Eligard 7.5mg Injection 1'S

Introduction About ELIGARD 7.5MG INJECTION

ELIGARD 7.5MG INJECTION contains Leuprolide which belongs to the group of
medicines called Gonadotropin Releasing Hormone (GnRH) agonist. It is used for
palliative management (relieving symptoms and minimize the associated suffering)
of advanced prostatic cancer. It is also used in children to manage central
precocious puberty (CPP).

Advanced prostatic cancer is the cancer (abnormal cell multiplication and
differentiation) that originates in the prostate gland and spreads to the other
parts of the body. It is characterized by the symptoms such as painful
urination, decreased urine pressure, blood in the semen, bone pain, leg
swelling, and weakness.

Central precocious puberty (CPP) is the early onset of sexual characteristics in
girls (generally earlier than 8 years) and boys (generally earlier than 9 years
of age in boys) due to activation of pubertal pituitary gonadotropins. It may
result in diminished adult height.

Do not receive ELIGARD 7.5MG INJECTION if you are allergic to Leuprolide, GnRH,
GnRH agonist analogs.

Before receiving this medicine, inform your doctor if you have liver impairment,
kidney impairment, congenital long QT syndrome, congestive heart failure,
frequent electrolyte abnormalities, metastatic vertebral lesions, urinary tract
obstruction, or diabetes.

Before receiving this medicine, inform your doctor if you have history of
seizures, epilepsy, cerebrovascular disorders, or central nervous system
anomalies/tumours.

ELIGARD 7.5MG INJECTION is not recommended for use in pregnant women,
breastfeeding women, and children (below 2 years). It should be used with
caution in elderly patients (aged above 65 years). Consult your doctor before
receiving.

The common side effects associated with the use of ELIGARD 7.5MG INJECTION are
hot flashes/sweating, general pain, headache, infection, gastrointestinal
disorders, swelling due to water retention, and respiratory disorders. Consult
your doctor if any of these side effects worsens.

Uses Of ELIGARD 7.5MG INJECTION

It is used:

• for palliative management (relieving symptoms and minimize the associated suffering) of advanced prostatic cancer
• to manage central precocious puberty (CPP)

How ELIGARD 7.5MG INJECTION Works

ELIGARD 7.5MG INJECTION contains Leuprolide works by blocking the secretion of
gonadotropin releasing hormone (GnRH) following an initial stimulation,
resulting in suppression of ovarian and testicular steroidogenesis (process of
synthesis of steroid hormones), thereby relieving the symptoms associated with
increased levels of sex hormones.

How to use ELIGARD 7.5MG INJECTION

ELIGARD 7.5MG INJECTION will be administered to you only by a doctor or a nurse
intramuscularly (into the muscle). Your doctor will administer the correct dose
and duration for you depending upon your age, body weight and disease condition.

Side Effects Of ELIGARD 7.5MG INJECTION

Common

• hot flashes/sweating
• general pain
• headache
• infection
• gastrointestinal disorders
• swelling due to water retention
• respiratory disorders
• urinary disorders
• shrinking of testicles
• impotence
• reduced libido
• injection site reactions including abscess
• dilation of blood vessels
• acne
• seborrhoea (scaly condition of scalp)
• rash including erythema multiforme (a condition causing red patches)
• emotional lability
• vaginitis, abnormal vaginal discharge or vaginal bleeding

Rare

Stop receiving ELIGARD 7.5MG INJECTION and contact your doctor if you experience
any of the following side effects:

• signs of pituitary apoplexy such as sudden headache, visual changes, vomiting, weakened eye muscles, altered mental status, sudden loss of heart function

How To Manage Side Effects

Headache:

Take rest and plenty of water. Avoid taking alcohol and skipping meals. Do not
strain your eyes by watching screen for long time. Consult your doctor if the
condition persists for long or gets worsened.

Warning & Precautions

!### Pregnancy

ELIGARD 7.5MG INJECTION is not recommended for use during pregnancy. Consult
your doctor before receiving.

!### Breastfeeding

ELIGARD 7.5MG INJECTION is not recommended for use in breastfeeding women as it
is not known whether it can pass through milk. Consult your doctor before
receiving.

!### Kidney

ELIGARD 7.5MG INJECTION should be used with caution in patients with renal
impairment. Consult your doctor before receiving.

!### Liver

ELIGARD 7.5MG INJECTION should be used with caution in patients with hepatic
impairment. Consult your doctor before receiving.

