LUPNIZA DEPOT Combi Kit 1's

Introduction About LUPNIZA DEPOT COMBI KIT

LUPNIZA DEPOT COMBI KIT contains Leuprolide which belongs to the group of
medicines called Gonadotropin Releasing Hormone (GnRH) agonist. It is used to
manage endometriosis, relieving pain and reducing endometriotic lesions. It is
also used for preoperative hematologic improvement in women having fibroids
(abnormal growth in uterus) induced anaemia for whom hormonal suppression is
considered necessary for three months.

Endometriosis is a chronic disease in which a tissue like the uterus lining
grows outside the uterus, resulting in pain and/or infertility. It is
characterized by symptoms such as pain during periods, pelvic pain, pain
associated with sexual intercourse, painful urination, fatigue, depression,
bloating and nausea.

Do not receive LUPNIZA DEPOT COMBI KIT if you are allergic to Leuprolide, GnRH,
or GnRH agonist analogs.

Before receiving this medicine, inform your doctor if you have liver impairment,
kidney impairment, or undiagnosed abnormal uterine bleeding.

Inform your doctor if you are chronic alcohol or tobacco user or have strong
family history of osteoporosis or chronic use of medicines.

LUPNIZA DEPOT COMBI KIT is not recommended for use in pregnant women. It should
be used with caution in breastfeeding women only if considered necessary. It is
not recommended for use in premenarcheal children and postmenopausal women.
Consult your doctor before receiving.

The common side effects associated with the use of LUPNIZA DEPOT COMBI KIT are
hot flashes/sweating, general pain, headache, gastrointestinal disorders,
swelling due to water retention, nausea, vomiting, reduced libido, and
dizziness. Consult your doctor if any of these side effects worsens.

Uses Of LUPNIZA DEPOT COMBI KIT

It is used:

• to manage endometriosis, relieving pain and reducing endometriotic lesions
• used for preoperative hematologic improvement in women having fibroids induced anaemia for whom hormonal suppression is considered necessary for three months

How LUPNIZA DEPOT COMBI KIT Works

LUPNIZA DEPOT COMBI KIT contains Leuprolide which helps in managing
endometriosis and fibroids. It 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 LUPNIZA DEPOT COMBI KIT

LUPNIZA DEPOT COMBI KIT will be administered to you only by a doctor or a nurse
intramuscularly (into the muscle). Your doctor will adminster the correct dose
and duration for you depending upon your age, body weight and disease condition.

Side Effects Of LUPNIZA DEPOT COMBI KIT

Common

• hot flashes/sweating
• headache
• vaginitis (inflammation in the vagina)
• depression/emotional lability
• general pain
• weight gain or loss
• nausea
• vomiting
• reduced libido
• dizziness
• acne
• skin reactions
• joint disorder
• oedema (swelling due to water retention)
• paraesthesia (sensation of burning and pricking)
• gastrointestinal disturbances
• neuromuscular disorders
• breast changes or breast pain
• nervousness
• extreme weakness
• urinary tract infection

Rare

Stop receiving LUPNIZA DEPOT COMBI KIT 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
• urinary tract infection
• renal calculus (kidney stones)
• depression

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.

Dizziness:

Lie down  until the dizziness passes and get up slowly. Do not bend down
suddenly. Get a lot of rest. Walk slowly and carefully. Take plenty of fluids.
Avoid drinking coffee, alcohol, or smoking. Consult your doctor if the condition
persists for long or gets worsened.

Nausea and Vomiting:

Try to eat more high-fibre foods such as fresh fruit, vegetables, cereals, and
drink plenty of water. Try doing exercise regularly (going for a daily walk or
run). Stick to simple meals. Avoid eating rich or spicy food. Consult your
doctor if the symptom gets worse.

Warning & Precautions

!### Pregnancy

LUPNIZA DEPOT COMBI KIT is not recommended for use during pregnancy as it may
increase the risk of pregnancy complications such as early pregnancy loss and
foetal harm. Consult your doctor before receiving.

!### Breastfeeding

LUPNIZA DEPOT COMBI KIT should be used with caution breastfeeding women only if
considered necessary because it is not known whether it can pass through milk.
Consult your doctor before receiving.

