Levin 400mg Tablet 30'S

Introduction About LEVIN 400MG TABLET

LEVIN 400MG TABLET contains Imatinib which belongs to the group of medicines
called Tyrosine Kinase Inhibitors. It is used in adults, children and
adolescents to manage chronic myeloid leukaemia (CML) (a form of leukaemia in
which certain abnormal white cells (named myeloid cells) start growing out of
control) and philadelphia chromosome positive acute lymphoblastic leukaemia
(Ph-positive ALL) (a form of leukaemia in which certain abnormal white cells
(named lymphoblasts) start growing out of control).

Also, it is used in adults only to manage myelodysplastic/myeloproliferative
diseases (MDS/MPD) (a group of blood diseases in which some blood cells start
growing out of control), hyper eosinophilic syndrome (HES) and/or chronic
eosinophilic leukaemia (CEL) (a blood diseases in which some blood cells (named
eosinophils) start growing out of control), gastrointestinal stromal tumours
(GIST) (cancer of the stomach and bowels) and dermatofibrosarcoma protuberans
(DFSP) (cancer of the tissue beneath the skin in which some cells start growing
out of control).

Before taking LEVIN 400MG TABLET, inform your doctor if you have or ever had
kidney, liver or heart problems, hepatitis B infection and thrombotic
microangiopathy (symptoms include bruising, bleeding, fever, fatigue and
confusion).

LEVIN 400MG TABLET is generally not recommended for use in pregnant women unless
advised by the doctor and it is not recommended for use in breastfeeding women.
LEVIN 400MG TABLET should be used with caution in children, adolescents and
elderly patients (aged 65 years and above).

The most common side effects of taking LEVIN 400MG TABLET are nausea, vomiting,
diarrhea, headache, weight gain, loss of appetite, disturbed sense of taste,
blurred vision and weakness. Consult your physician if any of the side effects
worsen.

Uses Of LEVIN 400MG TABLET

Manage adults, children and adolescents for:

• chronic myeloid leukaemia (CML)
• philadelphia chromosome positive acute lymphoblastic leukaemia (Ph-positive ALL)

Manage adults for:

• myelodysplastic/myeloproliferative diseases (MDS/MPD)
• hyper-eosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL)
• gastrointestinal stromal tumors (GIST)
• dermatofibrosarcoma protuberans (DFSP)

How LEVIN 400MG TABLET Works

LEVIN 400MG TABLET is a protein-tyrosine kinase inhibitor. Tyrosine kinases are
proteins which act as chemical messengers that are used by the cancer cells to
signal each other for their growth, therefore this medicine works by blocking
the enzyme which stops the cancer cells from growing.

How to use LEVIN 400MG TABLET

Take LEVIN 400MG TABLET as advised by your physician. Swallow the LEVIN 400MG
TABLET 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 LEVIN 400MG TABLET

Common

• headache or feeling tired
• nausea, vomiting, diarrhea or indigestion
• rash
• muscle cramps, joint, muscle or bone pain
• swelling such as round ankles or puffy eyes
• weight gain
• loss of appetite, weight loss or disturbed sense of taste
• feeling dizzy or weak
• insomnia
• conjunctivitis watery eyes, or blurred vision
• nose bleeds
• pain or swelling in the abdomen, flatulence, heartburn or constipation
• itching
• unusual hair loss or thinning
• numbness of the hands or feet
• mouth ulcers
• dry mouth, dry skin or dry eye
• decreased or increased skin sensitivity
• hot flushes, chills or night sweats

Rare

Stop taking LEVIN 400MG TABLET and contact your doctor immediately if you
experience any of the following side effects:

• rapid weight gain, severe fluid retention
• infection symptoms such as fever, severe chills, sore throat or mouth ulcers, low white blood cells
• unexpected bleeding or bruising
• sign of heart problems like chest pain or irregular heart rhythm
• sign of lung problems like cough, difficulty in breathing or painful breathing
• signs of low blood pressure like feeling light-headed, dizzy or fainting
• sign of liver problems like nausea, loss of appetite, dark-colored urine, yellow skin or eyes
• sign of skin problems like rash, red skin with blisters on the lips, eyes, skin or mouth, peeling skin, fever, raised red or purple skin patches, itching, burning sensation, a pustular eru
• sign of gastrointestinal disorders like severe abdominal pain, blood in vomit, stools or urine, black stools
• signs of kidney problems like severely decreased urine output and feeling thirsty
• signs of bowel problems like nausea with diarrhea and vomiting, abdominal pain or fever
• signs of nervous system problems like severe headache, weakness or paralysis of limbs or face, difficulty speaking, sudden loss of consciousness, bleeding or swelling in skull/brain
• signs of low levels of red blood cells like pale skin, feeling tired and breathlessness and having dark urine
• signs of raynaud’s syndrome like numb or cold toes and fingers
• signs of muscle problems like muscle spasms with a fever, red-brown urine, pain or weakness in your muscles
• eye pain or deterioration in vision, bleeding in the eyes
• pain in hips or difficulty walking
• difficulty in hearing
• signs of problems with ovaries or womb like pelvic pain with unexpected vaginal bleeding
• thrombotic microangiopathy (blood clots in small blood vessels)

How To Manage Side Effects

Nausea or vomiting:

Try to take LEVIN 400MG TABLET with or just after a meal or a snack. Stick to
simple meals. Avoid eating oil rich, fried or spicy foods. Consult your doctor
if the symptom does not improve.

