DICLOFENAC SODIUM(CADILA) Injection 3ml

Introduction About DICLOFENAC SODIUM(CADILA) INJECTION

DICLOFENAC SODIUM(CADILA) INJECTION contains Diclofenac, which belongs to a
group of medicines called Nonsteroidal anti-inflammatory drugs (NSAIDs).
DICLOFENAC SODIUM(CADILA) INJECTION is used to manage various painful conditions
such as flare-ups of joint or back pain, gout attacks (a common and complex form
of arthritis that is characterized by sudden, severe attacks of pain, swelling,
redness, and tenderness in one or more joints), pain caused by kidney stones or
due to injuries, fractures, or trauma. It is also used to manage or manage pain
following an operation.

Before receiving DICLOFENAC SODIUM(CADILA) INJECTION, inform your doctor if you
have any allergies, heart, liver, or kidney problems, clotting disorders, high
blood pressure, diabetes, or any respiratory conditions; gastrointestinal
problems such as stomach ulcers, ulcerative colitis, or Crohn's disease; and
bleeding in the stomach with symptoms such as black stools or blood in vomit.

DICLOFENAC SODIUM(CADILA) INJECTION is not recommended for use in pregnant
women, especially if you are more than 6 months pregnant, and it should be used
with caution in breast-feeding women only if clearly advised by the doctor.
DICLOFENAC SODIUM(CADILA) INJECTION is not recommended for use in children and
adolescents (below 18 years of age). It should be used with caution in elderly
patients.

The common side effects of receiving DICLOFENAC SODIUM(CADILA) INJECTION are
nausea and discomfort, pain, redness, or lumps at the site of injection. Inform
your doctor if any of the side effects get worse.

Uses Of DICLOFENAC SODIUM(CADILA) INJECTION

Manages painful conditions such as:

• Flare-ups of joint or back pain
• Gout attacks
• Pain caused by kidney stones or injuries, fractures, or trauma
• Pain following an operation

How DICLOFENAC SODIUM(CADILA) INJECTION Works

DICLOFENAC SODIUM(CADILA) INJECTION works by inhibiting the activity of certain
enzymes (called cyclooxygenase (COX) enzymes), which manage the excess
production of prostaglandins (which is responsible for causing pain and
inflammation), thus helping in managing various painful conditions.

How to use DICLOFENAC SODIUM(CADILA) INJECTION

DICLOFENAC SODIUM(CADILA) INJECTION will be given to you only by a doctor or a
nurse into a muscle (usually into buttocks as an intramuscular injection) or
under the skin (usually into buttocks or thighs as a subcutaneous injection) or
into a vein (usually in the upper arm as an intravenous injection). Your doctor
will decide the correct dose and duration of DICLOFENAC SODIUM(CADILA) INJECTION
for you depending upon your age, body weight, and disease condition.

Side Effects Of DICLOFENAC SODIUM(CADILA) INJECTION

Common

• Pain, redness, or lumps at the injection site
• Nausea
• Discomfort in the injection site

Uncommon

• Dizziness and headache
• Diarrhoea, vomiting and constipation
• Stomach pain, sickness, and loss of appetite due to an inflammatory stomach lining
• Problems in liver function
• Skin rash, itching

Rare

Inform your doctor immediately if you experience any of the following side
effects while receiving DICLOFENAC SODIUM(CADILA) INJECTION:

• Signs of bleeding in the stomach or intestine (bleeding while emptying your bowel, blood in vomit, black or tarry stools)
• Persistent sore throat or high temperature
• Sudden change in urine production and colour
• Signs of severe allergic reactions (skin rash, swelling of the face, throat, or tongue, breathing difficulties, wheezing, and runny nose)
• Yellowing of the skin or white of the eyes
• Chest pain due to a serious allergic reaction called Kounis syndrome
• Serious skin rashes with itching, hives, bruising, painful red areas, peeling or blistering of skin, giant wheals (burning itchy swollen skin), affecting the mouth, lips, eyes, nose, and genitals.
• Bruising more easily than usual or having frequent sore throats or infections.
• Severe stomach pain or persistent problem with indigestion, heartburn, wind, and nausea or vomiting
• Mild cramping or tenderness of the abdomen, followed by rectal bleeding or bloody diarrhea (usually within 24 hours of the onset of abdominal pain)

How To Manage Side Effects

!### Constipation

Try to eat more high-fiber foods such as fresh fruit, vegetables, and cereals,
and drink plenty of water. If this does not help, inform your doctor about
receiving alternate management for constipation.

