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Drug Guide

The information contained in the following drug guide is intended as an educational resource only. This guide is not exhaustive and does not contain all available information about this drug.This guide is not intended as medical advice for individual conditions or treatment.

The information provided in this guide does not replace the need for the advice and services of medical professionals or the need for medical examination. Always talk to your physician or pharmacist before taking any prescription medication or over the counter drugs (including any supplements) or before making any changes to your treatment. Only your doctor, nurse or pharmacist can provide you with safe and effective advice regarding your drug treatment.

The use of the information in this guide is at your sole risk. This information is provided "AS IS" with no warranties to accuracy or timeliness.

**All trademarks and registered trademarks are the property of their respective owners.

What is Paxil CR?

Paxil CR is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors, or SSRIs. Paxil CR helps to treat patients with depression, obsessive-compulsive disorder, anxiety disorders, post-traumatic stress disorder (PTSD), and premenstrual dysphoric disorder (PMDD). Paxil CR is a controlled-release tablet that helps by affecting the chemicals in your brain which may be unbalanced.

Paxil CR may also be used for reasons not listed in this medication guide.

Key Facts About Paxil CR

Paxil CR is in an antidepressant in a group of drugs known as selective serotonin reuptake inhibitors, or SSRIs. Paxil CR helps people with major depressive disorder, generalized anxiety disorder, panic disorder, obsessive compulsive disorder, post-traumatic stress disorder, premenstrual dysphoric disorder and obsessive-compulsive disorder by affecting the chemicals in the brain that are imbalanced and may cause these conditions.

You should not take Paxil CR if you are currently taking thioridazine (Mellaril), pimozide (Orap), linezolid (Zyvox), methylene blue (Urolene Blue) or an MAO inhibitor like furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate). You could suffer from a dangerous drug interaction if you take any of the above medications along with Paxil CR. You should wait at least 14 days after stopping an MAO inhibitor before starting treatment with Paxil CR.

When you first start taking Paxil CR you may have thoughts about suicide, especially if you are younger than 24 years of age. You must tell your doctor if you have these thoughts, and be sure to keep regular appointments with your physician, particularly for the first 3 months of treatment with Paxil CR.

Tell your doctor if you are pregnant or plan to become pregnant. Paxil CR is in FDA pregnancy category D. Using Paxil CR during your pregnancy may cause heart defects or serious lung problems in your newborn. Do not start or stop taking Paxil CR during pregnancy without your doctor’s advice. Paxil CR can pass into breast milk and may harm a nursing baby. Do not use Paxil CR if you are breast-feeding.

If you have any new or worsening symptoms, like mood changes, panic attacks, trouble sleeping, impulsiveness, irritability, aggression, hyperactivity, or thoughts of suicide or harming yourself tell your doctor immediately.

You should not drink alcohol and take Paxil CR, as it may increase the some of this medication’s side effects.

Paxil CR can impair your thinking or reaction time. Be careful if you drive or do any task that requires you to be alert.

Before You Take Paxil CR

Do not use Paxil CR if you are allergic to paroxetine or any of the components in the tablet.

Let your doctor know about any other antidepressants that you may take, especially Celexa, Cymbalta, Desyrel, Effexor, Lexapro, Luvox, Oleptro, Prozac, Sarafem, Symbyax, Viibryd, and Zoloft.

Tell your doctor if you are currently taking an MAO inhibitor like furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate). You will need to wait at least 14 days after stopping your MAO inhibitor before you can take Paxil CR.

Tell your doctor before starting Paxil CR if you have liver or kidney disease.

You should inform your doctor if you have previously been diagnosed as manic depressive, bipolar, or if you have had a history of suicidal thoughts or drug abuse.

If you have seizures or epilepsy you should tell your doctor before starting treatment with Paxil CR.

If you have narrrow-angle glaucoma tell your physician.

Tell your doctor if you have a bleeding or blood clotting disorder before you take Paxil CR.

Paxil CR Drug Interactions

You should inform your doctor if you are taking any of the following:

• almotriptan (Axert)
• antidepressants like desipramine (Norpramin), fluoxetine (Prozac, Sarafem), or paroxetine (Paxil CR)
• aspirin
• cimetidine (Tagamet)
• cold or allergy medications, over the counter
• chlorpromazine (Thorazine)
• diclofenac (Voltaren)
• digitoxin (Crystodigin)
• disopyramide (Norpace)
• etodolac (Lodine)
• fentanyl (Abstral, Actiq, Fentora, Duragesic, Ionsys, Lazanda, Onsolis)
• flecaininde (Tambocor)
• fluphenazine (Permitil, Prolixin)
• fluvoxamine (Luvox)
• fosamprenavir (Lexiva)
• frovatriptan (Frova)
• haloperidol (Haldol)
• ibuprofen (Advil, Motrin)
• indomethacin
• linezolid (Zyvox)
• lithium (Lithobid, Eskalith)
• mexiletine (Mexitil)
• nabumetone (Relafen)
• naproxen (Aleve, Naprosyn)
• naratriptan (Amerge)
• narcotic pain medications
• perphenazine (Trilafon)
• piroxicam (Feldene)
• procainamide (Pronestyl)
• propafenone (Rythmol)
• quinidine (Quin-G)
• risperidone (Risperdal)
• ritonavir (Norvir, Kaletra)
• rizatriptan (Maxalt)
• St. John’s wort
• sumatriptan (Imitrex)
• tamoxifen (Nolvadex, Soltamox)
• theophylline (Elixophyllin, Theo-24, Theochron, Uniphyl)
• tramadol (Ultram)
• tryptophan (sometimes called L-tryptophan)
• valium or sleeping pills
• valproate (Depacon, Depakene)
• warfarin (Coumadin)
• zolmitriptan (Zomig)

