Citafine 1000mg Injection 1'S

Introduction About CITAFINE 1000MG INJECTION

CITAFINE 1000MG INJECTION contains Gemcitabine which belongs to the group of
medicines called Antimetabolites. CITAFINE 1000MG INJECTION is used in the
management of non-small cell lung cancer (alone or combined with cisplatin),
pancreatic cancer, breast cancer (with paclitaxel), ovarian cancer (with
carboplatin) and bladder cancer (with cisplatin).

Cancer is a disease in which there is uncontrollable growth of some of the
body’s cells that spread to other parts of the body. During CITAFINE 1000MG
INJECTION management, your doctor might ask you to take certain blood tests to
check your blood cell count, kidney function or liver function.

Avoid drinking alcohol during CITAFINE 1000MG INJECTION management as it can
make you feel sleepy. Before receiving CITAFINE 1000MG INJECTION, inform your
doctor if you had or are going to have radiotherapy, have been vaccinated
recently or if you have any liver, kidney or heart diseases.

CITAFINE 1000MG INJECTION is not recommended for use in pregnant women,
breastfeeding women, children and adolescents (under 18 years of age). Consult
your doctor before receiving it.

The most common side effects of receiving CITAFINE 1000MG INJECTION are
vomiting, constipation, hair loss, poor appetite, headache, insomnia, cough,
itching, sweating, etc. Contact your doctor if any of the symptoms or side
effects bother you.

Uses Of CITAFINE 1000MG INJECTION

Used in the management of:

• non-small cell lung cancer (alone or with cisplatin)
• pancreatic cancer
• breast cancer (with paclitaxel)
• ovarian cancer (with carboplatin)
• bladder cancer (with cisplatin)

How CITAFINE 1000MG INJECTION Works

CITAFINE 1000MG INJECTION kills the dividing cancer cells by inhibition of their
DNA (hereditary material) synthesis.

How to use CITAFINE 1000MG INJECTION

CITAFINE 1000MG INJECTION will be given to you only by a doctor or a nurse into
a vein as an intravenous infusion. Your doctor will decide the correct dose and
duration for you depending upon your age, body weight and surface area and
disease condition.

Side Effects Of CITAFINE 1000MG INJECTION

Common

• vomiting, nausea, constipation, diarrhoea
• hair loss
• liver problems
• blood or protein in urine, abnormal urine test
• swollen ankles, fingers, feet, face
• poor appetite
• headache
• insomnia, sleepiness
• cough, runny nose
• itching, sweating
• muscle or back pain
• fever, weakness, chills, infections

Uncommon

• scarring of air sacs of the lungs
• wheezing
• scarring of the lungs seen as abnormal chest X ray/scan
• heart, kidney or liver failure
• stroke

Rare

• low blood pressure
• skin scaling, ulceration or blistering
• skin sloughing and severe blistering
• injection site reactions
• radiation recall (a skin rash like severe sunburn which can occur on skin that has been exposed to radiotherapy in the past)
• fluid in the lungs
• radiation toxicity (scarring of the air sacs of the lung related to radiation therapy)
• gangrene of fingers or toes
• inflammation of the blood vessels

Stop receiving CITAFINE 1000MG INJECTION and contact your doctor immediately if
you experience any of the following side effects:

• allergic reactions (mild to moderate skin rash, fever, itching)
• low haemoglobin (tiredness, feeling faint, easy breathlessness, paleness)
• low platelet count (bleeding from the gums, nose or mouth, any bleeding that would not stop, reddish or pinkish urine, unexpected bruising)
• low white blood cell count with fever, sweating or other signs of infection
• stomatitis (pain, redness, swelling, mouth ulcers)
• mild breathing trouble
• irregular heartbeat
• capillary leak syndrome (generalised swelling, shortness of breath, weight gain due to fluid leakage from small blood vessels into tissues)
• posterior reversible encephalopathy syndrome (headache with vision changes, confusion, seizures or fits)
• thrombotic microangiopathy and haemolytic uraemic syndrome (extreme tiredness and weakness, bruises, low or no urine output, signs of infection)

How To Manage Side Effects

Nausea:

Take regular sips of a cold drink. Have ginger or peppermint tea. Stick to
simple meals. Avoid eating oily or spicy foods. If symptom persists, contact
your doctor.

Vomiting:

Get adequate rest. Drink lots of fluids, especially water. Have small sips if
you feel sick. Eat when you feel like it – no need to eat or avoid any specific
foods. If symptom persists, contact your doctor.

Diarrhea:

Drink fluids such as water or fruit juices so that you are sufficiently
hydrated. If symptom persists, contact your doctor.

Constipation:

Have plenty of fiber rich foods like fresh fruits, vegetables, cereals and drink
ample amount of water. Exercise more regularly. If symptom persists, contact
your doctor.

Poor appetite:

Eat when you are hungry. Eat smaller meals more often than usual. Snack only
when you're hungry. Eat a protein-rich or other healthy snack such as dried
fruit and nuts. If symptom persists, contact your doctor.

Headache:

Drink plenty of water and get adequate rest. Try to be relaxed and stress free.
Take medicine for headache after asking your doctor. If symptom persists,
contact your doctor.

Skin rash:

Avoid hot showers to manage further irritation of skin. Do not scratch the
affected area. Use protective clothing when going outdoors. Regularly moisturize
your skin. If symptom persists, contact your doctor.

Warning & Precautions

!### Pregnancy

CITAFINE 1000MG INJECTION is not recommended for use in pregnancy. Consult your
doctor before receiving it.

!### Breastfeeding

CITAFINE 1000MG INJECTION is not recommended for use in breastfeeding women.
Consult your doctor before receiving it.

!### Driving and Using Machines

Do not drive or operate any machines if you feel sleepy after receiving CITAFINE
1000MG INJECTION.

!### Alcohol

Do not consume alcohol during the management with CITAFINE 1000MG INJECTION as
it can make you feel sleepy.

!### Kidney

CITAFINE 1000MG INJECTION should be used with caution in patients who had or
have any kidney diseases. Contact your doctor before receiving it.

!### Liver

CITAFINE 1000MG INJECTION should be used with caution in patients who had or
have any liver diseases. Contact your doctor before receiving it.

!### Allergy

Do not receive CITAFINE 1000MG INJECTION if you are allergic to gemcitabine or
any of the other ingredients of this medicine.

!### Heart Disease

CITAFINE 1000MG INJECTION should be used with caution in patients who had or
have any heart or vascular diseases. Contact your doctor before receiving it.

Others

Before receiving CITAFINE 1000MG INJECTION, inform your doctor if you:

• had or are about to have radiotherapy
• have been vaccinated recently

Use in paediatrics:

CITAFINE 1000MG INJECTION is not recommended for use in children and adolescents
(under 18 years of age) due to insufficient data on safety and efficacy. Consult
your child’s doctor for advice.

Use in geriatrics:

No dose adjustment of CITAFINE 1000MG INJECTION is required for elderly
patients, however, consult your doctor before receiving it.

Interactions

A. Drug - Drug interactions:

Before receiving CITAFINE 1000MG INJECTION, inform your doctor if you are
taking, have taken or might take any other medicine, including prescri
non-prescri

Overdosage:

CITAFINE 1000MG INJECTION will be administered to you only by a doctor or a
nurse in a hospital and so it is unlikely to receive an overdose. However,
consult your doctor or nurse if you experience anything unusual.

Synopsis

Drug	:	Gemcitabine
Pharmacological Category	:	Pyrimidine antagonists
Therapeutic Indication	:	Cancer management
Dosage Forms	:	Injection

More Information

• Keep CITAFINE 1000MG INJECTION out of reach of children
• Store CITAFINE 1000MG INJECTION between 25°C

FAQs About CITAFINE 1000MG INJECTION

Can CITAFINE 1000MG INJECTION cause hearing loss?

According to some studies, CITAFINE 1000MG INJECTION is ototoxic, which means it
can cause hearing or balance problems. Consult your doctor if you experience any
problems with hearing during this management.

How long do I need to take CITAFINE 1000MG INJECTION?

You usually have CITAFINE 1000MG INJECTION as a course of several cycles of
management. This means that you receive the medicine and then rest to allow your
body to recover. Usually, a cycle of CITAFINE 1000MG INJECTION is over 3 to 4
weeks (21 to 28 days), but your doctor will determine the duration of management
according to your condition.

Is it safe to have a baby during management with CITAFINE 1000MG INJECTION?

For women, CITAFINE 1000MG INJECTION is not recommended for use if you are
pregnant or planning for a baby. Men are advised not to father a child during
and up to 6 months after management with CITAFINE 1000MG INJECTION. You may want
to seek counselling on sperm storage before starting your management. Consult
your doctor for advice.

Can I receive CITAFINE 1000MG INJECTION if I got recently vaccinated?

Before receiving CITAFINE 1000MG INJECTION, inform your doctor if you recently
got vaccinated as it can affect the number of blood cells that are tested during
this management. Consult your doctor for advice.

Can I drive a car during management with CITAFINE 1000MG INJECTION?

CITAFINE 1000MG INJECTION may make you feel sleepy, especially if you have
consumed any alcohol. Do not drive a car until you are sure that this management
has not made you feel sleepy. Consult your doctor if you feel any side effect
during management with CITAFINE 1000MG INJECTION that may stop you from driving
or using machines.

Useful Diagnostic Tests

• Complete Blood Count (CBC)