Dimethyl fumarate SUN
This medicine treats a type of multiple sclerosis (MS) in people aged 13 and older by protecting the brain and spinal cord and may slow down the disease.
Form
enterokapseli, kova
Strength
120 mg
Active Ingredient
Dimethyl fumarate
Manufacturer
Sun Pharmaceutical Industries Europe B.V.
How to Use
Dosage
Start with 120 mg twice a day for 7 days, then take the usual dose of 240 mg twice a day.
Method
Swallow the capsules whole with water. Do not break, 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
- •Redness of the face or body, feeling of warmth, heat, burning, or itching on the body (flush).
- •Diarrhea.
- •Nausea.
- •Stomach pain or cramps.
- •Inflammation of the intestines (gastroenteritis).
- •Vomiting.
- •Indigestion (dyspepsia).
- •Inflammation of the stomach lining (gastritis).
- •Burning sensation.
- •Hot flashes, feeling of warmth.
- •Skin itching (pruritus).
- •Rash.
- •Pink or red patches on the skin (erythema).
- •Hair loss (alopecia).
- •Low number of white blood cells (lymphopenia, leukopenia) in the blood.
- •Protein (albumin) in urine.
- •Increased levels of liver enzymes (ALAT, ASAT) in the blood.
- •Headache (more common in children aged 13 and older).
- •Sore throat (more common in children aged 13 and older).
- •Cough (more common in children aged 13 and older).
- •Painful periods (more common in girls aged 13 and older).
RARE
- •Allergic reactions (hypersensitivity).
- •Decreased number of platelets.
- •Liver inflammation and increased levels of liver enzymes (ALAT or ASAT combined with bilirubin).
- •Shingles (herpes zoster) with symptoms like blisters, burning, itching, or pain on one side of the body or face, along with fever, weakness, numbness, or red patches with severe pain.
- •Runny nose (rhinorrhea).
Important Warnings
- Do not take this medicine if you are allergic to dimethyl fumarate or any other ingredient in it.
- Do not take this medicine if you have or are thought to have a rare brain infection called PML.
- This medicine can affect your white blood cells, kidneys, and liver. Your doctor will do regular blood tests to check these.
- Tell your doctor if you have severe kidney or liver disease, stomach or bowel problems, or a serious infection (like pneumonia).
- This medicine may cause shingles (herpes zoster). Tell your doctor right away if you think you have symptoms of shingles.
Show 7 more warnings
- If your MS symptoms worsen or you get new ones, talk to your doctor immediately. These could be signs of a rare but serious brain infection (PML).
- A rare but serious kidney problem (Fanconi syndrome) has been reported. Contact your doctor quickly if you pee more, feel very thirsty, have weak muscles, bone pain, or broken bones.
- Avoid strong alcoholic drinks (over 30% alcohol by volume) for one hour before and after taking this medicine, as it can cause stomach inflammation.
- Do not use this medicine if you are pregnant unless your doctor says it is absolutely necessary and you have discussed it with them.
- Do not give this medicine to children under 10 years old.
- Tell your doctor if you are taking other medicines, especially those for psoriasis (fumarates), other MS treatments, medicines affecting your immune system (like chemotherapy), kidney-affecting medicines (like some antibiotics, diuretics, certain pain relievers, lithium), or if you are receiving live vaccines.
- If you notice signs of a severe allergic reaction (like swelling of the face, lips, mouth, or tongue, wheezing, trouble breathing, dizziness, or fainting), stop taking the medicine and contact your doctor immediately.