Paroxetine

IMPORTANT WARNING:

A small number of children, teenagers, and young adults (up to 24 years of age) who took antidepressants ('mood elevators') such as paroxetine during clinical studies became suicidal (thinking about harming or killing oneself or planning or trying to do so). Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal than children, teenagers, and young adults who do not take antidepressants to treat these conditions. However, there are also risks when depression is not treated in children and teenagers. Talk to your child's doctor about these risks and whether your child should take an antidepressant, Children younger than 18 years of age should not normally take paroxetine, but in some cases, a doctor may decide that paroxetine is the best medication to treat a child's condition.

You should know that your mental health may change in unexpected ways when you take paroxetine or other antidepressants to treat depression or other mental illness even if you are an adult over 24 years of age. You may also experience changes in your mental health if you are a woman taking a low dose of paroxetine to treat hot flashes and you have never had depression or another mental illness. You may become suicidal, especially at the beginning of your treatment and any time that your dose is increased or decreased. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and frenzied abnormal excitement. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

Your healthcare provider will want to see you often while you are taking paroxetine, especially at the beginning of your treatment. Be sure to keep all appointments for office visits with your doctor.

The doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with paroxetine. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also obtain the Medication Guide from the FDA website: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273.

No matter what your age, before you take an antidepressant, you, your parent, or your caregiver should talk to your doctor about the risks and benefits of treating your condition with an antidepressant or with other treatments. You should also talk about the risks and benefits of not treating your condition. You should know that having depression or another mental illness greatly increases the risk that you will become suicidal. This risk is higher if you or anyone in your family has or has ever had bipolar disorder (mood that changes from depressed to abnormally excited) or mania (frenzied, abnormally excited mood) or has thought about or attempted suicide. Talk to your doctor about your condition, symptoms, and personal and family medical history. You and your doctor will decide what type of treatment is right for you.

WHY is this medicine prescribed?

Paroxetine tablets, suspension (liquid), and extended-release (long-acting) tablets are used to treat depression, panic disorder (sudden, unexpected attacks of extreme fear and worry about these attacks), and social anxiety disorder (extreme fear of interacting with others or performing in front of others that interferes with normal life). Paroxetine tablets and suspension are also used to treat obsessive-compulsive disorder (bothersome thoughts that won't go away and the need to perform certain actions over and over), generalized anxiety disorder (GAD; excessive worrying that is difficult to control), and posttraumatic stress disorder (disturbing psychological symptoms that develop after a frightening experience). Paroxetine extended-release tablets are also used to treat premenstrual dysphoric disorder (PMDD, physical and psychological symptoms that occur before the onset of the menstrual period each month). Paroxetine capsules (Brisdelle) are used to treat hot flashes (sudden feelings of warmth, especially in the face, neck, and chest) in women who are experiencing menopause (stage of life when menstrual periods become less frequent and stop and women may experience other symptoms and body changes). Paroxetine is in a class of medications called selective serotonin-reuptake inhibitors (SSRIs). It treats depression and other mental illnesses by increasing the amount of serotonin, a natural substance in the brain that helps maintain mental balance. There is not enough information available at this time to know how paroxetine works to treat hot flashes.

Are there OTHER USES for this medicine?

Paroxetine is also sometimes used to treat chronic headaches, tingling, pain, or numbness in the hands and feet caused by diabetes, and certain male sexual problems. Paroxetine is also used with other medications to treat bipolar disorder (mood that changes from depressed to abnormally excited). Talk to your doctor about the possible risks of using this drug for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Paroxetine comes as a tablet, a suspension (liquid), a controlled-release (long-acting) tablet, and a capsule to take by mouth. The tablets, suspension, and controlled-release tablets are usually taken once daily in the morning or evening, with or without food. The capsules are usually taken once a day at bedtime with or without food. You may want to take paroxetine with food to prevent stomach upset. Take paroxetine at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take paroxetine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Shake the liquid well before each use to mix the medication evenly.

