Paroxetine Controlled Release tablet

What is this medicine?

PAROXETINE is used to treat depression. It may also be used to treat anxiety disorders, obsessive compulsive disorder, panic attacks, post traumatic stress, and premenstrual dysphoric disorder (PMDD).

What should I tell my health care provider before I take this medicine?

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

• bipolar disorder or a family history of bipolar disorder
• heart disease
• kidney or liver disease
• receiving electroconvulsive therapy
• seizures (convulsions)
• suicidal thoughts or a previous suicide attempt
• an unusual or allergic reaction to paroxetine, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I take this medicine?

Take this medicine by mouth with a glass of water. You can take it with or without food. Do not crush or chew this medicine. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine 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 medicine?

Do not take this medicine with any of the following:

• antacids
• certain diet drugs like dexfenfluramine, fenfluramine, phentermine
• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
• medicines similar to paroxetine like fluoxetine, sertraline, citalopram
• phenothiazines like thioridazine
• pimozide
• procarbazine
• St. John's wort
• tryptophan

This medicine may also interact with the following:

• aspirin and aspirin-like drugs
• cimetidine
• digoxin
• fosamprenavir
• linezolid
• medicines for depression, anxiety, or psychotic disturbances
• medicines for migraine headache like almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan
• medicines that treat or prevent blood clots like warfarin, enoxaparin, and dalteparin
• NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen
• phenobarbital
• phenytoin
• procyclidine
• ritonavir
• theophylline

This list may not describe all possible interactions. Give your health care providers 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 taking this medicine?

Visit your doctor or health care professional for regular checks on your progress. Continue to take your medicine even if you do not immediately feel better. It can take several weeks before you feel the full effect of this medicine.

Patients and their families should watch out for depression or thoughts of suicide that get worse. Also watch out for sudden or severe changes in feelings such as feeling anxious, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and hyperactive, or not being able to sleep. If this happens, especially at the beginning of antidepressant treatment or after a change in dose, call your health care professional.

If you have been taking this medicine regularly for some time, do not suddenly stop taking it. You must gradually reduce the dose or your symptoms may get worse. Ask your doctor or health care professional for advice.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine 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 can increase or decrease the effects of this medicine. Avoid alcoholic drinks.

Do not treat yourself for coughs, colds or allergies without asking your doctor or health care professional for advice. Some ingredients can increase possible side effects.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water will help.

What side effects may I notice from this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• black or bloody stools, blood in the urine or vomit
• fast, irregular heartbeat
• hallucination, loss of contact with reality
• painful or prolonged erection (men)
• seizures
• suicidal thoughts or other mood changes
• trouble passing urine or change in the amount of urine
• unusual bleeding or bruising
• unusually weak or tired
• vomiting

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

• change in appetite, weight
• change in sex drive or performance
• constipation or diarrhea
• difficulty sleeping
• drowsy
• headache
• increased sweating
• muscle pain or weakness
• tremors

This list may not describe all possible side effects.

Where can I keep my medicine?

Keep out of the reach of children.

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