Mylostat 500mg Capsule 10'S

Introduction About MYLOSTAT 500MG CAPSULE

MYLOSTAT 500MG CAPSULE contains Hydroxyurea, which belongs to a group of
medicines called Antimetabolites. It is used to manage resistant chronic myeloid
leukaemia and locally advanced squamous cell cancer of the head and neck
(excluding the lip) and cervical cancer.

MYLOSTAT 500MG CAPSULE is not recommended for use in patients with a history of
any blood problems or severe anaemia. MYLOSTAT 500MG CAPSULE should be used with
caution in patients with liver, lung or kidney disease and myelosuppression
(leukopenia, thrombocytopenia, anaemia).

MYLOSTAT 500MG CAPSULE is not recommended for use during pregnancy. MYLOSTAT
500MG CAPSULE is not recommended for use by breastfeeding women. MYLOSTAT 500MG
CAPSULE is also not recommended for use in children as its safety and
effectiveness are not established. MYLOSTAT 500MG CAPSULE should be used with
caution in the elderly aged 65 years or above.

The most common side effects of taking MYLOSTAT 500MG CAPSULE are loss of
appetite, weakness, loss of energy, sickness, diarrhoea, constipation, abdominal
pain, hair loss, blood disorders (decrease in white blood cells, red blood cells
and platelets), low back pain, black tarry stools or blood in the stools,
unusual bleeding or bruising, muscle weakness, sores on the lips or mouth etc.
Contact your physician if any of the symptoms worsen.

Uses Of MYLOSTAT 500MG CAPSULE

• Manage resistant chronic myeloid leukaemia
• Manage locally advanced squamous cell carcinomas of the head and neck, (excluding lip)
• Manage cervical cancer

How MYLOSTAT 500MG CAPSULE Works

MYLOSTAT 500MG CAPSULE gets converted to free radical nitroxide (NO), which
enters the cells, inactivates the ribonucleotide reductase enzyme and causes
immediate inhibition of DNA synthesis, leading to cell death.

How to use MYLOSTAT 500MG CAPSULE

Take MYLOSTAT 500MG CAPSULE as advised by your physician. Swallow the medicine
with a glass of water. Do not crush or chew the medicine. Your physician will
decide the correct dose and duration for you depending upon your age, body
weight and disease condition.

Side Effects Of MYLOSTAT 500MG CAPSULE

Common

• blood disorders (decrease in white blood cells, red blood cells and platelets)
• low back pain
• black tarry or blood in stools
• unusual bleeding or bruising
• skin changes (dermatomyositis) a scaly, purple, raised rash on the face, hands or other parts of the body with redness, darkening of the skin, peeling of the skin and worsening of redness or skin and mucous membrane discomfort in patients with a history of radiation
• muscle weakness - symptoms such as muscle tenderness, muscle weakness or tiredness when climbing stairs, walking or rising from a chair etc
• sores on the lips or mouth
• difficulty or pain passing urine
• azoospermia or oligospermia (absence or decreased amount of sperm in the semen)
• anorexia, weakness, decreased energy
• sickness, diarrhoea, constipation, abdominal pain
• hair loss
• kidney problems
• unexplained shortness of breath or cough with fever
• numbness or tingling of hands or feet
• skin cancer
• problems with the flow of the bile (cholestasis) causing itchiness, yellowish discolouration of skin or whites of eye, very dark urine, pale stools
• inflammation of the liver (hepatitis), which causes flu-like symptoms, including tiredness, loss of appetite, fever, pain, nausea, vomiting, pressure or pain below the right ribs and might also include yellowing of the skin or eyes
• drowsiness, dizziness, fits, confusion or hallucinations
• headache

Rare

• skin ulceration with severe infection
• tumour lysis syndrome

Stop taking MYLOSTAT 500MG CAPSULE and contact your physician immediately if you
experience any of the following side effects:

• allergic reaction such as skin rashes, itching, swelling of the face, lips, tongue or throat causing difficulty breathing
• unexplained fever, chills, sore throat or cough
• wasting of muscles
• peeling of the skin and nails
• high fever with stomach, lung, muscle, liver, skin or heart problems within 6 weeks of taking MYLOSTAT 500MG CAPSULE

How To Manage Side Effects

Headache:

Rest and relax. Drink plenty of fluids such as water and electrolytes. Apply a
pain-relieving balm to your forehead if necessary. Contact your doctor if the
symptom does not improve.

Nausea and vomiting:

Take the medicine with or just after a meal. Stick to simple meals. Avoid eating
oily or spicy foods. Contact your doctor if the symptom does not improve.

Diarrhoea: Drink lots of fluids, such as water or fruit juices, to keep you
hydrated. Do not take any medicine on your own to manage diarrhoea. Contact your
doctor if the symptom does not improve.

Stomach pain:

Try to rest and relax. Eat small meals but take them frequently. Keep a heating
pad on your stomach to ease stomach pain. Contact your doctor if the symptom
does not improve.

Constipation:

Eat plenty of fiber-rich foods such as fresh fruits, vegetables and cereals.
Drink plenty of water and exercise more regularly. Contact your doctor if the
symptom does not improve.

Dizziness or drowsiness:

Try to rest and relax. Get enough sleep. Avoid driving or operating any machines
if you feel dizzy. Contact your doctor if the symptom does not improve.

Warning & Precautions

!### Pregnancy

MYLOSTAT 500MG CAPSULE is not recommended for use by pregnant women. Inform your
doctor if you expect or are planning for pregnancy. Avoid becoming pregnant
while taking MYLOSTAT 500MG CAPSULE. Contact your doctor before taking MYLOSTAT
500MG CAPSULE.

