SCLERIFUMA 120 Capsule 10's

Introduction About SCLERIFUMA 120 CAPSULE

SCLERIFUMA 120 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 120 CAPSULE as it may cause gastritis (inflammation of the stomach).
SCLERIFUMA 120 CAPSULE is not recommended in patients with (PML) progressive
multifocal leukoencephalopathy (a rare brain infection). SCLERIFUMA 120 CAPSULE
should be used with caution in patients with lung problems (such as pneumonia),
severe kidney and liver problems, stomach or bowel disease.

SCLERIFUMA 120 CAPSULE is generally not recommended for use in pregnant
or breastfeeding women. Safety data of SCLERIFUMA 120 CAPSULE for children below
13 years of age has not been established yet. The most common side effects of
taking SCLERIFUMA 120 CAPSULE are flushing (reddening of face), diarrhea, nausea
or stomach pain. Contact your doctor if your symptoms get worse.

Uses Of SCLERIFUMA 120 CAPSULE

• manages relapsing-remitting forms of multiple sclerosis

How SCLERIFUMA 120 CAPSULE Works

SCLERIFUMA 120 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 120 CAPSULE

Take SCLERIFUMA 120 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 120 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 120 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 120 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 120 CAPSULE.

!### Breastfeeding

SCLERIFUMA 120 CAPSULE is generally not recommended for use in breastfeeding
women, unless considered necessary. Contact your doctor before taking SCLERIFUMA
120 CAPSULE.

!### Driving and Using Machines

SCLERIFUMA 120 CAPSULE does not affect your ability to drive or operate
machines.

!### Alcohol

Avoid consum
gastritis (inflammation of the stomach), especially in those who are already at
risk for gastritis. Contact your doctor before taking SCLERIFUMA 120 CAPSULE.

!### Kidney

SCLERIFUMA 120 CAPSULE should be used with caution in patients with severe
kidney disease. Contact your doctor before taking SCLERIFUMA 120 CAPSULE.

!### Liver

SCLERIFUMA 120 CAPSULE should be used with caution in patients with severe liver
diseases. Contact your doctor before taking SCLERIFUMA 120 CAPSULE.

!### Allergy

Do not take SCLERIFUMA 120 CAPSULE if you are allergic (hypersensitive) to
dimethyl fumarate or any other ingredients of this medicine.

!### Lungs

SCLERIFUMA 120 CAPSULE should be used with caution in patients with lung
diseases (such as pneumonia). Contact your doctor before taking SCLERIFUMA 120
CAPSULE.

Others

SCLERIFUMA 120 CAPSULE is not recommended for use if you:

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

Before taking SCLERIFUMA 120 CAPSULE, inform your doctor if you have:

• stomach or bowel disease

Use in paediatrics:

Safety data of SCLERIFUMA 120 CAPSULE for children below 13 years of age has not
been established yet. Contact your doctor before taking SCLERIFUMA 120 CAPSULE.

Interactions

A. Drug-Drug interactions:

Before taking SCLERIFUMA 120 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 120 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 120 CAPSULE out of the sight and reach of children
• Store SCLERIFUMA 120 CAPSULE below 25°C

FAQs About SCLERIFUMA 120 CAPSULE

What is SCLERIFUMA 120 CAPSULE used for?

SCLERIFUMA 120 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 120 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 120 CAPSULE work?

SCLERIFUMA 120 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 120 CAPSULE be used in pregnant and breastfeeding women?

No, SCLERIFUMA 120 CAPSULE is generally not recommended for use in pregnant and
breastfeeding women, unless considered necessary. Contact your doctor before
taking SCLERIFUMA 120 CAPSULE.

Can SCLERIFUMA 120 CAPSULE affect thyroid function?

No, SCLERIFUMA 120 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