Colette 0.5mg Tablet 2'S

Introduction About COLETTE 0.5MG TABLET

COLETTE 0.5MG TABLET contains cabergoline, which belongs to the group of
medicines called dopamine agonists. Dopamine is a chemical produced naturally in
the body that helps transmit messages to the brain. Cabergoline works by
blocking the release of prolactin hormone in the brain and controlling symptoms
associated with hormonal disturbances.

COLETTE 0.5MG TABLET is not recommended for use in patients with severe liver
disease, stiff and inflamed heart valves (cardiac valvulopathy) and uncontrolled
high blood pressure. Consult your doctor before taking it.

COLETTE 0.5MG TABLET should be used with caution in patients with pain in the
chest while breathing, fluid in the lungs, inflammation or infection of the
lungs, reduced liver function, kidney problems, cardiovascular diseases, low
blood pressure. Consult your doctor before taking it.

COLETTE 0.5MG TABLET is not recommended for use in pregnant women and
breast-feeding women. It is also not recommended for use in children under 16
years of age. Consult your doctor before taking it.

The most common side effects after taking COLETTE 0.5MG TABLET are drowsiness,
nausea, headache, dizziness, vertigo, stomach pain, indigestion, inflamed
stomach lining, fatigue, lack of bodily strength, weakness. Consult your doctor
if any of the symptoms worsen.

Uses Of COLETTE 0.5MG TABLET

• Blocks the release of prolactin hormone in the brain

How COLETTE 0.5MG TABLET Works

COLETTE 0.5MG TABLET works by decreasing the amount of a hormone called
prolactin (a hormone that is responsible for milk production and breast tissue
development).

How to use COLETTE 0.5MG TABLET

Take COLETTE 0.5MG TABLET as advised by your physician. Swallow the medicine
with a glass of water. Do not crush or chew the medicine.

It can be taken with or after food to help reduce feelings of nausea or
vomiting. Your doctor will decide the correct dose and duration for you
depending upon your age, body weight and disease condition. You should not stop
taking COLETTE 0.5MG TABLET until your doctor tells you.

Side Effects Of COLETTE 0.5MG TABLET

Common

• drowsiness, headache
• nausea, vomiting, stomach pain, indigestion, inflamed stomach lining, constipation
• dizziness, vertigo
• fatigue, lack of bodily strength, weakness
• blurred vision
• low blood pressure after childbirth
• breast pain
• depression
• sleep disturbances, excessive daytime drowsiness/sleepiness
• low blood pressure (which can result in dizziness upon standing)
• hot flushes

Uncommon

• loss of hair
• severe itching, rash, hypersensitivity reaction
• fainting, shortness of breath
• nosebleed
• leg cramps, muscle spasm
• oedema
• irregular or strong heartbeat (palpitations)
• crawling, pins and needles sensation
• temporary partial vision loss
• cold hands and feet
• fibrotic reactions (including fibrosis affecting the lungs), fluid in the layers of the membrane lining the lungs and chest cavity (pleural effusion)

Rare

• cramp in fingers

Stop taking COLETTE 0.5MG TABLET and contact your doctor immediately if you
experience any of the following side effects:

• abnormal or unusual thoughts
• heart valve and related disorders Ex. inflammation of heart (pericarditis) or leakage of fluid in the pericardium (pericardial effusion). Symptoms include difficulty breathing, shortness of breath, pounding heart, feeling faint, chest pain, back pain, pelvic pain or swollen legs. These may be the first signs of a condition called pulmonary fibrosis, which can affect the lungs, heart or heart valves or lower back
• allergic reactions such as widespread itchy rash, difficulty breathing with or without wheezing, feeling faint, unexplained swelling of the body or tongue

How To Manage Side Effects

!### Constipation

Eat plenty of fibre rich foods such as fresh fruits, vegetables, and cereals and
drink plenty of water. Exercise more regularly. Contact your doctor if
constipation persist.