!### Breastfeeding

MYLOSTAT 500MG CAPSULE is not recommended for use by breastfeeding women as it
may pass through breast milk to the breastfed baby. Contact your doctor before
taking MYLOSTAT 500MG CAPSULE.

!### Driving and Using Machines

Do not drive or operate any machines if you feel drowsy after taking MYLOSTAT
500MG CAPSULE.

!### Alcohol

Avoid consuming alcohol while taking this medicine, as it may lead to unwanted
effects.

!### Kidney

MYLOSTAT 500MG CAPSULE should be used with caution in patients with kidney
disease. Contact your doctor before taking MYLOSTAT 500MG CAPSULE.

!### Liver

MYLOSTAT 500MG CAPSULE should be used with caution in patients with liver
disease. Contact your doctor before taking MYLOSTAT 500MG CAPSULE.

!### Allergy

Do not take MYLOSTAT 500MG CAPSULE if you are allergic to Hydroxyurea or lactose
or some sugars or other ingredients in this medicine.

!### Lungs

MYLOSTAT 500MG CAPSULE should be used with caution in patients with pulmonary
fibrosis, lung infiltration, pneumonitis and alveolitis or allergic alveolitis.
Contact your doctor before taking MYLOSTAT 500MG CAPSULE.

Others

MYLOSTAT 500MG CAPSULE is not recommended for use if you have:

• history of blood disorders
• severe anaemia

Before taking MYLOSTAT 500MG CAPSULE, inform your doctor if you have:

• myelosuppression (leukopenia, thrombocytopenia, anaemia)
• previously received radiotherapy or chemotherapy
• myeloproliferative disorders
• secondary leukaemia
• skin cancer
• cutaneous vasculitis ulcers and gangrene
• gout
• leg ulcers
• folic acid deficiency
• HIV infection
• pancreatitis, hepatotoxicity and peripheral neuropathy
• live vaccines
• radiation
• macrocytosis (enlarged red blood cells)
• sickle cell anaemia
• blood test for uric acid, urea or lactic acid

Use in paediatrics:

MYLOSTAT 500MG CAPSULE is not recommended for use in children as safety and
effectiveness are not established. Contact your doctor before taking MYLOSTAT
500MG CAPSULE.

Use in geriatrics:

MYLOSTAT 500MG CAPSULE should be used with caution in elderly patients aged 65
years or above. Contact your doctor before taking MYLOSTAT 500MG CAPSULE.

Interactions

A. Drug-Drug interactions:

Before taking MYLOSTAT 500MG CAPSULE, inform your doctor if you are taking any
of the following medicine:

• antiretroviral medicines (medicines used to manage viral infections such as HIV) Ex. didanosine, stavudine and indinavir
• medicines which suppress the bone marrow (Ex. chemotherapies and radiation therapy)
• vaccines (medicines used to manage infections)

Overdosage:

If you or anyone else accidentally take too much of MYLOSTAT 500MG CAPSULE,
consult your doctor immediately or visit the nearby hospital. Symptoms of
overdose are acute mucocutaneous toxicity, soreness, violet erythema, swelling
of hands and feet, followed by scaling of hands and feet, severe generalized
hyperpigmentation of the skin and stomatitis.

Synopsis

Drug	:	Hydroxyurea
Pharmacological Category	:	Antimetabolites
Therapeutic Indication	:	resistant chronic myeloid leukaemia, locally advanced squamous cell cancer of the head and neck (excluding lip), cervical cancer
Dosage Forms	:	Capsule

More Information

• Keep MYLOSTAT 500MG CAPSULE out of the sight and reach from children
• Store MYLOSTAT 500MG CAPSULE below 25°C

FAQs About MYLOSTAT 500MG CAPSULE

How does MYLOSTAT 500MG CAPSULE work?

MYLOSTAT 500MG CAPSULE gets converted to free radical nitroxide (NO), which
enters the cells, inactivates the ribonucleotide reductase enzyme and causes
immediate inhibition of DNA synthesis, leading to cell death.

Can MYLOSTAT 500MG CAPSULEbe used to manage cancer in the neck?

MYLOSTAT 500MG CAPSULE is used to manage resistant chronic myeloid leukaemia and
locally advanced squamous cell carcinomas of the head and neck (excluding the
lip) and cervical cancer.  Contact your doctor before taking MYLOSTAT 500MG
CAPSULE.

What are the possible side effects of taking MYLOSTAT 500MG CAPSULE?

The most common side effects of taking MYLOSTAT 500MG CAPSULE are loss of
appetite, weakness, loss of energy, sickness, diarrhoea, constipation, abdominal
pain, hair loss, blood disorders (decrease in white blood cells, red blood cells
and platelets), low back pain, black tarry stools or blood in the stools,
unusual bleeding or bruising, muscle weakness, sores on the lips or mouth etc.
Contact your physician if any of the symptoms get worse.

Can MYLOSTAT 500MG CAPSULE cause liver damage?

Yes. MYLOSTAT 500MG CAPSULE can cause liver damage. Contact your doctor if you
experience any unusual symptoms like yellowish discolouration of the skin or
whites of the eyes, dark urine or pale stools.

Does MYLOSTAT 500MG CAPSULE cause cancer?

Yes. Avoid prolonged exposure to sunlight and wear protective clothing,
sunglasses, and sunscreen while using MYLOSTAT 500MG CAPSULE. Contact your
doctor before taking MYLOSTAT 500MG CAPSULE.

Useful Diagnostic Tests

• Complete blood count
• Kidney function test
• Liver function test
• Biopsy
• Computerised Tomography (CT) scan
• Magnetic Resonance Imaging (MRI) scan
• Positron emission tomography (PET) scan