INTRODUCTION:

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TOLSAMA contains tolvaptan belongs to a group of medicines called vasopressin antagonists. This medicine is indicated in Autosomal dominant polycystic kidney disease (ADPKD) and also clinically significant hypervolemic and euvolemic hyponatremia in adults with conditions such as heart failure, liver disease, and certain hormone imbalances. Vasopressin by reducing urine output causes fluid retention and prevent the loss of water from the body. Autosomal dominant polycystic kidney disease (ADPKD) is a condition where fluid-filled cysts grow in the kidneys leading to increased pressure on the surrounding tissues that impairs the kidney function leading to kidney failure.

nTOLSAMA prevents the vasopressin having effect on the water retention. This reduces the amount of water in the body which slows the growth of kidney cysts in patients with ADPKD, reduces symptoms of the disease and increases urine production. It also increases the sodium and salt levels in your blood by removing extra water content in the body as urine in patients with heart failure, liver disease, and certain hormone imbalances.
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USES OF TOLSAMA:

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Treat a disease called autosomal dominant polycystic kidney disease (ADPKD)
nTreat significant hypervolemic and euvolemic hyponatremia (low serum sodium levels in adults)

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HOW TOLSAMA WORKS:

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TOLSAMA prevents the vasopressin having effect on the water retention. This reduces the amount of water in the body which slows the growth of kidney cysts in patients with ADPKD, reduces symptoms of the disease and increases urine production. It also increases the sodium and salt levels in your blood by removing extra water content in the body as urine in patients with heart failure, liver disease, and certain hormone imbalances.

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DIRECTIONS FOR USE:

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Always take TOLSAMA exactly as prescribed by your doctor. Swallow the medicine whole with plenty of water.

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SIDE EFFECTS OF TOLSAMA 15MG:

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SERIOUS

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• Difficult to urinate
n• Swelling of the face, lips or tongue, itching, generalized rash, or severe wheezing or breathlessness (symptoms of an allergic reaction)

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COMMON

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• Dizziness, drowsiness, headache
n• Dehydration
n• High levels of sodium, potassium, creatinine, uric acid and blood sugar
n• Decrease in level of blood sugar
n• Decreased appetite
n• Fainting
n• Low blood pressure when standing up
n• Constipation
n• Diarrhea
n• Dry mouth
n• Feeling sick, thirst, rapid rise in level of sodium
n• Patchy bleeding in the skin
n• Itching
n• General feeling of being unwell
n• Blood in urine
n• Raised levels of liver enzymes in the blood

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HOW TO MANAGE SIDE EFFECTS:

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Skin rash and itching:

nAvoid bathing with hot water because hot water can irritate the skin. Moisturizers can be used regular basis to soothe and hydrate the affected area.
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nHeadache:
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nApply hot or cold-water bag on your head. Take rest in a quiet and dark room. Drink tea or coffee.
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nDiarrhea:
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nDrink lot of fluid, such as water or squash, to avoid dehydration. Do not take any other medicines consulting your doctor.
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WARNING & PRECAUTION:

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PREGNANCY

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TOLSAMA is not recommended for use in pregnant women unless necessary. Consult your doctor for advice.

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BREASTFEEDING

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TOLSAMA is not recommended for use in breastfeeding women unless necessary. Consult your doctor for advice.

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DRIVING AND USING MACHINES

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Do not drive or operate any machinery while taking this medicine, it may make you feel dizziness.

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ALCOHOL

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Avoid drinking too much of alcohol while taking this medicine.

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KIDNEY

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This medicine should be taken with caution in patients with severe kidney disease. Consult your doctor for advice.

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LIVER

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This medicine should be taken with caution in patients with severe liver disease. Consult your doctor for advice.

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ALLERGY

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If you are allergic (hypersensitive) to this medicine or any other ingredients in this medicine.

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HEART DISEASE

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This medicine should be taken with caution in patients with severe heart disease. Consult your doctor for advice.

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INTERACTIONS:

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Talk to your doctor if you are taking:

nKetoconazole
nMacrolide antibiotics
nMedicines to treat high blood pressure and chest pain
nMedicines used to treat epilepsy/seizures and some sleep disorders
nRifampicin (used to treat tuberculosis)
nDigoxin (used for treatment of irregularities of heartbeat and heart failure)
nDesmopressin (used to increase blood clotting factors)
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SYNOPSIS:

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Drug :
nTolvaptan

nPharmacological Category : Vasopressin antagonists
nTherapeutic Indication :
nAutosomal dominant polycystic kidney disease (ADPKD), Significant hypervolemic and euvolemic hyponatremia
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nDosage Forms : Tablet
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MORE INFORMATION:

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Store at room temperature 15-25°C and keep out of reach of children.

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FAQ’s ABOUT TOLSAMA:

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Q: What is TOLSAMA used to treat?
nA: It is used to treat low levels of salt (sodium) in the blood, which can result from conditions such as heart failure and certain hormone imbalances.

nQ: Can TOLSAMA be used in pregnant women?
nA: No. It is not recommended for use in the pregnant women. Consult your doctor before taking.
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nQ: What causes low sodium?
nA: A low sodium level has many causes, including consumption of too many fluids, kidney failure, heart failure, cirrhosis, and use of diuretics. Symptoms result from brain dysfunction.