Asunra 400mg Tablet 6'S

Introduction About ASUNRA 400MG TABLET

ASUNRA 400MG TABLET contains Deferasirox which belongs to the group of medicines
called Iron chelators. ASUNRA 400MG TABLET is used to remove chronic iron
overload (excess iron in the body) caused by frequent blood transfusions in
patients with Beta thalassemia major aged 6 years and older. ASUNRA 400MG TABLET
is also used to manage chronic iron overload when deferoxamine therapy is
contraindicated or inadequate in patients with beta thalassaemia major and other
types of anaemia with iron overload caused by repeated blood transfusions and in
children 2 to 5 years of age.

ASUNRA 400MG TABLET is also used when deferoxamine therapy is contraindicated or
inadequate for patients aged 10 years or older who have iron overload associated
with non-transfusion-dependent thalassaemia syndromes. Your doctor may advise
you to undergo relevant tests to analyze your existing condition and monitor
your kidney and liver function during management.

ASUNRA 400MG TABLET is not recommended for use in patients with moderate to
severe kidney disease, severe liver disease, advanced stage of myelodysplastic
syndrome (decreased production of blood cells by the bone marrow) or advanced
stage of cancer.

Inform your doctor if you have heart disease. ASUNRA 400MG TABLET is generally
not recommended for use by pregnant and breastfeeding women, unless recommended
by your doctor. ASUNRA 400MG TABLET is not recommended for use in children under
2 years of age.

The most common side effects of taking ASUNRA 400MG TABLET are nausea, vomiting,
diarrhoea, abdominal pain, bloating, constipation, indigestion, rash, itching,
headache, and change in liver or kidney function tests or urine tests. Consult
your physician if any of your side effects get worse or persists for a longer
duration.

Uses Of ASUNRA 400MG TABLET

It is used to manage:

• chronic iron overload due to blood transfusion (transfusional haemosiderosis) in patients aged 2 years and above
• chronic iron overload in patients with non-transfusion dependent thalassemia (NTDT) syndromes aged 10 years and older

How ASUNRA 400MG TABLET Works

ASUNRA 400MG TABLET works by trapping and removing excess iron from the body,
which is then excreted mainly in the form of stools and reduces the risk of
organ damage to the liver and heart. As a result, ASUNRA 400MG TABLET helps to
remove excess iron from the body.

How to use ASUNRA 400MG TABLET

Take ASUNRA 400MG TABLET 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 ASUNRA 400MG TABLET

Common

• nausea, vomiting
• diarrhoea
• abdominal pain
• bloating
• constipation
• indigestion
• rash
• headache
• itching

Uncommon

• dizziness
• fever, sore throat
• swelling of the arms or legs
• change in the skin’s colour
• anxiety
• sleep disorder
• tiredness

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

• severe allergic reactions such as rash, red skin, blistering of the lips, eyes or mouth, skin peeling, high fever, flu-like symptoms, enlarged lymph nodes rash, swelling of the face, throat causing difficulty breathing and dizziness
• decrease in urine output
• signs of liver problems such as drowsiness, upper right abdominal pain, yellowish discolouration of skin or whites of the eye (jaundice) and dark urine
• signs of a high level of ammonia in your blood, such as difficulty thinking or remembering information, solving problems, being less alert, aware, or feeling very sleepy with low energy, which may be associated with liver or renal problems and lead to a change in brain function
• vomiting blood and/or black-coloured stools
• severe abdominal pain
• frequent heartburn
• partial loss of vision
• severe upper stomach pain (pancreatitis)
• blurred or cloudy eyesight
• reduced hearing

How To Manage Side Effects

!### Constipation

Eat fiber-rich foods such as fresh fruits, vegetables, and cereals. Drink lots
of water and exercise more regularly. Contact your doctor if your symptoms do
not improve.

!### Diarrhea

Drink lots of fluids, such as water or fruit juices, to keep yourself hydrated.
Do not take any medicine on your own to manage diarrhoea. Contact your doctor if
your symptoms do not improve.

