Paroxetine

What it is used for

Paroxetine tablets are indicated in adults for the treatment of: Major depressive disorder (MDD) Obsessive compulsive disorder (OCD) Panic disorder (PD) Social anxiety disorder (SAD) Generalized anxiety disorder (GAD) Posttraumatic stress disorder (PTSD) Paroxetine tablets are a selective serotonin reuptake inhibitor (SSRI) indicated in adults for the treatment of: Major Depressive Disorder (MDD) Obsessive Compulsive Disorder (OCD) Panic Disorder (PD) Social Anxiety Disorder (SAD) Generalized Anxiety Disorder (GAD) Posttraumatic Stress Disorder (PTSD)

The most important thing to know

Paroxetine tablets can cause serious side effects, including: ● Increased risk of suicidal thoughts or actions. Paroxetine tablets and other antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed.

Paroxetine tablets are not for use in children. ○ Depression or other mental illnesses are the most important causes of suicidal thoughts and actions. How can I watch for and try to prevent suicidal thoughts and actions? ○ Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts or feelings or if you develop suicidal thoughts or actions.

This is very important when an antidepressant medicine is started or when the does is changed. ○ Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts or feelings or if you develop suicidal thoughts or actions. ○ Keep all follow-up visits with your healthcare provider as scheduled.

Call your healthcare provider between visits as needed, especially if you have concerns about symptoms. Call your healthcare provider or get emergency medical help right away if you have any of the following symptoms, especially if they are new, worse, or worry you: ○ attempts to commit suicide ○ acting on dangerous impulses ○ acting aggressive or violent ○ thoughts about suicide or dying ○ new or worse depression ○ new or worse anxiety or panic attacks ○ feeling agitated, restless, angry, or irritable ○ trouble sleeping ○ an increase in activity and talking more than what is normal for you ○ other unusual changes in behavior or mood What are paroxetine tablets?

Paroxetine tablets are prescription medicine used in adults to treat: ● A certain type of depression called Major Depressive Disorder (MDD) ● Obsessive Compulsive Disorder (OCD) ● Panic Disorder (PD) ● Social Anxiety Disorder (SAD) ● Generalized Anxiety Disorder (GAD) ● Posttraumatic Stress Disorder (PTSD)

How to take it

Take paroxetine tablets exactly as prescribed. Your healthcare provider may need to change the dose of paroxetine tablets until it is the right dose for you. ● Take paroxetine tablet 1 time each day in the morning. ● Paroxetine tablets may be taken with or without food. ● If you take too much paroxetine tablets, call your poison control center at 1-800-222-1222 or go to the nearest hospital emergency room right away.

What are possible side effects of paroxetine tablets? Paroxetine tablets can cause serious side effects, including: ● See, "What is the most important information I should know about paroxetine tablets?" ● Serotonin syndrome. A potentially life-threatening problem called serotonin syndrome can happen when you take paroxetine tablets with certain other medicines.

See, "Who should not take paroxetine tablets?" Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the following signs and symptoms of serotonin syndrome: ○ agitation ○ sweating ○ seeing or hearing things that are not real (hallucinations) ○ flushing ○ confusion ○ high body temperature (hyperthermia) ○ coma ○ shaking (tremors), stiff muscles, or muscle twitching ○ fast heart beat ○ loss of coordination ○ changes in blood pressure ○ seizures ○ dizziness ○ nausea, vomiting, diarrhea ● Eye problems (angle-closure glaucoma).

Paroxetine tablets may cause a type of eye problem called angle-closure glaucoma in people with certain other eye conditions. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. Call your healthcare provider if you have eye pain, changes in your vision, or swelling or redness in or around the eye.

● Medicine interactions. Taking paroxetine tablets with certain other medicines including thioridazine and pimozide may increase the risk of developing a serious heart problem called QT prolongation. ● Seizures (convulsions). ● Manic episodes. Manic episodes may happen in people with bipolar disorder who take paroxetine tablets.

Symptoms may include: ○ greatly increased energy ○ severe problems sleeping ○ racing thoughts ○ reckless behavior ○ unusually grand ideas ○ excessive happiness or irritability ○ talking more or faster than usual ● Discontinuation syndrome. Suddenly stopping paroxetine tablets may cause you to have serious side effects. Your healthcare provider may want to decrease your dose slowly.

Symptoms may include: ○ nausea ○ electric shock feeling (paresthesia) ○ tiredness ○ sweating ○ tremor ○ problems sleeping ○ changes in your mood ○ anxiety ○ hypomania irritability and agitation ○ confusion ○ ringing in your ears (tinnitus) ○ dizziness ○ headache ○ seizures ● Low sodium levels in your blood (hyponatremia).

Low sodium levels in your blood that may be serious and may cause death, can happen during treatment with paroxetine tablets. Elderly people and people who take certain medicines may be at a greater risk for developing low sodium levels in your blood. Signs and symptoms may include: ○ headache ○ difficulty concentrating ○ memory changes ○ confusion ○ weakness and unsteadiness on your feet which can lead to falls In more severe or more sudden cases, signs and symptoms include: ○ seeing or hearing things that are not real (hallucinations) ○ fainting ○ seizures ○ coma ○ stopping breathing (respiratory arrest) ● Abnormal bleeding.

Taking paroxetine tablets with aspirin, NSAIDs, or blood thinners may increase this risk. Tell your healthcare provider about any unusual bleeding or bruising. ● Bone fractures. ● Sexual problems (dysfunction). Taking selective serotonin reuptake inhibitors (SSRIs), including paroxetine, may cause sexual problems. Symptoms in males may include: o Delayed ejaculation or inability to have an ejaculation o Decreased sex drive o Problems getting or keeping an erection Symptoms in females may include: o Decreased sex drive o Delayed orgasm or inability to have an orgasm Talk to your healthcar

Side effects, and when to stop

" Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

Who should not take it

Do not take paroxetine tablets if you: ● take a monoamine oxidase inhibitor (MAOI) ● have stopped taking an MAOI in the last 14 days ● are being treated with the antibiotic linezolid or the intravenous methylene blue ● are taking pimozide ● are taking thioridazine ● are allergic to paroxetine or any of the ingredients in paroxetine tablets.

See the end of this Medication Guide for a complete list of ingredients in paroxetine tablets. Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI or one of these medicines, including the antibiotic linezolid or intravenous methylene blue. Do not start taking an MAOI for at least 14 days after you stop treatment with paroxetine tablets.

Before taking paroxetine tablets, tell your healthcare provider about all your medical conditions, including if you: ● have heart problems ● have or had bleeding problems ● have, or have a family history of, bipolar disorder, mania or hypomania ● have or had seizures or convulsions ● have glaucoma (high pressure in the eye) ● have low sodium levels in your blood ● have bone problems ● have kidney or liver problems ● are pregnant or plan to become pregnant.

Paroxetine tablets may harm your unborn baby. o Taking paroxetine during your first trimester of pregnancy may cause your baby to be at an increased risk of having a heart problem (cardiac malformations) at birth. o Taking paroxetine during your third trimester of pregnancy may cause your baby to have breathing, temperature and feeding problems, low muscle tone and irritability after birth and may cause your baby to be at an increased risk of a serious lung problem at birth.

Talk to your healthcare provider about the risk to your unborn baby if you take paroxetine during pregnancy. o Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with paroxetine. o There is a pregnancy registry for females who are exposed to paroxetine during pregnancy.

The purpose of the registry is to collect information about the health of females exposed to paroxetine and their baby. If you become pregnant during treatment with paroxetine talk to your healthcare provider. ● are breastfeeding or plan to breastfeed. Paroxetine passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with paroxetine tablets.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Paroxetine tablets and some other medicines may affect each other causing possible serious side effects. Paroxetine tablets may affect the way other medicines work and other medicines may affect the way paroxetine tablet works.

Especially tell your healthcare provider if you take: medicines used to treat migraine headaches called triptans tricyclic antidepressants lithium Tramadol, fentanyl, meperidine, methadone, or other opioids tryptophan buspirone amphetamines St. John's Wort medicines that can affect blood clotting such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), warfarin diuretics tamoxifen medicines used to treat mood, anxiety, psychotic, or thought disorders, including selective serotonin reuptake (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs) Ask your healthcare provider if you are not sure if you are taking any of these medicines.

Your healthcare provider can tell you if it is safe to take paroxetine tablets with your other medicines. Do not start or stop any other medicines during treatment with paroxetine tablets without talking to your healthcare provider first. Stopping paroxetine tablets suddenly may cause you to have serious side effects. See, "

Storing it

Store paroxetine tablets between 68°F to 77°F (20°C to 25°C). Paroxetine tablets come in child-resistant bottle pack of 30's and 90's. Keep paroxetine tablets and all medicines out of the reach of children.