Tredia 240 mg 60 Capsule

Product Name

TREDIA Delayed Release Capsules 240 mg

Product Description

TREDIA Delayed Release Capsules contain Dimethyl Fumarate, a medicine used in adults for the treatment of relapsing-remitting multiple sclerosis (MS). It helps protect the brain and spinal cord from damage caused by the body’s immune system and may help delay worsening of the disease over time.

Uses

TREDIA 240 mg is used for:

• Treatment of relapsing-remitting multiple sclerosis (MS) in adults


• Helping reduce repeated MS relapses


• Supporting protection of the central nervous system


• Helping delay progression or worsening of MS symptoms

How to Use

• Always take this medicine exactly as prescribed by your doctor


• Starting dose: 120 mg twice daily for the first 7 days


• Regular dose: 240 mg twice daily


• For oral use


• Swallow each capsule whole with water


• Do not divide, crush, dissolve, suck, or chew the capsule


• Take TREDIA with food to help reduce common side effects


• If a dose is missed, do not take a double dose. The missed dose may be taken only if there are at least 4 hours before the next dose

Warnings and Precautions

Consult your doctor before taking TREDIA if you have:

• Severe kidney disease


• Severe liver disease


• Stomach or bowel disease


• A serious infection such as pneumonia

Important precautions:

• TREDIA may affect white blood cell count, kidneys, and liver


• Blood tests may be required before and during treatment


• Tell your doctor if you develop symptoms of infection or shingles


• Avoid medicines that affect the immune system unless advised by your doctor


• Avoid live vaccines during treatment unless your doctor recommends otherwise


• Avoid drinking more than 50 ml of strong alcohol (more than 30%) within 1 hour of taking the medicine

Pregnancy and Breastfeeding

• Do not use during pregnancy unless discussed with your doctor


• TREDIA should not be used during breastfeeding unless advised by your doctor

Possible Side Effects

Serious Side Effects

Seek medical help immediately if you notice:

• New or worsening weakness on one side of the body


• Clumsiness


• Changes in vision, memory, or thinking


• Confusion or personality changes


• Swelling of the face, lips, mouth, or tongue


• Difficulty breathing, wheezing, or dizziness

Very Common Side Effects

• Flushing (redness, warmth, burning, or itching)


• Diarrhea


• Nausea


• Stomach pain or cramps

Common Side Effects

• Vomiting


• Indigestion


• Gastritis


• Gastrointestinal disorders


• Burning sensation


• Feeling hot or hot flush


• Itchy skin


• Rash


• Red or pink skin patches

Other Effects Seen in Tests

• Low white blood cell count


• Protein in urine


• Increased liver enzymes

Uncommon Side Effects

• Allergic reactions


• Reduced blood platelets


• Liver inflammation


• Herpes zoster (shingles)

Storage

• Keep out of reach of children


• Store below 30°C


• Do not use after the expiry date shown on the pack


• Do not dispose of medicines in household waste or wastewater

Active Ingredient

• Dimethyl Fumarate 240 mg

Other Ingredients

Includes:

• Microcrystalline cellulose


• Croscarmellose sodium


• Colloidal silicon dioxide


• Magnesium stearate


• Methacrylic acid copolymers


• Triethyl citrate


• Talc


• Isopropyl alcohol


• Purified water


• Hard gelatin capsule

Pack Size

• 60 capsules in HDPE bottle