!### Dizziness Or Drowsiness

Try to rest and relax. Get enough sleep. Avoid driving or operating any machines
while you are feeling dizzy. Do not drink alcohol, as it can aggravate your
dizziness. Contact your doctor if your symptoms do not improve.

Headache

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

!### Indigestion

Eat small meals but take them frequently. Eat and exercise regularly. Contact
your doctor if your symptoms do 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 your symptoms do not improve.

!### Stomach Pain

Try to rest and relax. Eat small meals but take them frequently. Keep a heating
pad on your stomach if needed. Contact your doctor if your symptoms do not
improve.

Warning & Precautions

!### Pregnancy

Monitoring requiredASUNRA 400MG TABLET is generally not recommended for use in pregnant women
unless considered necessary. Contact your doctor before taking ASUNRA 400MG
TABLET.

!### Breastfeeding

ContraindicatedASUNRA 400MG TABLET is generally not recommended for use in breastfeeding women
as it may pass through the breast milk unless considered necessary. Contact your
doctor before taking ASUNRA 400MG TABLET.

!### Driving and Using Machines

Use with CautionDo not drive or operate any machines if you feel dizziness, after taking ASUNRA
400MG TABLET.

!### Kidney

Consult your doctorASUNRA 400MG TABLET is not recommended for use in patients with moderate to
severe kidney disease and should be used with caution in patients with decreased
urine output. Contact your doctor before taking ASUNRA 400MG TABLET.

!### Liver

ContraindicatedASUNRA 400MG TABLET is not recommended for use in patients with severe liver
disease. Contact your doctor before taking ASUNRA 400MG TABLET.

!### Allergy

ContraindicatedDo not take ASUNRA 400MG TABLET if you are allergic to Deferasirox or to other
ingredients in this medicine.

!### Heart Disease

Use with CautionASUNRA 400MG TABLET should be used with caution in patients with heart diseases
due to iron overload. Contact your doctor before taking ASUNRA 400MG TABLET.

!### Use In Pediatrics

Consult your doctorASUNRA 400MG TABLET is not recommended for use in children under 2 years of age.
It should be used with caution in children (above 2 years of age) and
adolescents, who receive or do not receive blood transfusions. Contact your
doctor before taking ASUNRA 400MG TABLET.

!### Use In Geriatrics

Use with CautionASUNRA 400MG TABLET should be used with caution in elderly patients aged 65
years or above. Contact your doctor before taking ASUNRA 400MG TABLET.

Others

ASUNRA 400MG TABLET is not recommended for use if you have:

• advanced stage of myelodysplastic syndrome (decreased production of blood cells by the bone marrow)
• have advanced stage of cancer
• poor performance status
• severe thrombocytopenia

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

• low levels of white blood cells, worsening anaemia, pancytopenia, or bone marrow failure
• blurred vision, decreased hearing
• diarrhoea, vomiting
• gastrointestinal ulcers or haemorrhages

Interactions

A. Drug-Drug interactions:

Before taking ASUNRA 400MG TABLET inform your doctor if you are taking any of
the following medicine:

