MEDICATION GUIDE

Carbamazepine Oral Suspension, USP

100 mg/5 mL

(Carbamazepine)

Read this Medication Guide before you start taking Carbamazepine and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

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

Do not stop taking Carbamazepine without first talking to your healthcare provider.

Stopping Carbamazepine suddenly can cause serious problems.

Carbamazepine can cause serious side effects, including:

   1.    Carbamazepine may cause rare but serious skin rashes that may lead to death. These serious skin reactions are more likely to happen when you begin taking Carbamazepine within the first four months of treatment but may occur at later times. These reactions can happen in anyone, but are more likely in people of Asian descent. If you are of Asian descent, you may need a genetic blood test before you take Carbamazepine to see if you are at a higher risk for serious skin reactions with this medicine. Symptoms may include:

• skin rash
• hives
• sores in your mouth
• blistering or peeling of the skin

   2.    Carbamazepine may cause rare but serious blood problems. Symptoms may include:

• fever, sore throat, or other infections that come and go or do not go away
• easy bruising
• red or purple spots on your body
• bleeding gums or nose bleeds
• severe fatigue or weakness

3. Carbamazepine may cause allergic reactions or serious problems, which may affect organs and other parts of your body like the liver or blood cells. You may or may not have a rash with these types of reactions.

Call your healthcare provider right away if you have any of the following:

1. swelling of your face, eyes, lips, or tongue
2. a skin rash
3. painful sores in the mouth or around your eyes
4. unusual bruising or bleeding
5. frequent infections or infections that do not go away
6. fever, swollen glands, or sore throat that do not go away or come and go
7. trouble swallowing or breathing
8. hives
9. yellowing of your skin or eyes
10. severe fatigue or weakness
11. severe muscle pain

   4.    Like other antiepileptic drugs, Carbamazepine may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

• thoughts about suicide or dying
• attempts to commit suicide
• new or worse depression
• new or worse anxiety
• feeling agitated or restless
• panic attacks
• trouble sleeping (insomnia)
• new or worse irritability
• acting aggressive, being angry, or violent
• acting on dangerous impulses
• an extreme increase in activity and talking (mania)
• other unusual changes in behavior or mood

How can I watch for early symptoms of suicidal thoughts and actions?

• Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
• Keep all follow-up visits with your healthcare provider as scheduled.

Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Do not stop Carbamazepine without first talking to a healthcare provider.

Stopping Carbamazepine suddenly can cause serious problems. You should talk to your healthcare provider before stopping.

Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

What is Carbamazepine?

Carbamazepine is a prescription medicine used to treat:

• certain types of seizures (partial, tonic-clonic, mixed)
• certain types of nerve pain (trigeminal and glossopharyngeal neuralgia)

Carbamazepine is not a regular pain medicine and should not be used for aches or pains.

Who should not take Carbamazepine?

Do not take Carbamazepine if you:

• have a history of bone marrow depression.
• are allergic to Carbamazepine or any of the ingredients in Carbamazepine. See the end of this Medication Guide for a complete list of ingredients in Carbamazepine.
• take nefazodone.
• are allergic to medicines called tricyclic antidepressants (TCAs). Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.
• have taken a medicine called a Monoamine Oxidase Inhibitor (MAOI) in the last 14 days. Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.

What should I tell my healthcare provider before taking Carbamazepine?

Before you take Carbamazepine, tell your healthcare provider if you:

• have or have had suicidal thoughts or actions, depression, or mood problems
• have or ever had heart problems
• have or ever had blood problems
• have or ever had liver problems
• have or ever had kidney problems
• have or ever had allergic reactions to medicines
• have or ever had increased pressure in your eye
• have any other medical conditions
• drink grapefruit juice or eat grapefruit
• use birth control. Carbamazepine may make your birth control less effective. Tell your healthcare provider if your menstrual bleeding changes while you take birth control and Carbamazepine.
• are pregnant or plan to become pregnant. Carbamazepine may harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking Carbamazepine. You and your healthcare provider should decide if you should take Carbamazepine while you are pregnant.
• If you become pregnant while taking Carbamazepine, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy. You can enroll in this registry by calling 1-888-233-2334.
• are breastfeeding or plan to breastfeed. Carbamazepine passes into breast milk. You and your healthcare provider should discuss whether you should take Carbamazepine or breastfeed; you should not do both.

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

Taking Carbamazepine with certain other medicines may cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.

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 Carbamazepine?

• Do not stop taking Carbamazepine without first talking to your healthcare provider. Stopping Carbamazepine suddenly can cause serious problems. Stopping seizure medicine suddenly in a patient who has epilepsy may cause seizures that will not stop (status epilepticus).
• Take Carbamazepine exactly as prescribed. Your healthcare provider will tell you how much Carbamazepine to take.
• Your healthcare provider may change your dose. Do not change your dose of Carbamazepine without talking to your healthcare provider.
• Take Carbamazepine with food.

• Carbamazepine Oral Suspension:
  • Shake the bottle well each time before use.
  • Do not take Carbamazepine Oral Suspension at the same time you take other liquid medicines.
• If you take too much Carbamazepine, call your healthcare provider or local Poison Control Center right away.

What should I avoid while taking Carbamazepine?

• Do not drink alcohol or take other drugs that make you sleepy or dizzy while taking Carbamazepine until you talk to your healthcare provider. Carbamazepine taken with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse.
• Do not drive, operate heavy machinery, or do other dangerous activities until you know how Carbamazepine affects you. Carbamazepine may slow your thinking and motor skills.

What are the possible side effects of Carbamazepine?

See "What is the most important information I should know about Carbamazepine?"

Carbamazepine may cause other serious side effects. These include:

• Irregular heartbeat - symptoms include:
  • Fast, slow, or pounding heartbeat
  • Shortness of breath
  • Feeling lightheaded
  • Fainting
• Liver problems - symptoms include:
  • yellowing of your skin or the whites of your eyes
  • dark urine
  • pain on the right side of your stomach area (abdominal pain)
  • easy bruising
  • loss of appetite
  • nausea or vomiting

Get medical help right away if you have any of the symptoms listed above or listed in "What is the most important information I should know about Carbamazepine".

The most common side effects of Carbamazepine include:

• dizziness
• drowsiness
• problems with walking and coordination (unsteadiness)
• nausea
• vomiting

These are not all the possible side effects of Carbamazepine. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

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 Carbamazepine Oral Suspension?

• Store Carbamazepine Oral Suspension at 20° to 25° C (68° to 77° F)
• Shake well before using.
• Keep Carbamazepine Oral Suspension in a tight, light-resistant container.

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

General Information about Carbamazepine

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

This Medication Guide summarizes the most important information about Carbamazepine. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for the full prescribing information about Carbamazepine that is written for health professionals.

For more information, go to www.wockhardtusa.com or call 1-800-346-6845.

What are the ingredients in Carbamazepine?

Active ingredient: carbamazepine

Inactive ingredients:

• Carbamazepine Oral Suspension: alcohol free lemon lime flavor, citric acid anhydrous, FD&C Yellow No. 6, hypromellose, orange flavor, potassium sorbate, propylene glycol, purified water, sorbitol solution, sucrose, vanillin, and xanthan gum. It may contain 10% citric acid solution or 10% sodium citrate solution to adjust pH between 3.0 and 5.0.

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

Prod. No.: 8129

Manufactured For:

Wockhardt USA, LLC

Parsippany, NJ 07054

Manufactured By:

Morton Grove Pharmaceuticals, Inc.

Morton Grove, IL 60053

28129AP Rev. 08-18