Uses of Lithium Controlled-Release and Extended-Release Tablets:

• It is used to treat bipolar problems.
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Lithium Controlled-Release and Extended-Release Tablets?

• If you have an allergy to lithium or any other part of this medicine (lithium controlled-release and extended-release tablets).
• If you are allergic to this medicine (lithium controlled-release and extended-release tablets); any part of this medicine (lithium controlled-release and extended-release tablets); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Fluid loss (dehydrated), heart disease, kidney disease, low levels of salt in your blood, or if you are very sick or weak.
• If you have a certain heart problem called Brugada syndrome or you have ever passed out for an unknown reason.
• If a family member has Brugada Syndrome or has suddenly died before 45 years of age.
• If you are taking drugs for blood pressure or heart problems. You may need to have your blood work checked more closely.

This is not a list of all drugs or health problems that interact with this medicine (lithium controlled-release and extended-release tablets).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine (lithium controlled-release and extended-release tablets) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Lithium Controlled-Release and Extended-Release Tablets?

• Tell all of your health care providers that you take this medicine (lithium controlled-release and extended-release tablets). This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine (lithium controlled-release and extended-release tablets) affects you.
• If you start on a low-salt diet, tell your doctor. It will change the way your body handles the lithium.
• Talk with your doctor before you drink alcohol.
• Fever, infection, throwing up, diarrhea, or sweating a lot may change how much of this medicine (lithium controlled-release and extended-release tablets) is in your blood. If any of these happen, talk with the doctor.
• Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.
• Tell your doctor if you have signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• A certain heart problem (Brugada Syndrome) has shown up in some people taking this medicine (lithium controlled-release and extended-release tablets). These people had this problem but did not know it at the time. People with Brugada Syndrome have a heartbeat that is not normal and are at risk for sudden death. Talk with the doctor.
• Brain problems have rarely happened in people taking this medicine (lithium controlled-release and extended-release tablets) with certain other drugs like haloperidol. Sometimes, these brain problems have led to long-lasting brain damage. Talk with the doctor.
• A severe and sometimes deadly problem called serotonin syndrome may happen. The risk may be greater if you also take certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; severe diarrhea, upset stomach, or throwing up; or very bad headache.
• Raised pressure in the brain and swelling in the eye has happened with this medicine (lithium controlled-release and extended-release tablets). This can lead to eyesight problems like loss of eyesight. Call your doctor right away if you have a very bad headache; ringing in the ears; or eyesight problems like blurred eyesight, seeing double, or loss of eyesight.
• Call your doctor right away if you have signs of kidney problems like not able to pass urine; change in how much urine is passed; bloody, brown, or foamy urine; shortness of breath or cough; or puffy or swollen face, feet, or hands.
• If you are 65 or older, use this medicine (lithium controlled-release and extended-release tablets) with care. You could have more side effects.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this medicine (lithium controlled-release and extended-release tablets), call your doctor right away.
• Tell your doctor if you are breast-feeding or plan to breast-feed. This medicine passes into breast milk and may harm your baby.

How is this medicine (Lithium Controlled-Release and Extended-Release Tablets) best taken?

Use this medicine (lithium controlled-release and extended-release tablets) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food. Take with food if it causes an upset stomach.
• Keep your salt use the same from day to day.
• Follow what your doctor has told you about the type of liquids to drink and how much liquid to drink while you take this medicine (lithium controlled-release and extended-release tablets).
• Swallow whole. Do not chew or crush.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• If you are not sure what to do if you miss a dose, call your doctor.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of too much acid in the blood (acidosis) like confusion; fast breathing; fast heartbeat; a heartbeat that does not feel normal; very bad stomach pain, upset stomach, or throwing up; feeling very sleepy; shortness of breath; or feeling very tired or weak.
• Signs of thyroid problems like change in weight; feeling nervous, excitable, restless, or weak; hair thinning; depression; neck swelling; not able to focus; trouble with heat or cold; menstrual changes; shakiness; or sweating.
• Signs of fluid and electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, very bad dizziness or passing out, fast heartbeat, more thirst, seizures, feeling very tired or weak, not hungry, unable to pass urine or change in the amount of urine produced, dry mouth, dry eyes, or very bad upset stomach or throwing up.
• Bloating.
• Diarrhea.
• Giddiness.
• Trouble walking.
• Trouble controlling body movements, twitching, change in balance, trouble swallowing or speaking.
• Muscle weakness.
• Feeling sluggish.
• Not able to control eye movements.
• Mood changes.
• Fever.
• Hallucinations (seeing or hearing things that are not there).
• Memory problems or loss.
• Restlessness.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• A change in weight without trying.
• Not able to control bladder.
• Not able to control bowels.
• Sex problems.

What are some other side effects of Lithium Controlled-Release and Extended-Release Tablets?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling dizzy, sleepy, tired, or weak.
• Upset stomach.
• Not hungry.
• Stomach pain.
• More saliva.
• Gas.
• Dry mouth.
• Headache.
• Dry or thin hair.
• Hair loss.
• Change in taste.
• Joint pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Lithium Controlled-Release and Extended-Release Tablets?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine (lithium controlled-release and extended-release tablets), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Frequently asked questions

• What is a proper diet to go on with lithium?