Carbamazepine

REMEDYREPACK INC.

FULL PRESCRIBING INFORMATION: CONTENTS*

• BOXED WARNING
• CARBAMAZEPINE DESCRIPTION
• CLINICAL PHARMACOLOGY
• PHARMACOKINETICS
• INDICATIONS & USAGE
• CARBAMAZEPINE CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
• INFORMATION FOR PATIENTS
• LABORATORY TESTS
• DRUG INTERACTIONS
• CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
• PREGNANCY
• LABOR & DELIVERY
• NURSING MOTHERS
• PEDIATRIC USE
• GERIATRIC USE
• CARBAMAZEPINE ADVERSE REACTIONS
• DRUG ABUSE AND DEPENDENCE
• OVERDOSAGE
• DOSAGE & ADMINISTRATION
• HOW SUPPLIED
• STORAGE AND HANDLING
• SPL MEDGUIDE
• PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

FULL PRESCRIBING INFORMATION

CARBAMAZEPINE DESCRIPTION

CLINICAL PHARMACOLOGY

PHARMACOKINETICS

INDICATIONS & USAGE

CARBAMAZEPINE CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

INFORMATION FOR PATIENTS

LABORATORY TESTS

DRUG INTERACTIONS

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

PREGNANCY

LABOR & DELIVERY

NURSING MOTHERS

PEDIATRIC USE

GERIATRIC USE

CARBAMAZEPINE ADVERSE REACTIONS

DRUG ABUSE AND DEPENDENCE

OVERDOSAGE

DOSAGE & ADMINISTRATION

HOW SUPPLIED

STORAGE AND HANDLING

SPL MEDGUIDE

• ●     skin rash

• ●     hives

• ●     sores in your mouth

• ●     blistering or peeling of the skin

• ●     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

• ●     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

• ●     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.

• ●     certain types of seizures (partial, tonic-clonic, mixed)

• ●     certain types of nerve pain (trigeminal and glossopharyngeal neuralgia)

• ●     have a history of bone marrow depression.

• ●     are allergic to carbamazepine or any of the ingredients in carbamazepine tablets or carbamazepine tablets (chewable). See the end of this Medication Guide for a complete list of ingredients in carbamazepine tablets and carbamazepine tablets (chewable).

• ●     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.

• ●     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 tablets or carbamazepine tablets (chewable) may make your birth control less effective. Tell your healthcare provider if your menstrual bleeding changes while you take birth control and carbamazepine tablets or carbamazepine tablets (chewable) .

• ●     are pregnant or plan to become pregnant. Carbamazepine tablets or carbamazepine tablets (chewable) may harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking carbamazepine tablets or carbamazepine tablets (chewable). You and your healthcare provider should decide if you should take carbamazepine tablets or carbamazepine tablets (chewable) while you are pregnant.

• ●               If you become pregnant while taking carbamazepine tablets or carbamazepine tablets (chewable), 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.

• ●

• ●     Do not stop taking carbamazepine tablets or carbamazepine tablets (chewable) without first talking to your healthcare provider. Stopping carbamazepine tablets or carbamazepine tablets (chewable) 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 tablets or carbamazepine tablets (chewable) exactly as prescribed. Your healthcare provider will tell you how many carbamazepine tablets or carbamazepine tablets (chewable) to take.

• ●     Your healthcare provider may change your dose. Do not change your dose of carbamazepine tablets or carbamazepine tablets (chewable) without talking to your healthcare provider.

• ●     Take carbamazepine tablets or carbamazepine tablets (chewable) with food.

• ●     If you take too many carbamazepine tablets or carbamazepine tablets (chewable), call your healthcare provider or local Poison Control Center right away.

• ●     Do not drink alcohol or take other drugs that make you sleepy or dizzy while taking carbamazepine tablets or carbamazepine tablets (chewable) until you talk to your healthcare provider. Carbamazepine tablets or carbamazepine tablets (chewable) 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 tablets or carbamazepine tablets (chewable) affect you. Carbamazepine tablets or carbamazepine tablets (chewable) may slow your thinking and motor skills.

• ●     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

• ●     dizziness

• ●     drowsiness

• ●     problems with walking and coordination (unsteadiness)

• ●     nausea

• ●     vomiting

• ●     Store carbamazepine tablets at 20to 25(68to 77

• ●               Keep carbamazepine tablets dry.

• ●     Store carbamazepine tablets (chewable) at 20to 25(68to 77

• ●               Keep carbamazepine tablets (chewable) out of the light.

• ●               Keep carbamazepine tablets (chewable) dry.

• ●     Carbamazepine tablets: colloidal silicon dioxide, croscarmellose sodium, ethylcellulose, glycerin, lactose monohydrate, magnesium stearate, and sodium starch glycolate.

• ●     Carbamazepine tablets (chewable): acacia, colloidal silicon dioxide, croscarmellose sodium, ethylcellulose, FD&C Red #40 aluminum lake, flavoring, glycerin, lactose monohydrate, magnesium stearate, pregelatinized corn starch, and sucrose.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION