Tecfidera 240 mg dimethyl fumarate Capsules × 56

What is Dimethyl Fumarate used for:

• • Dimethyl Fumarate is a medicine that is used to treat relapsing-remitting multiple sclerosis (MS) in adult patients.

• • MS is a chronic medical problem that affects the central nervous system, including the spinal cord and the brain.

• • Relapsing-remitting MS is a type of MS that consists of relapses of nervous system signs and symptoms.

• • MS symptoms usually involve walking problems, unsteadiness and visual problems

• • Double or blurred vision).

• • These symptoms may differ from one patient to another and usually stop completely once the relapse is over, however, the patient may still experience some of these symptoms.

• • This medicine acts by inhibiting the body’s defense system thus stopping it from causing damage to your spinal cord and brain, which may also aid in delaying any deterioration of your MS symptoms.

Do not take Dimethyl Fumarate:

• • If you are allergic to Dimethyl Fumarate, or any of the ingredients in this medicine.

• • Tell your doctor about the allergy and what signs you had.

• • If you may have a rare brain infection known as progressive multifocal leukoencephalopathy (PML) or if you have been diagnosed with PML.

Possible side effects:

• • Possible side effects include allergic reaction and signs of PML like clumsiness, new or worsening weakness on one side of the body, vision changes, memory or thinking problems, confusion or personality changes, communication and speech problems that last for more than several days.

• • Very common side effects include flushing, diarrhea, nausea and stomach cramps or pain.

• • Common side effects include inflammation of the intestines lining, burning sensation, indigestion, rash, bowel and stomach problems, hot flush and feeling hot, inflammation of the stomach lining, itchy skin, skin redness and vomiting.

Other medicines and Dimethyl Fumarate:

• • Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medications including prescription medicines, over the counter medicines, herbals, vitamins and supplements.

• • If you are taking medicines that contain fumaric acid esters (fumarates) used to treat psoriasis

• • If you are taking medicines that affect your immune system including other medications that are used in the treatment of MS, like natalizumab, fingolimod, alemtuzumab, ocrelizumab, teriflunomide or cladribine, or some cancer medications (mitoxantrone or rituximab).

• • If you are taking medicines that affect the kidneys including diuretics (increase urination), some antibiotics, some types of painkillers (like ibuprofen) and medicines containing lithium.

• • If you are expected to receive a live vaccine.

• • Taking dimethyl fumarate with live vaccines may cause you to develop an infection and therefore you should not receive this type of vaccines when being treated with dimethyl fumarate.

• • Talk to your doctor before receiving a vaccine when taking this medicine, your doctor may suggest other types of vaccines (killed vaccines) when possible.

How to take Dimethyl Fumarate:

Adults:

• • Start by taking a dose of 120 mg orally twice a day for the first 7 days, then take a regular dose of 240 mg twice a day.

Children:

• • This medicine is not recommended for use in children and adolescents due to the limited experience of its use in this population.

• • Take your medication exactly as prescribed by your doctor.

• • Your doctor will determine the dose that you need to take.

• • This medicine is for oral use only.

• • Swallow each capsule whole with some water.

• • Do not crush, divide, suck, dissolve, or chew the capsule to avoid an increase in some side effects.

• • Take dimethyl fumarate with food to help in decreasing its side effects.

How to store Dimethyl Fumarate:

• • Keep out of the reach of children and pets

• • Do not store this medication above 30 °C

• • Do not use beyond the expiry date mentioned on the box

• • Keep medication in its original pack to protect it from moisture and light

• Do not dispose medication in the wastewater or household waste