Lupibose 125mg Tablet 10'S

Introduction About LUPIBOSE

LUPIBOSE contains Bosentan which belongs to the group of medicines called
Endothelin receptor antagonists. LUPIBOSE is used to manage pulmonary arterial
hypertension in affected individuals which is a disease that occurs due to high
blood pressure in blood vessels that carry blood from heart to the lungs.

LUPIBOSE is also used in adults to reduce digital ulcers (sores on the fingers
and toes) that occurs due to scleroderma which is a chronic disease that cause
skin to become thick and hard.

LUPIBOSE is not recommended for use in patients allergic to Bosentan. It is also
not recommended for use in patients suffering from liver problems.

Before taking LUPIBOSE, inform your doctor if you are planning to father a
child, and/or have kidney problems (such as impaired renal function).

LUPIBOSE is generally not recommended for use during pregnancy and in women
planning for pregnancy since the medicine may cause harm to the unborn child. It
is also not recommended for use in breastfeeding women since it is not known
whether the medicine may pass through breastmilk.

LUPIBOSE is recommended for use in children and adolescents (aged 1 year and
above) to manage only pulmonary hypertension and is not indicated for use to
manage systemic sclerosis and digital ulcer disease in affected children. The
medicine is advised to be used with caution in elderly patients (aged 65
years/above) after consulting the doctor.

The most common side effects of taking LUPIBOSE are headache, oedema (swelling
of legs & ankles), flushing/redness of skin, diarrhoea, low blood pressure,
and/or nasal congestion. Consult your doctor if any of these symptoms worsen.

Uses Of LUPIBOSE

• Manage pulmonary artery hypertension
• Manage digital ulcers (that occurs due to scleroderma) in affected individuals

How LUPIBOSE Works

LUPIBOSE works by blocking the action of endothelin-1 hormone (chemical that
cause vasoconstriction) which leads to relaxation and widening of blood vessel
wall resulting in reduced pressure on the blood vessel wall and managing
pulmonary hypertension in affected individuals.

How to use LUPIBOSE

Take LUPIBOSE 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 and duration for you depending upon your age, body weight and disease
condition.

Side Effects Of LUPIBOSE

Common

• headache
• oedema (swelling of legs & ankles)
• flushed appearance/redness of skin
• signs of hypersensitivity reactions (immune mediated allergic reaction) such as skin inflammation, itching, and/or rashes
• gastroesophageal reflux disease (acid reflux)
• diarrhoea
• syncope (fainting)
• palpitations (fast/irregular heartbeats)
• low blood pressure
• nasal congestion

Rare

• signs of anaphylactic reaction (life threatening allergic reaction) such as skin rash, nausea, difficulty in breathing, and/or shock
• cirrhosis/scarring of the liver
• liver failure.

Stop taking LUPIBOSE and consult your doctor immediately if you experience any
of the following side effects:

• signs of abnormal/impaired liver function such as nausea, fever, pain in the stomach, jaundice (yellowing of the skin/whites of eyes), dark-coloured urine, itching, lethargy/fatigue, and/or flu-like symptoms such as joint & muscle pain with fever

How To Manage Side Effects

Headache:

If LUPIBOSE causes headache, then take rest and drink plenty of fluids. Try to
avoid drinking alcohol. Ask your doctor to recommend a painkiller. Headaches
should usually go away after the first week of taking LUPIBOSE. If it lasts more
than a week or becomes severe, then consult your doctor.

Diarrhea:

Drink plenty of water and stay hydrated. Try to avoid taking any medicine on
your own to manage diarrhea. Consult your doctor if the symptom worsens.

Warning & Precautions

!### Pregnancy

LUPIBOSE is generally not recommended for use during pregnancy and in women
planning for pregnancy since the medicine may cause harm to the unborn child.
Women of child-bearing potential should use effective contrace
manage accidental pregnancy while in management with LUPIBOSE. Consult your
doctor before taking the medicine.

!### Breastfeeding

LUPIBOSE is not recommended for use in breastfeeding women since it is not known
whether the medicine may pass through breastmilk. Consult your doctor before
taking the medicine.

!### Driving and Using Machines

Do not drive/operate any machines if you feel dizzy or experience blurred vision
after taking LUPIBOSE.

!### Kidney

LUPIBOSE should be used with caution in patients with kidney problems such as
impaired renal function. Consult your doctor before taking the medicine.

!### Liver

LUPIBOSE is not recommended for use in patients with liver problems. Consult
your doctor before taking the medicine.

!### Allergy

Do not take LUPIBOSE if you are allergic to Bosentan, and/or any other
ingredients of the medicine.

Others

Before taking LUPIBOSE, inform your doctor if you:

• are planning to father a child (since this medicine may lower the sperm count).

Use in Paediatrics:

LUPIBOSE is recommended for use in children and adolescents (aged 1 year and
above) to manage only pulmonary hypertension. It is not recommended for use to
manage systemic sclerosis and ongoing digital ulcer disease in affected
children. Consult your doctor before administering the medicine to the child.

Use in Geriatrics:

LUPIBOSE should be used with caution in elderly patients (aged 65 years and
above). Consult your doctor before taking the medicine.

Interactions

A. Drug-Drug interactions:

Before taking LUPIBOSE, inform your doctor if you are taking any of the
following medicine:

• ciclosporin A (used after transplants and to manage psoriasis)
• sirolimus, tacrolimus (medicines used after transplants to manage organ rejection)
• glibenclamide (used to manage diabetes)
• rifampicin (use to manage tuberculosis)
• fluconazole, ketoconazole (medicines used to manage fungal infections)
• nevirapine (used to manage HIV infection)
• warfarin (used to manage blood clots)
• other medicine used to manage pulmonary hypertension (Ex. sildenafil, tadalafil)
• simvastatin (used to manage hypercholesterolaemia)
• hormonal contrace

Overdosage:

If you or anyone else accidentally take too much of LUPIBOSE, consult your
doctor immediately or visit the nearby hospital to manage overdose symptoms.

Synopsis

Drug	:	Bosentan
Pharmacological Category	:	Endothelin receptor antagonists
Therapeutic Indication	:	Pulmonary artery hypertension, Digital ulcers (due to scleroderma)
Dosage Forms	:	Tablet

More Information

• Keep LUPIBOSE out of reach of children
• Do not store LUPIBOSE above 30 °C

FAQs About LUPIBOSE

What is LUPIBOSE used for?

LUPIBOSE is used to manage pulmonary arterial hypertension in affected
individuals which is a disease that occurs due to high blood pressure in blood
vessels that carry blood from heart to the lungs. It is also used in adults to
reduce digital ulcers (sores on the fingers and toes) that occurs due to
scleroderma which is a chronic disease that cause skin to become thick and hard
in affected individuals.

What are the side effects of taking LUPIBOSE?

The most common side effects of taking LUPIBOSE are headache, oedema (swelling
of legs & ankles), flushing/redness of skin, diarrhoea, low blood pressure,
and/or nasal congestion. Contact your doctor if any of these symptoms worsen.

How LUPIBOSE works?

LUPIBOSE works by blocking the action of endothelin-1 hormone (chemical that
cause vasoconstriction) which leads to relaxation and widening of blood vessel
wall resulting in reduced pressure on the blood vessel wall and managing
pulmonary hypertension in affected individuals.

How LUPIBOSE should be taken?

Take LUPIBOSE 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 and duration for you depending upon your age, body weight and disease
condition.

Can LUPIBOSE be used in pregnant women?No, LUPIBOSE is generally not recommended for use during pregnancy and in
women planning for pregnancy since the medicine may cause harm to the unborn
child. Women of child-bearing potential should use effective contrace
measures to manage accidental pregnancy while in management with LUPIBOSE.
Consult your doctor before taking the medicine.

Useful Diagnostic Tests

• Echocardiogram
• Right heart catheterization