Other drugs you take that are not listed may interact with Paxil CR. You should tell your doctor about all of the medications you use. This includes prescription drugs, vitamins, supplements and herbal products, and over the counter medications. You should not begin taking a new medication without telling your doctor first.

Directions for Taking Paxil CR

You should take Paxil CR exactly as prescribed by your doctor. Do not take Paxil CR in larger or smaller amounts, or for shorter or longer than recommended. Follow the directions on your prescription label.

You should take Paxil CR at the same time every day.

Paxil CR may be taken with or without food.

Do not break, chew or crush the Paxil CR extended-release tablet. Swallow it whole.

It may take at least 4 weeks or longer before your symptoms improve while you are taking Paxil CR. Continue using Paxil CR as your doctor has directed you to do so. Do not stop using Paxil CR without consulting your doctor, as you may experience adverse side effects if you stop taking this medication suddenly.

Paxil CR needs to be stored at room temperature, and away from light, moisture and heat.

If you miss a dose of Paxil CR you should attempt to take the missed dose as soon as you remember. However, if it is almost time for your next scheduled dose do not take the missed dose in addition to your regular dose.

When you stop taking Paxil CR you may have withdrawal symptoms like agitation, dizziness, numbness or tingling, ringing in your ears, confusion, or behavior changes. Do not stop taking this medication suddenly without talking to your doctor first.

Paxil CR Side Effects

If you experience any of the following adverse effects you should stop taking Paxil CR and seek emergency medical help immediately:

• aggressive, agitated or hostile behavior
• allergic reaction such as breathing difficulties, hives, swelling of your face, lips, throat or tongue
• bleeding from unusual places such as your nose, mouth, vagina, or rectum
• bone pain, bruising, swelling or tenderness
• bruising easily
• coughing up blood
• diarrhea
• fainting
• fast heart rate
• fever
• hallucinations
• headache
• loss of coordination
• memory problems and trouble concentrating
• nausea
• overactive reflexes
• seizures
• severe skin reaction including a fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) that causes blistering and peeling.
• shallow breathing or breathing that stops
• tremors
• vomiting

Less serious Paxil CR side effects may include:

• constipation
• decreased libido
• dizziness
• drowsiness
• dry mouth
• headache (mild)
• impotence
• insomnia
• nausea (mild)
• nervousness
• ringing in your ears
• weight changes;
• yawning,

It should be noted that this is not a complete list of possible side effects of Paxil CR. You should contact your physician for a complete list and medical advice regarding these effects.

Paxil CR Description and Dosing

Paxil CR is supplied as an enteric film-coated, controlled-release, round tablet, as follows:

12.5 mg tablets, which are yellow and engraved with GSK and 12.5

25 mg tablets, which are pink and engraved with GSK and 25

37.5 mg tablets, which are blue and engraved with GSK and 37.5

The dose of Paxil CR is based on each individual. Your doctor will tell you what dose of Paxil CR is right for you and will treat your condition effectively.

All people taking Paxil CR should consult their doctor for specific dosing pertaining to them. Do not attempt to alter or change your dose without your physician’s consent.

If you suspect that you have overdosed with Paxil CR you should seek emergency help immediately.

Ingredients in Paxil CR

The main active ingredient in Paxil CR is paroxetine hydrochloride. Inactive ingredients in the enteric, film-coated, controlled-release tablets are hypromellose, polyvinylpyrrolidone, lactose monohydrate, magnesium stearate, silicon dioxide, glyceryl behenate, methacrylic acid copolymer type C, sodium lauryl sulfate, polysorbate 80, talc, triethyl citrate, titanium dioxide, polyethylene glycols, and 1 or more of the following colorants: Yellow ferric oxide, red ferric oxide, D&C Red No. 30 aluminum lake, FD&C Yellow No. 6 aluminum lake, D&C Yellow No. 10 aluminum lake, FD&C Blue No. 2 aluminum lake.

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The information contained in this drug guide is intended as an educational resource only. This guide is not exhaustive and does not contain all available information about this drug.This guide is not intended as medical advice for individual conditions or treatment.

The information provided in this guide does not replace the need for the advice and services of medical professionals or the need for medical examination. Always talk to your physician or pharmacist before taking any prescription medication or over the counter drugs (including any supplements) or before making any changes to your treatment. Only your doctor, nurse or pharmacist can provide you with safe and effective advice regarding your drug treatment.

The use of the information in this guide is at your sole risk. This information is provided "AS IS" with no warranties to accuracy or timeliness.

**All trademarks and registered trademarks are the property of their respective owners.