Nortriptyline Hydrochloride

REMEDYREPACK INC.

FULL PRESCRIBING INFORMATION: CONTENTS*

• BOXED WARNING
• NORTRIPTYLINE HYDROCHLORIDE DESCRIPTION
• CLINICAL PHARMACOLOGY
• INDICATIONS & USAGE
• NORTRIPTYLINE HYDROCHLORIDE CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
• INFORMATION FOR PATIENTS
• DRUG INTERACTIONS
• PEDIATRIC USE
• GERIATRIC USE
• NORTRIPTYLINE HYDROCHLORIDE ADVERSE REACTIONS
• OVERDOSAGE
• DOSAGE & ADMINISTRATION
• HOW SUPPLIED
• SPL MEDGUIDE
• INACTIVE INGREDIENT
• PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

FULL PRESCRIBING INFORMATION

NORTRIPTYLINE HYDROCHLORIDE DESCRIPTION

CLINICAL PHARMACOLOGY

INDICATIONS & USAGE

NORTRIPTYLINE HYDROCHLORIDE CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

INFORMATION FOR PATIENTS

DRUG INTERACTIONS

PEDIATRIC USE

GERIATRIC USE

NORTRIPTYLINE HYDROCHLORIDE ADVERSE REACTIONS

OVERDOSAGE

DOSAGE & ADMINISTRATION

HOW SUPPLIED

SPL MEDGUIDE

• ●all risks and benefits of treatment with antidepressant medicines

• ●all treatment choices for depression or other serious mental illness

• ●What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions?

• ●1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.

• ●Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

• ●Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:

• ●thoughts about suicide or dying

• ●new or worse depression

• ●new or worse anxiety

• ●feeling very 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

• ●What else do I need to know about antidepressant medicines?

• ●Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.

• ●Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.

• ●Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.

• ●Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child's healthcare provider for more information.

• ●Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• ●This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants.

INACTIVE INGREDIENT

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION