Tofanta 15mg Tablet 4'S

Introduction About TOFANTA 15MG TABLET

TOFANTA 15MG TABLET contains Tolvaptan, which belongs to the group of medicines
called Vasopressin antagonists. It is used to manage low serum sodium levels in
adults who have a "syndrome of inappropriate antidiuretic hormone secretion"
(SIADH), a condition in which the kidneys retain too much water.

The symptoms of SIADH may include nausea, vomiting, headache, confusion,
weakness, and feeling sick; muscle weakness, irritability, mental confusion, and
tremors (involuntary shaking or movements affecting hands, legs, face, head, or
vocal cords).

TOFANTA 15MG TABLET is not recommended for use in patients having problems with
kidney function. TOFANTA 15MG TABLET should be used with caution in patients
with diabetes, heart disease, liver problems, and a kidney disease called
autosomal dominant polycystic kidney disease (ADPKD).

If you are pregnant or breastfeeding, consult your doctor for advice before
taking TOFANTA 15MG TABLET. TOFANTA 15MG TABLET should not be used in children
or adolescents under the age of 18. The most common side effects of taking
TOFANTA 15MG TABLET are thirst, dehydration, nausea, headache, and diarrhea.
Consult your doctor if the symptom worsens.

Uses Of TOFANTA 15MG TABLET

• Manage low serum sodium levels (hyponatremia) in adults who have “syndrome of inappropriate antidiuretic hormone secretion” (SIADH)

How TOFANTA 15MG TABLET Works

TOFANTA 15MG TABLET works by suppressing vasopressin (a hormone that helps
manage the loss of water from the body by reducing urine output) leading to
increased urine production and a raise in sodium concentration in blood.

How to use TOFANTA 15MG TABLET

Take TOFANTA 15MG TABLET as advised by your physician. Swallow this medicine, do
not crush, or chew the medicine. Your doctor will decide the correct dose and
duration for you depending on your age, body weight and disease condition.

Side Effects Of TOFANTA 15MG TABLET

Common

• thirst
• signs of high sodium level such as restlessness, extreme thirst, confusion, and lethargy)
• excessive drinking of water
• dehydration
• nausea
• signs of high potassium levels like shortness of breath, chest pain, nausea, or vomiting
• signs of high creatinine in the blood such as swelling or oedema, high blood pressure, muscle cramps and chest pain
• signs of high uric acid (severe pain in joints, joint stiffness, difficulty in moving affected joints)
• increase or decrease in blood sugar level
• decreased appetite
• fainting
• headache
• dizziness
• low blood pressure when standing up
• constipation
• diarrhoea
• dry mouth
• patchy bleeding in the skin
• itching
• frequent urination
• tiredness, general weakness
• fever
• general feeling of being unwell
• blood in the urine
• signs of raised levels of liver enzymes in the blood include stomach pain, dark urine, itching, jaundice

Uncommon

• altered taste sensation
• signs of kidney problems such as loss of appetite, decreased urinary output, fatigue

Rare

Stop taking TOFANTA 15MG TABLET and contact your doctor immediately if you
experience any of the following side effects:

• difficulty in urination
• symptoms of allergic reaction included swelling of the face, lips or tongue, itching, generalised rash, or severe wheezing or breathlessness
• feel sick, loss of appetite, upper right abdominal discomfort, dark urine, yellowing of skin or eyes (jaundice)

How To Manage Side Effects

Diarrhoea:

Drink lots of fluids, such as water or fruit juice, to keep yourself hydrated.
Do not consume any medicine on your own without consulting your doctor. Consult
your doctor if your symptoms do not improve.

Dizziness:

When you feel dizzy, lie down or sit down immediately. If you're experiencing a
severe episode of vertigo, lie in a dark, quiet place with your eyes closed.
Vehicle driving should be avoided if you experience frequent dizziness without
warning. Consult your doctor if your symptoms do not improve.

Dry mouth:

A dry mouth can be managed by chewing sugar-free gum or sucking on sugar-free
hard candies to stimulate the flow of saliva. Drink water at regular intervals.
Do not use mouthwashes that contain alcohol because they can be drying. Consult
your doctor if your symptoms do not improve.

Warning & Precautions

!### Pregnancy

TOFANTA 15MG TABLET is not recommended for use in pregnant women or if you think
you might become pregnant. Women should use appropriate contrace
to avoid pregnancy while taking this medicine. Consult your doctor before taking
TOFANTA 15MG TABLET.

!### Breastfeeding

TOFANTA 15MG TABLET is not recommended for use in breastfeeding women. Discuss
with your doctor before taking TOFANTA 15MG TABLET.

!### Driving and Using Machines

Do not drive or operate any machines if you feel dizzy, weak or feeling of
fainting for a short period after taking TOFANTA 15MG TABLET. Consult your
doctor before taking TOFANTA 15MG TABLET.