!### Diarrhea

Drink a lot of fluids, such as water, to keep yourself hydrated. Avoid eating
high-fat or spicy foods. Inform your doctor if the symptom gets worse.

Headache

Drink an ample amount of water and avoid skipping meals. Get adequate rest. Try
to be relaxed and stress-free. Apply pain-relieving balm on your forehead if
necessary. Inform your doctor if the symptom does not improve.

!### Nausea And Vomiting

Stick to simple meals while receiving DICLOFENAC SODIUM(CADILA) INJECTION. Avoid
eating oily, rich, fried, or spicy foods. Do not lie down or sleep immediately
after eating. Inform your doctor if the symptom does not improve.

!### Stomach Pain

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

Warning & Precautions

!### Pregnancy

RiskyDICLOFENAC SODIUM(CADILA) INJECTION is not recommended for use during pregnancy,
especially if you are more than 6 months pregnant, as it may affect the baby’s
circulation or damage the baby’s kidney and may delay or prolong your labour.
Your doctor may make a decision whether to continue the use of DICLOFENAC
SODIUM(CADILA) INJECTION if you are pregnant or planning to get pregnant.
Consult your doctor before receiving DICLOFENAC SODIUM(CADILA) INJECTION, as it
may make it more difficult to get pregnant during management with this medicine.

!### Breastfeeding

Monitoring requiredDICLOFENAC SODIUM(CADILA) INJECTION should be used in breastfeeding women only
if clearly advised by the doctor. Therefore, consult your doctor before
receiving DICLOFENAC SODIUM(CADILA) INJECTION.

!### Driving and Using Machines

ContraindicatedDo not drive or operate any machines if you feel dizzy, tired, sleepy, or have
blurred vision after receiving DICLOFENAC SODIUM(CADILA) INJECTION.

!### Kidney

Consult your doctorDICLOFENAC SODIUM(CADILA) INJECTION is not recommended for patients having or
having had severe kidney failure and moderate or severe impairment in kidney
function. It should be used with caution in patients having or having ever had
kidney problems. Consult your doctor for advice before receiving DICLOFENAC
SODIUM(CADILA) INJECTION.

!### Liver

Consult your doctorDICLOFENAC SODIUM(CADILA) INJECTION is not recommended for use in patients
having or having had liver failure. It should be used with caution in patients
with liver problems. Consult your doctor for advice before receiving DICLOFENAC
SODIUM(CADILA) INJECTION.

!### Allergy

ContraindicatedDICLOFENAC SODIUM(CADILA) INJECTION is not recommended for use if you are
allergic to diclofenac, aspirin, ibuprofen, or any other non-steroidal
anti-inflammatory drugs (NSAIDs) (such as indomethacin).

!### Lungs

Consult your doctorDICLOFENAC SODIUM(CADILA) INJECTION is not recommended for use in patients with
history of asthma. It should be used with caution in patients with chronic
obstructive pulmonary disease (COPD) or hay fever. Consult your doctor for
advice before receiving DICLOFENAC SODIUM(CADILA) INJECTION.

!### Heart Disease

Consult your doctorDICLOFENAC SODIUM(CADILA) INJECTION is not recommended for use in patients with
severe heart failure, heart disease, or cerebrovascular disease such as heart
attack, stroke, mini-stroke (TIA), or blockages to blood vessels to the heart or
brain or who have had an operation to clear or bypass blockages and
cerebrovascular bleeding. It should be used with caution in patients with
angina, blood clots, high blood pressure, raised cholesterol, or raised
triglycerides. Consult your doctor for advice before receiving DICLOFENAC
SODIUM(CADILA) INJECTION.

!### Use In Pediatrics

ContraindicatedDICLOFENAC SODIUM(CADILA) INJECTION is not recommended for use in children and
adolescents (below 18 years of age). Consult the child's doctor for advice.

!### Use In Geriatrics

Use with CautionDICLOFENAC SODIUM(CADILA) INJECTION should be used with caution in elderly
patients. Your doctor may initiate the management with the lowest effective
dose. Consult your doctor for advice before receiving DICLOFENAC SODIUM(CADILA)
INJECTION.

