When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to paroxetine, or if you are pregnant.

How to Use This Medicine:
Capsule, Liquid, Tablet, Long Acting Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Oral liquid, Tablet, Extended-release Tablet: These are usually taken in the morning.
• Brisdelle™ capsule: Take at bedtime.
• Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup. Shake the bottle well just before you measure each dose.
• Tablet or Extended-release Tablet: Swallow whole. Do not crush, break, or chew it. Do not use an extended-release tablet that is cracked or chipped.
• You may need to take this medicine for a month or longer before you feel better. If you feel that the medicine is not working well, do not take more than your normal dose. Call your doctor for instructions.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use paroxetine and an MAO inhibitor (MAOI) within 14 days of each other. Do not use this medicine if you are using pimozide or thioridazine.
• Some foods and medicines can affect how paroxetine works. Tell your doctor if you are using any of the following:
  
  • Buspirone, cimetidine, digoxin, fentanyl, fosamprenavir/ritonavir, lithium, procyclidine, risperidone, St John's wort, tamoxifen, theophylline, tramadol, or tryptophan supplements
  • Blood thinner (such as warfarin), diuretic (water pill), medicine for heart rhythm problems, NSAID pain or arthritis medicine (such as aspirin, celecoxib, diclofenac, ibuprofen, naproxen), other medicine for depression or anxiety, phenothiazine medicine (such as chlorpromazine, perphenazine, promethazine, prochlorperazine), triptan medicine for migraine headaches
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Tell your doctor if you are breastfeeding, or if you have kidney disease, liver disease, glaucoma, or a history of epilepsy or seizures.
• For some children, teenagers, and young adults, this medicine may increase mental or emotional problems. This may lead to thoughts of suicide and violence. Talk with your doctor right away if you have any thoughts or behavior changes that concern you. Tell your doctor if you or anyone in your family has a history of bipolar disorder or suicide attempts.
• This medicine may cause the following problems:
  
  • Serotonin syndrome (may be life-threatening when used with certain other medicines)
  • Low sodium levels in the blood
  • Higher risk of bleeding problems
  • Higher risk of broken bones
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• This medicine may make you dizzy or drowsy. Do not drive or do anything that could be dangerous until you know how this medicine affects you.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, restlessness, fast heartbeat, fever, sweating, muscle spasms, nausea, vomiting, diarrhea, seeing or hearing things that are not there
• Bone pain, tenderness, swelling, or bruising
• Changes in behavior, thoughts of hurting yourself or others
• Confusion, weakness, and muscle twitching
• Eye pain, vision changes, seeing halos around lights
• Trouble keeping still, feeling restless and agitated, racing thoughts, excessive energy
• Trouble sleeping
• Unusual bleeding or bruising

If you notice these less serious side effects, talk with your doctor:

• Blurred vision, dizziness, drowsiness, or sleepiness
• Constipation, upset stomach, loss of appetite, weight loss
• Dry mouth
• Sexual problems

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088