Tecfidera 240 mg 56 Capsules

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 (e.g.


• 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 toDimethyl Fumarate, or any of the ingredients inthis 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.

Warnings and precautions:

• Stop the medication right away and talk to your doctor or pharmacist if you develop allergic reactions such as shortness of breath, skin rash, swelling of the face or neck, decreased blood pressure and dizziness.


• This medicine may affect your kidneys, white blood cell counts and liver.


• Therefore, your doctor will check if your liver and kidneys are functioning properly and will order a blood test to check your white blood cells count before you start taking this medicine.


• Your doctor may recommend doing these tests regularly during treatment.


• In case of decreased number of white blood cells, your doctor may either take into consideration doing additional analytic measures or may completely stop your treatment with this medicine.


• Talk to your doctor before starting this medicine if you have a severe infection, severe kidney or liver problems, bowel or stomach problem or a serious infection.


• This medicine may cause Herpes zoster (shingles) which may lead to serious complications.


• Talk to your doctor right away if you experience any symptoms of shingles.


• This medicine may cause a rare brain infection known as progressive multifocal leukoencephalopathy (PML) which is a serious medical problem that may lead to death or severe disability.


• Talk to your doctor immediately if you feel that your MS symptoms are getting worse (e.g.


• Vision problems) or if you experience any new symptoms as this may be due to a PML.

• A medicine containing dimethyl fumarate was reported to cause a rare but serious kidney disorder known as Fanconi Syndrome when given in combination with other fumaric acid esters that are used in the treatment of psoriasis which is a skin problem.


• Talk to your doctor if you experience signs like breaking a bone, urinating more frequently, increased thirst, drinking more than usual, muscles weakness, body pains and aches.

• Dimethyl fumarate may interact with alcohol which may cause inflammation of your stomach, therefore, make sure that you do not drink alcohol within an hour of taking this medicine.

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