Others

DICLOFENAC SODIUM(CADILA) INJECTION is not recommended for use if you:

• Have a history of bleeding in your stomach or bowels after you have taken NSAIDs
• Had two or more episodes of stomach or duodenal ulcers or bleeding in the digestive tract
• Have a blood clotting disorder
• Have a history of bleeding diathesis (specifically cerebrovascular bleeding)
• Had operation with high risk of haemorrhage
• Are dehydrated
• Have suffered from heavy blood loss

Before receiving DICLOFENAC SODIUM(CADILA) INJECTION, inform your doctor if you:

• Have smoking habit
• Have diabetes
• Have systemic lupus erythematosus or any similar problem
• Have porphyria or nasal polyps
• Are recovering from surgery?
• Are going to undergo gut surgery?
• Have any bowel disorders, including ulcerative colitis or Crohn’s disease

Interactions

A. Drug-Drug Interactions:

Before receiving DICLOFENAC SODIUM(CADILA) INJECTION, inform your doctor if you
are taking any of the following medicines:

• Other medicines used to provide pain relief (Ex. aspirin, ibuprofen)
• Medicines used to manage high blood pressure (Ex. captopril, atenolol, metoprolol)
• Digoxin (used to manage heart problems)
• Methotrexate, pemetrexed (used in cancer management)
• Spironolactone, furosemide (used to remove excess water from the body)
• Lithium (used to manage mental health problems)
• Warfarin or heparin (used to manage or manage blood clots)
• Mifepristone (used to terminate pregnancy)
• Medicine used to suppress inflammation (Ex. prednisolone)
• Medicines used to suppress immunity (Ex. ciclosporin and tacrolimus)
• Citalopram (used to manage depression)
• Medicines used to manage bacterial infections (Ex. ciprofloxacin, ofloxacin)
• Phenytoin (used to manage seizures)
• Voriconazole (used to manage fungal infections)
• Medicines used to lower cholesterol (Ex. colestipol, cholestyramine)
• Sulfinpyrazone (used in gout management)
• Zidovudine (used in HIV management)
• Anti-diabetics such as metformin (used to manage diabetics)
• Deferasirox (used to manage iron overload due to blood transfusions)

Overdosage:

DICLOFENAC SODIUM(CADILA) 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 any unusual symptoms such as
nausea, vomiting, stomach pain, stomach or bowel bleeding, dizziness, tinnitus
(ringing noise in ears), and occasionally convulsions (fits). In severe cases,
it may cause kidney or liver damage (signs include difficulty passing urine or
passing more water than usual, tiredness, muscle cramps, swelling in your hands,
feet, or face, nausea or vomiting, and yellowing of the skin).

Synopsis

Drug	:	Diclofenac
Pharmacological Category	:	Cyclooxygenase Inhibitors
Therapeutic Indication	:	Pain relief
Dosage Forms	:	Tablet, Capsule, Dispersible tablet, Injection, Eye drops, Gel, Spray, Solution, Liniment, Suppository, Ointment, Transdermal patch, Spray

More Information

Storage

• Store DICLOFENAC SODIUM(CADILA) INJECTION at room temperature

FAQs About DICLOFENAC SODIUM(CADILA) INJECTION

Q: What is DICLOFENAC SODIUM(CADILA) INJECTION used for?

A: DICLOFENAC SODIUM(CADILA) INJECTION is used to manage various painful
conditions such as flare-ups of joint or back pain, gout attacks, pain caused by
kidney stones or due to injuries, fractures or trauma. DICLOFENAC SODIUM(CADILA)
INJECTION is also used to manage or manage pain following an operation.

Q: What common side effects are seen with DICLOFENAC SODIUM(CADILA) INJECTION?

A: The common side effects of receiving DICLOFENAC SODIUM(CADILA) INJECTION are
nausea and discomfort, pain, redness or lumps at the site of injection. Inform
your doctor if any of the side effect gets worse during or after management with
DICLOFENAC SODIUM(CADILA) INJECTION.

Q: Can DICLOFENAC SODIUM(CADILA) INJECTION be used in breast-feeding women?

A: DICLOFENAC SODIUM(CADILA) INJECTION should be used in breastfeeding women
only if clearly advised by your doctor. Consult your doctor before receiving
DICLOFENAC SODIUM(CADILA) INJECTION if you are breast-feeding your child or wish
to breast-feed if your baby is born prematurely.

