Paroxetine Controlled-Release Tablets

What is this medication?

PAROXETINE (pa ROX e teen) treats depression, anxiety, obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), and premenstrual dysphoric disorder (PMDD). It increases the amount of serotonin in the brain, a hormone that helps regulate mood. It belongs to a group of medications called SSRIs.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Paxil CR

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Bipolar disorder or a family history of bipolar disorder
• Bleeding disorders
• Glaucoma
• Heart disease
• Kidney disease
• Liver disease
• Low levels of sodium in the blood
• Seizures
• Suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member
• Take MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
• Take medications that treat or prevent blood clots
• Thyroid disease
• An unusual or allergic reaction to paroxetine, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with a glass of water. Follow the directions on the prescription label. You can take it with or without food. Do not crush or chew this medication. Take your medication at regular intervals. Do not take your medication more often than directed. Do not stop taking this medication suddenly except upon the advice of your care team. Stopping this medication too quickly may cause serious side effects or your condition may worsen.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team regarding the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Linezolid
• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
• Methylene blue (injected into a vein)
• Pimozide
• Thioridazine

This medication may also interact with the following:

• Alcohol
• Amphetamines
• Aspirin and aspirin-like medications
• Atomoxetine
• Certain medications for depression, anxiety, or psychotic disturbances
• Certain medications for irregular heart beat like propafenone, flecainide, encainide, and quinidine
• Certain medications for migraine headache like almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan
• Cimetidine
• Digoxin
• Diuretics
• Fentanyl
• Fosamprenavir
• Furazolidone
• Isoniazid
• Lithium
• Medications that treat or prevent blood clots like warfarin, enoxaparin, and dalteparin
• Medications for sleep
• NSAIDs, medications for pain and inflammation, like ibuprofen or naproxen
• Phenobarbital
• Phenytoin
• Procarbazine
• Rasagiline
• Ritonavir
• Supplements like St. John's wort, kava kava, valerian
• Tamoxifen
• Tramadol
• Tryptophan

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Tell your care team if your symptoms do not get better or if they get worse. Visit your care team for regular checks on your progress. Because it may take several weeks to see the full effects of this medication, it is important to continue your treatment as prescribed by your care team.

Watch for new or worsening thoughts of suicide or depression. This includes sudden changes in mood, behaviors, or thoughts. These changes can happen at any time but are more common in the beginning of treatment or after a change in dose. Call your care team right away if you experience these thoughts or worsening depression.

Manic episodes may happen in patients with bipolar disorder who take this medication. Watch for changes in feelings or behaviors such as feeling anxious, nervous, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and hyperactive, or trouble sleeping. These changes can happen at any time but are more common in the beginning of treatment or after a change in dose. Call your care team right away if you notice any of these symptoms.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medication affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medication. Avoid alcoholic drinks.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water will help. Contact your care team if the problem does not go away or is severe.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bleeding—bloody or black, tar-like stools, red or dark brown urine, vomiting blood or brown material that looks like coffee grounds, small, red or purple spots on skin, unusual bleeding or bruising
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Low sodium level—muscle weakness, fatigue, dizziness, headache, confusion
• Serotonin syndrome—irritability, confusion, fast or irregular heartbeat, muscle stiffness, twitching muscles, sweating, high fever, seizure, chills, vomiting, diarrhea
• Sudden eye pain or change in vision such as blurry vision, seeing halos around lights, vision loss
• Thoughts of suicide or self-harm, worsening mood, feelings of depression

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Change in sex drive or performance
• Diarrhea
• Excessive sweating
• Nausea
• Tremors or shaking
• Upset stomach

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at or below 25 degrees C (77 degrees F). Throw away any unused medication after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.