SCLERIFUMA 240mg Capsule 10's

Introduction About SCLERIFUMA 240MG CAPSULE

SCLERIFUMA 240MG CAPSULE contains Dimethyl Fumarate which belongs to the group
of medicines called Immunosuppressive Agent. It is used to manage
relapsing-remitting forms of multiple sclerosis in patients aged 13 years and
older. Multiple sclerosis is a long-term condition that affects the brain and
the spinal cord. Relapsing-remitting Multiple sclerosis is characterised by
repeated attacks (relapses) of nervous system symptoms such as walking
difficulties, feeling off balance, visual difficulties (e.g., blurred, or double
vision).

Before and during the management your doctor will perform blood tests to
determine your health condition. Avoid consum
SCLERIFUMA 240MG CAPSULE as it may cause gastritis (inflammation of the
stomach). SCLERIFUMA 240MG CAPSULE is not recommended in patients with (PML)
progressive multifocal leukoencephalopathy (a rare brain infection). SCLERIFUMA
240MG CAPSULE should be used with caution in patients with lung problems (such
as pneumonia), severe kidney and liver problems, stomach or bowel disease.

SCLERIFUMA 240MG CAPSULE is generally not recommended for use in pregnant
or breastfeeding women. Safety data of SCLERIFUMA 240MG CAPSULE for children
below 13 years of age has not been established yet. The most common side effects
of taking SCLERIFUMA 240MG CAPSULE are flushing (reddening of face), diarrhea,
nausea or stomach pain. Contact your doctor if your symptoms get worse.

Uses Of SCLERIFUMA 240MG CAPSULE

• manages relapsing-remitting forms of multiple sclerosis

How SCLERIFUMA 240MG CAPSULE Works

SCLERIFUMA 240MG CAPSULE functions by managing the body's defence mech
destroying the brain and spinal cord. Additionally, it might manage multiple
sclerosis from getting worse in the future.

How to use SCLERIFUMA 240MG CAPSULE

Take SCLERIFUMA 240MG CAPSULE as advised by your physician. Take the medicine
with a glass of water. Do not crush, dissolve or chew the medicine. Take it with
food. Depending on your age, body weight, and medical state, your doctor will
determine the appropriate dose and duration for you.

Side Effects Of SCLERIFUMA 240MG CAPSULE

Common

• reddening of the face or body feeling warm, hot, burning or itchy (flushing)
• loose stools (diarrhoea)
• nausea and vomiting
• stomach pain or stomach cramps
• gastroenteritis (inflammation of the lining of intestines), gastritis (stomach lining inflammation)
• dyspepsia (unable to digest)
• itchy skin, rashes
• erythema (red or pink blotches on the skin)
• hair loss
• throat pain, cough, and painful menstrual periods (mostly in children)

Rare

• allergic reactions

Stop taking SCLERIFUMA 240MG CAPSULE and contact your physician immediately if
you experience any of the following side effects:

• severe (anaphylaxis) allergic reactions such as reddening of the face or body,feeling warm, hot, burning, or itchy (flushing), red rash or hives (rashes), angioedema (swelling of the face, lips, mouth, or tongue), wheezing, shortness of breath or difficulty breathing, hypotension (loss of consciousness or dizziness)
• serious kidney disorder (Fanconi Syndrome) (symptoms include passing more urine, drinking more water than normal, weaker muscles, you break a bone, or just have aches and pains)
• symptoms of herpes zoster (shingles)
• a rare brain infection called progressive multifocal leukoencephalopathy (PML) (symptoms include new or worsening weakness on one side of the body, clumsiness, changes in vision, thinking, memory, personality changes, or communication difficulties)

How To Manage Side Effects

Diarrhoea:

Drink plenty of water and fruit juice to keep yourself hydrated. Contact your
doctor if the diarrhoea did not improve.

Nausea and vomiting:

Stick to simple meals. Avoid eating oily or spicy food. If nausea and vomiting
does not improve, consult your doctor.

Skin rash:

Hot water can irritate the skin, so avoid taking hot showers. Do not scratch the
affected area. Contact your doctor if the rashes did not improve.

Stomach pain:

Avoid oily and spicy food. Keep a heat pad on your stomach. consult your doctor
if symptoms do not improve.

Warning & Precautions

!### Pregnancy

SCLERIFUMA 240MG CAPSULE is generally not recommended for use in pregnant women
or women planning to have a baby, unless considered necessary. Contact your
doctor before taking SCLERIFUMA 240MG CAPSULE.

!### Breastfeeding

SCLERIFUMA 240MG CAPSULE is generally not recommended for use in breastfeeding
women, unless considered necessary. Contact your doctor before taking SCLERIFUMA
240MG CAPSULE.

