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
240 mg
Active Ingredient
Dimethyl fumarate
Manufacturer
ratiopharm GmbH
How to Use
Dosage
Start with 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 the medicine with food to help reduce some common side effects.
Important
The maximum daily dose is 480 mg (240 mg taken twice daily).
Possible Side Effects
COMMON
- •Flushing or a sensation of warmth, heat, burning, or itching in the body (flush)
- •Diarrhea
- •Nausea
- •Abdominal pain or cramps
- •Stomach or bowel inflammation (gastroenteritis)
- •Vomiting
- •Indigestion (dyspepsia)
- •Inflammation of the stomach lining (gastritis)
- •Gastrointestinal symptoms
- •Burning sensation
- •Hot flashes or sensation of warmth
- •Skin itching (pruritus)
- •Rash
- •Pinkish or reddish patches on the skin (erythema)
- •Hair loss (alopecia)
- •Low white blood cell count (lymphopenia, leukopenia)
- •Protein in urine (albuminuria)
- •Elevated liver enzymes (ALAT, ASAT) in blood
RARE
- •Allergic reactions (hypersensitivity)
- •Decreased platelets
- •Liver inflammation and elevated liver enzyme levels (ALAT or ASAT in combination with bilirubin)
- •Shingles (herpes zoster infection) with symptoms like blisters, skin burning, itching, or pain, fever, weakness, numbness, red patches, and severe pain.
- •Severe, watery runny nose (rhinorrhea)
- •Severe allergic reactions such as swelling of the face, lips, mouth or tongue (angioedema), wheezing, difficulty breathing or shortness of breath (dyspnea, hypoxia), dizziness or loss of consciousness (hypotension).
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 suspect or have confirmed a rare brain infection called progressive multifocal leukoencephalopathy (PML).
- Talk to your doctor before taking this medicine if you have severe kidney disease, severe liver disease, stomach or bowel disease, or a serious infection (e.g., pneumonia).
- Be aware of symptoms of PML (e.g., weakness on one side, clumsiness, vision changes, confusion, speech issues) that might resemble MS flares; contact your doctor immediately if you notice new or worsening symptoms.
- This medicine can affect your white blood cell count, kidneys, and liver. Your doctor will perform blood tests regularly to monitor these.
Show 6 more warnings
- If you suspect you have shingles, tell your doctor right away.
- This medicine is not for children under 13 years of age.
- Avoid strong alcoholic drinks (over 30% alcohol by volume) for one hour before and after taking this medicine, as it may cause stomach inflammation.
- Do not use if you are pregnant unless discussed with your doctor and absolutely necessary.
- If you are breastfeeding, consult your doctor to decide whether to stop breastfeeding or stop treatment.
- Tell your doctor if you are taking other fumarate medicines for psoriasis, as this could lead to a rare kidney disease (Fanconi syndrome). Symptoms include increased urination, thirst, muscle weakness, or bone pain.