Diarrhoea:

Drink lot of fluids such as water or fruit juices to keep yourself hydrated.
Avoid taking any medicine on your own for managing diarrhea. Consult your doctor
if the symptom does not improve.

Headache:

Rest and relax. Drink plenty of fluids such as water or electrolytes. Apply a
pain-relieving balm on the forehead if required. Do not consume too much of
alcohol. Consult your doctor if the symptom does not improve.

Dry mouth:

Sip water regularly and other sugar free liquids. Do not use mouthwashes that
contain alcohol because they can make your mouth dry, use mouthwash that is used
only for dry mouth. Limit your caffeine intake. Avoid smoking or using tobacco
products. Consult your doctor if the symptom does not improve.

Tiredness:

Drink plenty of fluid and eat balanced diet and frequent meals. Do regular
minimal exercise and follow regular sleep schedule. Consult your doctor if the
symptom does not improve.

Warning & Precautions

!### Pregnancy

LEVIN 400MG TABLET is generally not recommended for use in pregnant women unless
considered clearly necessary. Women who might become pregnant are advised to use
effective contrace
the> management. Consult your doctor before taking LEVIN 400MG TABLET.

!### Breastfeeding

LEVIN 400MG TABLET is not recommended for use during breastfeeding and for 15
days after ending the management as it may harm the baby. Consult your doctor
before taking LEVIN 400MG TABLET.

!### Driving and Using Machines

Do not drive or operate any machines if you experience dizziness, drowsiness or
blurred vision after taking LEVIN 400MG TABLET.

!### Kidney

LEVIN 400MG TABLET should be used with caution in patients with kidney problem.
Consult your doctor before taking LEVIN 400MG TABLET.

!### Liver

LEVIN 400MG TABLET should be used with caution in patients with liver problems
and hepatitis B infection. Consult your doctor before taking LEVIN 400MG TABLET.

!### Allergy

Do not take LEVIN 400MG TABLET if you are allergic to imatinib or any other
ingredients of this medicine.

!### Heart Disease

LEVIN 400MG TABLET should be used with caution in patients with heart problem.
Consult your doctor before taking LEVIN 400MG TABLET.

Others

Before taking LEVIN 400MG TABLET, inform your doctor if you have:

• thrombotic microangiopathy symptoms such as bruising, bleeding, fever, fatigue and confusion

Use in pediatrics:

LEVIN 400MG TABLET should be used with caution in children and adolescents.
Consult your child’s doctor for advice.

Use in geriatrics:

LEVIN 400MG TABLET should be used with caution in elderly patients (aged 65
years and above). Consult your doctor before taking LEVIN 400MG TABLET.

Interactions

A. Drug-Drug interactions:

Before taking LEVIN 400MG TABLET, inform your doctor if you are taking any of
the following medicines:

• medicines used to manage fever and pain (Ex. paracetamol)
• st. john’s wort (used to manage depression)
• medicines used to manage blood clots (Ex. clopidogrel)
• medicine used to manage thyroid (levothyroxine)

Overdosage:

If you or anyone else accidentally take too much of LEVIN 400MG TABLET, consult
your doctor immediately or visit the nearby hospital.

Synopsis

Drug	:	Imatinib
Pharmacological Category	:	Tyrosine kinase inhibitor
Therapeutic Indication	:	Chronic myeloid leukaemia, Philadelphia chromosome positive acute lymphoblastic leukaemia, myelodysplastic/myeloproliferative diseases hyper eosinophilic syndrome or chronic eosinophilic leukaemia, Gastrointestinal stromal tumors, dermatofibrosarcoma protuberans
Dosage Forms	:	Tablet, Capsule

More Information

• Keep LEVIN 400MG TABLET out of reach of children
• Store LEVIN 400MG TABLET at room temperature

FAQs About LEVIN 400MG TABLET

What happens if I stop taking LEVIN 400MG TABLET on my own?

Do not stop taking LEVIN 400MG TABLET unless your doctor tells you to stop even
if the condition improves. If you are not able to take the LEVIN 400MG TABLET as
your doctor prescribed or feel you do not need it anymore, contact your doctor
immediately.

It is safe to drive after taking LEVIN 400MG TABLET?

In some patients LEVIN 400MG TABLET may cause dizziness, drowsiness or blurred
vision. So, it is better to avoid driving or operating any machine after taking
LEVIN 400MG TABLET. Consult your doctor for advice before taking it.

Can I take LEVIN 400MG TABLET during pregnancy?

LEVIN 400MG TABLET is generally not recommended for use in pregnant women unless
advised by the doctor. Women who might become pregnant are advised to use
effective contrace
the management. Consult your doctor before taking this medicine.

How does LEVIN 400MG TABLET work?

LEVIN 400MG TABLET is a protein-tyrosine kinase inhibitor. Tyrosine kinases are
proteins which act as chemical messengers that are used by the cancer cells to
signal each other for their growth, therefore this medicine works by blocking
the enzyme which stops the cancer cells from growing.

CanLEVIN 400MG TABLET be used in patients with liver problems?

LEVIN 400MG TABLET should be used with caution in patients with liver problems
and hepatitis B infection. Your doctor may monitor your liver function during
and after management with this medicine to manage the risk of any unusual
effects. Consult your doctor before taking it.

Useful Diagnostic Tests

• Bcr-Abl Gene Translocation
• Bcr-Abl Gene Translocation
• Complete Blood Count
• Peripheral Smear Examination