NEWMON R 225 Prefilled Syringe(Pfs) 0.4ml

Introduction About NEWMON R 225 PREFILLED SYRINGE(PFS)

NEWMON R 225 PREFILLED SYRINGE(PFS) contains Urofollitropin which belongs to the
group of medicines called Gonadotropins. It helps your body produce sufficient
levels of female sex hormones (estrogen) that is required for conce

Prior to the management, your doctor may evaluate your and your partner’s
fertility status thoroughly as a precaution. During management with NEWMON R 225
PREFILLED SYRINGE(PFS), your doctor will closely monitor your health condition
through several blood tests and ultrasounds to avoid the risk of side effects.

Before receiving NEWMON R 225 PREFILLED SYRINGE(PFS) inform your doctor if you
have any unexplained vaginal bleeding, blood clot problems or any tumours in the
brain, breast, uterus or ovaries. You must also inform your doctor if you have
any damage in the fallopian tubes, as management with NEWMON R 225 PREFILLED
SYRINGE(PFS) may cause ectopic pregnancy (pregnancy outside of the womb) in such
cases.

NEWMON R 225 PREFILLED SYRINGE(PFS) should not be used in pregnant women after
successful conce
and in children or adolescents (aged below 18 years) due to lack of safety data.

The most common side effects of receiving NEWMON R 225 PREFILLED SYRINGE(PFS)
are hot flushes, stomach pain, headache and injection site reactions (such as
pain, redness, and swelling). Consult your doctor if they worsen.

Uses Of NEWMON R 225 PREFILLED SYRINGE(PFS)

• Supports reproductive health in women

How NEWMON R 225 PREFILLED SYRINGE(PFS) Works

NEWMON R 225 PREFILLED SYRINGE(PFS) supplements your body with a sufficient
levels of a female sex hormone called estrogen that is required to maintain
proper functioning of female genital system.

How to use NEWMON R 225 PREFILLED SYRINGE(PFS)

NEWMON R 225 PREFILLED SYRINGE(PFS) will be given to you only by a doctor or a
nurse into the muscles (intramuscularly) or under the skin (subcutaneously). It
can also be self-administered by the patient if instructed by the doctor.
Carefully follow the instructions given by your doctor in case of
self-administration.

Your doctor will decide the correct dose and duration of therapy depending upon
your age, body weight and disease condition.

Side Effects Of NEWMON R 225 PREFILLED SYRINGE(PFS)

Common

• injection site reactions (pain, redness, itching or swelling)
• headache
• stomach pain, bloated stomach
• urinary tract infection
• inflammation of throat and nasal passage
• hot flushes
• nausea, vomiting, stomach discomfort, diarrhoea, constipation
• skin rash

Uncommon

• overactive thyroid gland (hyperthyroidism)
• changes in mood
• feeling tired
• dizziness
• nose bleeds
• breast enlargement and pain
• vaginal bleeding or discharge

Contact your doctor immediately if you experience any of the following side
effects after receiving NEWMON R 225 PREFILLED SYRINGE(PFS):

• signs of ovarian hyperstimulation syndrome (such as lower abdominal pain with sensation of nausea or vomiting, weight gain, difficulty in breathing, difficulty in passing urine, enlarged ovaries and fluid build-up in chest or abdomen)
• signs of allergic reactions (such as skin rash, itching, swelling of the eyes, face, lips, tongue or throat leading to difficulty in breathing or swallowing)

How To Manage Side Effects

!### Constipation

Taking NEWMON R 225 PREFILLED SYRINGE(PFS) with meals may reduce the chances of
constipation. However, if you experience constipation, eat plenty of fiber rich
foods such as fresh fruits, vegetables and cereals. Drink plenty of fluids.
Exercise more regularly. Consult your doctor if this side effect bothers you.

!### Dizziness Or Drowsiness

Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or
machines completely while you are feeling dizzy. Do not consume excessive
alcohol, as it could aggravate your dizziness. Consult your doctor if your
dizziness worsens.

Headache

Rest and relax. Keep yourself hydrated by drinking plenty of fluids such as
water or electrolytes. Applying a pain-relieving balm on your forehead can be
beneficial. Do not consume excessive alcohol, as it could aggravate your
headache. Consult your doctor if your headache worsens.

!### Injection Site Reactions

Place an ice pack on the affected area. Do not frequently move the injection
site. Consult your doctor if the symptom did not improve.

!### Nausea And Vomiting

Take NEWMON R 225 PREFILLED SYRINGE(PFS) with or just after meals. Stick to
simple meals. Avoid eating oil rich or spicy foods. Consult your doctor if your
symptom worsens.

Warning & Precautions

!### Pregnancy

ContraindicatedNEWMON R 225 PREFILLED SYRINGE(PFS) is not recommended for use in pregnant
women. Therefore, consult your doctor before receiving it.

!### Breastfeeding

ContraindicatedNEWMON R 225 PREFILLED SYRINGE(PFS) is not recommended for use in breastfeeding
women. Therefore, consult your doctor before receiving it.

!### Driving and Using Machines

Use with CautionNEWMON R 225 PREFILLED SYRINGE(PFS) does not affect your ability to drive or
operate machinery. However, do not drive or handle any heavy tools or machines
if your ability is affected by NEWMON R 225 PREFILLED SYRINGE(PFS).

