stopping treatment. If blood tests are needed, inform the doctor about taking fingolimod. Otherwise, the doctor may not be able to interpret blood test results, and for certain tests, the doctor may order a larger blood sample than usual.
Before starting fingolimod, the doctor will confirm that the number of white blood cells in the blood is adequate to start treatment and may order regular repeat tests. If there are insufficient white blood cells, fingolimod treatment may need to be discontinued.

Posterior reversible encephalopathy syndrome (PRES)
Posterior reversible encephalopathy syndrome (PRES) has been rarely reported in MS patients treated with fingolimod. Symptoms of this condition may include sudden severe headache, confusion, seizures, and vision changes. If any of these symptoms occur during fingolimod treatment, the patient should immediately inform the doctor, as this condition may be serious.

Cancer
Skin cancers have been reported in MS patients treated with fingolimod. If any nodules (e.g. shiny, pearly nodules), spots, or open sores that do not heal within several weeks are noticed on the skin, the doctor should be informed immediately. Symptoms of skin cancer may include abnormal growths or changes in skin tissue (e.g. new moles) that change in colour, shape, or size over time. Before starting fingolimod treatment, a skin examination should be performed to check for any skin nodules. The treating doctor will also perform regular skin checks during fingolimod treatment. 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.

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

Sun exposure and sun protection
Fingolimod weakens the immune system. This condition increases the risk of malignant tumours, especially skin cancers. The patient should limit exposure to sunlight and UV radiation by:

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

Unusual brain changes associated with MS relapse
Rare cases of unusually large brain lesions associated with MS relapse have been reported in patients treated with fingolimod. In case of a severe MS relapse, the treating doctor will consider performing an MRI scan to assess this condition and decide whether fingolimod treatment should be discontinued.

Switching from other medicines to fingolimod
The doctor may switch treatment directly from interferon-beta, glatiramer acetate, or dimethyl fumarate to Fingolimod Reddy if there are no symptoms of abnormalities caused by previous treatment. The doctor may order a blood test to rule out these abnormalities. After stopping natalizumab treatment, a waiting period of 2 to 3 months may be necessary before starting fingolimod treatment. When switching from teriflunomide, the doctor may advise the patient to wait a certain time or undergo an accelerated elimination procedure. Patients previously treated with alemtuzumab require careful assessment and discussion of their situation with the doctor before deciding whether fingolimod is appropriate.

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

Worsening of MS after stopping fingolimod treatment
Do not stop taking fingolimod or change the dose without first consulting a doctor.
Inform the doctor immediately if the patient feels their MS is worsening after stopping fingolimod treatment. This situation may be serious (see "Stopping Fingolimod Reddy" in section 3 and section 4 "Possible side effects").

Elderly patients
Experience with fingolimod use in elderly patients (over 65 years) is limited. If in doubt, consult a doctor.

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

Before starting fingolimod treatment, the doctor will check the patient's vaccination status. If the patient has not received certain vaccinations, vaccination may be necessary before starting fingolimod treatment.
During the first dose of fingolimod or when changing the daily dose from 0.25 mg to 0.5 mg, the doctor will monitor heart rate and pulse (see "Slow heart rate (bradycardia) and irregular heartbeat" above).
If the patient has seizures or epileptic fits before or during fingolimod treatment, inform the doctor.
If the patient develops depression or anxiety or feels low mood or restlessness during fingolimod treatment, inform the doctor. The patient may require closer monitoring.

Fingolimod Reddy and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take:

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. Fingolimod must not be used together with these medicines, as this could intensify the effect on the immune system (see also "When not to take Fingolimod Reddy").
corticosteroids, due to the possibility of additive effects on the immune system.
vaccines. If the patient needs vaccination, they should first consult the doctor. During and for 2 months after fingolimod treatment, patients should not receive certain types of vaccines (live attenuated vaccines), as they could cause the infection they are meant to prevent. Other vaccines may also be ineffective if given during this period.
medicines that slow heart rate (e.g. beta-blockers such as atenolol). Using fingolimod together with these medicines could intensify the effect on heart rate in the first days of fingolimod treatment.
medicines for irregular heartbeat, such as quinidine, disopyramide, amiodarone, or sotalol. Fingolimod must not be used in patients taking these medicines, as it could intensify the effect on irregular heartbeat (see also "When not to take Fingolimod Reddy").
other medicines: protease inhibitors, antifungal azoles such as ketoconazole, clarithromycin or telithromycin; carbamazepine, rifampicin, phenobarbital, phenytoin, efavirenz, or St John's wort (possible risk of reduced fingolimod efficacy).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor before taking this medicine.
Pregnancy
Fingolimod must not be used during pregnancy, if the patient is trying to become pregnant, or if the patient may become pregnant and is not using effective contraception. If fingolimod is used during pregnancy, there is a risk of harmful effects on the unborn child. The rate of congenital malformations observed in children exposed to fingolimod during pregnancy is about twice that observed in the general population (where the rate of congenital malformations is approximately 2-3%).
The most commonly reported congenital malformations include developmental abnormalities of the heart, kidneys, and musculoskeletal system.
Therefore, if the patient is of childbearing age:

