MEDICATION GUIDE

Paroxetine Capsules

(PA-rox-eh-tine)

Read the Medication Guide that comes with Paroxetine Capsules 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. Paroxetine Capsules contain a lower dose of paroxetine, a medicine also used to treat a number of psychiatric disorders. The lower dose of paroxetine in Paroxetine Capsules has not been studied in any psychiatric conditions and Paroxetine Capsules are not approved for any psychiatric uses.

What is the most important information I should know about Paroxetine Capsules?

Paroxetine Capsules may cause serious side effects.

Call your healthcare provider right away if you have any of the following symptoms, or go to the nearest emergency room:

1.   Suicidal thoughts or actions:

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Paroxetine Capsules, and related antidepressant medicines, may increase suicidal thoughts or actions within the first few months of treatment.

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Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.

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Watch for these changes and call your healthcare provider right away if you notice:

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New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.

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Pay particular attention to such changes when Paroxetine Capsules are started.

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 or go to the nearest emergency room if you have any of the following symptoms, especially if they are new, worse, or worry you:

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attempts to commit suicide

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acting on dangerous impulses

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acting aggressive or violent

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thoughts about suicide or dying

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new or worse depression

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new or worse anxiety or panic attacks

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feeling agitated, restless, angry or irritable

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trouble sleeping

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an increase in activity or talking more than what is normal for you

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other unusual changes in behavior or mood.

2.   Serotonin Syndrome. This condition can be life-threatening and may include:

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agitation (nervousness), hallucinations, coma or other changes in mental status

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coordination problems or muscle twitching (small movements of the muscles that you cannot control)

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racing heartbeat, high or low blood pressure

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sweating or fever

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nausea, vomiting, or diarrhea

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muscle rigidity

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dizziness

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flushing

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tremors

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seizures

3.   Reduced effectiveness of tamoxifen. Tamoxifen (a medicine used to treat breast cancer) may not work as well if it is taken while you take Paroxetine Capsules. If you are taking tamoxifen, tell your healthcare provider before starting Paroxetine Capsules.

4.   Abnormal bleeding. Paroxetine Capsules may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin or non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen, naproxen, or aspirin.

5.   Visual problems.

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Eye pain

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Changes in vision

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Swelling or redness in or around the eye

 

Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.

6.   Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this condition. Symptoms may include:

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headache

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weakness or feeling unsteady

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confusion, problems concentrating or thinking or memory problems.

7.   Bone Fractures. Women who take Paroxetine Capsules may have a higher risk of bone fractures. Contact your healthcare provider if you have pain in a bone.

8.   Manic episodes:

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greatly increased energy

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severe trouble sleeping

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racing thoughts

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reckless behavior

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unusually grand ideas

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excessive happiness or irritability

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talking more or faster than usual.

9.   Seizures or convulsions.

10.   Restlessness. Women who take Paroxetine Capsules may feel an inner restlessness, agitation (nervousness), or be unable to sit still or stand still especially when they start taking Paroxetine Capsules. Call your healthcare provider if this happens to you.

11.  Driving. Paroxetine Capsules may affect your ability to make decisions, think clearly, or react quickly. Do not drive, operate heavy machinery, or do other potentially dangerous activities until you know how Paroxetine Capsules affect you.

What are Paroxetine Capsules?

Paroxetine Capsules are prescription medicine used to reduce moderate to severe hot flashes associated with menopause. Paroxetine Capsules are selective serotonin reuptake inhibitor (SSRI). It is not a hormone. The way Paroxetine Capsules treat hot flashes associated with menopause is not known. Paroxetine Capsules do not prevent or treat osteoporosis or dryness, itching or burning in and around the vagina.

Paroxetine Capsules are not for psychiatric problems such as depression, obsessive compulsive disorder, panic disorder, generalized anxiety disorder, social anxiety disorder, and post-traumatic stress disorder.

Paroxetine Capsules are not for use in children.

Talk to your healthcare provider if you do not think that your hot flashes are getting better while taking Paroxetine Capsules.

Who should not take Paroxetine Capsules?

Do not take Paroxetine Capsules if you:

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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.

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Do not take an MAOI within 14 days of stopping Paroxetine Capsules unless directed to do so by your healthcare provider.

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Do not start Paroxetine Capsules if you stopped taking an MAOI in the last 14 days unless directed to do so by your healthcare provider.

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People who take Paroxetine Capsules close in time to an MAOI may have serious or life-threatening side effects. Get medical help right away if you have any of these symptoms:

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high fever

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uncontrolled muscle spasms

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stiff muscles

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rapid changes in heart rate or blood pressure

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confusion

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loss of consciousness (pass out)

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take thioridazine. Do not take thioridazine together with Paroxetine Capsules because this can cause serious heart rhythm problems or sudden death.