!### Alcohol

Consult your doctorAvoid consum
SYRINGE(PFS).

!### Allergy

ContraindicatedTalk to your doctor before receiving NEWMON R 225 PREFILLED SYRINGE(PFS) if you
are allergic to Urofollitropin.

!### Use In Pediatrics

Consult your doctorThe safety and effectiveness of NEWMON R 225 PREFILLED SYRINGE(PFS) have not
been established in children and adolescents (aged below 18 years). Therefore,
consult your doctor for advice.

!### Use In Geriatrics

Use with CautionNEWMON R 225 PREFILLED SYRINGE(PFS) should be used with caution in elderly
patients (aged 65 years or older). Therefore, consult your doctor before
receiving it.

Others

NEWMON R 225 PREFILLED SYRINGE(PFS) is not recommended for use if you:

• have primary ovarian failure (ovaries that do not produce eggs)
• have problems with thyroid, pituitary or adrenal glands

Before receiving NEWMON R 225 PREFILLED SYRINGE(PFS), inform your doctor if you:

• have overactive thyroid gland
• have hyperprolactinemia (high levels of a hormone called prolactin in blood)
• have any tumours in the breasts, uterus, pituitary gland or hypothalamus
• have polycystic ovarian disease or enlarged ovaries
• have any malformation of sex organs that hinders pregnancy
• have undiagnosable vaginal bleeding
• have fibroids in the uterus
• had an early menopause
• have blood clots in the body or have a family history of blood clots
• are overweight

Interactions

A. Drug-Drug interactions:

Before receiving NEWMON R 225 PREFILLED SYRINGE(PFS), inform your doctor if you
are taking any of the following medicines:

• Clomiphene citrate (another medicine used in the management of female infertility)

Overdosage:

NEWMON R 225 PREFILLED SYRINGE(PFS) 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.

Synopsis

Drug	:	Urofollitropin
Pharmacological Category	:	Ovulation stimulators
Therapeutic Indication	:	Female Infertility
Dosage Forms	:	Injection, Pre-filled syringes (PFS), Cartridge

More Information

Storage

• Keep NEWMON R 225 PREFILLED SYRINGE(PFS) out of reach of children
• Store NEWMON R 225 PREFILLED SYRINGE(PFS) at room temperature

FAQs About NEWMON R 225 PREFILLED SYRINGE(PFS)

Q. What is the use of NEWMON R 225 PREFILLED SYRINGE(PFS)?

A. NEWMON R 225 PREFILLED SYRINGE(PFS) supplements your body with a sufficient
levels of a female sex hormone called estrogen that is required to maintain
proper functioning of female genital system.

Q. How NEWMON R 225 PREFILLED SYRINGE(PFS) is administered?

A. NEWMON R 225 PREFILLED SYRINGE(PFS) will be given to you only by a doctor or
a nurse into the vein (intravenously) or under the skin (subcutaneously). It can
also be self-administered by the patients if advised by the physician.
Carefully, follow the instructions given by the doctor in case of
self-administration.

Q. What precautions must be followed while receiving NEWMON R 225 PREFILLED SYRINGE(PFS)?

A. Before receiving NEWMON R 225 PREFILLED SYRINGE(PFS) inform your doctor if
you have any unexplained vaginal bleeding, blood clot problems or any tumours in
the brain, breast, uterus or ovaries. You must also inform your doctor if you
have any damage in the fallopian tubes, as management with NEWMON R 225
PREFILLED SYRINGE(PFS) may cause ectopic pregnancy (pregnancy outside of the
womb) in such cases. NEWMON R 225 PREFILLED SYRINGE(PFS) should not be used in
pregnant women after successful conce
perform all blood tests and ultrasounds recommended by him/her without fail.

Q. Is NEWMON R 225 PREFILLED SYRINGE(PFS) safe?

A. NEWMON R 225 PREFILLED SYRINGE(PFS) is considered safe at the doses
administered by the physician. However, consult your doctor if you experience
any unusual side effects.

Q. What are the common side effects of receiving NEWMON R 225 PREFILLED SYRINGE(PFS)?

A. The most common side effects of receiving NEWMON R 225 PREFILLED SYRINGE(PFS)
are hot flushes, stomach pain, headache and injection site reactions (such as
pain, redness, and swelling). Consult your doctor if they worsen.

Q. Can I stop receiving NEWMON R 225 PREFILLED SYRINGE(PFS) once my symptoms subside?

A. Do not stop taking NEWMON R 225 PREFILLED SYRINGE(PFS) without consulting
your doctor. You need to receive NEWMON R 225 PREFILLED SYRINGE(PFS) for the
duration recommended by your doctor to achieve better results.

Q. Can I use NEWMON R 225 PREFILLED SYRINGE(PFS) during pregnancy?

A. NEWMON R 225 PREFILLED SYRINGE(PFS) should not be used in pregnant women
after successful conce

Q. Can NEWMON R 225 PREFILLED SYRINGE(PFS) be used in children?

A. The safety and effectiveness of NEWMON R 225 PREFILLED SYRINGE(PFS) have not
been established in children and adolescents (aged below 18 years). Therefore,
consult your doctor for advice.

Useful Diagnostic Tests

• Anti-Mullerian Hormone
• Glycosylated Haemoglobin
• Testosterone Total
• Thyroid Stimulating Hormone