FINGOMOD Capsule 7's

Introduction About FINGOMOD CAPSULE

FINGOMOD CAPSULE contains Fingolimod which belongs to the group of medicines
called Sphingosine 1 Phosphate Receptor Modulators. FINGOMOD CAPSULE is used to
manage relapsing-remitting multiple sclerosis (chronic disease that affects
central nervous system) in patients who failed to respond to earlier multiple
sclerosis management.

FINGOMOD CAPSULE is also used to manage multiple sclerosis in patients when it
rapidly evolves to severe form of disease.

FINGOMOD CAPSULE is not recommended for use in patients allergic to Fingolimod.
It is also not recommended for use in patients suffering from low immune
response (due to immunodeficiency syndrome), active cancer, severe liver
problems (such as hepatitis), and/or irregular/abnormal heartbeats. The medicine
is also not indicated for use in patients with a history (last 6 months) of
heart disease such as heart attack, angina, stroke/warning of stroke, and/or
certain types of heart failure.

Before taking FINGOMOD CAPSULE inform your doctor if you have a history of
sudden loss of consciousness/fainting, diabetes, high blood pressure, and/or
scheduled for vaccination/or have severe lung/breathing problems or kidney
problems such as mild, moderate/severe renal impairment.

FINGOMOD CAPSULE is not recommended for use during pregnancy and in women
planning for pregnancy since the medicine may cause harm to the unborn baby.
Women of childbearing potential should use effective contrace
management with FINGOMOD CAPSULE and should continue using the medicine for next
two months after stopping management with FINGOMOD CAPSULE to avoid accidental
pregnancy. It is also not recommended for use in breastfeeding women since the
medicine may pass through breast milk and can cause serious harm to the nursing
child.

FINGOMOD CAPSULE is not recommended for use in children (aged below 10 years)
and is advised to use the medicine with caution in elderly patients (aged 65
years and above) after consulting the doctor.

The most common side effects of taking FINGOMOD CAPSULE are feeling
pressure/pain in cheeks/forehead, headache (which may get severe associated with
nausea, vomiting, and/or sensitivity to light), diarrhea, back pain, cough,
dizziness, weakness, and/or blurred vision. Consult your doctor if any of these
symptoms worsens.

Uses Of FINGOMOD CAPSULE

• Manage relapsing-remitting multiple sclerosis (chronic disease that affects central nervous system)
• Manage multiple sclerosis in patients when it rapidly evolves to severe form of disease

How FINGOMOD CAPSULE Works

FINGOMOD CAPSULE works by reducing the number of lymphocytes (white blood cell
that helps body fight the infection and disease) in the body which helps in
stopping the lymphocytes from entering the brain and affecting the central
nervous system thus managing multiple sclerosis and managing its recurrence in
affected individuals.

How to use FINGOMOD CAPSULE

Take FINGOMOD CAPSULE as advised by your physician. Swallow the medicine with a
glass of water. Do not crush or chew the medicine. Your doctor will decide the
correct dose and duration for you depending upon your age, body weight and
disease condition.

Side Effects Of FINGOMOD CAPSULE

Common

• signs of flu infection such as tiredness, chills, sore throat, joint/muscle ache, fever
• feeling pressure/pain in cheeks and forehead
• headache which may get severe associated with nausea, vomiting, and/or sensitivity to light
• diarrhea
• back pain
• cough
• ringworm (fungal skin infection)
• dizziness, weakness, blurred vision
• itchy red burning rash
• hair loss
• breathlessness
• depression
• high blood pressure
• muscle/joint pain

Rare

• cancer of the lymphatic system (network of vessels, nodes, and ducts that collect and circulate excess fluid in the body).