!### Driving and Using Machines

SCLERIFUMA 240MG CAPSULE does not affect your ability to drive or operate
machines.

!### Alcohol

Avoid consum
cause gastritis (inflammation of the stomach), especially in those who are
already at risk for gastritis. Contact your doctor before taking SCLERIFUMA
240MG CAPSULE.

!### Kidney

SCLERIFUMA 240MG CAPSULE should be used with caution in patients with severe
kidney disease. Contact your doctor before taking SCLERIFUMA 240MG CAPSULE.

!### Liver

SCLERIFUMA 240MG CAPSULE should be used with caution in patients with severe
liver diseases. Contact your doctor before taking SCLERIFUMA 240MG CAPSULE.

!### Allergy

Do not take SCLERIFUMA 240MG CAPSULE if you are allergic (hypersensitive) to
dimethyl fumarate or any other ingredients of this medicine.

!### Lungs

SCLERIFUMA 240MG CAPSULE should be used with caution in patients with lung
diseases (such as pneumonia). Contact your doctor before taking SCLERIFUMA 240MG
CAPSULE.

Others

SCLERIFUMA 240MG CAPSULE is not recommended for use if you:

• have (PML) progressive multifocal leukoencephalopathy (a rare brain infection)

Before taking SCLERIFUMA 240MG CAPSULE, inform your doctor if you have:

• stomach or bowel disease

Use in paediatrics:

Safety data of SCLERIFUMA 240MG CAPSULE for children below 13 years of age has
not been established yet. Contact your doctor before taking SCLERIFUMA 240MG
CAPSULE.

Interactions

A. Drug-Drug interactions:

Before taking SCLERIFUMA 240MG CAPSULE, inform your doctor if you are taking any
of the following medicine:

• fumarates (fumaric acid esters) (used to manage psoriasis)
• other medications that affect the immune system (Ex. natalizumab, fingolimod, alemtuzumab, teriflunomide, ocrelizumab or cladribine)
• medicines to manage cancer (Ex. rituximab or mitoxantrone)
• medications that can have harmful effects on the kidneys, which include some antibiotics (Ex. gentamicin, neomycin)
• diuretics (used to manage blood pressure)
• specific types of painkillers (such as ibuprofen)
• lithium (used for mental illness)
• live vaccines (medicines used to manage infections)

Overdosage:

If you or anyone else accidentally takes too much of SCLERIFUMA 240MG CAPSULE,
consult your doctor immediately or visit the nearby hospital.

Synopsis

Drug	:	Dimethyl Fumarate
Pharmacological Category	:	Immunosuppressive Agent
Therapeutic Indication	:	Relapsing forms of multiple sclerosis
Dosage Forms	:	Capsule

More Information

• Keep SCLERIFUMA 240MG CAPSULE out of the sight and reach of children
• Store SCLERIFUMA 240MG CAPSULE below 25°C

FAQs About SCLERIFUMA 240MG CAPSULE

What is SCLERIFUMA 240MG CAPSULE used for?

SCLERIFUMA 240MG CAPSULE is used to manage relapsing-remitting forms of multiple
sclerosis in patients aged 13 years and older. Relapsing-remitting Multiple
sclerosis is characterised by repeated attacks (relapses) of nervous system
symptoms such as walking difficulties, feeling off balance, visual difficulties
(e.g., blurred, or double vision).

What are the parameters to be monitored while taking SCLERIFUMA 240MG
CAPSULE?

Prior to the management your doctor will perform blood tests to determine the
number of white blood cells and frequent monitoring of the liver and kidney is
recommended during therapy. Consult your doctor for more information.

How does SCLERIFUMA 240MG CAPSULE work?

SCLERIFUMA 240MG CAPSULE functions by managing the body's defence mech
destroying the brain and spinal cord. Additionally, it might manage Multiple
Sclerosis from getting worse in the future.

Can SCLERIFUMA 240MG CAPSULE be used in pregnant and breastfeeding women?

No, SCLERIFUMA 240MG CAPSULE is generally not recommended for use in pregnant
and breastfeeding women, unless considered necessary. Contact your doctor before
taking SCLERIFUMA 240MG CAPSULE.

Can SCLERIFUMA 240MG CAPSULE affect thyroid function?

No, SCLERIFUMA 240MG CAPSULE does not affect the functioning of the thyroid
gland (an organ that secretes hormones to regulate metabolism). Consult your
doctor for more information.

Useful Diagnostic Tests

• complete blood count
• kidney function test
• liver function test
• magnetic resonance imaging scan