Product Description

TOLVASCA 15 MG (TOLVAPTAN)

WHAT IS TOLVAPTAN (TOLVASCA 15 MG)?

Tolvaptan reduces the level of a hormone that regulates the balance of water and salt (sodium) in the body. High levels of this hormone can cause an imbalance that results in low sodium levels and fluid retention. Tolvaptan is used to treat hyponatremia (low levels of sodium in your blood) in people with heart failure, and certain hormonal imbalances. Tolvaptan improves urine flow without causing the body to lose too much sodium as you urinate. Tolvaptan may also be used for purposes not listed in this medication guide.

WHAT IS USES FOR TOLVAPTAN (TOLVASCA 15 MG)?

HOW TOLVAPTAN (TOLVASCA 15 MG) WORKS?

WHAT IS IMPORTANT INFORMATION FOR TOLVAPTAN (TOLVASCA 15 MG)?

You should not use Tolvaptan if you have cirrhosis or other liver diseases if you are unable to urinate if you are unable to tell that you are thirsty, or if you are severely dehydrated and feel like you might pass out. Also tell your doctor if you have been drinking large amounts of alcohol, or if you are malnourished. You will receive your first few doses of Tolvaptan in a hospital setting where your heart rhythm can be monitored, in case the medication causes serious side effects. Tell your caregivers at once if you have any of these signs that your hyponatremia is being reversed too quickly: problems with speech or muscle control, trouble swallowing, trouble moving your arms and legs, mood changes, and seizure (convulsions). If you stop taking Tolvaptan for any length of time, do not start taking it again at home. You will need to be in a hospital under observation at any time you start or restart treatment.

BEFORE TAKING TOLVAPTAN (TOLVASCA 15 MG) MEDICINE

You should not use Tolvaptan if you are allergic to tolvaptan, or if you have: cirrhosis or other liver diseases; if you are unable to urinate; if you are unable to tell that you are thirsty; or if you are severely dehydrated and feel like you might pass out. Many drugs can interact with Tolvaptan and some should not be used at the same time. Tell your doctor about all other medications you use, especially: nefazodone; an antibiotic–clarithromycin, telithromycin; antifungal medication–itraconazole, ketoconazole, voriconazole; hepatitis C medications–boceprevir, telaprevir; or HIV/AIDS medication–atazanavir, cobicistat, delavirdine, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir. Your doctor will tell you if any of your medications need to be changed while taking Tolvaptan. To make sure Tolvaptan is safe for you, tell your doctor about your other medical conditions, especially: a history of alcoholism or liver disease; kidney disease; if you are malnourished; or if you have been drinking large amounts of alcohol.

HOW SHOULD I TAKE TOLVAPTAN (TOLVASCA 15 MG)?

Tolvaptan is usually given once per day. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended. Long-term use of Tolvaptan can damage your liver or cause death. You should not use this medicine for longer than 30 days. You will receive your first few doses of Tolvaptan in a hospital setting where your heart rhythm can be monitored, in case the medication causes serious side effects. You may take Tolvaptan with or without food. Take this medicine with a full glass (8 ounces) of water. Drink plenty of fluids during the first 24 hours of treatment with Tolvaptan. It is best to drink something as soon as you feel thirsty but avoid alcoholic drinks. Follow your doctor’s instructions about the type and amount of liquids you should drink while treating hyponatremia. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking this medication, which can lead to serious side effects. To be sure this medicine is helping your condition, you may need frequent blood tests. If you stop taking Tolvaptan for any length of time, do not start taking it again at home. You will need to be in a hospital under observation at any time you start or restart treatment. Store at room temperature away from moisture and heat.

WHAT HAPPENS IF I MISS A DOSE FOR TOLVAPTAN (TOLVASCA 15 MG)?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up for the missed dose.

WHAT SHOULD I AVOID FOR TOLVAPTAN (TOLVASCA 15 MG)?

Avoid alcoholic drinks. Grapefruit and grapefruit juice may interact with tolvaptan and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.

WHAT OTHER DRUGS WILL AFFECT TOLVAPTAN (TOLVASCA 15 MG)?

Many drugs can interact with tolvaptan. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with Tolvaptan, especially: cyclosporine; St. John’s wort; seizure medication–carbamazepine, phenobarbital, phenytoin; or tuberculosis medication–rifabutin, rifampin, rifapentine. This list is not complete and many other drugs can interact with tolvaptan. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

WHAT IS COMMON SIDE EFFECTS FOR TOLVAPTAN (TOLVASCA 15 MG)?

WHAT IS EXPERT ADVICE FOR TOLVAPTAN (TOLVASCA 15 MG)?

• Do not eat grapefruit or drink grapefruit juice while taking this medication. If you stop taking tolvaptan for any length of time, do not start taking it again at home. You will need to be in a hospital under observation at any time you start or restart treatment with tolvaptan.
• Consult your doctor immediately if you have any of these signs: problems with speech or muscle control, trouble swallowing, trouble moving your arms and legs, mood changes, and seizure (convulsions).

• if you are allergic to tolvaptan, or to any of the other ingredients of this medicine.
• if your kidneys do not work (no urine production).
• if you have a condition that increases the salt in your blood (“hypernatraemia”).
• if you have a condition that is associated with a very low blood volume.
• if you do not realize when you are thirsty.
• if you are pregnant or breastfeeding.

• if you cannot drink enough water or if you are fluid restricted.
• if you have difficulties in urination or have an enlarged prostate.
• if you suffer from liver disease.
• if you have diabetes.

FREQUENTLY ASKED QUESTIONS FOR TOLVAPTAN (TOLVASCA 15 MG)

TOLVAPTAN