Alembic Pharmaceuticals Inc.



 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: 
  •  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 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:
•   have kidney problems
•   have heart problems
•   have breathing problems
•    have thyroid problems
•    are pregnant or plan to become pregnant. Lithium Carbonate 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. Talk to your healthcare provider about the best way to feed your baby if you take Lithium Carbonate.
 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?
•        Take your Lithium Carbonate exactly as prescribed by your healthcare provider.
•        Your healthcare provider will do certain blood tests before starting and during treatment with Lithium Carbonate. 
• 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 suddenly without talking to your healthcare provider.
 •       Your healthcare provider may change your Lithium Carbonate dose to make sure you are taking the dose that is right for you.
 •       If you take too much Lithium Carbonate, 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?
 •        Do not drive, operate heavy machinery, or do other dangerous activities when you start taking Lithium Carbonate, when your dose is changed, or until you know how Lithium Carbonate affects you. Lithium Carbonate 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?
 See “What is the most important information I should know about Lithium Carbonate?
 Lithium Carbonate may cause serious side effects, including:
 •         kidney problems. People who take Lithium Carbonate 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 or after taking Lithium Carbonate for a long time.
 •         low levels of sodium (salt) in your blood (hyponatremia). Lithium Carbonate 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. 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 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 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
• 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.
• heart problems. People who take Lithium Carbonate 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 effectsof 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 Capsules?
Store Lithium Carbonate Capsules 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 Capsules 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 Capsules?
 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.
 Medication Guide available at or call
 Manufactured by:
 Alembic Pharmaceuticals Limited
 (Formulation Division),
 Panelav 389350, Gujarat, India
 Manufactured for:
 Alembic Pharmaceuticals, Inc.
 Bedminster, NJ 07921, USA

 This Medication Guide has been approved by the U.S. Food and Drug Administration.   Revised: 11/2022

Revised: 11/2022
Alembic Pharmaceuticals Inc.