What is the most important information I should know 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 Paxil 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 Paxil before you can take thioridazine (Mellaril).

What is Paxil?

Paxil is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs). Paxil affects chemicals in the brain that may become unbalanced and cause depression, panic, anxiety or obsessive-compulsive symptoms.

Paxil is used to treat depression, obsessive-compulsive disorder, panic disorder, anxiety disorders, post-traumatic stress disorder (PTSD) and premenstrual dysphoric disorder (PMDD).

Paxil may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking 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.

Do not use Paxil if you are using any of the following drugs:

pimozide (Orap);

thioridazine (Mellaril); or

an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil) or selegiline (Eldepryl, Emsam).

Serious and sometimes fatal reactions can occur when these medicines are taken with Paxil. You must wait at least 14 days after stopping an MAO inhibitor before you can take Paxil. You must wait 5 weeks after stopping Paxil before you can take thioridazine (Mellaril).

Before taking Paxil, tell your doctor if you have:

liver or kidney disease;

bipolar disorder (manic depression);

seizures or epilepsy; or

a history of drug abuse or suicidal thoughts.

If you have any of these conditions, you may not be able to use Paxil or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category D. This medication can cause harm to an unborn baby. Do not use Paxil if you are pregnant. Tell your doctor if you become pregnant during treatment. Use an effective form of birth control while you are using this medication.

Do not use this medication without telling your doctor if you are breast-feeding a baby. Paxil can pass into breast milk and may harm a nursing baby.

How should I take Paxil?

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 Paxil 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 Paxil without first talking to your doctor. You may have unpleasant side effects if you stop taking this medication suddenly.

Store Paxil at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the missed dose and take the next one as directed. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have taken too much of this medication. Symptoms of a Paxil overdose may include nausea, vomiting, aggression, tremor, sweating, blurred vision, decreased urination, rapid heartbeat, confusion, fainting, seizures and coma.

What should I avoid while taking Paxil?

Do not take Paxil together with pimozide (Orap), thioridazine (Mellaril), isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam) or tranylcypromine (Parnate).

Avoid drinking alcohol, which can increase some of the side effects of Paxil.

Avoid using other medicines that make you sleepy (such as cold medicine, other pain medication, muscle relaxants). They can add to sleepiness caused by Paxil.

Paxil can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

What are the possible side effects of Paxil?

Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

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.

Call your doctor at once if you have any of these serious side effects:

tremors, shivering, muscle stiffness or twitching;

seizure (convulsions);

problems with balance or coordination; or

agitation, confusion, sweating, fast heartbeat.

Other less serious side effects are more likely to occur, such as:

feeling nervous, restless, or unable to sit still;

sleep problems (insomnia);

drowsiness, dizziness, weakness;

nausea, constipation, loss of appetite;

weight changes;

decreased sex drive, impotence or difficulty having an orgasm; or

dry mouth, yawning or ringing in your ears.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Paxil?

Talk to your doctor before taking any medicine for pain, arthritis, fever or swelling. This includes aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn), diclofenac (Voltaren), indomethacin, piroxicam (Feldene), nabumetone (Relafen), etodolac (Lodine) and others. Taking any of these drugs with Paxil may cause you to bruise or bleed easily.

Before taking Paxil, tell your doctor if you are using any of the following medicines:

atomoxetine (Strattera);

tryptophan (also called L-tryptophan);

risperidone (Risperdal);

St. John's wort;

cimetidine (Tagamet);

tramadol (Ultram);

lithium (Lithobid, Eskalith);

a blood thinner such as warfarin (Coumadin);

any other antidepressants such as amitriptyline (Elavil), citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Tofranil), nortriptyline (Pamelor) or sertraline (Zoloft);

a phenothiazine such as prochlorperazine (Compazine), chlorpromazine (Thorazine), fluphenazine (Prolixin), mesoridazine (Serentil), perphenazine (Trilafon) and others;

almotriptan (Axert), frovatriptan (Frova), sumatriptan (Imitrex), naratriptan (Amerge), rizatriptan (Maxalt) or zolmitriptan (Zomig); or

heart rhythm medication such as flecainide (Tambocor), propafenone (Rhythmol) and others.

If you are using any of these drugs, you may not be able to use Paxil or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect Paxil. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.