Dimethyl fumarate ratiopharm GmbH
Dimethyl fumarate ratiopharm GmbH is used to treat relapsing-remitting multiple sclerosis (MS) in patients aged 13 years and older.
Form
enterokapseli, kova
Strength
120 mg
Active Ingredient
Dimethyl fumarate
Manufacturer
ratiopharm GmbH
How to Use
Dosage
Initial dose is 120 mg twice daily for 7 days, then the usual dose is 240 mg twice daily.
Method
Swallow capsules whole with water. Do not divide, crush, dissolve, suck, or chew. Take with food to help reduce side effects.
Important
The usual maximum daily dose is 480 mg.
Possible Side Effects
COMMON
- •Facial or body redness, feeling of warmth, heat, burning, or itching (flush)
- •Diarrhea
- •Nausea
- •Stomach pain or cramps
- •Stomach and bowel inflammation (gastroenteritis, gastritis)
- •Vomiting
- •Indigestion
- •Itching skin
- •Rash
- •Red patches on skin (erythema)
- •Hair loss (alopecia)
- •Low white blood cell count (may increase infection risk)
- •Protein (albumin) in urine
- •High liver enzymes in blood (ALAT, ASAT)
- •Ketones in urine
RARE
- •Allergic reactions (hypersensitivity)
- •Low platelet count
- •Liver inflammation with high liver enzymes and bilirubin
- •Shingles (herpes zoster) with blisters, burning, itching, or pain on one side of the body/face, plus fever, weakness, and numbness
- •Severe, watery runny nose (rhinorrhea)
Important Warnings
- Do not take if you are allergic to dimethyl fumarate or any other ingredients.
- Do not take if you have or might have a rare brain infection called PML (Progressive Multifocal Leukoencephalopathy).
- Tell your doctor if you have severe kidney disease, severe liver disease, stomach or bowel disease, or a serious infection (e.g., pneumonia).
- Tell your doctor right away if your MS gets worse or if you notice new symptoms, as these could be signs of a serious brain infection (PML).
- Avoid strong alcoholic drinks for one hour before and after taking this medicine, as it can irritate your stomach.
Show 5 more warnings
- Do not use if pregnant unless absolutely necessary and after talking to your doctor.
- If you miss a dose, do not take a double dose to make up for it.
- If you get serious allergic reactions (e.g., swelling of your face/lips/tongue, trouble breathing, dizziness), stop taking the medicine and get medical help right away.
- Tell your doctor immediately if you notice signs of shingles (herpes zoster).
- If you urinate more, are very thirsty, have weak muscles, bone pain, or fractures (signs of Fanconi syndrome), contact your doctor.