VAPTOLVA Tablet 7's

Introduction About VAPTOLVA TABLET

VAPTOLVA 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).

VAPTOLVA TABLET is not recommended for use in patients having problems with
kidney function. VAPTOLVA 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 VAPTOLVA TABLET. VAPTOLVA TABLET should not be used in children or
adolescents under the age of 18. The most common side effects of taking VAPTOLVA
TABLET are thirst, dehydration, nausea, headache, and diarrhea. Consult your
doctor if the symptom worsens.

Uses Of VAPTOLVA TABLET

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

How VAPTOLVA TABLET Works

VAPTOLVA 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 VAPTOLVA TABLET

Take VAPTOLVA 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 VAPTOLVA 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 VAPTOLVA 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

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

!### Breastfeeding

VAPTOLVA TABLET is not recommended for use in breastfeeding women. Discuss with
your doctor before taking VAPTOLVA 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 VAPTOLVA TABLET. Consult your doctor
before taking VAPTOLVA TABLET.

!### Alcohol

Avoid consum
VAPTOLVA TABLET.

!### Kidney

VAPTOLVA TABLET is not recommended for use if you have improper kidney function
(no urine production). VAPTOLVA 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 VAPTOLVA TABLET.

!### Liver

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

Allergy

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

!### Heart Disease

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

Others

VAPTOLVA 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 VAPTOLVA 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:

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

Use in geriatrics:

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

Interactions

A. Drug-Drug interactions:

Before taking VAPTOLVA 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 VAPTOLVA TABLET.

Overdosage:

If you or anyone else accidentally take too much of VAPTOLVA 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 VAPTOLVA TABLET out of reach from children
• Store at room temperature

FAQs About VAPTOLVA TABLET

Can VAPTOLVA TABLET cause high blood pressure?

VAPTOLVA 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 VAPTOLVA TABLET?

Patients taking VAPTOLVA 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 VAPTOLVA TABLET.

How much water should I drink while taking VAPTOLVA TABLET?

VAPTOLVA 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 VAPTOLVA TABLET cause high blood sugar levels?

VAPTOLVA 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 VAPTOLVA TABLET be used by children and elderly people?

VAPTOLVA 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 VAPTOLVA TABLET.