Gabapentin

REMEDYREPACK INC.

FULL PRESCRIBING INFORMATION: CONTENTS*

• GABAPENTIN DESCRIPTION
• CLINICAL PHARMACOLOGY
• PHARMACOKINETICS AND DRUG METABOLISM
• CLINICAL STUDIES
• INDICATIONS & USAGE
• GABAPENTIN CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
• LABORATORY TESTS
• DRUG INTERACTIONS
• DRUG & OR LABORATORY TEST INTERACTIONS
• CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
• PREGNANCY
• NURSING MOTHERS
• PEDIATRIC USE
• GERIATRIC USE
• GABAPENTIN 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

GABAPENTIN DESCRIPTION

CLINICAL PHARMACOLOGY

PHARMACOKINETICS AND DRUG METABOLISM

CLINICAL STUDIES

INDICATIONS & USAGE

GABAPENTIN CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

LABORATORY TESTS

DRUG INTERACTIONS

DRUG & OR LABORATORY TEST INTERACTIONS

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

PREGNANCY

NURSING MOTHERS

PEDIATRIC USE

GERIATRIC USE

GABAPENTIN ADVERSE REACTIONS

DRUG ABUSE AND DEPENDENCE

OVERDOSAGE

DOSAGE & ADMINISTRATION

HOW SUPPLIED

STORAGE AND HANDLING

SPL MEDGUIDE

• ●     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.

• ●     Stopping gabapentin tablets suddenly can cause serious problems. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).

• ●     skin rash

• ●     hives

• ●     fever

• ●     swollen glands that do not go away

• ●     swelling of your lip and tongue

• ●     yellowing of your skin or of the whites of the eyes

• ●     unusual bruising or bleeding

• ●     severe fatigue or weakness

• ●     unexpected muscle pain

• ●     frequent infections

• ●     Pain from damaged nerves (postherpetic pain) that follows healing of shingles (a painful rash that comes after a herpes zoster infection) in adults.

• ●     Partial seizures when taken together with other medicines in adults and children 3 years of age and older.

• ●     have or have had kidney problems or are on hemodialysis

• ●     have or have had depression, mood problems, or suicidal thoughts or behavior

• ●     are pregnant or plan to become pregnant. It is not known if gabapentin tablets can harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking gabapentin tablets. You and your healthcare provider will decide if you should take gabapentin tablets while you are pregnant.

• ●               If you become pregnant while taking gabapentin tablets, 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 drugs during pregnancy. You can enroll in this registry by calling 1-888-233-2334.

• ●     are breastfeeding or plan to breastfeed. Gabapentin can pass into breast milk. You and your healthcare provider should decide how you will feed your baby while you take gabapentin tablets.

• ●     Take gabapentin tablets exactly as prescribed. Your healthcare provider will tell you how much gabapentin tablets to take.

• ●               Do not change your dose of gabapentin tablets without talking to your healthcare provider. If you break a tablet in half the unused half of the tablet should be taken at your next scheduled dose. Half tablets not used within several days of breaking should be thrown away.

• ●     Gabapentin tablets can be taken with or without food. If you take an antacid containing aluminum and magnesium, such as MaaloxMylantaGelusilGavisconor Di-Gelyou should wait at least 2 hours before taking your next dose of gabapentin tablets.

• ●     If you take too much gabapentin tablets, call your healthcare provider or your local Poison Control Center right away.

• ●     Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking gabapentin tablets without first talking with your healthcare provider. Taking gabapentin tablets 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 gabapentin tablets affect you. Gabapentin tablets can slow your thinking and motor skills.

• ●     SeeWhat is the most important information I should know about gabapentin tablets?

• ●      The most common side effects of gabapentin tablets include:

• ●               dizziness

• ●               difficulty with speaking

• ●               lack of coordination

• ●               temporary loss of memory (amnesia)

• ●               viral infection

• ●               tremor

• ●               feeling drowsy

• ●               difficulty with coordination

• ●               feeling tired

• ●               double vision

• ●               fever

• ●               unusual eye movement

• ●               jerky movements

• ●     Store gabapentin tablets between 20to 25(68to 77

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION