Sclerifuma 240 Cap

SCLERIFUMA 240 CAP by SUN PHARMA VV

Name

• Common Name: Dimethyl Fumarate
• Brand Name: SCLERIFUMA 240 CAP (manufactured by Sun Pharmaceutical Industries Ltd.)

Composition

• Active Ingredient: Dimethyl Fumarate 240 mg

Uses

SCLERIFUMA 240 CAP is primarily prescribed for the treatment of relapsing forms of multiple sclerosis (MS) in adults and children aged 13 and older. This includes:

• Relapsing-Remitting Multiple Sclerosis (RRMS)
• Active Secondary Progressive Multiple Sclerosis (SPMS)
• Clinically Isolated Syndrome (CIS)

It works by reducing the damage caused by the body's defense system to the brain and spinal cord, helping to lessen the number of MS attacks and slow the worsening of the condition. It also has anti-inflammatory and immunomodulatory properties. Some sources also mention its use for moderate to severe plaque psoriasis.

Dosage and Administration

• Typical Dosage: The usual starting dose is 120 mg taken orally twice daily for 7 days. After this initial period, the dose is typically increased to 240 mg taken orally twice daily.
• Administration: Capsules should be swallowed whole with water. Do not crush, chew, dissolve, suck, or break the capsule. It is recommended to take Sclerifuma with food to help reduce common gastrointestinal side effects. Always follow your doctor's instructions regarding dosage and duration.

Side Effects

Common Side Effects:

• Flushing (redness, warmth, burning, or itching of the face or body)
• Diarrhea, loose stools
• Nausea, feeling sick
• Stomach pain or cramps, abdominal pain
• Vomiting
• Indigestion, heartburn
• Rash

Serious Side Effects (Consult your doctor if experienced):

• Low white blood cell counts (lymphopenia), increasing infection risk
• Increased liver enzymes or liver injury
• Progressive multifocal leukoencephalopathy (PML), a rare brain infection
• Severe allergic reactions (facial swelling, difficulty breathing, hives)
• Kidney disorders
• Dizziness, fatigue

Precautions

• Allergies: Do not take if allergic to dimethyl fumarate or any other ingredients.
• Infections/Immune System: Inform your doctor if you have low white blood cell counts, an infection, or other conditions affecting your immune system.
• PML: Avoid use if you have or are suspected of having progressive multifocal leukoencephalopathy (PML).
• Liver/Kidney Conditions: Use with caution if you have liver or kidney problems; regular monitoring may be required.
• Gastrointestinal Issues: Inform your doctor if you have stomach or bowel diseases.
• Pregnancy & Breastfeeding: Consult your doctor before use if pregnant, planning pregnancy, or breastfeeding. Effective contraception is recommended during and for two months after treatment.
• Alcohol: Avoid alcohol consumption as it may increase side effects like flushing or gastric inflammation.
• Driving/Operating Machinery: May cause dizziness or fatigue, so exercise caution.
• Drug Interactions: Inform your doctor about all medicines you are taking, especially other fumaric acid esters, immunosuppressants, chemotherapy, or medications affecting kidney function.
• Children: Safety and efficacy have not been established for individuals under 13 or 18 years of age.

Storage

Store in a cool and dry place, away from direct sunlight and moisture. Keep this medicine out of the sight and reach of children. Store below 30°C or between 10°C to 25°C.

What is Sclerifuma 240 CAP used for?

Sclerifuma 240 CAP, which contains Dimethyl fumarate, is primarily used to treat various forms of multiple sclerosis (MS) in adults and children 13 years and older. This includes relapsing-remitting MS (RRMS), active secondary progressive MS (SPMS), and clinically isolated syndrome (CIS). The medicine helps to reduce the frequency of relapses and slows the progression of nerve damage and physical disability associated with MS.

How does Sclerifuma 240 CAP work?

Sclerifuma 240 CAP works as a neuroprotective and anti-inflammatory agent. Its active ingredient, Dimethyl fumarate, functions by reducing inflammation and preventing nerve damage. It helps to stop the body's immune system from attacking and damaging the brain and spinal cord. The medicine also activates the Nrf2 pathway, which contributes to reducing oxidative stress and modulating immune responses, thereby protecting nerve cells.

What is the usual dosage for Sclerifuma 240 CAP?

The typical starting dosage is 120 mg taken orally twice daily for the first 7 days. Following this initial period, the dosage is usually increased to 240 mg taken orally twice daily. Sclerifuma 240 CAP can be taken with or without food, though taking it with food may help to reduce gastrointestinal side effects. It is important to swallow the capsule whole with water and not to crush, chew, break, or dissolve it. Always follow your doctor's prescribed dosage and timing.

What are the possible side effects of Sclerifuma 240 CAP?

Common side effects include flushing (redness, warmth, burning, itching of the face or body), nausea, vomiting, diarrhea, stomach pain or cramps, indigestion, and headache. More serious or less common side effects can include a decrease in white blood cell counts (lymphopenia), which may increase the risk of infections, elevated liver enzymes, severe allergic reactions (e.g., swelling of the face or throat, difficulty breathing), kidney disorders, shingles (herpes zoster), and a rare brain infection called progressive multifocal leukoencephalopathy (PML). If side effects persist or worsen, consult your doctor.

Is Sclerifuma 240 CAP safe during pregnancy or breastfeeding?

Sclerifuma 240 CAP is generally not recommended for use during pregnancy or while breastfeeding unless specifically deemed necessary by a doctor after evaluating the potential risks and benefits. If you are pregnant or planning to become pregnant, or are breastfeeding, discuss this with your healthcare provider. Effective contraception should be used during treatment and for two months after stopping the medication if you are a woman of childbearing potential. It is not known if dimethyl fumarate passes into breast milk.

Can Sclerifuma 240 CAP be taken with other medications?

It is crucial to inform your doctor about all medications, supplements, and vaccinations you are currently taking to avoid potential drug interactions. Sclerifuma 240 CAP should be used with caution alongside other immunosuppressive medications due to an increased risk of infections. Live vaccines should generally be avoided during treatment. Special care is also needed if you are taking other medicines containing fumaric acid esters (used for psoriasis) or medications that can affect your kidneys, such as certain antibiotics, diuretics ("water tablets"), specific painkillers like ibuprofen, or lithium.

What precautions should be taken while using Sclerifuma 240 CAP?

Before starting Sclerifuma 240 CAP, inform your doctor if you have any known allergies to its components, a history of lowered immune response, severe active infections, low white blood cell counts, or liver disorders. Regular blood tests and liver function tests may be necessary during treatment to monitor your health. You should avoid consuming alcohol as it may increase side effects like flushing or liver stress. Exercise caution if you have severe kidney disease, stomach, bowel, or lung conditions. If you experience dizziness, avoid driving or operating machinery.

What happens if a dose of Sclerifuma 240 CAP is missed?

If you miss a dose of Sclerifuma 240 CAP, take it as soon as you remember. However, if it is close to the time for your next scheduled dose (e.g., within 4 hours), skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for the missed one.

How should Sclerifuma 240 CAP be stored?

Sclerifuma 240 CAP should be stored in a cool and dry place, protected from direct sunlight and moisture. It does not typically require special temperature storage but should generally be kept below 30ºC. Always keep this medicine out of the sight and reach of children. Do not use the medicine after its expiry date.