Tolsama 30mg Tablet 4'S

Introduction About TOLSAMA

TOLSAMA 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).

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

Uses Of TOLSAMA

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

How TOLSAMA Works

TOLSAMA 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 TOLSAMA

Take TOLSAMA 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 TOLSAMA

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 TOLSAMA 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

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

!### Breastfeeding

TOLSAMA is not recommended for use in breastfeeding women. Discuss with your
doctor before taking TOLSAMA.

!### 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 TOLSAMA. Consult your doctor before
taking TOLSAMA.

!### Alcohol

Avoid consum
TOLSAMA.

!### Kidney

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

!### Liver

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

!### Allergy

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

!### Heart Disease

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

Others

TOLSAMA 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 TOLSAMA, 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:

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

Use in geriatrics:

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

Interactions

A. Drug-Drug interactions:

Before taking TOLSAMA, 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 TOLSAMA.

Overdosage:

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

FAQs About TOLSAMA

Can TOLSAMA cause high blood pressure?

TOLSAMA 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 TOLSAMA?

Patients taking TOLSAMA 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 TOLSAMA.

How much water should I drink while taking TOLSAMA?

TOLSAMA 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 TOLSAMA cause high blood sugar levels?

TOLSAMA 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 TOLSAMA be used by children and elderly people?

TOLSAMA 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 TOLSAMA.