Stop taking FINGOMOD CAPSULE and contact your doctor immediately if you
experience any of the following side effects:

• signs of lung disorder such as cough with phlegm, chest discomfort, and/or fever
• signs of herpes virus infection such as blisters, burning, itching/pain of skin (especially on upper abdomen/face)
• slow heartbeat, irregular heart rhythm
• basal cell carcinoma (type of skin cancer) which appears as pearly nodule
• depression, anxiety
• weight loss
• pneumonia associated with symptoms such as fever, cough, and/or difficulty breathing
• macular edema (swelling in the central vision area of the retina at the back of the eye) associated with symptoms such as shadows/blind spot at the center of the vision, blurred vision, problems with identifying colors
• signs of reduced blood platelet count such as increased bleeding/bruising
• malignant melanoma (type of skin cancer) associated with symptoms such as moles which may change size, shape, color or may itch/bleed
• convulsion, fits
• signs of posterior reversible encephalopathy syndrome (clinico-radiological syndrome) such as severe headache, confusion, seizures, and/or vision disturbance
• lymphoma (affecting lymph nodes)
• signs of squamous cell carcinoma (type of skin cancer) such as firm red nodule, sore with crust, and/or new sore on existing scar
• signs of Kaposi’s sarcoma (cancer that cause lesions in soft tissues) such as cancerous lesions on skin that appear purple, red, brown in color
• signs of allergic reactions such as swelling of lips, tongue/face, rash, and/or itchy hives (red itchy welts)
• signs of liver disease (including liver failure) such as yellowing of skin or the whites of eyes (jaundice), nausea, vomiting, pain on the right abdominal side, dark urine, feeling less hungry than usual, and/or tiredness
• signs of progressive multifocal leukoencephalopathy (rare viral disease that affects white matter of brain) such as clumsiness, progressive weakness, and visual/speech impairment
• cryptococcal infection (type of fungal infection) including cryptococcal meningitis associated with symptoms such as headache with neck stiffness, sensitivity to light, nausea, and/or confusion
• Merkel cell carcinoma (rare form of skin cancer) associated with symptoms such as flesh-colored/bluish-red, painless nodule often appearing on the face, head/neck).

How To Manage Side Effects

Headache:

If FINGOMOD CAPSULE causes headache, then take rest and drink plenty of fluids.
Try to avoid drinking alcohol. Ask your doctor to recommend a painkiller.
Headaches should usually go away after the first week of taking FINGOMOD
CAPSULE. If it lasts more than a week or becomes severe, then consult and inform
your doctor.

Diarrhea:

Drink plenty of water and stay hydrated. Try to avoid taking any medicine on
your own to manage diarrhea. Consult and inform your doctor if the symptom
worsens.

Dizziness:

Try to rest and get enough sleep. Try to avoid driving or operating any tools or
machines while you feel dizzy. Limit consum
dizziness. Consult and inform your doctor if the symptom worsens.

Warning & Precautions

!### Pregnancy

FINGOMOD CAPSULE is not recommended for use during pregnancy and in women
planning for pregnancy since the medicine may cause harm to the unborn baby.
Women of childbearing potential should use effective contrace
management with FINGOMOD CAPSULE and should continue using the medicine for next
two months after stopping management with FINGOMOD CAPSULE to avoid accidental
pregnancy. Consult your doctor before taking the medicine and inform your doctor
immediately if you become pregnant while in management with FINGOMOD CAPSULE.

!### Breastfeeding

FINGOMOD CAPSULE is not recommended for use in breastfeeding women since the
medicine may pass through breast milk and can cause serious harm to the nursing
child. Consult your doctor before taking the medicine.

!### Driving and Using Machines

Do not drive/operate machines if FINGOMOD CAPSULE affects your ability to drive
or operate machines.

Kidney

FINGOMOD CAPSULE should be used with caution in patients with kidney problems
such as mild, moderate/severe renal impairment. Consult your doctor before
taking FINGOMOD CAPSULE.

Liver

FINGOMOD CAPSULE is not recommended for use in patients with severe liver
problems such as hepatitis. It should be used with caution in patients with mild
to moderate liver disease. Consult your doctor before taking FINGOMOD CAPSULE.

!### Allergy

Do not take FINGOMOD CAPSULE if you are allergic to Fingolimod, and/or any other
ingredients of this medicine.

!### Lungs

FINGOMOD CAPSULE should be used with caution in patients with severe lung
problems and in patients who suffer from severe breathing problems (during
sleep), and/or smoker’s cough. Consult your doctor before taking the medicine.

!### Heart Disease

FINGOMOD CAPSULE is not recommended for use in patients with a history (last 6
months) of heart disease such as heart attack, angina, stroke/warning of stroke,
and/or certain types of heart failure. It is also not recommended for use in
patients with irregular/abnormal heartbeats. It should be used with caution in
patients with other heart problems such as slow heartrate (associated with
symptoms such as dizziness, nausea/palpitations). Consult your doctor before
taking FINGOMOD CAPSULE.

