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|Paroxetine Suspension

Paroxetine Suspension

Paroxetine Suspension is used for:

Treating depression, obsessive-compulsive disorder (OCD), generalized and social anxiety disorders, posttraumatic stress disorder, and panic disorders with or without the fear of being in open or public places. It may also be used for other conditions as determined by your doctor.

Paroxetine Suspension is a selective serotonin reuptake inhibitor (SSRI). It works by restoring the balance of certain natural substances in the brain, which help to elevate moods.

Do NOT use Paroxetine Suspension if:

• you are allergic to any ingredient in Paroxetine Suspension
• you are taking dextromethorphan, fenfluramine, nefazodone, pimozide, selegiline, sibutramine, St. John"s wort, thioridazine, tramadol, or tryptophan
• you have taken a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Paroxetine Suspension:

Some medical conditions may interact with Paroxetine Suspension. 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 supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of seizures, mania, or thoughts of suicide, or you have attempted suicide
• if you have severe liver or kidney disease, an illness that alters your metabolism or blood circulation response, or a history of stomach or intestinal bleeding
• if you have a history of narrow-angle glaucoma
• if you are dehydrated

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

• Cyproheptadine because the effectiveness of Paroxetine Suspension may be decreased
• Anorexiants (eg, phentermine, fenfluramine), cimetidine, dextromethorphan, linezolid, lithium, MAO inhibitors (eg, phenelzine), metoclopramide, nefazodone, selegiline, St. John"s wort, serotonin 5-HT receptor agonists (eg, sumatriptan, sibutramine, trazodone, or tryptophan because side effects, such as serotonin syndrome and central nervous system toxicity, may occur
• Antiarrhythmics (eg, propafenone, flecainide, quinidine), anticoagulants (eg, warfarin), aspirin, aripiprazole, clozapine, digoxin, diuretics (eg, furosemide), H₁ antagonists (eg, astemizole), norepinephrine reuptake inhibitors (eg, atomoxetine), nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), phenothiazines (eg, thioridazine), tramadol, pimozide, procyclidine, risperidone, theophylline, or tricyclic antidepressants (eg, amitriptyline) because side effects associated with these medicines may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Paroxetine Suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Paroxetine Suspension:

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

• Paroxetine Suspension comes with an additional patient information sheet called a Medication Guide. Read it carefully and reread it each time you get Paroxetine Suspension refilled.
• Paroxetine Suspension may be taken on an empty stomach or with food.
• Paroxetine Suspension is usually taken in the morning.
• Shake well before each use.
• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
• Symptoms usually improve within 1 to 4 weeks. Continue taking your medicine even though you feel better.
• If you miss a dose of Paroxetine Suspension and you are taking it in the morning, take it during the afternoon if you remember. If you do not remember until the next morning, skip the missed dose and go back to your regular dosing schedule. If you miss a dose and you are taking one dose daily at bedtime and do not remember until the next day, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If you miss more than one dose, contact your doctor or pharmacist.

Ask your health care provider any questions you may have about how to use Paroxetine Suspension.

Important safety information:

• Paroxetine Suspension may cause drowsiness, dizziness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Paroxetine Suspension. Using Paroxetine Suspension alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
• Do NOT suddenly stop taking Paroxetine Suspension. Suddenly stopping Paroxetine Suspension may cause irritability, a state of feeling unwell or unhappy, agitation, dizziness, electric shock sensations, anxiety confusion, headache, lack of energy, mood swings, inability to sleep, or mild mania. If therapy is to be discontinued, it should be gradually decreased.
• Antidepressants can increase suicidal thoughts and actions in some children and teenagers. Adults taking Paroxetine Suspension may also be affected. This risk may be higher in individuals with bipolar illness (also called manic-depressive illness), a family history of bipolar illness, or a history of attempting suicide. Pay close attention to changes in moods or actions, especially if changes occur suddenly. Contact your health care provider right away if any of the following effects occur or worsen: depression, anxiety, restlessness or irritability, panic attacks, thoughts or attempts of suicide, or other unusual changes in behavior or mood.
• Avoid drinking alcohol while taking Paroxetine Suspension.
• Paroxetine Suspension will add to the drowsiness effect of other medicines. Check the labels of all your medicines for ingredients that may cause drowsiness. Ask your pharmacist if you are unsure which products may cause drowsiness. Do NOT start any new medicines without checking with your doctor or pharmacist.
• Additional monitoring of your condition is recommended at the start of treatment with Paroxetine Suspension and whenever a change to your dose is made.
• Paroxetine Suspension contains the same active ingredient as Paxil tablets. Do not take Paroxetine Suspension with Paxil tablets.
• If you experience a prolonged or painful erection, stop using Paroxetine Suspension, and seek immediate medical attention or permanent problems can occur.
• LAB TESTS, including liver function, kidney function, and complete blood cell counts, may be performed to monitor your progress or to check for side effects. Be sure to keep your appointments.
• Caution is advised when using Paroxetine Suspension in the ELDERLY because they may be more sensitive to its effects, especially decreased blood sodium levels.
• Use Paroxetine Suspension with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Paroxetine Suspension may cause harm to the fetus. If you think you may be pregnant, discuss with your doctor the benefits and risks of using Paroxetine Suspension during pregnancy. Paroxetine Suspension is excreted in breast milk. If you are or will be breast-feeding while you are using Paroxetine Suspension, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Paroxetine Suspension:

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:

Abnormal dreams; abnormal ejaculation; abnormal skin sensations; blurred vision; constipation; decreased appetite; decreased sexual desire or ability; diarrhea; dizziness; drowsiness; dry mouth; fatigue; headache; impotence; nausea; nervousness; painful period; runny nose; sleepiness; sore throat; stomach pain; sweating; vomiting; weakness; weight loss; yawning.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black or bloody stools; chest pain; confusion; extreme mood swings; fever, chills, or persistent sore throat; hallucinations; heart problems; fast or irregular heartbeat; mental or mood changes; new or worsening agitation, anxiety, panic attacks, aggressiveness, impulsiveness, irritability, hostility, sleeplessness, exaggerated feeling of well being, or inability to sit still; pounding in the chest; prolonged, painful erection; suicidal thoughts or attempts; tremors; unexplained shivering; unusual bleeding or bruising; urinary changes; seizures; vision changes; worsening of depression.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include: confusion; difficulty breathing; dilated pupils; excessive sweating; fainting; fast or irregular heartbeat; fever; loss of consciousness; severe drowsiness; twitching; seizures. Do not take more medicine than prescribed unless advised to do so by your health care provider.

Store Paroxetine Suspension at room temperature, at 77 degrees F (25 degrees C) in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep this medicine out of the reach of children and away from pets.

General information:

• If you have any questions about Paroxetine Suspension, please talk with your doctor, pharmacist, or other health care provider.
• Paroxetine Suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Paroxetine Suspension. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.