PAROXETINE- paroxetine hydrochloride hemihydrate tablet, film coated 
Cardinal Health

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MEDICATION GUIDE
PAROXETINE TABLETS, USP
(pa rox′ e teen hye″ droe klor′ ide)

Read the Medication Guide that comes with paroxetine tablets before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. Talk with your healthcare provider if there is something you do not understand or want to learn more about.

What is the most important information I should know about paroxetine tablets?

Paroxetine tablets and other antidepressant medicines may cause serious side effects, including:

1.
Suicidal thoughts or actions:
1.
Paroxetine tablets and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers or young adults within the first few months of treatment or when the dose is changed.
2.
Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.
3.
Watch for these changes and call your healthcare provider right away if you notice:
 
New or sudden changes in mood, behavior, actions, thoughts or feelings, especially if severe.
 
Pay particular attention to such changes when paroxetine tablets are started or when the dose is changed.
 
 
Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.
 
 
Call your healthcare provider right away if you have any of the following symptoms or call 911 if an emergency, especially if they are new, worse or worry you:
4.
attempts to commit suicide
5.
acting on dangerous impulses
6.
acting aggressive or violent
7.
thoughts about suicide or dying
8.
new or worse depression
9.
new or worse anxiety or panic attacks
10.
feeling agitated, restless, angry or irritable
11.
trouble sleeping
12.
an increase in activity or talking more than what is normal for you
13.
other unusual changes in behavior or mood
 
 
Call your healthcare provider right away if you have any of the following symptoms or call 911 if an emergency. Paroxetine tablets may be associated with these serious side effects:
 
2.
Serotonin Syndrome or Neuroleptic Malignant Syndrome-like reactions. This condition can be life threatening and may include:
14.
agitation, hallucinations, coma or other changes in mental status
15.
coordination problems or muscle twitching (overactive reflexes)
16.
racing heartbeat, high or low blood pressure
17.
sweating or fever
18.
nausea, vomiting or diarrhea
19.
muscle rigidity
3.
Severe allergic reactions:
20.
trouble breathing
21.
swelling of the face, tongue, eyes or mouth
22.
rash, itchy welts (hives) or blisters, alone or with fever or joint pain
4.
Abnormal bleeding: Paroxetine tablets and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin®*, Jantoven®*), a non-steroidal anti-inflammatory drug (NSAIDs, like ibuprofen or naproxen) or aspirin.
5.
Seizures or convulsions
6.
Manic episodes:
23.
greatly increased energy
24.
severe trouble sleeping
25.
racing thoughts
26.
reckless behavior
27.
unusually grand ideas
28.
excessive happiness or irritability
29.
talking more or faster than usual
7.
Changes in appetite or weight. Children and adolescents should have height and weight monitored during treatment.
8.
Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this. Symptoms may include:
30.
headache
31.
weakness or feeling unsteady
32.
confusion, problems concentrating or thinking or memory problems

Do not stop paroxetine tablets without first talking to your healthcare provider.

Stopping paroxetine tablets too quickly may cause serious symptoms including:

anxiety, irritability, high or low mood, feeling restless or changes in sleep habits
headache, sweating, nausea, dizziness
electric shock-like sensations, shaking, confusion

What are paroxetine tablets?

Paroxetine tablets are a prescription medicine used to treat depression. It is important to talk with your healthcare provider about the risks of treating depression and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider. Paroxetine tablets are also used to treat:

1.
Major Depressive Disorder (MDD)
2.
Obsessive Compulsive Disorder (OCD)
3.
Panic Disorder
4.
Social Anxiety Disorder
5.
Generalized Anxiety Disorder (GAD)

Talk to your healthcare provider if you do not think that your condition is getting better with treatment using paroxetine tablets.

Who should not take paroxetine tablets?

Do not take paroxetine tablets if you:

1.
are allergic to paroxetine or any of the ingredients in paroxetine tablets. See the end of this Medication Guide for a complete list of ingredients in paroxetine tablets.
2.
take a Monoamine Oxidase Inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.
3.
Do not take an MAOI within 2 weeks of stopping paroxetine tablets unless directed to do so by your physician.
4.
Do not start paroxetine tablets if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.
5.
People who take paroxetine tablets close in time to an MAOI may have serious or even life threatening side effects. Get medical help right away if you have any of these symptoms:
1.
high fever
2.
uncontrolled muscle spasms
3.
stiff muscles
4.
rapid changes in heart rate or blood pressure
5.
confusion
6.
loss of consciousness (pass out)
6.
take MELLARIL®* (thioridazine). Do not take MELLARIL®* together with paroxetine tablets because this can cause serious heart rhythm problems or sudden death.
7.
take the antipsychotic medicine pimozide (ORAP®*) because this can cause serious heart problems.

What should I tell my healthcare provider before taking paroxetine tablets? Ask if you are not sure.

Before starting paroxetine tablets, tell your healthcare provider if you:

1.
are pregnant, may be pregnant or plan to become pregnant. There is a possibility that paroxetine tablets may harm your unborn baby, including an increased risk of birth defects, particularly heart defects. Other risks may include a serious condition in which there is not enough oxygen in the baby’s blood. Your baby may also have certain other symptoms shortly after birth. Premature births have also been reported in some women who used paroxetine tablets during pregnancy.
2.
are breast-feeding. Paroxetine passes into your milk. Talk to your healthcare provider about the best way to feed your baby while taking paroxetine tablets.
3.
are taking certain drugs such as:
1.
triptans used to treat migraine headache
2.
other antidepressants (SSRIs, SNRIs, tricyclics or lithium) or antipsychotics
3.
drugs that affect serotonin, such as lithium, tramadol, tryptophan, St. John’s wort
4.
certain drugs used to treat irregular heart beats
5.
certain drugs used to treat schizophrenia
6.
certain drugs used to treat HIV infection
7.
certain drugs that affect the blood, such as warfarin, aspirin and ibuprofen
8.
certain drugs used to treat epilepsy
9.
atomoxetine
10.
cimetidine
11.
fentanyl
12.
metoprolol
13.
pimozide
14.
procyclidine
15.
tamoxifen
4.
have liver problems
5.
have kidney problems
6.
have heart problems
7.
have or had seizures or convulsions
8.
have bipolar disorder or mania
9.
have low sodium levels in your blood
10.
have a history of a stroke
11.
have high blood pressure
12.
have or had bleeding problems
13.
have glaucoma (high pressure in the eye)

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Paroxetine tablets and some medicines may interact with each other, may not work as well or may cause serious side effects.

Your healthcare provider or pharmacist can tell you if it is safe to take paroxetine tablets with your other medicines. Do not start or stop any medicine while taking paroxetine tablets without talking to your healthcare provider first.

If you take paroxetine tablets, you should not take any other medicines that contain paroxetine, including paroxetine hydrochloride extended-release tablets and PEXEVA®* (paroxetine mesylate).

Revised: 04/2014
 
Cardinal Health