!### Kidney

LUPNIZA DEPOT COMBI KIT should be used with caution in patients with renal
impairment. Consult your doctor before receiving.

!### Liver

LUPNIZA DEPOT COMBI KIT should be used with caution in patients with hepatic
impairment. Consult your doctor before receiving.

!### Allergy

Do not receive LUPNIZA DEPOT COMBI KIT if you are allergic to Leuprolide, GnRH,
GnRH agonist analogs, or to any of the other ingredients of this medicine.

Others

LUPNIZA DEPOT COMBI KIT is not recommended for use if you:

• have undiagnosed abnormal uterine bleeding

Before receiving LUPNIZA DEPOT COMBI KIT, inform your doctor if you:

• have strong family history of osteoporosis

Use in pediatrics:

LUPNIZA DEPOT COMBI KIT is not recommended for use in premenarcheal children and
adolescents (below 18 years). Consult your doctor before receiving.

Use in geriatrics:

LUPNIZA DEPOT COMBI KIT is not recommended for use in postmenopausal women.
Consult your doctor before receiving.

Interactions

A. Drug-Drug Interactions:

Before receiving LUPNIZA DEPOT COMBI KIT, inform your doctor, if you are taking
any of the following medicine:

• medicines used to manage convulsions (Ex. carbamazepine)
• corticosteroids (Ex. dexamethasone)

Overdosage:

LUPNIZA DEPOT COMBI KIT 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.

Synopsis

Drug	:	Leuprolide
Pharmacological Category	:	Gonadotropin Releasing Hormone (GnRH) agonist
Therapeutic Indication	:	Endometriosis, Fibroids
Dosage Forms	:	Injection, Injection depot

More Information

• Keep LUPNIZA DEPOT COMBI KIT out of reach of children
• Store at 2° to 8°C

FAQs About LUPNIZA DEPOT COMBI KIT

What is LUPNIZA DEPOT COMBI KIT used for?

LUPNIZA DEPOT COMBI KIT is used to manage endometriosis, relieving pain, and
reducing endometriotic lesions. It is also used for preoperative hematologic
improvement in women having fibroids (abnormal growth in uterus) induced anaemia
for whom hormonal suppression is considered necessary for three months. Consult
your doctor before receiving.

What side effects are seen with LUPNIZA DEPOT COMBI KIT?

The common side effects associated with the use of LUPNIZA DEPOT COMBI KIT are
hot flashes/sweating, general pain, headache, gastrointestinal disorders,
swelling due to water retention, nausea, vomiting, reduced libido, and
dizziness. Consult your doctor if any of these side effects worsens.

Who should avoid receiving LUPNIZA DEPOT COMBI KIT?

Do not receive LUPNIZA DEPOT COMBI KIT if you are allergic to Leuprolide, GnRH,
or GnRH agonist analogs. It is not recommended for use in pregnant women,
premenarcheal children and postmenopausal women. Consult your doctor before
receiving.

Is LUPNIZA DEPOT COMBI KIT safe to use in children?

LUPNIZA DEPOT COMBI KIT is not recommended for use in premenarcheal children and
adolescents (below 18 years). However, the efficacy of this medicine is expected
to be the same for post pubertal adolescents (below 18 years) as for women (aged
18 years or older). Consult your doctor before receiving.

Is LUPNIZA DEPOT COMBI KIT safe to use in elderly patients?

LUPNIZA DEPOT COMBI KIT is not recommended for use in postmenopausal women.
Menopause is natural cessation of menstrual cycles that marks the end of
reproductive life in females. Consult your doctor before receiving this
medicine.

Is LUPNIZA DEPOT COMBI KIT safe to use in pregnant women?

LUPNIZA DEPOT COMBI KIT is not recommended for use during pregnancy as it may
increase the risk of pregnancy complications such as early pregnancy loss and
foetal harm. Consult your doctor before receiving.

Is LUPNIZA DEPOT COMBI KIT safe to use in breastfeeding women?

LUPNIZA DEPOT COMBI KIT should be used with caution breastfeeding women only if
considered necessary because it is not known whether it can pass through milk.
Consult your doctor before receiving.