Others

FINGOMOD CAPSULE is not recommended for use if you:

• have a lowered immune response (due to immunodeficiency syndrome)
• suffer from severe active/chronic infections such as tuberculosis
• have an active cancer

Before taking FINGOMOD CAPSULE, inform your doctor if you:

• have a history of sudden loss of consciousness/fainting
• are scheduled for vaccination
• never had chickenpox infection
• have/ever had visual disturbances such as macular edema (swelling in the retina part of eye)
• have diabetes
• have high blood pressure

Use in Pediatrics:

FINGOMOD CAPSULE is not recommended for use in children (aged below 10 years).
It is advised to complete all vaccinations before child is started management
with FINGOMOD CAPSULE. Consult your doctor before administering the medicine to
the child.

Use in Geriatrics:

FINGOMOD CAPSULE should be used with caution in elderly patients (aged 65 years
and above). Consult your doctor before taking the medicine.

Interactions

A. Drug - Drug interactions:

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

• medicines that suppress immune system such as beta interferon, glatiramer acetate, natalizumab, mitoxantrone, teriflunomide, dimethyl fumarate, alemtuzumab
• corticosteroids (used to reduce inflammation) Ex. hydrocortisone
• vaccine (medicine used to stimulate body’s immune system to fight against infection)
• medicines that slow heartbeat such as beta blockers (Ex. atenolol)
• medicines used to manage irregular heartbeats (Ex. quinidine, disopyramide, amiodarone, sotalol)
• protease inhibitors (used to manage HIV) Ex. saquinavir, indinavir, ritonavir
• anti-infectives (used to manage/prevent infections) Ex. ketoconazole, azole antifungals, clarithromycin, telithromycin
• carbamazepine, phenobarbital, phenytoin (used to manage epilepsy)
• rifampicin (used to manage tuberculosis)
• St. John’s Wort (herbal medicine used to manage depression).

Overdosage:

If you or anyone else accidentally takes too much of FINGOMOD CAPSULE, consult
your doctor immediately or visit the nearby hospital to manage overdose
symptoms.

Synopsis

Drug	:	Fingolimod
Pharmacological Category	:	Sphingosine l-phosphate receptor modulators
Therapeutic Indication	:	Multiple sclerosis
Dosage Forms	:	Capsule

More Information

• Keep FINGOMOD CAPSULE out of reach of children
• Do not store FINGOMOD CAPSULE above 25°C

FAQs About FINGOMOD CAPSULE

Q. What is FINGOMOD CAPSULE used for?A. FINGOMOD CAPSULE is used to manage relapsing-remitting multiple sclerosis
(chronic disease that affects central nervous system) in patients who failed to
respond to earlier multiple sclerosis management. It is also used to manage
multiple sclerosis in patients when it rapidly evolves to severe form of disease
in affected individuals.

Q. What are the common side effects of taking FINGOMOD CAPSULE?A. The most common side effects of taking FINGOMOD CAPSULE are feeling
pressure/pain in cheeks/forehead, headache (which may get severe associated with
nausea, vomiting, and/or sensitivity to light), diarrhea, back pain, cough,
dizziness, weakness, and/or blurred vision. Consult your doctor if any of these
symptoms worsens.

Q. How FINGOMOD CAPSULE should be taken?A. Take FINGOMOD CAPSULE as advised by your physician. Swallow the medicine
with a glass of water. Do not crush or chew the medicine. Your doctor will
decide the correct dose and duration for you depending upon your age, body
weight and disease condition.

Q. Can FINGOMOD CAPSULE be used in pregnant women?A. No, FINGOMOD CAPSULE is not recommended for use during pregnancy and in
women planning for pregnancy since the medicine may cause harm to the unborn
baby. Consult your doctor before taking the medicine.

Q. How FINGOMOD CAPSULE works?A. FINGOMOD CAPSULE works by reducing the number of lymphocytes (white blood
cell that helps body fight the infection and disease) in the body which helps in
stopping the lymphocytes from entering the brain and affecting the central
nervous system thus managing multiple sclerosis and managing its recurrence in
affected individuals.

Useful Diagnostic Tests

• Magnetic resonance imaging (MRI)