MEDICATION GUIDE

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MEDICATION GUIDE
Lithium (LITH-ee-əm) Carbonate Tablets USP

What is the most important information I should know about lithium carbonate tablets?

Lithium carbonate tablets can cause serious side effects, including:

•   too much lithium in your blood (lithium toxicity). Lithium toxicity that can cause death may happen even if the lithium level in your blood is close to the right level for you. Your healthcare provider will need to monitor your blood levels of lithium to find the best dose for you. Take your lithium carbonate tablets exactly as your healthcare provider tells you to take it. Stop taking lithium carbonate tablets and call your healthcare provider right away if you have any symptoms of lithium toxicity including:
  • abnormal heartbeat
  • vomiting
  • diarrhea
  • drowsiness
  • weak muscles
  • blurred vision
  • clumsiness
  • ringing in your ears
  • muscle twitching

Other symptoms may include:

• • lightheadedness
  • confusion
  • bloating
  • mood changes
  • slurred speech
  • breathing problems
  • seizure
  • coma

What are lithium carbonate tablets?

Lithium carbonate tablets are a prescription medicine called mood-stabilizing agents used alone (monotherapy) for:

• the acute (short-term) treatment of people 7 years of age and older with manic and mixed episodes that happen with bipolar I disorder.
• maintenance treatment of bipolar I disorder in people 7 years of age and older.

It is not known if lithium carbonate tablet is safe and effective in children under 7 years of age with bipolar I disorder.

Who should not take lithium carbonate tablets?

Do not take lithium carbonate tablets if you are allergic to lithium or any of the ingredients in lithium carbonate tablets. See the end of this Medication Guide for a complete list of ingredients in lithium carbonate tablets.

What should I tell my healthcare provider before taking lithium carbonate tablets?

Before taking lithium carbonate tablets, tell your healthcare provider if you:

• have kidney problems
• have heart problems
• have breathing problems
• have thyroid problems
• are pregnant or plan to become pregnant. Lithium carbonate tablets may harm your unborn baby.
• are breastfeeding or plan to breastfeed. Lithium carbonate can pass into your breastmilk and may harm your baby. You should not breastfeed during treatment with lithium carbonate tablets. Talk to your healthcare provider about the best way to feed your baby if you take lithium carbonate tablets.

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

Using lithium carbonate tablets with certain other medicines may affect each other causing possible side effects. Lithium carbonate tablets may affect the way other medicines work, and other medicines may affect how lithium carbonate tablets work.

Especially tell your healthcare provider if you take:

• MAOIs
• selective serotonin reuptake inhibitors (SSRIs)
• serotonin norepinephrine reuptake inhibitors (SNRIs)
• medicines used to treat migraine headaches called triptans
• tricyclic antidepressants
• fentanyl
• antipsychotic medicines
• tramadol
• tryptophan
• buspirone
• St John’s Wort

Your healthcare provider can tell you if it is safe to take lithium carbonate tablets with your other medicines. Do not start or stop any medicines while taking lithium carbonate tablets without talking to your healthcare provider first.

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

How should I take lithium carbonate tablets?

• Take your lithium carbonate tablets exactly as prescribed by your healthcare provider.
• Your healthcare provider will do certain blood tests before starting and during treatment with lithium carbonate tablets.
• Your healthcare provider may change your dose if needed. Do not change your dose on your own.
• Do not double your dose if a dose is missed. Talk with your healthcare provider if you miss a dose.
• Do not stop taking lithium carbonate tablets suddenly without talking to your healthcare provider.
  • Your healthcare provider may change your lithium carbonate tablet dose to make sure you are taking the dose that is right for you.

If you take too many lithium carbonate tablets, call your healthcare provider or poison control center, or go to the nearest hospital emergency room right away. In case of poisoning, call your poison control center at 1-800-222-1222.

What should I avoid while taking lithium carbonate tablets?

• Do not drive, operate heavy machinery, or do other dangerous activities when you start taking lithium carbonate tablets, when your dose is changed, or until you know how lithium carbonate tablets affect you. Lithium carbonate tablets can make you sleepy. Talk to your healthcare provider about these activities.
• Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your healthcare provider instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

Do not change the amount of salt in your diet. Changing the amount of salt in your diet could change the amount of lithium carbonate in your blood.

