Carbamazepine

What it is used for

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.

How to take it

• 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.
• 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.

Side effects, and when to stop

Carbamazepine may cause other serious side effects. These include:

• Irregular heartbeat - symptoms include:

o Fast, slow, or pounding heartbeat

o Shortness of breath

o Feeling lightheaded

o Fainting

• Liver problem-symptoms include:

o yellowing of your skin or the whites of your eyes

o dark urine

o pain on the right side of your stomach area (abdominal pain)

o easy bruising

o loss of appetite

o 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.

Who should not take it

Do not take carbamazepine if you:

• have a history of bone marrow depression.
• are allergic to carbamazepine or any of the ingredients in Carbamazepine Tablets. See the end of this Medication Guide for a complete list of ingredients in Carbamazepine Tablets.

• 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 to say before you start

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.

Storing it

• Store Carbamazepine Tablets at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F).
• Do not store Carbamazepine Tablets above 30°C (86°F)
• Keep Carbamazepine Tablets dry.

Keep Carbamazepine Tablets 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. PHARMACIST: Umedica Laboratories Pvt. Ltd. intent to provide a sufficient quantity of medication guide with each bottle such that the pharmacist may provide one with each prescription that is dispensed.