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Paroxetine HCl 37.5mg 24 Hour Tablets – Generic Paxil CR

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Antidepressants may increase the risk of suicidal thoughts
or actions in children,
teenagers, and young adults. However, depression and certain other mental
problems may also increase the risk of suicide. Talk with the patient’s doctor
to be sure that the benefits of using Paroxetine outweigh the risks.

and caregivers must closely watch patients who take Paroxetine . It is
important to keep in close contact with the patient’s doctor. Tell the doctor
right away if the patient has symptoms like worsened depression, suicidal
thoughts, or changes in behavior. Discuss any questions with the patient’s

Paroxetine is used for:

Treating depression or obsessive-compulsive disorder (OCD).
It may be used to treat panic disorder or posttraumatic stress disorder (PTSD).
It may also be used to treat generalized anxiety disorder or social anxiety
disorder. It may also be used for other conditions as determined by your doctor.

Paroxetine is a selective serotonin reuptake inhibitor (SSRI).
It works by restoring the balance of serotonin, a natural substance in the
brain, which helps to improve certain mood problems.

Do NOT use Paroxetine if:

  • you are allergic to any
    ingredient in Paroxetine

  • you are taking or have taken
    linezolid, a monoamine oxidase inhibitor (MAOI) (eg, phenelzine),
    selegiline, or St. John’s wort within the last 14 days

  • you are taking a fenfluramine
    derivative (eg, dexfenfluramine), nefazodone, pimozide, a serotonin
    norepinephrine reuptake inhibitor (SNRI) (eg, venlafaxine), another SSRI (eg,
    fluoxetine), sibutramine, thioridazine, or tryptophan

Before using Paroxetine :

Some medical conditions may interact with Paroxetine . Tell
your doctor or pharmacist if you have any medical conditions, especially if any
of the following apply to you:

  • if you are pregnant, planning to
    become pregnant, or are breast-feeding

  • if you are taking any
    prescription or nonprescription medicine, herbal preparation, or dietary

  • if you have allergies to
    medicines, foods,
    or other substances

  • if you or a family member has a
    history of bipolar disorder (manic-depression), other mental or mood
    problems, suicidal thoughts or attempts, or alcohol or substance abuse

  • if you have a history of
    seizures, heart problems, liver problems, severe kidney problems, stomach or
    bowel bleeding, narrow-angle glaucoma, diabetes, or metabolism problems

  • if you are dehydrated, have low
    blood sodium levels, or drink alcohol

  • if you will be having
    electroconvulsive therapy (ECT)

Some MEDICINES MAY INTERACT with Paroxetine . Tell your
health care provider if you are taking any other medicines, especially any of
the following:

  • Anorexiants (eg, phentermine),
    cimetidine, fenfluramine derivatives (eg, dexfenfluramine), linezolid,
    lithium, MAOIs (eg, phenelzine), metoclopramide, nefazodone, selegiline,
    serotonin 5-HT1
    receptor agonists (eg, sumatriptan), sibutramine, SNRIs (eg, venlafaxine),
    another SSRI (eg, fluoxetine), St. John’s wort, tramadol, trazodone, or
    tryptophan because severe side effects, such as a reaction that may include
    fever, rigid muscles, blood pressure
    changes, mental changes, confusion, irritability, agitation,
    delirium, or coma, may occur

  • Anticoagulants (eg, warfarin),
    aspirin, or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen)
    because the risk of bleeding, including stomach bleeding, may be increased

  • Diuretics (eg, furosemide,
    hydrochlorothiazide) because the risk of low blood sodium levels may be

  • Antiarrhythmics (eg, flecainide,
    propafenone, quinidine), H1
    antagonists (eg, astemizole, terfenadine), or phenothiazines (eg,
    chlorpromazine, thioridazine) because severe heart problems, including
    irregular heartbeat, may occur

  • Cyproheptadine, HIV protease
    inhibitors (eg, ritonavir), phenobarbital, or phenytoin because they may
    decrease Paroxetine ‘s effectiveness

  • Aripiprazole, atomoxetine,
    clozapine, fluoxetine, pimozide, procyclidine, risperidone, theophylline, or
    tricyclic antidepressants (eg, amitriptyline) because the risk of their side
    effects may be increased by Paroxetine

  • Digoxin or tamoxifen because
    their effectiveness may be decreased by Paroxetine

How to use Paroxetine :

Use Paroxetine as directed by your doctor. Check the label on
the medicine for exact dosing instructions.

  • Paroxetine comes with an extra
    patient information sheet called a Medication Guide. Read it carefully. Read
    it again each time you get Paroxetine refilled.

  • Take Paroxetine by mouth with or
    without food.

  • Swallow Paroxetine whole. Do not
    break, crush, or chew before swallowing.

  • Taking Paroxetine at the same
    time each day will help you remember to take it.

  • Continue to take Paroxetine even
    if you feel well. Do not miss any doses.