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take the antipsychotic medicine pimozide. Do not take pimozide together with Paroxetine Capsules because this can cause serious heart problems.

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are allergic to paroxetine or any of the ingredients in Paroxetine Capsules. See the end of this Medication Guide for a complete list of ingredients in Paroxetine Capsules.

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are pregnant. Paroxetine Capsules are not for pregnant women. Paroxetine, the active ingredient in Paroxetine Capsules, can harm your unborn baby. Risks to your unborn baby include an increased risk of birth defects, particularly heart defects. Your baby may also have certain other serious symptoms shortly after birth.

What should I tell my healthcare provider before taking Paroxetine Capsules?

Before starting Paroxetine Capsules, tell your healthcare provider if you:

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have liver problems

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have kidney problems

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have or had seizures or convulsions

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have bipolar disorder or mania

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have low sodium levels in your blood

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have or had bleeding problems

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have glaucoma (high pressure in the eye)

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have any other medical conditions

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are breastfeeding or plan to breastfeed. Paroxetine passes into breast milk. Talk to your healthcare provider before taking Paroxetine Capsules if you are breast-feeding.

Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Paroxetine Capsules and some medicines may interact with each other, may not work as well, or may cause serious side effects when taken together.

If you take Paroxetine Capsules, you should not take any other medicines that contain paroxetine, including Paxil, Paxil CR and Pexeva.

Especially tell your healthcare provider if you take:

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triptans used to treat migraine headache

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medicines used to treat mood, anxiety, psychotic or thought disorders, including MAOIs, SSRIs, tricyclics, lithium, buspirone, or antipsychotics

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tramadol, fentanyl or over-the-counter supplements such as tryptophan or St. John’s Wort

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amphetamines,

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thioridazine

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pimozide

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tamoxifen

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atomoxetine

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cimetidine

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digoxin

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theophylline

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medicines to treat irregular heart rate (like propafenone, flecainide, and encainide)

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medicines used to treat schizophrenia

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certain medicines used to treat HIV infection

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the blood thinner warfarin

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nonsteroidal anti-inflammatory drugs (NSAIDs) (like ibuprofen, naproxen, or aspirin)

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certain medicines used to treat seizures (like phenobarbital and phenytoin)

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other drugs containing paroxetine, the medicine in Paroxetine Capsules.

Ask your healthcare provider if you are not sure if you are taking any of these medications.

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

How should I take Paroxetine Capsules?

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Take Paroxetine Capsules exactly as your healthcare provider tells you to take it.

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Take Paroxetine Capsules 1 time each day at bedtime.

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Paroxetine Capsules may be taken with or without food.

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If you miss a dose of Paroxetine Capsules, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Paroxetine Capsules at the same time.

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If you take too many Paroxetine Capsules, call your healthcare provider or poison control center right away, or go to the nearest emergency room right away.

What should I avoid while taking Paroxetine Capsules?

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Paroxetine Capsules can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how Paroxetine Capsules affect you.

What are the possible side effects of Paroxetine Capsules?

Paroxetine Capsules may cause serious side effects, including:

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See “What is the most important information I should know about Paroxetine Capsules?”

The most common side effects of Paroxetine Capsules include:

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headache

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tiredness

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nausea and vomiting

Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Paroxetine Capsules. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Paroxetine Capsules?

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Store Paroxetine Capsules at room temperature between 68oF to 77oF (20oC to 25oC).

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Keep Paroxetine Capsules out of the light.

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Keep Paroxetine Capsules dry.

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Keep Paroxetine Capsules and all medicines out of the reach of children.

General information about the safe and effective use of Paroxetine Capsules.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Paroxetine Capsules for a condition for which it was not prescribed. Do not give Paroxetine Capsules to other people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about Paroxetine Capsules. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about Paroxetine Capsules that is written for healthcare professionals.

For more information about Paroxetine Capsules, call Solco Healthcare US, LLC at 1-866-257-2597.

What are the ingredients in Paroxetine Capsules?

Active ingredient: paroxetine

Inactive ingredients: anhydrous dibasic calcium phosphate, sodium starch glycolate, magnesium stearate, gelatin, titanium dioxide, propylene glycol, potassium hydroxide, shellac, and black iron oxide.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Distribute by:

Solco Healthcare US, LLC

Somerset, NJ 08873, USA

Manufactured by:

Zhejiang Huahai Pharmaceutical Co., Ltd.

Xunqiao, Linhai, Zhejiang, 317024, China

Revised: 04/2021