!### Diarrhea

Drink lots of fluids, such as water or fruit juices to keep yourself hydrated.
Do not take any medicine on your own for managing diarrhea. Contact your doctor
if the diarrhea did not improve.

!### Dizziness Or Drowsiness

Try to rest and relax. Get enough sleep. Avoid driving or operate any machines
while you are feeling dizzy. Do not consume alcohol, as it can aggravate your
dizziness. Contact your doctor if the dizziness did not improve.

Headache

Rest and relax. Drink plenty of fluids such as water or electrolytes and apply a
pain-relieving balm on the head if necessary. Do not consume alcohol. Contact
your doctor if the headache did not improve.

!### Nausea And Vomiting

Take the medicine with or just after a meal. Stick to simple meals. Avoid eating
oily or spicy food. Contact your doctor if nausea or vomiting did not improve.

!### Stomach Pain

Try to have smaller meals but take frequently. Keep a heat pad on your stomach.
Do not self-manage and contact your doctor if the stomach pain did not improve.

Warning & Precautions

!### Pregnancy

ContraindicatedCOLETTE 0.5MG TABLET is not recommended for use in pregnant women and you should
also take care not to become pregnant for at least one month once you have
stopped taking COLETTE 0.5MG TABLET.

If you become pregnant during management with COLETTE 0.5MG TABLET, stop taking
this medicine and contact your doctor who will then monitor your pregnancy as
COLETTE 0.5MG TABLET can result in congenital abnormalities if you use it during
pregnancy.

!### Breastfeeding

ContraindicatedCOLETTE 0.5MG TABLET is not recommended for use in breast feeding as this
medicine will stop you producing milk for your baby. If you need to take COLETTE
0.5MG TABLET you should use another method of feeding your baby.

!### Driving and Using Machines

Use with CautionDo not drive or operate any machines if you feel drowsy, and sudden sleepy after
taking COLETTE 0.5MG TABLET.

!### Alcohol

Consult your doctorAvoid alcohol consum
risk of dizziness.

!### Kidney

Use with CautionCOLETTE 0.5MG TABLET should be used with caution in patients with kidney
problems. Consult your doctor before taking COLETTE 0.5MG TABLET.

!### Liver

Consult your doctorCOLETTE 0.5MG TABLET is not recommended for use in patients with severe liver
disease. It should be used with caution in patients with reduced liver function.
Contact your doctor before taking COLETTE 0.5MG TABLET.

!### Allergy

Use with CautionDo not take COLETTE 0.5MG TABLET if you are allergic to Cabergoline or to other
medicines called ergot alkaloids (Ex. pergolide, bromocri
ergotamine or ergometrine) or to any of the other ingredients of this medicine
(lactose).

!### Lungs

Use with CautionCOLETTE 0.5MG TABLET should be used with caution in patients with pain in the
chest while breathing, fluid in the lungs, inflammation or infection of the
lungs. Consult your doctor before taking COLETTE 0.5MG TABLET.

!### Heart Disease

Consult your doctorCOLETTE 0.5MG TABLET is not recommended for use in patients with stiff and
inflamed heart valves (cardiac valvulopathy) and uncontrolled high blood
pressure.

It should be used with caution in patients with cardiovascular diseases (disease
that affects the heart and blood vessels), low blood pressure (postural
hypotension). Consult your doctor before taking COLETTE 0.5MG TABLET.

!### Use In Pediatrics

ContraindicatedCOLETTE 0.5MG TABLET is generally not recommended for use in children under 16
years of age. Consult your doctor before taking it.

!### Use In Geriatrics

Use with CautionCOLETTE 0.5MG TABLET should be used with caution in elderly patients (above 65
years). Consult your doctor before taking it.

Others

COLETTE 0.5MG TABLET is not recommended for use if you have:

• history of mental illness associated with childbirth (puerperal psychosis)
• fibrotic reactions (scar tissue) affecting the abdomen, heart or lungs
• swelling of hands and feet and a high blood pressure during pregnancy (preeclampsia, eclampsia)

Before taking COLETTE 0.5MG TABLET, inform your doctor if you have:

• cold hands and feet (Raynaud’s syndrome)
• pe
• history of serious mental disease (psychotic disorders)
• just given birth you may be more at risk of certain conditions like high blood pressure, convulsion, stroke or mental health problems
• increased blood pressure after giving birth

Interactions

A. Drug - Drug interactions:

Before taking COLETTE 0.5MG TABLET, inform your doctor if you are taking any of
the following medicine:

• medicines used to manage mental illness (Ex. chlorpromazine, haloperidol)
• medicines for nausea and vomiting (Ex. domperidone, metoclopramide)
• medicines for Parkinson’s disease (Ex. Levodopa, bromocri
• medicines for severe migraine headaches (Ex. pergolide, bromocri
• medicines used to manage infections (Ex. erythromycin)
• medicines to lower your blood pressure (Ex. amlodipine, lisinopril, metoprolol)

Overdosage:

If you or anyone else accidentally take too much of COLETTE 0.5MG TABLET,
consult your doctor immediately or visit the nearby hospital. Symptoms of
overdose are nausea, vomiting, gastric complaints, low blood pressure when
standing, confusion/psychosis or hallucinations.

Synopsis

Drug	:	Cabergoline
Pharmacological Category	:	Dopamine agonists
Therapeutic Indication	:	To stop breast milk production and manages hormonal disturbances
Dosage Forms	:	Tablet

More Information

• Keep COLETTE 0.5MG TABLET out of the sight and reach of children
• Store COLETTE 0.5MG TABLET below 30°C

FAQs About COLETTE 0.5MG TABLET

Q. Who should not take COLETTE 0.5MG TABLET?

A. COLETTE 0.5MG TABLET is not recommended for use in patients with severe liver
disease, stiff and inflamed heart valves (cardiac valvulopathy) uncontrolled
high blood pressure, history of mental illness associated with childbirth,
fibrotic reactions (scar tissue) affecting the abdomen, heart or lungs, swelling
of hands and feet and a high blood pressure during pregnancy (preeclampsia,
eclampsia) and in breastfeeding women. It is also not recommended for use in
children under 16 years of age, allergic history to cabergoline or to other
medicines called ergot alkaloids (Ex. pergolide, bromocri
ergotamine or ergometrine). Consult your doctor before taking it.

Q. Does COLETTE 0.5MG TABLET increase fertility?

A. COLETTE 0.5MG TABLET is taken as one to two tablets twice each week and helps
to restore ovulation and normal prolactin levels. Of the women
manageed, approximately 85% will ovulate and can become pregnant if no other
causes of infertility are present.

Q. Is COLETTE 0.5MG TABLET safe to use in patients with liver disease?

A. COLETTE 0.5MG TABLET should be used with caution in patients with pain in the
chest while breathing, fluid in the lungs, inflammation or infection of the
lungs. Consult your doctor before taking it.

Q. Is COLETTE 0.5MG TABLET safe in pregnancy?

A. COLETTE 0.5MG TABLET is not recommended for use in pregnant women and you
should also take care not to become pregnant for at least one month once you
have stopped taking this medicine. If you become pregnant during management with
COLETTE 0.5MG TABLET, stop taking this medicine and contact your doctor who will
then monitor your pregnancy as COLETTE 0.5MG TABLET can result in congenital
abnormalities if you use it during pregnancy.

Q. What side effects can be expected while using COLETTE 0.5MG TABLET?

A. The most common side effects after taking COLETTE 0.5MG TABLET are
drowsiness, nausea, headache, dizziness, vertigo, stomach pain, indigestion,
inflamed stomach lining, fatigue, lack of bodily strength, weakness. Consult
your doctor if any of the symptoms worsen.

Q. Can COLETTE 0.5MG TABLET be used in children?

A. The safety and effectiveness of COLETTE 0.5MG TABLET have not been
established in children and adolescents (aged below 16 years). Therefore,
consult your doctor for advice.

Useful Diagnostic Tests

• Prolactin
• Smear tests
• Echocardiogram
• Kidney function test