Swallow the extended-release and regular tablets whole; do not chew or crush them.

If you are taking paroxetine tablets, suspension, or controlled-release tablets, your doctor may start you on a low dose of paroxetine and gradually increase your dose, not more than once a week.

Paroxetine capsules contain a lower dose of paroxetine than is needed to treat depression and other forms of mental illness. Do not take paroxetine capsules to treat a mental illness. If you think you have depression or another mental illness, talk to your doctor about treatment.

Paroxetine may help control your symptoms but will not cure your condition. It may take several weeks or longer before you feel the full benefit of paroxetine. Continue to take paroxetine even if you feel well. Do not stop taking paroxetine without talking to your doctor. Your doctor may decrease your dose gradually. If you suddenly stop taking paroxetine tablets, suspension, or controlled-release tablets, you may experience withdrawal symptoms such as depression; mood changes; frenzied or abnormally excited mood; irritability; anxiety; confusion; dizziness; headache; tiredness; numbness or tingling in the arms, legs, hands, or feet; unusual dreams; difficulty falling asleep or staying asleep; nausea; or sweating. Tell your doctor if you experience any of these symptoms when your dose of paroxetine is decreased.

What SPECIAL PRECAUTIONS should I follow?

Before taking paroxetine,

• tell your doctor and pharmacist if you are allergic to paroxetine, any other medications, or any of the ingredients in paroxetine tablets, controlled-release tablets, capsules, or suspension. Ask your pharmacist or check the Medication Guide for a list of the ingredients

• tell your doctor if you are taking monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Emsam, Zelapar), and tranylcypromine (Parnate); if you have stopped taking them within the past 2 weeks; or if you are taking thioridazine or pimozide (Orap). Your doctor will probably tell you not to take paroxetine. If you stop taking paroxetine, you should wait at least 2 weeks before you start to take an MAO inhibitor.

• tell your doctor and pharmacist what other prescription and nonprescription medications and vitamins you are taking or plan to take. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven) and heparin; antidepressants ('mood elevators') such as amitriptyline, amoxapine, clomipramine (Anafranil), desipramine (Norpramin), doxepin, imipramine (Tofranil), nortriptyline (Pamelor), protriptyline, and trimipramine; antihistamines; aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin), and naproxen (Aleve, Naprosyn); atomoxetine (Straterra); buspirone (Buspar); chlorpromazine (Thorazine); cimetidine (Tagamet); clopidogrel (Plavix); dextromethorphan (found in many cough medications; in Nuedexta); digoxin (Lanoxin); dipyridamole (Persantine); diuretics ('water pills'); fentanyl (Actiq, Fentora, Lazanda, others); fosamprenavir (Lexiva); haloperidol (Haldol); isoniazid (INH, Nydrazid); lithium (Lithobid); medications for irregular heartbeat such as flecainide or propafenone (Rythmol); medications for mental illness and nausea; medications for migraine headaches such as almotriptan, eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex), and zolmitriptan (Zomig); medications for seizures such as phenobarbital and phenytoin (Dilantin);metoprolol (Lopressor, Toprol XL); other selective serotonin-reuptake inhibitors such as citalopram (Celexa), fluoxetine (Prozac), fluvoxamine (Luvox), and sertraline (Zoloft); propranolol (Inderal); risperidone (Risperdal); ritonavir (Norvir); serotonin–norepinephrine reuptake inhibitors (SNRI) medications such as desvenlafaxine (Khedezla, Pristiq), duloxetine (Cymbalta), levomilnacipran (Fetzima), and venlafaxine; tamoxifen (Soltamox); theophylline (Theobid, Theo-Dur); tramadol (Conzip, Qdolo,Ultram, in Ultracet); and trazodone. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with paroxetine, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

• you should know that paroxetine products that have different brand names are available and are used to treat different conditions. Do not take more than one product that contains paroxetine at a time.

• tell your doctor what herbal products and nutritional supplements you are taking, especially St. John's wort and tryptophan.

