NINTENA 100 Soft Gelatin Capsule 10's

Introduction About NINTENA 100 SOFT GELATIN CAPSULE

NINTENA 100 SOFT GELATIN CAPSULE contains Ninted
of medicines called Kinase inhibitors. It is used to manage idiopathic pulmonary
fibrosis (IPF), chronic fibrosing interstitial lung diseases (ILDs) with a
progressive phenotype, slowing the rate of decline in pulmonary function in
patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD).
It is used in combination with docetaxel in adult patients for the management of
locally advanced metastatic or recurrent non-small cell lung cancer (NSCLC) of
adenocarcinoma tumor histology after first line chemotherapy.

Idiopathic Pulmonary Fibrosis (IPF) is a chronic lung disorder in which the
lungs become scarred and breathing becomes increasingly difficult. Symptoms
include shortness of breath, persistent dry cough, tiredness, loss of appetite,
weight loss, rounded and swollen fingertips (clubbed fingers).

Before taking NINTENA 100 SOFT GELATIN CAPSULE inform your doctor if you have
liver, heart or bleeding problems, history of blood clots or had a recent
surgery in stomach. NINTENA 100 SOFT GELATIN CAPSULE is not recommended for use
in pregnant women unless advised by your doctor and it is not recommended for
use in breastfeeding women as it may pass through breast milk. Before starting
management with NINTENA 100 SOFT GELATIN CAPSULE, your doctor may want you to
take several blood tests to understand your existing condition.

NINTENA 100 SOFT GELATIN CAPSULE should be used with caution in elderly patients
(aged 65 years and above). The most common side effects of taking NINTENA 100
SOFT GELATIN CAPSULE are diarrhoea, nausea, vomiting, stomach pain, loss of
appetite, headache, weight loss and high blood pressure. Consult your doctor if
any of the symptom worsens.

Uses Of NINTENA 100 SOFT GELATIN CAPSULE

• Manage idiopathic pulmonary fibrosis (IPF)
• Manage chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype
• To slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD)

How NINTENA 100 SOFT GELATIN CAPSULE Works

NINTENA 100 SOFT GELATIN CAPSULE is a tyrosine kinase inhibitor (TKI) which
works by blocking the enzymes in cells of the lungs called tyrosine kinases.
Blocking these enzymes helps to decrease fibrous tissue formation in the lungs,
thereby stops the symptoms of lung disease getting worse.

How to use NINTENA 100 SOFT GELATIN CAPSULE

Take NINTENA 100 SOFT GELATIN CAPSULE as advised by your physician. Swallow the
medicine with a glass of water. Do not crush, chew, or open the medicine. Your
doctor will decide the correct dose and duration for you based upon your age,
body weight and disease condition. Do not stop taking NINTENA 100 SOFT GELATIN
CAPSULE unless your doctor advises you to stop.

Side Effects Of NINTENA 100 SOFT GELATIN CAPSULE

Common

• diarrhoea
• nausea, vomiting
• stomach pain
• liver problems
• decreased appetite
• headache
• weight loss
• high blood pressure

Rare

Stop taking NINTENA 100 SOFT GELATIN CAPSULE and contact your doctor immediately
if you experience any of the following side effects:

• severe liver problems symptoms such as yellowing of your skin or white part of your eyes (jaundice), dark or brown (tea colored) urine, pain on the upper right side of your stomach area (abdomen), bleeding or bruising more easily than normal, feeling tired, or loss of appetite
• severe diarrhoea, nausea and vomiting
• signs of heart attack such as chest pain or pressure, pain in arms, back, neck or jaw, or shortness of breath
• signs of stroke such as numbness or weakness on one side of your body, trouble talking, headache or dizziness
• signs of bleeding problem such as unusual bleeding, bruising, or wounds that do not heal
• signs of tear in stomach or intestinal wall (perforation) such as pain or swelling in stomach area
• signs of increased protein in urine (proteinuria) such as foamy urine, swelling of the hands, arms, legs, or feet or sudden weight gain

How To Manage Side Effects

!### Diarrhea

Drink lot of fluids, such as water to keep yourself hydrated. Try to avoid
taking any medicine on your own to manage diarrhea and consult your doctor if
the symptom gets worse.

Headache

Drink ample amount of water. Get adequate rest. Try to be relaxed and stress
free. Do not strain your eyes by watching screen for long time. Apply pain
relieving balm on your forehead if necessary. Consult your doctor if the symptom
gets worse.

!### Loss Of Appetite

Eat when you are hungry. Eat smaller meals more often than usual. Snack only
when you're hungry. Eat a nutritious snack which is rich in calories and
protein, such as dried fruit and nuts. Consult your doctor if the symptom does
not improve.

!### Nausea And Vomiting

Try to take NINTENA 100 SOFT GELATIN CAPSULE with or just after a meal or a
snack. Stick to simple meals. Avoid eating oily, fried or spicy foods. Consult
your doctor if the symptom gets worse.