Q: Can DICLOFENAC SODIUM(CADILA) INJECTION be used in elderly patients?

A: DICLOFENAC SODIUM(CADILA) INJECTION should be used with caution in elderly
patients. Your doctor may initiate the management with the lowest effective
dose. Consult your doctor for advice before receiving DICLOFENAC SODIUM(CADILA)
INJECTION.

Q: Is DICLOFENAC SODIUM(CADILA) INJECTION safe to use in patients with liver problems?

A: DICLOFENAC SODIUM(CADILA) INJECTION is not recommended for use in patients
with liver failure. It should be used with caution in patients with liver
problems and your doctor may monitor your liver function test during management
with this medicine. Consult your doctor for advice before receiving DICLOFENAC
SODIUM(CADILA) INJECTION.

Q: Is DICLOFENAC SODIUM(CADILA) INJECTION safe during pregnancy?

A: DICLOFENAC SODIUM(CADILA) INJECTION is not recommended for use during
pregnancy, especially if you are more than 6 months pregnant, as it may affect
the baby’s circulation or damage the baby’s kidney and may delay or prolong your
labour. Your doctor may decide whether to continue the use of DICLOFENAC
SODIUM(CADILA) INJECTION if you are pregnant or planning to get pregnant.
Consult your doctor before receiving DICLOFENAC SODIUM(CADILA) INJECTION, as it
may make it more difficult to get pregnant during management with this medicine.

Q: Can DICLOFENAC SODIUM(CADILA) INJECTION be used in children?

A: DICLOFENAC SODIUM(CADILA) INJECTION is not recommended for use in children
and adolescents (below 18 years of age). Consult the child's doctor for advice.

Q: Who should not use DICLOFENAC SODIUM(CADILA) INJECTION?

A: DICLOFENAC SODIUM(CADILA) INJECTION is not recommended for use if you have a
history of bleeding in your stomach or bowels after you have taken NSAIDs,
stomach or duodenal ulcers or bleeding in the digestive tract, blood clotting
disorders, history of bleeding diathesis (specifically cerebrovascular
bleeding), history of operation with high risk of haemorrhage, dehydration,
history of heavy blood loss, allergic to diclofenac, aspirin, ibuprofen or any
other non-steroidal anti-inflammatory drugs (NSAIDs) (such as indomethacin), or
if you have severe kidney failure and moderate or severe impairment in kidney
function, liver failure, history of asthma, severe heart failure, heart disease
or cerebrovascular disease such as heart attack, stroke, mini-stroke (TIA) or
blockages to blood vessels to the heart or brain or had an operation to clear or
bypass blockages and cerebrovascular bleeding.

Q: How DICLOFENAC SODIUM(CADILA) INJECTION is given?

A: DICLOFENAC SODIUM(CADILA) INJECTION will be given to you only by a doctor or
a nurse into a muscle (usually into buttocks as an intramuscular injection) or
under the skin (usually into buttocks or thighs as a subcutaneous injection) or
into a vein (usually in the upper arm as an intravenous injection). Your doctor
will decide the correct dose and duration of DICLOFENAC SODIUM(CADILA) INJECTION
for you depending upon your age, body weight, and disease condition.

Q: What precautions must be taken while using DICLOFENAC SODIUM(CADILA) INJECTION?

A: Before receiving DICLOFENAC SODIUM(CADILA) INJECTION, inform your doctor if
you have kidney problems, liver problems, chronic obstructive pulmonary disease
(COPD) or hay fever, angina, blood clots, high blood pressure, raised
cholesterol or raised triglycerides, have a smoking habit, diabetes, systemic
lupus erythematosus or any similar problem, porphyria or nasal polyps, are
recovering from surgery, scheduled for gut surgery, or have any bowel disorders,
including ulcerative colitis or Crohn’s disease.

Useful Diagnostic Tests

• Complete Blood Count (CBC)/ Hemogram
• Liver Function Test (LFT)
• Rheumatoid Factor (RF)/RA Test Rheumatoid Arthritis Factor, Qualitative
• Basic Arthritis Care
• Extended Arthritis Care
• Advance Bone Care
• Comprehensive Bone Care
• Frequent Pain Check Package
• Autoimmune Arthritis Panel
• Arthritis Profile – Advanced