before starting fingolimod treatment, the doctor will inform the patient of the risk to the unborn child and request a pregnancy test to confirm that the patient is not pregnant, and
effective contraception must be used during fingolimod treatment and for two months after stopping treatment to avoid pregnancy. Discuss effective contraceptive methods with the doctor.

The doctor will provide the patient with an information card explaining why pregnancy should be avoided during fingolimod use.
If the patient becomes pregnant while taking fingolimod, she must inform the doctor immediately.
The doctor will decide whether to discontinue treatment (see "Stopping Fingolimod Reddy" in section 3 and section 4 "Possible side effects"). The patient will also need to attend follow-up prenatal examinations.
Breastfeeding
Breastfeeding must not be used during fingolimod treatment. Fingolimod may pass into breast milk, posing a risk of serious adverse effects in the child.

Driving and operating machinery
The doctor will inform the patient whether their condition allows them to safely drive vehicles, including bicycles, and operate machinery. Fingolimod is not expected to affect the ability to drive vehicles and 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. During this time and potentially afterwards, the ability to drive vehicles and operate machinery may be impaired.

Fingolimod Reddy contains sodium.
The medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".

3. How to take Fingolimod Reddy

Treatment with fingolimod will be supervised by a doctor 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:
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 of 40 kg or less: one 0.25 mg capsule once daily. Fingolimod Reddy 0.5 mg hard capsules are not suitable for children with body weight of 40 kg or less. Other fingolimod-containing medicines are available in a lower strength (0.25 mg capsules).
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 daily and later achieve a stable body weight above 40 kg will be advised by their doctor to switch to one 0.5 mg capsule once daily. In such cases, a repeat observation period after the first dose is recommended.

Do not exceed the prescribed dose.
Fingolimod Reddy is intended for oral use.
Fingolimod Reddy should be taken once daily with a glass of water. Fingolimod Reddy capsules should always be swallowed whole, without opening. Fingolimod Reddy may be taken with or without food.

Taking Fingolimod Reddy at the same time each day will help you remember to take it.

For any questions regarding the duration of treatment with Fingolimod Reddy, consult your doctor or pharmacist.

If you take more Fingolimod Reddy than you should
If you have taken too much of this medicine, contact your doctor immediately.

If you forget to take Fingolimod Reddy
If you have been taking fingolimod for less than 1 month and have missed a dose for a full day, contact your doctor before taking the next dose. Your doctor may decide to keep you under observation when you take the next dose.

If you have been taking fingolimod 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 keep you under observation when you take the next dose.

However, if you have missed taking the medicine for up to 2 weeks, you may take the next dose as scheduled.

Do not take a double dose to make up for a missed dose.

Stopping Fingolimod Reddy
Do not stop treatment with Fingolimod Reddy or change the dose without first consulting your doctor.

Fingolimod 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 stopping fingolimod treatment, wait 6–8 weeks before starting a new multiple sclerosis treatment.

In patients restarting fingolimod treatment after a break of more than 2 weeks, effects on heart rate similar to those observed when starting treatment for the first time may reoccur, and monitoring in a doctor's office or clinic will be necessary upon resuming treatment. Do not restart fingolimod treatment after a break of more than two weeks without consulting your treating doctor.

