LITHIUM CARBONATE LITHIUM CARBONATE- lithium carbonate capsule 
Alembic Pharmaceuticals Inc.

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MEDICATION GUIDE
Lithium (LITH-ee-əm)
Carbonate Capsules

What is the most important information I should know about Lithium Carbonate?


Lithium Carbonate 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 exactly as your healthcare provider tells you to take it.

Stop taking Lithium Carbonate and call your healthcare provider right away if you have any symptoms of lithium toxicity including 

 o  abnormal heartbeat o  vomiting  o  diarrhea  o  drowsiness
 o  weak muscles o  blurred vision o  clumsiness o  ringing in your ears
 o  muscle twitching   

Other symptoms may include:

 o  light headedness o  confusion 
 o  bloating o  mood changes
 o  slurred speech o  breathing problems
 o  seizure o  coma

What is Lithium Carbonate?

Lithium Carbonate are prescription medicines called mood-stabilizing agents used alone (monotherapy) for:

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

Who should not take Lithium Carbonate?

Do not take Lithium Carbonate if you are allergic to any of the ingredients in Lithium Carbonate Capsules. See the end of this Medication Guide for a complete list of ingredients in Lithium Carbonate Capsules.


What should I tell my healthcare provider before taking Lithium Carbonate?

Before taking Lithium Carbonate, tell your healthcare provider if you:

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

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

Especially tell your healthcare provider if you take:

 •   MAOIs   •  selective serotonin reuptake inhibitor (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 with your other medicines. Do not start or stop any medicines while taking Lithium Carbonate 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?

What should I avoid while taking Lithium Carbonate?

What are the possible side effects of Lithium Carbonate?

See “What is the most important information I should know about Lithium Carbonate?

Lithium Carbonate may cause serious side effects, including:

• serotonin syndrome. A potentially life-threatening problem called serotonin syndrome can happen when you take Lithium Carbonate while you take certain medicines called serotonergic and MAOIs. Symptoms of serotonin syndrome include:


 o  agitation  o  seeing things that are not there o  confusion 
 o  coma   o  rapid pulse  o  high or low blood pressure
 o  dizziness  o  sweating  o  flushing
 o  fever   o  tremors  o  stiff muscles
 o  muscle twitching   o  become unstable  o  seizures
 o  nausea   o  vomiting  o  diarrhea

• 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 include:
• Adults with manic or mixed episodes of bipolar I disorder:
    o hand trembling
    o excessive urination
    o increased thirst
    o nausea   
    o general discomfort when you start treatment  

• Children 7 to 17 years of age with manic or mixed episodes of bipolar I disorder:

    o excessive urination
    o thyroid problems
    o hand trembling
    o excessive thirst
    o dizziness
    o rash
    o difficulty in walking
    o decreased appetite
    o blurred vision
    o nausea
    o vomiting
These are not all the possible side effects of Lithium Carbonate.
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?
Store Lithium Carbonate at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Keep capsules dry and keep in a tightly closed container.Keep Lithium Carbonate and all medicines out of the reach of children.

General information about the safe and effective use of Lithium Carbonate.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Lithium Carbonate for a condition for which it was not prescribed. Do not give Lithium carbonate 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 that is written for healthcare professionals.

For more information about Lithium Carbonate Capsules call Alembic Pharmaceuticals Limited at 1-866-210-9797.

What are the ingredients in Lithium Carbonate?

Active ingredient: lithium carbonate, USP  

Inactive ingredients: talc, gelatin, FD&C Red No. 40, titanium dioxide, D&C Yellow No. 10, FD&C Yellow No. 6, and the imprinting ink contains black iron oxide, & Pharmaceutical glaze.

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

Medication Guide available at http://www.alembicusa.com/medicationguide.aspx or call 1-866-210-9797.


Manufactured by:

Alembic Pharmaceuticals Limited

(Formulation Division),

Panelav 389350, Gujarat, India

Manufactured for:

Alembic Pharmaceuticals, Inc.

Bedminster, NJ 07921, USA

Revised: 09/2021

Revised: 10/2021
Alembic Pharmaceuticals Inc.