• tell your doctor if you use or have ever used street drugs or have overused prescription medications, if you have recently had a heart attack, and if you have a low level of sodium in your blood. Also tell your doctor if you have or have ever had seizures; glaucoma; bleeding problems; bone problems including osteoporosis (a condition in which the bones become thin and weak and break easily) or bone fractures; or liver, kidney, or heart disease.

• tell your doctor if you are pregnant, if you plan to become pregnant, or if you are breastfeeding. If you become pregnant while taking paroxetine, call your doctor immediately. Paroxetine may cause heart defects in the fetus if it is taken during early pregnancy and problems in newborns following delivery if it is taken during the last months of pregnancy.

• you should know that paroxetine may make you drowsy and affect your judgment and thinking. Do not drive a car or operate machinery until you know how this medication affects you.

• ask your doctor about the safe use of alcoholic beverages while you are taking paroxetine.

• talk to your doctor about the risks and benefits of taking paroxetine if you are 65 years of age or older. Older adults should not usually take paroxetine because it is not as safe or effective as other medications that can be used to treat the same condition.

• you should know that paroxetine may cause angle-closure glaucoma (a condition where the fluid is suddenly blocked and unable to flow out of the eye causing a quick, severe increase in eye pressure which may lead to a loss of vision). Talk to your doctor about having an eye examination before you start taking this medication. If you have nausea, eye pain, changes in vision, such as seeing colored rings around lights, and swelling or redness in or around the eye, call your doctor or get emergency medical treatment right away.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Paroxetine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• dizziness
• weakness
• difficulty concentrating
• nervousness
• forgetfulness
• confusion
• sleepiness
• nausea
• vomiting
• diarrhea
• constipation
• gas
• stomach pain
• heartburn
• changes in ability to taste food
• decreased appetite
• weight loss or gain
• sexual problems in males; decreased sex drive, inability to get or keep an erection, or delayed or absent ejaculation
• sexual problems in females; decreased sex drive, or delayed orgasm or unable to have an orgasm
• dry mouth
• sweating
• yawning
• pain in the back, muscles, bones, or anywhere in the body
• tenderness or swelling of joints

Some side effects can be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS sections, call your doctor immediately or get emergency medical treatment:

• seeing things or hearing voices that do not exist (hallucinating)
• fainting
• rapid, pounding, or irregular heartbeat
• chest pain
• difficulty breathing
• seizures
• agitation, fever, sweating, confusion, fast or irregular heartbeat, and severe muscle stiffness or twitching, hallucinations, loss of coordination, nausea, vomiting, or diarrhea
• abnormal bleeding or bruising
• tiny red spots directly under the skin
• peeling or blistering of skin
• sore throat, fever, chills, cough, and other signs of infection
• uncontrollable shaking of a part of the body
• unsteady walking that may cause falling
• numbness or tingling in your hands, feet, arms, or legs
• painful erection that lasts for hours
• sudden nausea, vomiting, weakness, cramping, bloating, swelling, tightness in hands and feet, dizziness, headache and/or confusion
• hives
• rash
• itching
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• hoarseness
• black and tarry stools
• red blood in stools
• bloody vomit
• vomit that looks like coffee grounds
• bone pain or fracture
• tenderness, swelling, or bruising of one part of your body

Paroxetine may decrease appetite and cause weight loss in children. Your child's doctor will watch his or her growth carefully. Talk to your child's doctor if you have concerns about your child's growth or weight while he or she is taking this medication. Talk to your child's doctor about the risks of giving paroxetine to your child.

Paroxetine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• drowsiness
• coma
• seizures
• fever, sweating, confusion, fast or irregular heartbeat, and severe muscle stiffness or twitching
• nausea, vomiting, diarrhea
• aggressive behavior
• dark red or brown urine
• frenzied, abnormally excited mood

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Before having any laboratory test (especially those that involve methylene blue), tell your doctor and the laboratory personnel that you are taking paroxetine.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.