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Paroxetine is used to treat depression, panic attacks, anxiety disorders, and a severe form of premenstrual syndrome (premenstrual dysphoric disorder). It works by helping to restore the balance of a certain natural substance (serotonin) in the brain.

Paroxetine is approved Depression and Anxiety Spectrum disorder

Paroxetine is the only SSRI indicated for all five anxiety disorders and in addition to major depressive disorder

Paroxetine is used to treat depression, panic attacks, anxiety disorders, and a severe form of premenstrual syndrome (premenstrual dysphoric disorder). It works by helping to restore the balance of a certain natural substance (serotonin) in the brain.

Paroxetine is known as a selective serotonin reuptake inhibitor (SSRI). This medication may improve your mood, sleep, appetite, and energy level and may help restore your interest in daily living. It may decrease fear, anxiety, unwanted thoughts, and the number of panic attacks. Paroxetine may lessen premenstrual symptoms such as irritability, increased appetite, and depression.

Take this medication by mouth with or without food as directed by your doctor, usually once daily in the morning. Taking this medication with food may decrease nausea. If this medication makes you sleepy during the day, talk to your doctor about taking it in the evening. Do not crush or chew this medication. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.

• Paroxetine CR is completely absorbed after oral dosing.
• Tmax was observed typically between 6 and 10 hours post-dose.
• Paroxetine is extensively metabolized after oral administration by CYP4502D6.
• Approximately 95% and 93% of paroxetine is bound to plasma protein.
• Approximately 64% of paroxetine was excreted in the urine , about 36% was excreted in the feces.

See also Warning section.

Nausea, drowsiness, dizziness, trouble sleeping, loss of appetite, weakness, dry mouth, sweating, blurred vision, and yawning may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: shaking (tremor), restlessness, inability to keep still, decreased interest in sex, changes in sexual ability, numbness/tingling, easy bruising/bleeding, fast/irregular heartbeat, muscle weakness/spasm, seizures.

Get medical help right away if you have any very serious side effects, including: black stools, vomit that looks like coffee grounds, eye pain/swelling/redness, widened pupils, vision changes (such as seeing rainbows around lights at night).

This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.

Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Before taking paroxetine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: personal or family history of bipolar/manic-depressive disorder, personal or family history of suicide attempts, liver problems, kidney problems, seizures, low sodium in the blood, intestinal ulcers/bleeding (peptic ulcer disease) or bleeding problems, personal or family history of glaucoma (angle-closure type).

This drug may make you dizzy or drowsy or blur your vision. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially bleeding or loss of coordination. Older adults may also be more likely to develop a type of salt imbalance (hyponatremia), especially if they are also taking "water pills" (diuretics). Loss of coordination can increase the risk of falling.

Children may be more sensitive to the side effects of this drug, especially loss of appetite and weight loss. Monitor weight and height in children who are taking this drug.

This medication is not recommended for use during pregnancy. It may harm an unborn baby, and babies born to mothers who have used it during the last 3 months of pregnancy may sometimes develop withdrawal symptoms such as feeding/breathing difficulties, seizures, muscle stiffness, or constant crying. However, since untreated mental/mood problems (such as depression, panic attack, obsessive-compulsive disorder, and anxiety) can harm a pregnant woman and her unborn baby, do not stop taking this medication unless directed by your doctor. Instead, ask your doctor if a different medication would be right for you. If you are planning pregnancy, become pregnant, or think you may be pregnant, tell your doctor right away.

This drug passes into breast milk. Consult your doctor before breast-feeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: thioridazine, other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, NSAIDs such as ibuprofen, "blood thinners" such as warfarin).

Aspirin can increase the risk of bleeding when used with this medication. However, if your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

This medication can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include atomoxetine, phenothiazines, pimozide, risperidone, tamoxifen, tetrabenazine, antiarrhythmics such as propafenone/flecainide, TCA antidepressants such as desipramine/amitriptyline, among others.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call your doctor. Symptoms of overdose may include: irregular heartbeat, fainting, severe dizziness, seizures.

Notes:

Do not share this medication with others.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed.