GEFITEC 250 Capsule 10's

Introduction About GEFITEC 250 CAPSULE

GEFITEC 250 CAPSULE contains Gefitinib which belongs to the group of medicines
called Antineoplastics. It is indicated for the first-line management of
patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)
who have activating mutation of the EGFR-TK.

It is generally characterized by symptoms such as chest pain or discomfort,
persistent cough, trouble breathing, wheezing, tiredness and difficulty while
swallowing which may be diagnosed as any of its type as adenocarcinoma (cancer
involving the outer part of the lung), squamous cell carcinoma (cancer occurring
in the centre part of the lungs), and large cell carcinoma (cancer that can
occur in any part of the lung).

Along with this management, your doctor might ask you to take liver function
test to assess your liver function.

GEFITEC 250 CAPSULE is not recommended for use in patients allergic to
Gefitinib. Before taking GEFITEC 250 CAPSULE, inform your doctor if you have
other lung problems, liver, or kidney problems.

GEFITEC 250 CAPSULE is not recommended for use in pregnant and breastfeeding
women. It is not recommended for use in children and adolescents (below 18
years). Consult your doctor before taking GEFITEC 250 CAPSULE.

The most common side effects of taking GEFITEC 250 CAPSULE are diarrhoea,
vomiting, nausea, skin reactions, loss of appetite, weakness, and red or sore
mouth. Consult with your doctor if any of the symptoms worsen.

Uses Of GEFITEC 250 CAPSULE

• Used to manage adults with non-small cell lung cancer

How GEFITEC 250 CAPSULE Works

GEFITEC 250 CAPSULE works by decreasing the survival rate and proliferation of
malignant cancer cells in lung tissues by blocking a protein called epidermal
growth factor receptor (EGFR) which is responsible for the growth and spread of
cancer cell thereby managing the growth and spread of cancer cells to other
parts of the body.

How to use GEFITEC 250 CAPSULE

Take GEFITEC 250 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 of GEFITEC 250 CAPSULE for you depending upon your
age, body weight and disease condition.

Side Effects Of GEFITEC 250 CAPSULE

Common

• diarrhoea
• vomiting
• nausea
• skin reactions (acne-like rash)
• loss of appetite
• weakness
• red or sore and dry mouth
• dry, red, or itchy eyes
• red and sore eyelids
• nail problems
• hair loss
• fever
• bleeding such as nosebleed or blood in urine
• signs of cystitis such as burning sensations while urinating, urgent need to urinate

Uncommon

• signs of inflamed pancreas such as very severe pain in the upper part of the abdomen, severe nausea and vomiting
• signs of inflammation of the liver such as general feeling of being unwell, with or without possible jaundice (yellowing of the skin and eyes).
• signs of gastrointestinal perforation such as severe stomach pain, chills, fever
• signs of palmar-plantar erythrodysaesthesia syndrome or hand and foot syndrome such as skin reaction on the palms of the hands and soles of the feet with tingling, numbness, swelling, redness, or pain

Rare

• signs of inflammation of the blood vessels in the skin such as bruising or patches of non-blanching rash on the skin
• signs of haemorrhagic cystitis (inflammatory condition of urinary bladder) such as burning sensation while urinating, urgent need to urinate along with blood in the urine

Stop taking GEFITEC 250 CAPSULE and contact your doctor immediately if you
experience any of the following side effects:

• signs of allergic reaction such as swollen face, lips, tongue or throat, red and itchy skin, nettle rash and difficulty breathing and difficulty in swallowing
• signs of interstitial lung disease (inflammation and scarring of lung disease) such as serious breathlessness, or sudden worsening of breathlessness possibly with a cough or fever
• dehydration due to long term or severe diarrhoea, vomiting, nausea, or loss of appetite
• signs of an ulcer on the surface of the eye (cornea) such as pain, redness, watery eyes, light sensitivity, changes in vision or ingrowing eyelashes

How To Manage Side Effects

Nausea or Vomiting:

Stick to simple meals. Avoid eating oily, fried, and spicy foods. Do not perform
any strenuous activities immediately after eating. Consult your doctor if the
symptom did not improve.

Constipation:

Eat plenty of fiber rich foods such as vegetables, fresh fruits, and cereals and
drink plenty of water while taking GEFITEC 250 CAPSULE. Exercise more regularly.
Consult your doctor if the symptom did not improve.

Diarrhea:

Drink a lot of fluids, such as water, squash, or fruit juice to keep yourself
hydrated. Do not take any medicine on your own for managing diarrhea without
consulting your doctor.

Warning & Precautions

!### Pregnancy

GEFITEC 250 CAPSULE is not recommended for use in pregnant women as it may harm
the baby. Consult your doctor before taking GEFITEC 250 CAPSULE.

!### Breastfeeding

GEFITEC 250 CAPSULE is not recommended for use in breastfeeding women as it is
unsafe to the baby. Consult your doctor before taking GEFITEC 250 CAPSULE.

!### Driving and Using Machines

If you feel weak while taking GEFITEC 250 CAPSULE, consult your doctor before
driving or using tools or machines.

!### Alcohol

Avoid consum
increase the risk of liver damage.

!### Kidney

GEFITEC 250 CAPSULE should be used with caution in patients having kidney
problems. Consult your doctor before taking GEFITEC 250 CAPSULE.

!### Liver

GEFITEC 250 CAPSULE should be used with caution in patients having liver
problems. Consult your doctor before taking GEFITEC 250 CAPSULE.

!### Allergy

Do not take GEFITEC 250 CAPSULE if you are allergic to Gefitinib or to any other
ingredients of this medicine.

!### Lungs

GEFITEC 250 CAPSULE should be used with caution in patients having other lung
disease. Consult your doctor before taking GEFITEC 250 CAPSULE.

Others

Use in pediatrics:

GEFITEC 250 CAPSULE is not recommended for use in children and adolescents
(below 18 years). Consult your doctor before taking GEFITEC 250 CAPSULE.

Use in geriatrics:

GEFITEC 250 CAPSULE should be used with caution in elderly patients (aged 65
years and above). Consult your doctor before taking GEFITEC 250 CAPSULE.

Interactions

A. Drug - Drug Interactions:

Before taking GEFITEC 250 CAPSULE, inform your doctor if you are taking any of
the following medicines:

• medicines used in the management of epilepsy (Ex. phenytoin, carbamazepine)
• medicines used in the management of tuberculosis (Ex. rifampicin)
• medicines used in the management of fungal infection (Ex. itraconazole)
• medicines used in the management of sleeping disorders (Ex. barbiturates such as phenobarbital)
• medicines used to manage blood clots (Ex. warfarin)
• medicines used in the management of ulcers, indigestion, heartburn and to reduce acids in the stomach such as proton-pump inhibitors (Ex. lansoprazole, omeprazole, aluminium hydroxide, magnesium carbonate, cimetidine, famotidine)
• St. John’s wort (herbal remedy used for depression and anxiety)

Overdosage:

If you or anyone else accidentally takes too much of GEFITEC 250 CAPSULE,
consult your doctor immediately or visit the nearby hospital.

Synopsis

Drug	:	Gefitinib
Pharmacological Category	:	Antineoplastic agents
Therapeutic Indication	:	Non-small cell lung cancer
Dosage Forms	:	Tablet

More Information

• Keep GEFITEC 250 CAPSULE out of reach of children
• Store at room temperature

FAQs About GEFITEC 250 CAPSULE

What is GEFITEC 250 CAPSULE and why is it given?

GEFITEC 250 CAPSULE contains Gefitinib which belongs to the group of medicines
called as Antineoplastic agents. It is used in adults to manage non-small cell
lung cancer in which malignant cells form in the lung tissue.

What are the most common side effects of GEFITEC 250 CAPSULE?

The most common side effects of taking GEFITEC 250 CAPSULE are diarrhoea,
vomiting, nausea, skin reactions, loss of appetite, weakness, and red or sore
mouth. Consult with your doctor if any of the symptoms worsen.

Can GEFITEC 250 CAPSULE be used in children?

No. GEFITEC 250 CAPSULE is not recommended for use in children and adolescents
(below 18 years). If GEFITEC 250 CAPSULE is accidentally ingested by a child or
adolescent, go to the hospital immediately and consult the doctor for further
management.

Is GEFITEC 250 CAPSULE safe for pregnant and breast-feeding women?

GEFITEC 250 CAPSULE is not recommended for use in pregnant and breast-feeding
women since it might cause harm to the foetus and nursing child. Consult your
doctor before taking GEFITEC 250 CAPSULE.

Useful Diagnostic Tests

• Liver function test
• CT Scan
• PET Scan
• Complete Blood Count (CBC)