Your treating doctor will decide whether and how you should be monitored after stopping fingolimod treatment. You should inform your doctor immediately if you feel your multiple sclerosis is worsening after stopping fingolimod treatment. 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 people):

productive cough, non-specific chest discomfort, fever (signs 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 weakness 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 lump, although it may also look different
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
weight loss

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

pneumonia with symptoms such as fever, cough, difficulty breathing
macular edema (swelling in the center 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, which increases 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 color over time, or new moles appearing. Moles may itch, bleed or ulcerate
seizures, epileptic seizures (more common in children and adolescents than in adults)

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

a condition called posterior reversible encephalopathy syndrome (PRES). Symptoms may include sudden, severe headache, confusion, seizures and (or) visual disturbances
lymphoma (a type of tumor involving the lymphatic system)
squamous cell carcinoma: a type of skin cancer that may appear as a hard, red lump,
a crusted ulcer or a new ulcer developing in an existing scar

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

abnormalities in ECG test results (T-wave inversion)
tumor associated with human herpesvirus type 8 infection (Kaposi's sarcoma)

Frequency not known (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 treatment with fingolimod is started
signs of liver disease (including liver failure), such as yellowing of the skin or whites of the eyes (jaundice), nausea or vomiting, pain in the right side of the abdomen, dark (brown) urine, reduced appetite, fatigue and abnormal liver function test results. 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 a relapse of MS. There may also be symptoms the patient is not 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 notice any new or unusual symptoms, it is very important to inform the treating physician as soon as possible
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 a painless, flesh-colored or bluish-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, 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 effects occur in the patient, you should inform the doctor immediately.
Other adverse reactions
Very common (may affect more than 1 in 10 people):

viral influenza infection with symptoms such as fatigue, chills, sore throat, joint or muscle pain, fever
feeling of pressure or pain in cheeks and forehead (sinusitis)
headache
diarrhea
back pain
increased liver enzyme activity in blood tests
cough

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

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 levels of fats (triglycerides) in the blood
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 may cause a mild increase in blood pressure)
muscle pain
joint pain

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

low number of white blood cells (neutrophils)
depressive mood
nausea

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

lymphatic system tumor (lymphoma)

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

peripheral edema

If any of these symptoms occur severely, you should inform the doctor.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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. Reporting adverse reactions helps to collect more information on the safety of the medicine.

5. How to store Fingolimod Reddy

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 pack after “Expiry date (EXP)” / “EXP”. The expiry date refers to the last day of the specified
month.
No special storage conditions apply for this medicine.
Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
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 Reddy contains
The active substance is fingolimod.
Each capsule contains 0.5 mg of fingolimod (as fingolimod hydrochloride).
The other ingredients are:
Capsule fill: betacyclodextrin, magnesium stearate.
Capsule shell: yellow iron oxide (E172), titanium dioxide (E171), gelatin, sodium lauryl sulfate.
Printing ink: shellac, black iron oxide (E172), potassium hydroxide.

What Fingolimod Reddy looks like and contents of the pack
Fingolimod Reddy 0.5 mg hard capsules are white to off-white, hard gelatin capsules, size 3, with a dark yellow opaque cap printed with "FGM" in black ink and a white opaque body printed with "0.5 mg" in black ink.
Fingolimod Reddy 0.5 mg hard capsules are available in packs containing 28 capsules.

Marketing Authorisation Holder
Reddy Holding GmbH
Kobelweg 95
86156 Augsburg
Germany
Tel.: +49 821 74881 0

Manufacturer/Importer
betapharm Arzneimittel GmbH
Kobelweg 95
86156 Augsburg
Germany
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola PLA 3000
Malta
Rual Laboratories SRL
Splaiul Unirii nr 313, building H, 1st floor, sector 3
030138 Bucharest
Romania
DR. REDDY'S LABORATORIES ROMANIA SRL
Daniel Danielopolu, nr 30 - 32, Spatiul 2, Etaj 5, Sectorul 1
014134 Bucharest
Romania

This medicinal product is authorised in the following European Economic Area countries under the following names:
Belgium: Fingolimod Reddy 0.5 mg hard capsules
Denmark: Fingolimod Reddy
Finland: Fingolimod Reddy 0.5 mg kova kapseli
Netherlands: Fingolimod Reddy 0.5 mg harde capsules
Germany: Fingolimod beta 0.5 mg Hartkapseln
Norway: Fingolimod Reddy
Poland: Fingolimod Reddy
Portugal: Fingolimod Reddy 0.5 mg cápsulas
Czech Republic: Fingolimod Reddy
Romania: Fingolimod Dr. Reddy’s 0.5 mg capsule
Slovakia: Fingolimod Reddy 0.5 mg tvrdé kapsuly
Sweden: Fingolimod Reddy 0.5 mg hårda kapslar

Fingolimod reddy