What are the possible side effects of lithium carbonate tablets?

See “What is the most important information I should know about lithium carbonate tablets?

Lithium carbonate tablets may cause serious side effects, including:

• kidney problems. People who take lithium carbonate tablets may have to urinate often (polyuria) and have other kidney problems that may affect how their kidneys work. These problems can happen within a few weeks of starting to take lithium carbonate tablets or after taking lithium carbonate tablets for a long time.
• low levels of sodium (salt) in your blood (hyponatremia). Lithium carbonate tablets can cause you to lose sodium. Talk to your healthcare provider about your diet and how much fluid you are drinking when starting lithium carbonate tablets. If you have been sweating more than usual or have had diarrhea, you may need extra salt and more fluids. Talk to your healthcare provider if this happens.
• neurological problems. People who take lithium carbonate tablets with certain other medicines called antipsychotics may have symptoms such as weakness, tiredness, fever, tremors, and confusion. Talk to your healthcare provider if this happens. Ask if you are not sure about the medicines you take.
• serotonin syndrome. A potentially life-threatening problem called serotonin syndrome can happen when you take lithium carbonate tablets while you take certain medicines called serotonergic and MAOIs. Symptoms of serotonin syndrome include:
  • agitation
  • seeing things that are not there
  • confusion
  • coma
  • rapid pulse
  • high or low blood pressure
  • dizziness
  • sweating
  • flushing
  • fever
  • tremors
  • stiff muscles
  • muscle twitching
  • become unstable
  • seizures
  • nausea
  • vomiting
  • diarrhea
• thyroid problems.
• high calcium levels in your blood (hypercalcemia) and changes in your parathyroid gland (hyperparathyroidism) that may not go away when you stop taking lithium carbonate tablets.
• heart problems. People who take lithium carbonate tablets may find out they also have a heart problem called Brugada Syndrome. People who have unexplained fainting or who have a family history of sudden unexplained death before 45 years of age may have Brugada Syndrome and not know it. If you faint or feel abnormal heartbeats, talk to your healthcare provider right away.
• increased pressure in the brain and swelling in the eye (pseudotumor cerebri) that can cause vision problems or blindness. If you have severe headaches behind your eyes, ringing in the ears, blurred vision, double vision, or brief periods of blindness, talk to your health care provider right away.

The most common side effects of lithium carbonate tablets, include:

• Adults with manic or mixed episodes of bipolar I disorder:
  • hand trembling
  • excessive urination
  • increased thirst
  • nausea
  • general discomfort when you start treatment
  • Children 7 to 17 years of age with manic or mixed episodes of bipolar I disorder:
    • excessive urination
    • thyroid problems
    • hand trembling
    • excessive thirst
    • dizziness
    • rash
    • difficulty walking
    • decreased appetite
    • blurred vision
    • nausea
    • vomiting

These are not all the possible side effects of lithium carbonate tablets.

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 lithium carbonate tablets?

Store lithium carbonate tablets at room temperature, between 68°F to 77°F (20°C to 25°C).

Keep tablets dry and keep in a tightly closed container.

Keep lithium carbonate tablets and all medicines out of the reach of children.

General information about the safe and effective use of lithium carbonate tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use lithium carbonate tablets for a condition for which it was not prescribed. Do not give lithium carbonate tablets to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about lithium carbonate tablets that is written for healthcare professionals.

For more information about lithium carbonate tablets, call 1-800-818-4555.

What are the ingredients in lithium carbonate tablets?

Active ingredient:lithium carbonate, USP

Inactive ingredients: microcrystalline cellulose, povidone, sodium lauryl sulfate, sodium starch glycolate type A, colloidal silicon dioxide and calcium stearate.

Dispense with Medication Guide available at: https://www.sunpharma.com/usa/products

Distributed by:

Sun Pharmaceutical Industries, Inc.

Cranbury, NJ 08512

Manufactured by:

Sun Pharmaceutical Industries Limited

Survey No. 1012, Dadra-396 193, 

U.T. of D & NH and Daman & Diu, India.

5245392

ISS. 09/2023

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