Simenda 12.5mg Injection 1's

Introduction About SIMENDA 12.5MG INJECTION

SIMENDA 12.5MG INJECTION contains Levosimendan, which belongs to the group of
medicines called Calcium Sensitizer. It is used in adults for the management of
heart failure, in people who still find it hard to breathe, even though they are
taking other medicines to get rid of extra water from the body. It helps to
relieve the shortness of breath from severe heart failure.

SIMENDA 12.5MG INJECTION should be used in pregnant women only if the benefits
for the mother outweigh the possible risks to the foetus. SIMENDA 12.5MG
INJECTION is not recommended for use in breastfeeding women as it may pass into
human breast milk to avoid potential cardiovascular side effects in the infant.

SIMENDA 12.5MG INJECTION is not recommended for use if you have severe kidney or
liver disease, very low blood pressure, or an abnormally fast heartbeat
(Torsade’s de Pointes) or have heart disease that makes filling or emptying of
the heart harder.

SIMENDA 12.5MG INJECTION should be used with caution if you have mild to
moderate kidney or liver disease, chest pain, low blood pressure, an abnormally
fast heartbeat, or an abnormal heart rhythm called ‘atrial fibrillation’.
Consult your doctor before receiving it.

SIMENDA 12.5MG INJECTION is not recommended for use in children and adolescents
under 18 years of age. The most common side effects of receiving SIMENDA 12.5MG
INJECTION are headache, abnormally fast heartbeat, and drop in blood pressure.
Consult your doctor if any of the side effects worsen.

Uses Of SIMENDA 12.5MG INJECTION

• It helps to relieve the shortness of breath from severe heart failure.

How SIMENDA 12.5MG INJECTION Works

SIMENDA 12.5MG INJECTION works by increasing the pumping force of the heart and
allows blood vessels to relax. Levosimendan will lessen the congestion in your
lungs and make it easier for blood and oxygen to go through your body. Thus,
SIMENDA 12.5MG INJECTION will help to relieve the shortness of breath from
severe heart failure.

How to use SIMENDA 12.5MG INJECTION

SIMENDA 12.5MG INJECTION will be administered only by a doctor or a nurse into
the veins as an intravenous infusion. Your doctor will decide the correct dose
and duration for you depending on your age, body weight, and disease condition.

Side Effects Of SIMENDA 12.5MG INJECTION

Common

• Headache
• Abnormally fast heartbeat
• Drop in blood pressure

Uncommon

• Low amount of potassium in your blood
• Insomnia
• Dizziness
• An abnormal heartbeat called ‘atrial fibrillation’ (a part of the heart flutters instead of beating properly)
• Increased heart rate
• Extra heartbeats
• Heart failure
• Your heart doesn’t get enough oxygen
• Nausea, constipation, diarrhea, vomiting
• Low blood counts

Rare

Stop receiving SIMENDA 12.5MG INJECTION and inform your doctor immediately if
you experience any of the following side effects:

• Abnormally fast heartbeat
• Headache
• Drop in blood pressure
• Low amount of potassium in your blood
• Insomnia
• Dizziness
• An abnormal heartbeat called atrial fibrillation (a part of the heart flutters instead of beating properly)
• Extra heartbeats
• Heart failure
• Your heart doesn’t get enough oxygen
• Low blood counts

How To Manage Side Effects

!### Constipation

Take fiber-rich foods in your diets, such as fresh fruits, vegetables, and whole
grain cereals, and drink plenty of fluids. Exercise more regularly and stay
active. Contact your doctor if constipation persists.

!### Diarrhea

Drink lots of fluids, such as water, to keep yourself hydrated. Try to avoid
taking any medicine on your own to manage diarrhea and consult your doctor if
the diarrhea gets worse.

!### 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.

!### Nausea And Vomiting

Take SIMENDA 12.5MG INJECTION with or just after meals. Stick to simple meals.
Avoid eating oil-rich or spicy foods. Consult your doctor if your nausea and
vomiting worsen.

Warning & Precautions

!### Pregnancy

Monitoring requiredSIMENDA 12.5MG INJECTION should be used in pregnant women only if the benefits
for the mother outweigh the possible risks to the foetus. If you are pregnant,
think you may be pregnant, or are planning to have a baby, ask your doctor for
advice before this medicine is given to you.

!### Breastfeeding

ContraindicatedSIMENDA 12.5MG INJECTION is not recommended for use in breastfeeding women as it
may pass into human breast milk to avoid potential cardiovascular side effects
in the infant. Your doctor will have to decide if the benefits to the mother
outweigh the possible risk to a baby.

!### Driving and Using Machines

Use with CautionSIMENDA 12.5MG INJECTION can affect your ability to drive or operate any
machinery.

!### Alcohol

Consult your doctorInform your doctor if you have alcohol addiction before using this medicine.

!### Kidney

Consult your doctorSIMENDA 12.5MG INJECTION is not recommended for use if you have severe kidney
disease. It should be used with caution if you have mild to moderate kidney
disease. Consult your doctor before receiving it.

!### Liver

Consult your doctorSIMENDA 12.5MG INJECTION is not recommended for use if you have severe liver
disease. It should be used with caution if you have mild to moderate liver
disease. Consult your doctor before receiving it.

!### Allergy

ContraindicatedSIMENDA 12.5MG INJECTION is not recommended for use if you are allergic to
Levosimendan or to any other ingredients of this medicine.