• iron chelators ex.  deferiprone (medicines used in iron overload)
• aluminium-containing antacids (medicines used to manage heartburn)
• cyclosporin (used for the rejection of the transplanted organ and manages other conditions, such as rheumatoid arthritis or atopic dermatitis)
• painkillers or anti-inflammatory medicines (ex. aspirin, ibuprofen, corticosteroids like fluticasone)
• oral bisphosphonates (medicines used to manage osteoporosis)
• warfarin (medicines used to manage blood clots)
• hormonal contrace
• bepridil (medicines used to manage heart problems)
• eletriptan, dihydroergotamine, ergotamine (medicines used for migraines)
• repaglinide (used to manage diabetes)
• rifampicin (used to manage tuberculosis)
• phenytoin, phenobarbital, carbamazepine (used to manage epilepsy)
• paclitaxel (medicines used for cancer)
• theophylline (used to manage asthma)
• tiz
• bile acid sequestrants like cholestyramine, colesevelam, colestipol) (medicines used to lower cholesterol levels)
• busulfan (used in bone marrow transplantation)
• midazolam (medicines used for anxiety and insomnia)
• alfent
• aprepitant (medicines used for nausea and vomiting after chemotherapy)
• budesonide (medicines used to manage asthma)
• buspirone (medicines used to manage anxiety)
• conivaptan, tolvaptan (medicines used for low sodium levels)
• darifenacin (medicines used to manage overactive bladder)
• darunavir, ritonavir, indinavir, lopinavir, maraviroc, saquinavir, tipranavir (medicines used to manage HIV infection)
• dasatinib (used for chronic myeloid leukaemia)
• dronedarone, quinidine (medicines used to manage heart rhythm disorders)
• eplerenone (medicines used to manage heart failure)
• everolimus, sirolimus, tacrolimus (medicines used for rejection of transplant organ)
• felodipine, nisoldipine (medicines used to manage high blood pressure)
• fentanyl (medicines used to relieve severe pain)
• lovastatin, simvastatin (medicines used to lower cholesterol levels)
• lurasidone, quetiapine, clozapine (medicines used to manage manage schizophrenia)
• pimozide (used for motor or verbal tics)
• sildenafil, vardenafil (medicines used for erectile dysfunction)
• triazolam (medicines used to manage insomnia)
• ticagrelor (medicines used to manage blood clots)
• alosetron (medicines used to manage irritable bowel syndrome)
• caffeine (medicines used to manage wakefulness, headache, migraine)
• duloxetine (a medicine used to manage depression)
• melatonin, ramelteon (medicines used for sleep problems)
• tacrine (medicines used for alzheimer’s disease)

Overdosage:

If you or anyone else accidentally have taken too much of ASUNRA 400MG TABLET,
consult your doctor immediately or visit the nearby hospital. Symptoms of
overdosage are nausea, vomiting, abdominal pain, diarrhoea, and kidney or liver
problems.

Synopsis

Drug	:	Deferasirox
Pharmacological Category	:	Iron Chelators
Therapeutic Indication	:	Chronic Iron overload
Dosage Forms	:	Tablet

More Information

• Keep ASUNRA 400MG TABLET out of the sight and reach of children
• Store ASUNRA 400MG TABLET below 30°C

FAQs About ASUNRA 400MG TABLET

Q: How does ASUNRA 400MG TABLET work?

A: ASUNRA 400MG TABLET works by trapping and removing excess iron from the body,
which is then excreted mainly in the form of stools and reduces the risk of
organ damage to the liver and heart.

Q: What are the side effects of taking ASUNRA 400MG TABLET?

A: The most common side effects of taking ASUNRA 400MG TABLET are nausea,
vomiting, diarrhoea, abdominal pain, bloating, constipation, indigestion, rash,
itching, headache, and change in liver or kidney function tests or urine tests.
Contact your physician if any of the side effects worsen.

Q: Who should not take ASUNRA 400MG TABLET?

A: ASUNRA 400MG TABLET should not be used if you are allergic to this medicine
or by pregnant or breastfeeding women, people with severe liver disease,
moderate to severe kidney disease, advanced stage myelodysplastic syndrome,
advanced cancer, poor performance status, or severe thrombocytopenia. Contact
your doctor before taking ASUNRA 400MG TABLET.

Q: Does ASUNRA 400MG TABLET cause liver damage?

A: Yes. ASUNRA 400MG TABLET may cause liver damage. If you experience any
unusual symptoms such as drowsiness, upper right abdominal pain, yellowish
discoloration of the skin or whites of the eyes (jaundice), or dark urine, stop
taking ASUNRA 400MG TABLET and contact your doctor.

Q: Does ASUNRA 400MG TABLET cause vision loss?

A: Yes. ASUNRA 400MG TABLET may cause partial vision loss. Stop taking ASUNRA
400MG TABLET and contact your doctor if you experience any unusual symptoms like
blurred or cloudy eyes.

Useful Diagnostic Tests

• Urine Routine & Microscopy
• Bilirubin Profile
• Kidney Function Test (KFT)
• Liver Function Test (LFT)
• Creatinine, Serum
• Uric Acid, Serum
• Albumin, Serum
• Alkaline Phosphatase, Serum
• Bilirubin Direct, Serum
• Bilirubin Total, Serum