!### Alcohol

Avoid consum
TOFANTA 15MG TABLET.

!### Kidney

TOFANTA 15MG TABLET is not recommended for use if you have improper kidney
function (no urine production). TOFANTA 15MG TABLET should be taken with caution
in patients suffering from a kidney disease called autosomal dominant polycystic
kidney disease (ADPKD). Consult your doctor before taking TOFANTA 15MG TABLET.

!### Liver

TOFANTA 15MG TABLET should be used with caution in patients having liver
disease. Consult your doctor before taking TOFANTA 15MG TABLET.

!### Allergy

TOFANTA 15MG TABLET is not recommended for use if you are allergic to Tolvaptan
or Benzazepine derivatives (Ex. benazepril, conivaptan, fenoldopam mesylate or
mirtazapine).

!### Heart Disease

TOFANTA 15MG TABLET should be used with caution in patients having congestive
heart failure. Consult your doctor before taking TOFANTA 15MG TABLET.

Others

TOFANTA 15MG TABLET is not recommended for use if you have:

• hypernatremia (a condition which increases the salt in blood)
• any condition which is associated with a very low blood volume
• feeling of not realising when you are thirsty

Before taking TOFANTA 15MG TABLET, inform your doctor if you have:

• cannot drink enough water or in fluid restricted diet
• have difficulties in urination or have an enlarged prostate
• diabetes

Use in pediatrics:

TOFANTA 15MG TABLET is not recommended for use in children and adolescents
(under 18 years of age). Consult your doctor before taking TOFANTA 15MG TABLET.

Use in geriatrics:

TOFANTA 15MG TABLET is used with caution in patients above 65 years of age.
Consult your doctor before taking TOFANTA 15MG TABLET.

Interactions

A. Drug-Drug interactions:

Before taking TOFANTA 15MG TABLET, inform your doctor if you are taking any of
the following medicine:

• ketoconazole (a medicine used against fungal infections)
• macrolide antibiotics such as erythromycin, azithromycin, and clarithromycin (medicines used to manage bacterial infections)
• diltiazem (a medicine used in the management of high blood pressure and chest pain)
• medicines that increase the salt in your blood or which contain large amounts of salt (Ex. Sodium bicarbonate, sodium chloride, diuretics like furosemide, and bumet
• barbiturates like phenobarbital, and pentobarbital (medicines used to manage epilepsy/seizures and some sleep disorders)
• rifampicin (a medicine used against tuberculosis)
• digoxin (medicine used in the management of irregular heartbeat and heart failure)
• desmopressin (a medicine used to increase blood clotting factors)

B. Drug–Food interactions:

Do not eat grapefruit or drink grapefruit juice while you are taking this
medicine as it can increase the risk of side effects of this medicine. Consult
your doctor before taking TOFANTA 15MG TABLET.

Overdosage:

If you or anyone else accidentally take too much of TOFANTA 15MG TABLET, consult
your doctor immediately or visit the nearby hospital. Symptoms of overdose are a
rise in serum sodium concentration, polyuria, thirst, and
dehydration/hypovolemia (profuse and prolonged aquaresis).

Synopsis

Drug	:	Tolvaptan
Pharmacological Category	:	Vasopressin antagonists
Therapeutic Indication	:	Low serum sodium levels
Dosage Forms	:	Tablet

More Information

• Keep TOFANTA 15MG TABLET out of reach from children
• Store at room temperature

FAQs About TOFANTA 15MG TABLET

Can TOFANTA 15MG TABLET cause high blood pressure?

TOFANTA 15MG TABLET did not cause any significant change in the heart rate or
blood pressure. If you experience any high blood pressure symptoms, consult your
doctor.

What precautions do I need to follow while taking TOFANTA 15MG TABLET?

Patients taking TOFANTA 15MG TABLET must notify their doctor if they have any
pre-existing disease conditions such as heart, kidney, liver, or diabetes.
Consult your doctor immediately if you experience any unusual symptoms after
taking TOFANTA 15MG TABLET.

How much water should I drink while taking TOFANTA 15MG TABLET?

TOFANTA 15MG TABLET causes thirst and excessive drinking, increased urine
volume, and frequent urination. Typically, patients will pass 5–6 litres of
urine per day. Therefore, you will need to drink 5 to 6 litres of water or
non-caffeinated drinks per day.

Does TOFANTA 15MG TABLET cause high blood sugar levels?

TOFANTA 15MG TABLET may cause an increase in blood sugar levels or may lead to a
loss of blood glucose control, and glucose tolerance may change. Your doctor may
check your blood sugar level before and after taking this medicine.

Can TOFANTA 15MG TABLET be used by children and elderly people?

TOFANTA 15MG TABLET should not be used in children or adolescents under the age
of 18. It is used with caution in people over the age of 65. Kindly take your
physician’s advice before using TOFANTA 15MG TABLET.