!### Stomach Pain

Try to rest and relax. Eat and drink slowly or try to have smaller meals more
frequently. Keep a heat pad on your stomach. If the stomach pain does not
improve, consult your doctor.

Warning & Precautions

!### Pregnancy

Monitoring requiredNINTENA 100 SOFT GELATIN CAPSULE is not recommended for use in pregnant women
unless considered clearly necessary. Consult your doctor before taking it.

!### Breastfeeding

ContraindicatedNINTENA 100 SOFT GELATIN CAPSULE is not recommended for use in breastfeeding
women as it may pass through breast milk. Consult your doctor before taking it.

!### Liver

Use with CautionNINTENA 100 SOFT GELATIN CAPSULE should be taken with caution in patients with
liver problems. Consult your doctor before taking it.

!### Allergy

ContraindicatedDo not take NINTENA 100 SOFT GELATIN CAPSULE if you are allergic to Ninted
or any of the other ingredients of this medicine.

!### Heart Disease

Use with CautionNINTENA 100 SOFT GELATIN CAPSULE should be taken with caution in patients with
heart problems. Consult your doctor before taking it.

!### Use In Pediatrics

Consult your doctorThere is no proper information regarding the use of this medicine in children.
Consult child’s doctor for advice

!### Use In Geriatrics

Use with CautionNINTENA 100 SOFT GELATIN CAPSULE should be used with caution in elderly patients
(aged 65 years and above). Consult your doctor before taking NINTENA 100 SOFT
GELATIN CAPSULE

Others

Before taking NINTENA 100 SOFT GELATIN CAPSULE inform your doctor if you:

• have history of blood clots
• have bleeding problem or a family history of bleeding problem
• had recent surgery in stomach (abdominal) area
• are a smoker

Interactions

A. Drug - Drug interactions:

Before taking NINTENA 100 SOFT GELATIN CAPSULE inform your doctor if you are
taking any of the following medicines:

• st. john’s wort (used to manage depression)
• laxatives such as bisacodyl, stool softeners such as lactulose (used to manage constipation)
• other medicines or dietary supplements (used to manage diarrhoea)
• blood thinners such as warfarin (used to manage or manage blood clots)
• aspirin (used to manage fever and pain)

Overdosage:

If you or anyone else accidentally take too much of NINTENA 100 SOFT GELATIN
CAPSULE, consult your doctor immediately or visit the nearby hospital.

Synopsis

Drug	:	Ninted
Pharmacological Category	:	Tyrosine Kinase Inhibitor
Therapeutic Indication	:	Idiopathic pulmonary fibrosis (IPF), Chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype, slows the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD)
Dosage Forms	:	Capsule

More Information

• Keep NINTENA 100 SOFT GELATIN CAPSULE out of reach of children
• Store at room temperature

FAQs About NINTENA 100 SOFT GELATIN CAPSULE

Q: Can I take NINTENA 100 SOFT GELATIN CAPSULE during pregnancy?

A: NINTENA 100 SOFT GELATIN CAPSULE is not recommended for use in pregnant women
unless clearly advised by your doctor. Consult your doctor before taking NINTENA
100 SOFT GELATIN CAPSULE if you are pregnant or planning to get pregnant.

Q: What to do If I forget to take a dose of NINTENA 100 SOFT GELATIN
CAPSULE?

A: You should take NINTENA 100 SOFT GELATIN CAPSULE immediately when you
remember. If it is time for your next dose skip the missed dose and follow your
regular dose schedule. Do not double the dose to match up your missed dose.

Q: Can I stop taking NINTENA 100 SOFT GELATIN CAPSULE on my own?

A: Do not stop taking NINTENA 100 SOFT GELATIN CAPSULE unless your doctor
advises you to stop. Remember that it works to slow the decline in lung function
only for as long as you keep taking it. If you stop taking NINTENA 100 SOFT
GELATIN CAPSULE suddenly it worsens the lung function and increases the risk of
life-threatening complications.

Q: What are the common side effects of NINTENA 100 SOFT GELATIN CAPSULE?

A: The common side effects of taking NINTENA 100 SOFT GELATIN CAPSULE are
diarrhoea, nausea, vomiting, stomach pain, loss of appetite, headache, weight
loss, altered liver enzymes and high blood pressure. Consult your doctor if any
of the side effect worsens.

Q: IsNINTENA 100 SOFT GELATIN CAPSULE safe to use in patients with liver
disease?

A: NINTENA 100 SOFT GELATIN CAPSULE should be taken with caution in patients
with liver problems. Your doctor may monitor your liver function before and
during management with NINTENA 100 SOFT GELATIN CAPSULE to assess the risk of
liver damage or any unusual effects. Consult your doctor before taking NINTENA
100 SOFT GELATIN CAPSULE.

Useful Diagnostic Tests

• Liver function tests
• Pulmonary function tests