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Dimethyl Fumarate oral delayed-release capsules

What is this medicine?

DIMETHYL FUMARATE (DYE meth il FUE ma rate) helps to decrease the number of multiple sclerosis relapses in people with relapsing-remitting forms of the disease. It is not a cure.

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not cut, crush or chew this medicine. Swallow the capsules whole. You can take it with or without food. If it upsets your stomach, take it with food. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

  • fever or chills, sore throat

  • signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin

  • signs and symptoms of a serious brain infection like changes in vision, confusion, weakness on one side of the body, loss of balance or coordination, loss of memory, or changes in personality

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • diarrhea

  • facial flushing

  • nausea

  • stomach pain

  • upset stomach

What may interact with this medicine?

Do not take this medicine with the following medications:

  • diroximel fumarate

  • monomethyl fumarate

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Keep this medicine in the original container. Protect from light. Throw away any unused medicine after the expiration date.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

  • immune system problems

  • infection

  • liver disease

  • low blood counts, like white cells

  • an unusual or allergic reaction to dimethyl fumarate, diroximel fumarate, other medicines, foods, dyes, or preservatives

  • pregnant or trying to get pregnant

  • breast-feeding

What should I watch for while using this medicine?

Visit your health care professional for regular checks on your progress. Tell your health care professional if your symptoms do not start to get better or if they get worse. You may need blood work done while you are taking this medicine.

Taking your medicine with food may help reduce flushing. Call your doctor if the flushing from this medicine bothers you or does not go away. Ask your doctor if taking aspirin before taking this medicine may reduce flushing.

This medicine may increase your risk of getting an infection. Call your health care professional for advice if you get a fever, chills, or sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

In some patients, this medicine may cause a serious brain infection that may cause death. If you have any problems seeing, thinking, speaking, walking, or standing, tell your healthcare professional right away. If you cannot reach your healthcare professional, urgently seek other source of medical care.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider. Copyright© 2020 Elsevier