SAMSCA- tolvaptan tablet 
Otsuka America Pharmaceutical, Inc.

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MEDICATION GUIDE

SAMSCA ® (sam-sca) tolvaptan
Tablets

Read the Medication Guide that comes with SAMSCA before you take it and each time you get a new prescription. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment. Share this important information with members of your household.

What is the most important information I should know about SAMSCA?

1) SAMSCA may make the salt (sodium) level in your blood rise too fast. This can increase your risk of a serious condition called osmotic demyelination syndrome (ODS). ODS can lead to coma or death. ODS can also cause new symptoms such as:

You or a family member should tell your healthcare provider right away if you have any of these symptoms even if they begin later in treatment. Also tell your healthcare provider about any other new symptoms while taking SAMSCA.

You may be more at risk for ODS if you have:

To lessen your risk of ODS while taking SAMSCA:

2) SAMSCA may cause liver problems, including life-threatening liver failure. SAMSCA should not be taken for more than 30 days. Tell your doctor right away if you develop or have worsening of any of these signs and symptoms of liver problems:

3) If you have autosomal dominant polycystic kidney disease (ADPKD), do not use SAMSCA because you should receive the medicine (tolvaptan) through a program that ensures laboratory monitoring of your liver.

What is SAMSCA?

SAMSCA is a prescription medicine used to help increase low sodium levels in the blood, in adults with conditions such as heart failure, and certain hormone imbalances. SAMSCA helps raise salt levels in your blood by removing extra body water as urine.

It is not known if SAMSCA is safe or works in children.

Who should not take SAMSCA?

Do not take SAMSCA if:

What should I tell my healthcare provider before taking SAMSCA?

Tell your healthcare provider about all your medical conditions, including if you:

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Using SAMSCA with certain medicines could cause you to have too much SAMSCA in your blood. See " Who should not take SAMSCA?"

SAMSCA may affect the way other medicines work, and other medicines may affect how SAMSCA works.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take SAMSCA?

What are the possible side effects of SAMSCA?

SAMSCA can cause serious side effects including:

Call your healthcare provider right away, if you have any of these symptoms.

The most common side effects of SAMSCA are:

These are not all the possible side effects of SAMSCA. Talk to your healthcare provider about any side effect that bothers you or that does not go away while taking SAMSCA.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store SAMSCA?

Store SAMSCA between 59°F to 86°F (15°C to 30°C).

Keep SAMSCA and all medicines out of the reach of children.

General Information about SAMSCA

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use SAMSCA for a condition for which it was not prescribed. Do not give SAMSCA to other people, even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information about SAMSCA. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about SAMSCA that is written for healthcare professionals. For more information about SAMSCA, call 1-877-726-7220 or go to www.samsca.com.

What are the ingredients in SAMSCA?

Active ingredient: tolvaptan.

Inactive ingredients: corn starch, hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate and microcrystalline cellulose, and FD&C Blue No. 2 Aluminum Lake as colorant

Manufactured by Otsuka Pharmaceutical Co., Ltd., Tokyo, 101-8535 Japan

Distributed and marketed by Otsuka America Pharmaceutical, Inc., Rockville, MD 20850

SAMSCA is a registered trademark of Otsuka Pharmaceutical Co., Ltd., Tokyo, 101-8535 Japan

Otsuka America Pharmaceutical, Inc.

07US14L-0919
Rev. 05/2019

This Medication Guide has been approved by the U.S. Food and Drug Administration.

© 2019 Otsuka Pharmaceutical Co., Ltd.

Revised: 5/2019
Otsuka America Pharmaceutical, Inc.