Dimethyl fumarate Hexal

Dimethyl fumarate Hexal is a medicine used to treat multiple sclerosis (MS) in people aged 13 years and older.

Form
enterokapseli, kova
Strength
120 mg
Active Ingredient
Dimethyl fumarate
Manufacturer
Hexal A/S

How to Use

Dosage

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

Method

Swallow the capsules whole with water. Do not split, crush, dissolve, suck, or chew them. Take with food to help reduce common side effects.

Important

The maximum daily dose is 480 mg.

Possible Side Effects

COMMON
  • Flushing (redness of face or body), feeling warm, hot, burning, or itchy in the body
  • Diarrhea
  • Nausea
  • Stomach pain or cramps
  • Inflammation of the stomach and intestines (gastroenteritis)
  • Vomiting
  • Indigestion (dyspepsia)
  • Inflammation of the stomach lining (gastritis)
  • Burning sensation
  • Hot flashes, feeling hot
  • Itching of the skin (pruritus)
  • Rash
  • Pink or red spots on the skin (erythema)
  • Hair loss (alopecia)
  • Low white blood cell count (lymphopenia, leukopenia)
  • Protein (albumin) in urine
  • Increased liver enzymes (ALAT, ASAT) in blood
RARE
  • Allergic reactions (hypersensitivity)
  • Decreased number of platelets
  • Liver inflammation and increased liver enzyme levels (ALAT or ASAT together with bilirubin)
  • Shingles (herpes zoster) with symptoms like blisters, burning, itching, or pain on the skin, typically on one side of the upper body or face, along with fever and weakness
  • Severe, watery runny nose (rhinorrhea)

Important Warnings

  • Do not take this medicine if you are allergic to dimethyl fumarate or any other ingredient in this medicine.
  • Do not take if you have a rare brain infection called Progressive Multifocal Leukoencephalopathy (PML) or if it's suspected.
  • This medicine can affect your white blood cell count, kidneys, and liver. Your doctor will do blood tests regularly.
  • Talk to your doctor before taking this medicine if you have severe kidney or liver disease, stomach or bowel issues, or a serious infection like pneumonia.
  • If you think you have shingles (herpes zoster) or any new or worsening MS symptoms (like weakness or vision changes), contact your doctor right away. These could be signs of PML.
Show 5 more warnings
  • If you notice you are urinating more, are unusually thirsty, or have muscle weakness, bone fractures, or pain, talk to your doctor as soon as possible. These could be signs of a rare but serious kidney problem.
  • Do not use this medicine if you are pregnant, unless your doctor says it is absolutely necessary.
  • Avoid strong alcoholic drinks for one hour after taking this medicine, as alcohol can interact with it and cause stomach irritation.
  • Avoid live vaccines while taking this medicine, as they might increase your risk of infection. Your doctor will advise on other types of vaccines.
  • Stop taking this medicine and contact your doctor right away if you have signs of a severe allergic reaction, such as swelling of your face, lips, mouth, or tongue, trouble breathing, dizziness, or fainting.