!### Heart Disease

Consult your doctorSIMENDA 12.5MG INJECTION is not recommended for use if you have very low blood
pressure or an abnormally fast heartbeat (Torsade’s de Pointes) or have heart
disease that makes filling or emptying of the heart harder. Inform your doctor
if you have chest pain, low blood pressure, an abnormally fast heartbeat, or an
abnormal heart rhythm called ‘atrial fibrillation’. Consult your doctor before
receiving it.

!### Use In Pediatrics

ContraindicatedSIMENDA 12.5MG INJECTION is not recommended for use in children and adolescents
under 18 years of age.

!### Use In Geriatrics

Consult your doctorThere is no specific dose recommendation for elderly patients. Consult your
doctor for advice.

Others

SIMENDA 12.5MG INJECTION is not recommended for use if you have:

NA

Before receiving SIMENDA 12.5MG INJECTION, inform your doctor if you:

• low blood counts (anemia)
• or an abnormally low amount of potassium in your blood
• severe decrease of blood volume in your body (hypovolaemia)
• epilepsy

Interactions

A. Drug-Drug Interactions:

Inform your physician if you are taking any of the following drugs before using
SIMENDA 12.5MG INJECTION:

• isosorbide mononitrate (used to manage angina (chest pain))

Overdose:

SIMENDA 12.5MG INJECTION will be given to you only by a doctor or nurse in a
hospital, and so it is unlikely to result in an overdose. However, if you are
given too much of this medicine, your blood pressure may drop and your heartbeat
may get faster; then please consult your doctor or nurse immediately.

Synopsis

Drug	:	Levosimendan
Pharmacological Category	:	Calcium Sensitizer
Therapeutic Indication	:	Heart failure
Dosage Forms	:	Injection

More Information

Storage

• Keep SIMENDA 12.5MG INJECTION out of reach of children
• Store SIMENDA 12.5MG INJECTION in a refrigerator (2 °C–8 °C)

FAQs About SIMENDA 12.5MG INJECTION

Q: What is SIMENDA 12.5MG INJECTION used for?

A:SIMENDA 12.5MG INJECTION is used in adults for the management of heart
failure, in people who still find it hard to breathe, even though they are
taking other medicines to get rid of extra water from the body. It helps to
relieve the shortness of breath from severe heart failure.

Q: What are the side effects of SIMENDA 12.5MG INJECTION?

A: The most common side effects of receiving SIMENDA 12.5MG INJECTION are
headache, abnormally fast heartbeat, and drop in blood pressure. Consult your
doctor if any of the side effects worsen.

Q: How does SIMENDA 12.5MG INJECTION work?

A: SIMENDA 12.5MG INJECTION works by increasing the pumping force of the heart
and allows blood vessels to relax. Levosimendan will lessen the congestion in
your lungs and make it easier for blood and oxygen to go through your body.
Thus, SIMENDA 12.5MG INJECTION will help to relieve the shortness of breath from
severe heart failure.

Q: Is SIMENDA 12.5MG INJECTION safe for pregnant women?

A: SIMENDA 12.5MG INJECTION should be used in pregnant women only if the
benefits for the mother outweigh the possible risks to the foetus. If you are
pregnant, think you may be pregnant, or are planning to have a baby, ask your
doctor for advice before this medicine is given to you.

Q: Who should avoid using SIMENDA 12.5MG INJECTION?

A: SIMENDA 12.5MG INJECTION is not recommended for use if you have severe kidney
disease, severe liver disease, are allergic to Levosimendan, have very low blood
pressure or an abnormally fast heartbeat (Torsade’s de Pointes), or have heart
disease that makes filling or emptying of the heart harder.

Q: What precautions must be taken while using SIMENDA 12.5MG INJECTION?

A: Before using SIMENDA 12.5MG INJECTION, inform your doctor if you have mild to
moderate kidney, liver disease, chest pain, low blood pressure, an abnormally
fast heartbeat, an abnormal heart rhythm called ‘atrial fibrillation, low blood
counts (anemia), or an abnormally low amount of potassium in your blood, a
severe decrease in blood volume in your body (hypovolaemia), and epilepsy.

Q: Is SIMENDA 12.5MG INJECTION safe for kids?

A: SIMENDA 12.5MG INJECTION is not recommended for use in children and
adolescents under 18 years of age.

Q: How SIMENDA 12.5MG INJECTION is given?

A: SIMENDA 12.5MG INJECTION will be administered only by a doctor or a nurse
into the veins as an intravenous infusion. Your doctor will decide the correct
dose and duration for you depending on your age, body weight, and disease
condition.

Q: How long does SIMENDA 12.5MG INJECTION last?

A: The effect on your heart will last for at least 24 hours after SIMENDA 12.5MG
INJECTION is stopped. The effect may continue for 7–10 days after the infusion
is stopped.

Q: Can I take other medicines while using SIMENDA 12.5MG INJECTION?

A: Inform your physician if you are taking any of the following drugs before
using SIMENDA 12.5MG INJECTION, such as isosorbide mononitrate (used to manage
angina (chest pain), as SIMENDA 12.5MG INJECTION may increase the drop of your
blood pressure when getting up.

Useful Diagnostic Tests

• Complete Blood Count (CBC)/ Hemogram
• Serum Electrolytes/ Electrolytes Profile
• Cardiac Risk Profile
• Basic Heart Care
• Comprehensive Heart Care
• Lipid Profile Test/Cholesterol-Total, Serum
• Health
• Jaanch Healthy Heart Advanced
• Cardiac Risk Markers - Advanced
• Jaanch Healthy Heart Basic