tolvaptan (Jynarque, Samsca)

Brand Names: Jynarque, Samsca

Generic Name: tolvaptan (Samsca)

• What is Samsca (Jynarque, Samsca)?
• What are the possible side effects of Samsca (Jynarque, Samsca)?
• What is the most important information I should know about Samsca (Jynarque, Samsca)?
• What should I discuss with my healthcare provider before taking Samsca (Jynarque, Samsca)?
• How should I take Samsca (Jynarque, Samsca)?
• What happens if I miss a dose (Jynarque, Samsca)?
• What happens if I overdose (Jynarque, Samsca)?
• What should I avoid while taking Samsca (Jynarque, Samsca)?
• What other drugs will affect Samsca (Jynarque, Samsca)?
• Where can I get more information (Jynarque, Samsca)?

This medication guide provides information about the Samsca brand of tolvaptan. Jynarque is another brand of tolvaptan that is not covered in this medication guide.

Tolvaptan (Samsca) 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.

Samsca may also be used for purposes not listed in this medication guide.

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

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;
• confusion, mood changes; or
• a seizure.

While taking Samsca at home, call your doctor at once if you have:

• weakness, or a light-headed feeling (like you might pass out);
• liver problems--right-sided upper stomach pain, vomiting, loss of appetite, fever, itching, yellowing of your skin or eyes, not feeling well; or
• dehydration symptoms--feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin.

Common side effects may include:

• dry mouth;
• increased thirst or urination;
• hunger, fruity breath odor;
• constipation; or
• weakness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You will need to be in a hospital under observation any time you start or restart treatment with Samsca.

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

Tell your caregivers at once if you have signs that your hyponatremia is being reversed too quickly: problems with speech or muscle control, trouble swallowing, trouble moving your arms and legs, confusion, or seizure.

Tolvaptan can cause serious or fatal liver problems. While taking Samsca at home, call your doctor right away if you don't feel well and you have right-sided upper stomach pain, vomiting, loss of appetite, or yellowing of your skin or eyes.

You should not use Samsca if you are allergic to tolvaptan, or if:

• you are unable to urinate;
• you are unable to tell that you are thirsty;
• you are severely dehydrated and feel like you might pass out; or
• you have autosomal dominant polycystic kidney disease (unless you receive Samsca through a special program that includes frequent liver function tests).

Some medicines can cause unwanted or dangerous effects when used with Samsca. Your doctor may change your treatment plan if you also use:

• nefazodone;
• an antibiotic--clarithromycin, telithromycin;
• antifungal medicine--itraconazole, ketoconazole; or
• HIV/AIDS medication--indinavir, nelfinavir, ritonavir, saquinavir.

Tell your doctor if you have ever had:

• kidney disease or urination problems;
• liver problems;
• allergies;
• if you drink large amounts of alcohol;
• if you are malnourished; or
• if you also use desmopressin (dDAVP), or a diuretic or "water pill."

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant.

You should not breastfeed while using Samsca.

You will receive your first dose in a hospital or clinic setting to quickly treat any serious side effects.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Long-term use of Samsca can damage your liver. You should not use Samsca for longer than 30 days.

You may take Samsca with or without food.

Drink plenty of fluids while taking Samsca, but avoid grapefruit juice or alcoholic drinks. Follow your doctor's instructions about the type and amount of liquids you should drink while treating hyponatremia.

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 Samsca, which can lead to serious side effects.

You will need frequent medical tests.

Store at room temperature away from moisture and heat.

If you stop taking Samsca for any length of time, do not start taking it again at home. You will need to be in a hospital under observation any time you start or restart treatment with Samsca.

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Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid alcoholic drinks.

Grapefruit may interact with tolvaptan and lead to unwanted side effects. Avoid the use of grapefruit products.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can affect Samsca, and some drugs should not be used at the same time. Tell your doctor about all your current medicines and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

Your pharmacist can provide more information about tolvaptan (Samsca).

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