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Fingolimod Zentiva

Fingolimod Zentiva is a medicine for adults and children (10 years and older, weighing over 40 kg) with multiple sclerosis (MS) that helps reduce flare-ups and slow down the progression of the disease.

Form
kapseli, kova
Strength
0.5 mg
Active Ingredient
Fingolimod hydrochloride
Manufacturer
Zentiva, k.s.

How to Use

Dosage

One 0.5 mg capsule once a day.

Method

Take one capsule whole with water, once a day. Do not open the capsule. You can take it with or without food.

Important

Do not take more than the recommended dose of one 0.5 mg capsule per day.

Possible Side Effects

COMMON
  • •Flu-like symptoms such as fatigue, chills, sore throat, joint or muscle pain, fever.
  • •Feeling of pressure or pain in cheeks and forehead (sinus infection).
  • •Headache.
  • •Diarrhea.
  • •Back pain.
  • •Increased liver enzyme levels in blood tests.
  • •Cough with mucus, chest discomfort, fever (signs of lung illness).
  • •Herpes virus infection (shingles) with blisters, burning, itching, or pain on the skin, usually on the upper body or face. Other symptoms can be fever, weakness, numbness, and red patches.
  • •Slow heartbeat, irregular heartbeat.
  • •A type of skin cancer called basal cell carcinoma, often appearing as pearly bumps.
  • •Depression and anxiety.
  • •Weight loss.
  • •Ringworm, a fungal skin infection.
  • •Dizziness.
  • •Severe headache often with nausea, vomiting, and sensitivity to light (migraine).
  • •Low white blood cell count (lymphocytes, leukocytes).
  • •Feeling weak.
  • •Itchy, red, burning rash (eczema).
  • •Itching.
  • •Increased blood fat levels (triglycerides).
  • •Hair loss.
  • •Shortness of breath.
  • •Blurred vision.
  • •High blood pressure.
  • •Muscle pain.
  • •Joint pain.
RARE
  • •Pneumonia with symptoms like fever, cough, difficulty breathing.
  • •Macular edema (swelling in the back of the eye) with symptoms like shadows, blind spots, blurred vision, or difficulty seeing colors or details.
  • •Low platelet count, increasing risk of bleeding or bruising.
  • •Melanoma (a type of skin cancer that often starts from an unusual mole). Moles might change in size, shape, height, or color, or new moles might appear. They can be itchy, bleed, or become sore.
  • •Seizures (more common in children and adolescents than adults).
  • •Low neutrophil count (a type of white blood cell) in the blood.
  • •Depressed mood.
  • •Nausea.
  • •Posterior reversible encephalopathy syndrome (PRES) with symptoms like sudden severe headache, confusion, seizures, and/or vision problems.
  • •Lymphoma (a type of cancer affecting the lymphatic system).
  • •Squamous cell carcinoma: a type of skin cancer that can appear as a firm, small, red lump, a scaly sore, or a new sore on an old scar.
  • •Abnormal heart electrical activity (T-wave inversion).
  • •Tumor related to human herpesvirus 8 infection (Kaposi's sarcoma).
  • •Allergic reactions, including rash, itchy hives, swelling of the lips, tongue, or face, most likely on the day you start treatment.
  • •Signs of liver disease (including liver failure), such as yellow skin or eyes (jaundice), nausea or vomiting, pain on the right side of the stomach, dark urine, less appetite, fatigue, and abnormal liver tests. In very rare cases, liver failure may lead to a liver transplant.
  • •Risk of a rare brain infection called Progressive Multifocal Leukoencephalopathy (PML). Symptoms can be similar to MS flare-ups or include mood or behavior changes, memory loss, and speech difficulties.
  • •Inflammatory disorder after stopping Fingolimod Zentiva treatment (Immune Reconstitution Inflammatory Syndrome or IRIS).
  • •Cryptococcal infections (a type of fungal infection), including cryptococcal meningitis, with symptoms like headache, stiff neck, sensitivity to light, nausea, and/or confusion.
  • •Merkel cell carcinoma (a type of skin cancer). A possible sign is a skin-colored or reddish-blue, painless lump, often on the face, head, or neck. Long-term sun exposure and a weakened immune system can increase the risk.
  • •MS symptoms may return and worsen after stopping Fingolimod Zentiva.
  • •Autoimmune anemia (reduced red blood cells) where red blood cells are destroyed.
  • •Peripheral swelling.

Important Warnings

  • Do not take if your immune system is weak (due to illness or other medicines).
  • Do not take if you have a severe active infection or a chronic infection like hepatitis or tuberculosis.
  • Do not take if you have active cancer.
  • Do not take if you have had a heart attack, chest pain, stroke, or certain types of heart failure in the last 6 months.
  • Do not take if you are pregnant or could become pregnant and are not using effective birth control.
Show 2 more warnings
  • Tell your doctor if you have or have had vision problems, swelling in the back of your eye (macular edema), eye inflammation, or diabetes.
  • Tell your doctor if you have liver problems.

Additional Information

ATC Code: L04AE01
→ View Professional Information (PDF)→ View Patient Leaflet (PDF)