FIBRISTONE 25mg Tablet 10's

Introduction About FIBRISTONE 25MG TABLET

FIBRISTONE 25MG TABLET contains Mifepristone which belongs to the group of
medicines called Progestin antagonist. It is used as an emergency contrace
to manage pregnancy in women after an unprotected sexual intercourse. It should
be used within 72 hours following sexual intercourse to achieve better birth
control.

It can also be used to reduce the size of the fibroid growths (non-cancerous
tumours) in the uterine layers. FIBRISTONE 25MG TABLET should only be used
during emergency situations and therefore should not replace a regular
contrace

Before taking FIBRISTONE 25MG TABLET inform your doctor if you have any sever
liver or kidney problems. You must also inform your doctor if you have any
hormonal problems due to problems in adrenal gland, unexplained vaginal
bleeding, cancer in the womb, overgrowth of uterine layers (endometrial
hyperplasia) or bleeding disorders.

FIBRISTONE 25MG TABLET is intended for use as a contrace
it should not be used in women who are pregnant or planning to conceive a child.
It is not recommended for use in breastfeeding women and in female children who
have not attained their puberty.

The most common side effects of taking FIBRISTONE 25MG TABLET areleg cramps, hot
flushes, weakness, racing heartbeat, headache and sleepiness. Consult your
doctor if any of these side effects trouble you.

Uses Of FIBRISTONE 25MG TABLET

• Prevents pregnancy after unprotected sex
• Controls fibroid growths (non-cancerous tumours) in the uterus

How FIBRISTONE 25MG TABLET Works

FIBRISTONE 25MG TABLET is a contrace
actions of a female sex hormone called progesterone which is responsible for
sustaining pregnancy. This causes shedding of the uterine layers which makes it
more difficult for the foetus to implant and grow and therefore manages
pregnancy. It also reduces fibroid growth in the uterus and maintains the
structure and functions of the uterine layers.

How to use FIBRISTONE 25MG TABLET

Take FIBRISTONE 25MG TABLET as advised by your physician. Swallow the medicine
with a glass of water. Do not crush or chew the medicine.

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

Side Effects Of FIBRISTONE 25MG TABLET

Common

• leg cramps
• hot flushes
• weakness
• racing heartbeat
• headache
• sleepiness

Rare

Stop taking FIBRISTONE 25MG TABLET and contact your doctor immediately if you
experience any of the following side effects such as:

• signs of allergic reactions (such as skin rash, itching, light headedness, wheezing, clammy skin, itchy welts, swelling (in legs and arms))
• abdominal pain, infection, sepsis
• vaginal bleeding

How To Manage Side Effects

Headache:

Take rest and relax. Drink plenty of fluids. Avoid alcohol consum
aggravate your headache. Ask your doctor to recommend a painkiller. Headaches
should usually go away after the first week of taking FIBRISTONE 25MG TABLET. If
it lasts more than a week or became severe, inform your doctor.

Warning & Precautions

!### Pregnancy

FIBRISTONE 25MG TABLET is indicated as a contrace
pill). Therefore, it should not be used in women who are pregnant or planning to
become pregnant. However, consult your doctor before taking it.

!### Breastfeeding

FIBRISTONE 25MG TABLET is generally not recommended for use in breastfeeding
women as it may pass to the nursing infant through the breast milk. Therefore,
consult your doctor before taking it.

!### Driving and Using Machines

Do not drive or operate any heavy tools or machines if your ability is affected
by FIBRISTONE 25MG TABLET.

!### Kidney

FIBRISTONE 25MG TABLET is not recommended for use in patients with severe kidney
disease (such as undiagnosed renal masses). Therefore, consult your doctor
before taking it.

!### Liver

FIBRISTONE 25MG TABLET is not recommended for use in patients with severe liver
disorders. Therefore, consult your doctor before taking it.

!### Allergy

Do not take FIBRISTONE 25MG TABLET if you are allergic to mifepristone or to any
other ingredients of this medicine.

Others

FIBRISTONE 25MG TABLET is not recommended for use if you:

• suffer from Cushing syndrome (a hormonal problem caused due to abnormal functions of the adrenal gland)
• have unexplained vaginal bleeding
• have endometrial cancer (a cancer that develops in the uterine lining)
• have endometrial hyperplasia (excessive growth of uterine tissues)
• have ectopic pregnancy (pregnancy outside the uterus)
• use intrauterine device (birth control device to manage pregnancy)
• have any bleeding disorders
• have severe anaemia

Use in Paediatrics:

FIBRISTONE 25MG TABLET should be used in post pubertal female children (aged
between 14-18 years) only if prescribed by the physician. It is not intended for
use in male children and should not be used in female children who have not
attained their puberty. Therefore, consult your doctor before taking it.

Use in Geriatrics:

FIBRISTONE 25MG TABLET should be used with caution in the elderly patients.
Therefore, consult your doctor before taking it.

Interactions

A. Drug - Drug interactions:

Before taking FIBRISTONE 25MG TABLET inform your doctor if you are taking any of
the following medicines such as:

• simvastatin, lovastatin (medicines used to reduce blood cholesterol levels)
• dihydroergotamine, ergotamine (used to manage migraine)
• fentanyl (a medicine used for pain relief)
• sirolimus, tacrolimus, cyclosporin (used to suppress immune function and to manage graft rejection)

Overdosage:

If you or anyone else accidentally took more FIBRISTONE 25MG TABLET, consult
your doctor immediately or visit the nearby hospital.

Synopsis

Drug	:	Mifepristone
Pharmacological Category	:	Progestin antagonist
Therapeutic Indication	:	Prevents Pregnancy, Manages Fibroids
Dosage Forms	:	Tablet, Capsule, Kit

More Information

• Keep FIBRISTONE 25MG TABLET out of reach of children
• Store FIBRISTONE 25MG TABLET below 30°C

FAQs About FIBRISTONE 25MG TABLET

What is the use of FIBRISTONE 25MG TABLET?

FIBRISTONE 25MG TABLET is an emergency contrace
women after an unprotected sexual intercourse. It should be used within 72 hours
following sexual intercourse to achieve better birth control. It can also be
used to reduce the size of the fibroid growths (non-cancerous tumours) in the
uterine layers

How FIBRISTONE 25MG TABLET works?

FIBRISTONE 25MG TABLET is a contrace
actions of a female sex hormone called progesterone which is responsible for
sustaining pregnancy. This causes shedding of the uterine layers which makes it
more difficult for the foetus to implant and grow and therefore manages
pregnancy. It also reduces fibroid growth in the uterus and maintains the
structure and functions of the uterine layers.

How should I take FIBRISTONE 25MG TABLET?

Take FIBRISTONE 25MG TABLET as advised by your physician. Swallow the medicine
with a glass of water. Do not crush or chew the medicine.

What are the common side effects of taking FIBRISTONE 25MG TABLET?

The most common side effects of taking FIBRISTONE 25MG TABLET are leg cramps,
hot flushes, weakness, racing heartbeat, headache, and sleepiness. Consult your
doctor if any of these side effects trouble you.

What precautions need to be followed while taking FIBRISTONE 25MG TABLET?

Before taking FIBRISTONE 25MG TABLET inform your doctor if you have any sever
liver or kidney problems. You must also inform your doctor if you have any
hormonal problems due to problems in adrenal gland, unexplained vaginal
bleeding, cancer in the womb, overgrowth of uterine layers (endometrial
hyperplasia) or bleeding disorders. Visit your gynaecologist as per the schedule
and confirm the management of pregnancy through blood tests and ultrasound.

Is it safe to take FIBRISTONE 25MG TABLET immediately after delivery?

Consult your doctor before taking FIBRISTONE 25MG TABLET as it may increase the
risk of blood clots in such patients. However, consult your doctor before taking
it.

Can FIBRISTONE 25MG TABLET be used in children?

FIBRISTONE 25MG TABLET should be used with caution in post pubertal female
children aged below 18 years. It is not intended for use in male children and in
female children who have not attained puberty. Therefore, consult your doctor
before taking it.

Can FIBRISTONE 25MG TABLET be used in post-menopausal women?

FIBRISTONE 25MG TABLET is a contrace
not intended for use in post-menopausal women.

Will the use FIBRISTONE 25MG TABLET affect my future chances for pregnancy?

Studies have not shown any negative effects of FIBRISTONE 25MG TABLET on
fertility. Therefore, your chances for pregnancy in the future will not be
affected by FIBRISTONE 25MG TABLET.

Can the use of FIBRISTONE 25MG TABLET cause unexpected bleeding?

Yes. Irregular vaginal bleeding or spotting may occur while you are taking
FIBRISTONE 25MG TABLET. Such bleeding may be temporary and usually does not
indicate any serious problems. However, consult your doctor if you experience
prolonged painful bleeding.

How and when should I take FIBRISTONE 25MG TABLET?

Take FIBRISTONE 25MG TABLET within 72 hours following unprotected intercourse.
You must follow the instructions of your doctor regarding the frequency of
administration. Swallow FIBRISTONE 25MG TABLET with a glass of water. Do not
crush or chew it.

What to do if I forgot to take FIBRISTONE 25MG TABLET?

Take FIBRISTONE 25MG TABLET within 72 hours following unprotected intercourse.
Failing to do so, may increase the chances of pregnancy. Consult your doctor
immediately regarding pregnancy termination if you forget to take your dose of
FIBRISTONE 25MG TABLET.

Will the use of FIBRISTONE 25MG TABLET change the length of menstrual cycle?

Yes. FIBRISTONE 25MG TABLET may delay your regular menstrual periods. Also,
there are chances for sudden spotting or vaginal bleeding while taking
FIBRISTONE 25MG TABLET. But there is no reported evidence for long menstrual
cycles.

Will the use of FIBRISTONE 25MG TABLET produce complete protection from
pregnancy?

FIBRISTONE 25MG TABLET may only help in managing pregnancy during emergency
conditions. You must follow your regular birth control pills along with
FIBRISTONE 25MG TABLET to achieve successful birth control. After taking
FIBRISTONE 25MG TABLET you must consult your doctor for advice. Your doctor will
analyse your condition and confirm whether pregnancy termination is required or
not.

Does FIBRISTONE 25MG TABLET stops periods?

No. FIBRISTONE 25MG TABLET is a birth control pill used to manage pregnancy. It
is not proven to stop periods. However, it may delay your periods or can cause
irregular or scanty periods.