DIMETHYL FUMARATE DELAYED RELEASE CAPSULE - ORAL

DIMETHYL FUMARATE DELAYED RELEASE CAPSULE - ORAL

PHONETIC PRONUNCIATION: (dye-METH-il FUE-ma-rate)

COMMON BRAND NAME(S): Tecfidera

GENERIC NAME(S): dimethyl fumarate

Uses

USES: Dimethyl fumarate is used to treat relapsing forms of multiple sclerosis (MS). It is not a cure for MS. It helps decrease the number of episodes of worsening MS.


How to use DIMETHYL FUMARATE DELAYED RELEASE CAPSULE - ORAL

HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking dimethyl fumarate and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with or without food as directed by your doctor, usually twice daily. Your doctor should usually direct you to start this medication at a low dose for the first 7 days of treatment and to increase your dose after 7 days. Follow your doctor's instructions carefully. If flushing occurs, taking this medication with food may reduce this side effect. Taking a plain (non-enteric coated) aspirin 30 minutes before taking this medication may also help prevent flushing. Ask your doctor if this treatment is right for you. Swallow the capsules whole. Do not open, crush, or chew the capsules. Doing so can release all of the drug at once, increasing the risk of side effects. Take this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. Tell your doctor if your condition worsens.

Side Effects

SIDE EFFECTS: Flushing/warmth, redness, itching, and burning feeling of the skin may occur. Taking this drug with food may reduce flushing. Stomach/abdominal pain, diarrhea, nausea, and vomiting may also occur. These effects usually improve or go away as your body adjusts to the medication. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as fever, chills, persistent sore throat, cough). Tell your doctor right away if you have any serious side effects, including: symptoms of liver damage (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine). This medication may increase your risk of getting a rare but very serious (sometimes fatal) brain infection (progressive multifocal leukoencephalopathy-PML). Get medical help right away if any of these rare but very serious side effects occur: clumsiness, loss of coordination, weakness, sudden change in your thinking (such as confusion, difficulty concentrating), difficulty moving your muscles, problems with speech, seizure, vision changes. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

PRECAUTIONS: Before taking dimethyl fumarate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: low white blood cell counts, infections (including any current infection), liver disease. Dimethyl fumarate can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details. Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose). Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Interactions

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: other drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab).

Overdose

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Images

TECFIDERA DR 120 MG CAPSULE

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green
shape
oblong
imprint
BG-12 120 mg
TECFIDERA DR 240 MG CAPSULE

color
green
shape
oblong
imprint
BG-12 240 mg
TECFIDERA STARTER PACK

color
multi-color
shape
oblong
imprint
BG-12 120 mg or BG-12 240 mg

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Faq for DIMETHYL FUMARATE DELAYED RELEASE CAPSULE - ORAL

Dimethyl fumarate delayed-release capsule is a medication used to treat relapsing forms of multiple sclerosis (MS). It helps reduce the frequency of relapses and slows down the progression of the disease.

This medication should be taken by mouth, usually with food to help reduce stomach upset. Follow the dosage instructions provided by your doctor or read the medication guide carefully. Do not crush or chew the capsules, as it is designed to be released slowly in the body.

Common side effects may include flushing, stomach upset, diarrhea, nausea, and abdominal pain. These usually improve over time as your body adjusts to the medication. However, if you experience severe or persistent side effects, contact your healthcare provider promptly.

Yes, there are a few precautions to consider. You should inform your doctor about any allergies, medical conditions, or medications you are currently taking. Dimethyl fumarate may decrease your white blood cell count, so regular blood tests are often required. It is also important to use effective contraception during treatment, as this medication may harm unborn babies.

It is important to let your doctor know about all the medications you are taking, including prescription, over-the-counter, and herbal products. Some drugs may interact with dimethyl fumarate, so dosage adjustments or careful monitoring may be necessary.

The exact time frame varies for each individual. Some patients may experience improvement in their MS symptoms within a few weeks, while for others, it may take several months. It's important to continue taking the medication as prescribed and discuss any concerns with your doctor.

It is generally recommended to avoid or limit alcohol consumption while taking this medication. Alcohol may increase the risk of certain side effects and may also reduce the effectiveness of the treatment.

If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose to catch up.

No, it is important to continue taking this medication as prescribed by your doctor, even if you start feeling better. Stopping the medication without medical guidance may lead to a recurrence of MS symptoms or worsening of the condition.



Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.