Dimethyl fumarate SUN

This medicine, Dimethyl fumarate SUN, helps treat a type of multiple sclerosis (MS) in people aged 13 and older by protecting the brain and spinal cord from immune system damage.

Form
enterokapseli, kova
Strength
240 mg
Active Ingredient
Dimethyl fumarate
Manufacturer
Sun Pharmaceutical Industries Europe B.V.

How to Use

Dosage

Start with 120 mg twice a day for the first 7 days. After that, take 240 mg twice a day.

Method

Take Dimethyl fumarate SUN by mouth with food. Swallow the capsules whole with water. Do not crush, chew, or open the capsules.

Important

The maximum daily dose is 480 mg (240 mg twice a day).

Possible Side Effects

COMMON
  • Flushing, warmth, burning, or itching on the face or body
  • Diarrhea
  • Nausea
  • Stomach pain or cramps
  • Stomach flu (gastroenteritis)
  • Vomiting
  • Indigestion
  • Stomach lining inflammation (gastritis)
  • Rash
  • Red or pink patches on the skin
  • Hair loss
  • Low white blood cell count
  • Protein in urine
  • Increased liver enzymes in blood
  • Headache (more common in children and adolescents)
  • Sore throat (more common in children and adolescents)
  • Cough (more common in children and adolescents)
  • Painful periods (more common in children and adolescents)
RARE
  • Allergic reactions (hypersensitivity)
  • Decreased platelets
  • Liver inflammation and increased liver enzymes (with bilirubin)
  • Shingles (blisters, burning, itching, pain on skin, fever, weakness, numbness)
  • Runny nose
  • Severe allergic reactions with swelling of the face, lips, mouth, or tongue
  • Severe allergic reactions with wheezing, difficulty breathing, or shortness of breath
  • Severe allergic reactions with dizziness or loss of consciousness

Important Warnings

  • Do not take this medicine if you are allergic to dimethyl fumarate or any other ingredient in this medicine.
  • Do not take this medicine if you have or are suspected to have a rare brain infection called progressive multifocal leukoencephalopathy (PML).
  • This medicine may affect your white blood cell count, kidneys, and liver. Your doctor will check these regularly with blood tests.
  • Talk to your doctor if you have severe kidney, liver, or stomach/bowel disease, or a serious infection like pneumonia.
  • If you develop symptoms of shingles (herpes zoster), tell your doctor immediately.
Show 5 more warnings
  • Seek medical attention immediately if your MS worsens or you develop new symptoms like weakness, changes in vision, or thinking. These could be signs of a serious brain infection (PML).
  • Contact your doctor if you experience increased thirst, urination, muscle weakness, or bone pain, as these could be symptoms of a rare kidney disease (Fanconi syndrome).
  • Avoid strong alcoholic drinks (over 30% by volume) for one hour before and after taking this medicine, as it may cause stomach inflammation.
  • Do not use this medicine if you are pregnant, unless you have discussed it with your doctor and it is clearly necessary.
  • Avoid certain live vaccines while taking this medicine, as they may increase your risk of infection.