!### Allergy

Do not receive ELIGARD 7.5MG INJECTION if you are allergic to Leuprolide, GnRH,
GnRH agonist analogs, or to any of the other ingredients of this medicine.

!### Heart Disease

ELIGARD 7.5MG INJECTION should be used with caution in patients with congenital
long QT syndrome and congestive heart failure only if clearly necessary. Consult
your doctor before receiving.

Others

Before receiving ELIGARD 7.5MG INJECTION, inform your doctor if you:

• have frequent electrolyte abnormalities
• have metastatic vertebral lesions
• have urinary tract obstruction
• have diabetes
• have history of seizures
• have history of cerebrovascular disorders
• have history of central nervous system anomalies or tumours

Use in pediatrics:

ELIGARD 7.5MG INJECTION is not recommended for use in children (below 2 years).
Consult your doctor before receiving.

Use in geriatrics:

ELIGARD 7.5MG INJECTION should be used with caution in elderly patients (above
65 years). Consult your doctor before receiving.

Interactions

A. Drug-Drug Interactions:

Before receiving ELIGARD 7.5MG INJECTION, inform your doctor, if you are taking
any of the following medicine:

• medicines that prolong the QT interval (Ex. haloperidol, amiodarone, erythromycin)

Overdosage:

ELIGARD 7.5MG INJECTION will be administered to you only by a doctor or nurse in
a hospital, and so it is unlikely to receive an overdose. If you or anyone else
accidentally receives too much of this medicine, consult your doctor immediately
or visit the nearby hospital. Symptoms of overdose are shortness of breath,
decreased activity, increased scratching, and irritation at the site of
injection.

Synopsis

Drug	:	Leuprolide
Pharmacological Category	:	Gonadotropin Releasing Hormone (GnRH) Agonist
Therapeutic Indication	:	Palliative management for advanced prostatic cancer, Central precocious puberty
Dosage Forms	:	Injection, Injection depot

More Information

• Keep ELIGARD 7.5MG INJECTION out of reach of children
• Store below 30°C

FAQs About ELIGARD 7.5MG INJECTION

What ELIGARD 7.5MG INJECTION is used for?

ELIGARD 7.5MG INJECTION for palliative management (relieving symptoms and
minimize the associated suffering) of advanced prostatic cancer. It is also used
in children to manage central precocious puberty (CPP). Consult your doctor
before receiving.

What side effects are seen with ELIGARD 7.5MG INJECTION?

The common side effects associated with the use of ELIGARD 7.5MG INJECTION are
hot flashes/sweating, general pain, headache, infection, gastrointestinal
disorders, swelling due to water retention, and respiratory disorders. Consult
your doctor if any of these side effects worsens.

Who should avoid receiving ELIGARD 7.5MG INJECTION?

Do not receive ELIGARD 7.5MG INJECTION if you are allergic to Leuprolide, GnRH,
GnRH agonist analogs. It is not recommended for use in pregnant women,
breastfeeding women, and children (below 2 years). Consult your doctor before
receiving.

Is ELIGARD 7.5MG INJECTION safe to use in children?

ELIGARD 7.5MG INJECTION is not recommended for use in children (below 2 years)
because safety and effectiveness of this medicine have not been established in
this population. Consult your doctor before receiving.

Is ELIGARD 7.5MG INJECTION safe to use in pregnant and breastfeeding women?

ELIGARD 7.5MG INJECTION is not recommended for use during pregnancy as it may
increase the risk for pregnancy loss. It is also not recommended for use in
breastfeeding women as it is not known whether it can pass through milk. Consult
your doctor before receiving.

What is the method of receivingELIGARD 7.5MG INJECTION?

ELIGARD 7.5MG INJECTION will be given to you only by a doctor or a nurse
intramuscularly (into the muscle). Your doctor will decide the correct dose and
duration for you depending upon your age, body weight and disease condition.

What happens if you take more ELIGARD 7.5MG INJECTION than your required
dose?

ELIGARD 7.5MG INJECTION will be given to you only by a doctor or nurse in a
hospital, and so it is unlikely to receive an overdose. If you or anyone else
accidentally receives too much of this medicine, consult your doctor immediately
or visit the nearby hospital. Symptoms of overdose are shortness of breath,
decreased activity, increased scratching, and irritation at the site of
injection.

Is ELIGARD 7.5MG INJECTION safe to use in heart patients?

ELIGARD 7.5MG INJECTION should be used with caution in patients with congenital
long QT syndrome and congestive heart failure only if clearly necessary. Consult
your doctor before receiving.