  • Do not suddenly stop taking
    Paroxetine without checking with your doctor. Side effects may occur. They
    may include mental or mood changes, numbness or tingling of the skin,
    dizziness, confusion, headache, trouble sleeping, or unusual tiredness. You
    will be closely monitored when you start Paroxetine and whenever a change in
    dose is made.

  • If you miss a dose of Paroxetine
    , take it as soon as possible. If it almost time for your next dose, skip
    the missed dose and go back to your regular dosing schedule. Do not take 2
    doses at once.

Important safety information:

  • Paroxetine may cause drowsiness,
    dizziness, or blurred vision. These effects may be worse if you take it with
    alcohol or certain medicines. Use Paroxetine with caution. Do not drive or
    perform other possibly unsafe tasks until you know how you react to it.

  • Do not drink alcohol while you
    are taking Paroxetine .

  • Check with your doctor before you
    use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers)
    while you are using Paroxetine ; it may add to their effects. Ask your
    pharmacist if you have questions about which medicines may cause drowsiness.

  • Several weeks may pass before
    your symptoms improve. Do NOT take more than the recommended dose, change
    your dose, or use Paroxetine for longer than prescribed without checking
    with your doctor.

  • Children, teenagers, and young
    adults who take Paroxetine may be at increased risk for suicidal thoughts or
    actions. Closely watch all patients who take Paroxetine . Contact the doctor
    at once if new, worsened, or sudden symptoms such as depressed mood;
    anxious, restless, or irritable behavior; panic attacks; or any unusual
    change in mood or behavior occur. Contact the doctor right away if any signs
    of suicidal thoughts or actions occur.

  • If your doctor tells you to stop
    taking Paroxetine , you will need to wait for several weeks before beginning
    to take certain other medicines (eg, MAOIs, nefazodone). Ask your doctor
    when you should start to take your new medicines after you have stopped
    taking Paroxetine .

  • Paroxetine may rarely cause a
    prolonged, painful erection. This could happen even when you are not having
    sex. If this is not treated right away, it could lead to permanent sexual
    problems such as impotence. Contact your doctor right away if this happens.

  • Serotonin syndrome is a possibly
    fatal syndrome that can be caused by Paroxetine . Your risk may be greater
    if you take Paroxetine with certain other medicines (eg, “triptans,”
    MAOIs). Symptoms may include agitation; confusion; hallucinations; coma;
    fever; fast or irregular heartbeat; tremor; excessive sweating; and nausea,
    vomiting, or diarrhea. Contact your doctor at once if you have any of these

  • Neuroleptic malignant syndrome (NMS)
    is a possibly fatal syndrome that can be caused by Paroxetine . Your risk
    may be greater if Paroxetine is used with certain other medicines called
    antipsychotics (eg, aripiprazole, risperidone). Symptoms may be similar to
    serotonin syndrome and may include fever, rigid muscles, blood pressure
    changes, and mental changes. Contact your doctor at once if you have any of
    these symptoms.

  • Use Paroxetine with caution in
    the ELDERLY; they may be more sensitive to its effects, especially low blood
    sodium levels.

  • Caution is advised when using
    Paroxetine in CHILDREN; they may be more sensitive to its effects,
    especially increased risk of suicidal thoughts and actions.

  • Paroxetine should be used with
    extreme caution in CHILDREN; safety and effectiveness in children have not
    been confirmed.

  • Paroxetine may cause weight
    changes. CHILDREN and teenagers may need regular weight and growth checks
    while they take Paroxetine .

    Paroxetine may cause harm to the fetus. If you become pregnant, contact your
    doctor. You will need to discuss the benefits and risks of using Paroxetine
    while you are pregnant. Paroxetine is found in breast milk. If you are or
    will be breast-feeding while you use Paroxetine , check with your doctor.
    Discuss any possible risks to your baby.

Possible side effects of Paroxetine :

All medicines may cause side effects, but many people have
no, or minor, side effects. Check with your doctor if any
of these most COMMON side effects persist or become bothersome:

Anxiety; blurred vision; constipation;
decreased sexual desire or ability; diarrhea; dizziness; drowsiness; dry
mouth; gas; increased sweating; increased urination; loss of appetite; nausea;
nervousness; numbness or tingling of the skin; stomach upset; trouble
concentrating; trouble sleeping; weakness; yawning.

Seek medical attention right away if any of these SEVERE
side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty
breathing; tightness in the chest; swelling of the mouth, face, lips, or
tongue); bizarre behavior; black or bloody stools; chest pain; confusion;
decreased concentration; decreased coordination; exaggerated reflexes;
fainting; fast or irregular heartbeat; fever, chills, or sore throat;
hallucinations; memory loss; new or worsening agitation, panic attacks,
aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of
well-being, restlessness, or inability to sit still; persistent or severe
ringing in the ears; persistent, painful erection; red, swollen, blistered, or
peeling skin; seizures; severe or persistent anxiety or trouble sleeping;
severe or persistent headache or dizziness; significant weight loss; stomach
pain; suicidal thoughts or attempts; tremor; unusual bruising or bleeding;
unusual or severe mental or mood changes; unusual weakness; vision changes;
worsening of depression.

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