IMPORTANT NOTE: The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

PAROXETINE - ORAL (pair-OX-eh-teen)

COMMON BRAND NAME(S): Paxil

PAROXETINE USAGE: Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Your doctor may occasionally change your dose to make sure you get the best results from the medication. Try to take the medicine at the same time each day. Do not crush, chew, or break a controlled-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time. Shake the liquid form of paroxetine well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. It may take 4 weeks or more for you to start feeling better. Do not stop using paroxetine without first talking to your doctor. You may have unpleasant side effects if you stop taking this medication suddenly. Store paroxetine at room temperature away from moisture and heat.

OTHER USES: Paxil has also been used to treat a severe form of premenstrual syndrome (premenstrual dysphoric disorder- PMDD), sexual function problems in men (premature ejaculation), nerve problems associated with diabetes (diabetic neuropathy), chronic headaches, or post-traumatic stress disorder (PTSD).

HOW TO USE: Take Paxil by mouth usually once daily in the morning, with or without food; or as directed by your doctor. The dosage is based on your medical condition and response to therapy. It is important to continue taking this medication as prescribed even if you feel well. Also, do not stop taking this medication without consulting your doctor. It may take up to several weeks before the full benefit of this drug takes effect.

IMPORTANT INFO ABOUT PAXIL: You may have an increased risk of suicidal thoughts or behavior at the start of treatment with an antidepressant medication, especially if you are a child or young adult. Talk with your doctor about this risk. While you are taking Paxil you will need to be monitored for worsening symptoms of depression and/ or suicidal thoughts during the first weeks of treatment, or whenever your dose is changed. In addition to you watching for changes in your own symptoms, your family or other caregivers should be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment. Contact your doctor promptly if you have any of the following side effects, especially if they are new symptoms or if they get worse: mood changes, anxiety, panic attacks, trouble sleeping, irritability, agitation, aggressiveness, severe restlessness, mania (mental and/ or physical hyperactivity), thoughts of suicide or hurting yourself. Do not use this medication if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment. Do not take paroxetine together with pimozide (Orap), thioridazine (Mellaril), or a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate). You must wait at least 14 days after stopping an MAOI before you can take Paxil. You must wait 5 weeks after stopping paroxetine before you can take thioridazine (Mellaril).

PRECAUTIONS: Tell your doctor your medical history, especially of: liver problems, kidney problems, seizures, heart problems, other mental/mood disorders (e.g., bipolar disorder), thyroid problems, any allergies. This drug may make you dizzy or drowsy; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages. Caution is advised when using this product in the elderly because they may be more sensitive to the effects of the drug. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. This drug passes into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Certain medications taken with Paroxetine could result in serious, even fatal, drug interactions. Avoid taking MAO inhibitors (e.g., furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, selegiline, tranylcypromine) within 2 weeks, and avoid taking thioridazine within 5 weeks, before or after treatment with this medication. Consult your doctor or pharmacist for additional information. This drug is not recommended for use with: weight loss drugs (e.g., sibutramine, phentermine), thioridazine, terfenadine, astemizole. Ask your doctor or pharmacist for more details. Tell your doctor of all prescription and nonprescription medication you may use, especially: other SSRI antidepressants (e.g., citalopram, fluoxetine), nefazodone, trazodone, tramadol, venlafaxine, "triptan" migraine drugs (e.g., sumatriptan, zolmitriptan), tricyclic antidepressants (e.g., amitriptyline, nortriptyline), cimetidine, digoxin, flecainide, propafenone, clozapine, lithium, tryptophan, "blood thinners" (e.g., warfarin), theophylline, herbal/natural products (e.g., melatonin, ayahuasca, St John's wort). Tell your doctor if you take any drugs that cause drowsiness such as: medicine for sleep, sedatives, tranquilizers, anti- anxiety drugs (e.g., diazepam), narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., phenothiazines such as chlorpromazine), anti-seizure drugs (e.g., carbamazepine), muscle relaxants, certain antihistamines (e.g., diphenhydramine). Report other drugs which affect the heart rhythm (QTc prolongation), such as: dofetilide, pimozide, sotalol, quinidine, procainamide, sparfloxacin, "water pills" (diuretics such as furosemide or hydrochlorothiazide). Ask your doctor or pharmacist for more details. Do not start or stop any medicine without doctor or pharmacist approval.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include: irregular heartbeat, fainting, severe dizziness or lightheadedness.

NOTES: Do not share this medication with others. Laboratory and/or medical tests may be performed to monitor your progress.

MISSED DOSE: If you miss a dose of Paxil, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59 and 86 degrees F (15 and 30 degrees C) away from light and moisture.