ISORUS Tablet 15's

Introduction About ISORUS TABLET

ISORUS TABLET is a combination of Hydralazine and Isosorbide dinitrate which
belongs to the group of medicines called Vasodilators. It is used to manage
heart failure along with standard therapy in patients to improve survival, delay
hospitalization for heart failure and to improve patient-reported functional
status.

Heart failure is defined as a progressive clinical disorder where your heart is
unable to pump sufficient blood to meet the body’s metabolic needs,
characterized by shortness of breath and extreme tiredness.

During course of the management your doctor might regularly monitor your blood
pressure to avoid any untoward side effects. The safety and effectiveness of
ISORUS TABLET in children have not been established.

Before taking ISORUS TABLET, inform your doctor if you have any kidney, heart,
lung or liver problems, too much sweating, fluid loss, vomiting or diarrhea or
if you consume alcohol.

ISORUS TABLET is not studied in pregnant and breastfeeding women, so consult
your doctor before taking it. The most common side effects of taking ISORUS
TABLET are headache and dizziness. Consult your doctor if any of the side
effects worsen.

Uses Of ISORUS TABLET

• Manage heart failure

How ISORUS TABLET Works

ISORUS TABLET helps in the management of heart failure,where hydralazine relaxes
the smooth muscles of arteries and isosorbide dinitrate acts by releasing nitric
oxide and subsequently activating guanylyl cyclase and ultimately relaxes smooth
muscles of both arteries and veins.

How to use ISORUS TABLET

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

Side Effects Of ISORUS TABLET

Common

• headache
• dizziness

Rare

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

• allergic reaction (signs include rash, hives, itching, red, swollen, blistered or peeling skin, wheezing, tightness in the chest or throat, difficulty breathing, swallowing or talking, unusual hoarseness or swelling of the mouth, face, lips, tongue or throat)
• lupus-like rash on the cheeks or other body parts, easy sunburn, muscle or joint pain, chest pain or breathlessness or swelling in the arms or legs
• low blood pressure (very bad dizziness or passing out)
• fever
• insufficient oxygen supply to heart muscle and angina (chest pain or pressure or a fast heartbeat)
• peripheral neuritis (numbness, prickling and tingling sensation)

How To Manage Side Effects

Headache:

Drink ample amount of water. Get adequate rest. Try to be relaxed and stress
free. Ask your doctor before taking any medicine for headache.

Dizziness:

When you start taking ISORUS TABLET, you may feel dizzy. If this happens,
resting or lying down for some time can help. Rise slowly after sitting or lying
down. Be careful while going up and down stairs. Consult your doctor if you
experience persistent dizziness.

Warning & Precautions

!### Pregnancy

ISORUS TABLET is not studied in pregnant women. Consult your doctor before
taking it.

!### Breastfeeding

ISORUS TABLET is not studied in breastfeeding women. Consult your doctor before
taking this medicine as it is not known if it passes into breast milk.

!### Driving and Using Machines

Do not drive or use any machines until you see how ISORUS TABLET affects you.

!### Alcohol

Avoid consum
increase the risk of vasodilating effects of this medicine.

!### Kidney

ISORUS TABLET is not studied in patients with kidney impairment. Consult your
doctor before taking it.

!### Liver

ISORUS TABLET is not studied in patients with liver impairment. Consult your
doctor before taking it.

!### Allergy

Do not take ISORUS TABLET if you are allergic to Hydralazine or Isosorbide
dinitrate.

!### Heart Disease

ISORUS TABLET should be used with caution in patients with hypertrophic
cardiomyopathy. Consult your doctor before taking it.

Others

Before taking ISORUS TABLET, inform your doctor if you:

• have too much sweating, fluid loss, vomiting or diarrhea

Use in pediatrics:

Safety and effectiveness of ISORUS TABLET in children and adolescents (aged less
than 18 years) have not been established. Consult your child’s doctor for
advice.

Use in geriatrics:

ISORUS TABLET should be used with caution in elderly patients. Consult your
doctor before taking it.

Interactions

A. Drug - Drug interactions:

Before taking ISORUS TABLET, inform your doctor if you are taking any of the
following medicines:

• medicines used to manage erectile dysfunction (Ex. avanafil, sildenafil, tadalafil, vardenafil)
• riociguat (used to manage high blood pressure in the vessels that carry blood to the lungs)

Overdosage:

If you or anyone else accidentally took too much of ISORUS TABLET, contact your
doctor immediately. Symptoms of overdose include headache, confusion, fast
heartbeat, generalized skin flushing, reduced cardiac output, low blood
pressure, irregular heartbeat and shock.

Synopsis

Drug	:	Hydralazine, Isosorbide dinitrate
Pharmacological Category	:	Vasodilators
Therapeutic Indication	:	As adjunct to standard management in heart failure
Dosage Forms	:	Tablet

More Information

• Keep ISORUS TABLET out of reach of children
• Store at room temperature

FAQs About ISORUS TABLET

Q:What do I need to inform my doctor before taking ISORUS TABLET?

A: Before taking ISORUS TABLET, inform your doctor about all the medicines that
you are taking (prescri
problems. This is necessary to make sure that it is safe for you to take this
medicine with all your other medicines and health problems. Do not start, stop
or change the dose of any medicine without consulting your doctor.

Q:How does ISORUS TABLET work?

A: ISORUS TABLET helps in the management of heart failure,where hydralazine
relaxes the smooth muscles of arteries and isosorbide dinitrate acts by
releasing nitric oxide and subsequently activating guanylyl cyclase and
ultimately relaxes smooth muscles of both arteries and veins.

Q: Can ISORUS TABLET make me feel dizzy?

A: ISORUS TABLET may cause a drop in your blood pressure that may make you feel
dizzy. If this happens, resting or lying down for some time can help. Rise
slowly after sitting or lying down. Be careful while going up and down stairs.
Consult your doctor if you experience persistent dizziness.

Q: Does ISORUS TABLET cause headache?

A: Yes, headache is a side effect of ISORUS TABLET. Drink ample amount of water.
Get adequate rest. Try to be relaxed and stress free. Ask your doctor before
taking any medicine for headache.

Q: Can ISORUS TABLET be used in children?

A: The safety and effectiveness of ISORUS TABLET in children and adolescents
(aged less than 18 years) have not been established. Your child’s doctor will
select a suitable alternative therapy for your child to manage the condition.