Mirtazapine

REMEDYREPACK INC.

FULL PRESCRIBING INFORMATION: CONTENTS*

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

FULL PRESCRIBING INFORMATION

MIRTAZAPINE DESCRIPTION

CLINICAL PHARMACOLOGY

PHARMACODYNAMICS

PHARMACOKINETICS

INDICATIONS & USAGE

MIRTAZAPINE CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

INFORMATION FOR PATIENTS

LABORATORY TESTS

DRUG INTERACTIONS

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

PREGNANCY

NURSING MOTHERS

PEDIATRIC USE

GERIATRIC USE

MIRTAZAPINE ADVERSE REACTIONS

DRUG ABUSE AND DEPENDENCE

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

• ●               Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.

• ●               Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.

• ●               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.

• ●     thoughts about suicide or dying

• ●     attempts to commit suicide

• ●     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

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

• ●     Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.

• ●     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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION