| IMPORTANT WARNING:
Studies have shown that children and teenagers who take antidepressants ('mood elevators') such as paroxetine may be more likely to think about harming or killing themselves or to plan or try to do so than children who do not take antidepressants. Children younger than 18 years of age should not normally take paroxetine.If your child's doctor has prescribed paroxetine for your child, you should watch his or her behavior very carefully, especially at the beginning of treatment and any time his or her dose is increased or decreased. Your child may develop serious symptoms very suddenly, so it is important to pay attention to his or her behavior every day. Call your child's doctor right away if he or she experiences any of these symptoms: new or worsening depression; thinking about harming or killing him- or herself or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling or staying asleep; irritability; aggressive behavior; acting without thinking; severe restlessness; frenzied, abnormal excitement; or any other sudden or unusual changes in behavior.Your child's doctor will want to see your child often while he or she is taking paroxetine, especially at the beginning of his or her treatment.Your child's doctor may also want to speak with you or your child by telephone from time to time. Be sure that your child keeps all appointments for office visits or telephone conversations with his or her doctor.Your child's doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when your child begins treatment with paroxetine. Read the information carefully and ask your child's doctor or pharmacist if you have any questions.
Medication Information
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 oral solution 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 (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 is in a class of medications called selective serotonin reuptake inhibitors (SSRIs). It works by increasing the amount of serotonin, a natural substance in the brain that helps maintain mental balance.
How should Paroxetine be used?
Paroxetine comes as a tablet, a suspension (liquid), and a controlled-release (long-acting) tablet to take by mouth. It is usually taken once daily in the morning or evening, with or without food. You may want to take paroxetine with food to stop it from upsetting your stomach. To help you remember to take paroxetine, take it 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 tablets whole; do not split, chew, or crush them.
Your doctor may start you on a low dose of paroxetine and gradually increase your dose, not more than once a week.
Paroxetine controls your condition but does not cure it. 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 will probably decrease your dose gradually. If you suddenly stop taking paroxetine, 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; upset stomach; or sweating. Tell your doctor if you experience any of these symptoms when your dose of paroxetine is decreased.
Other uses for Paroxetine
Paroxetine is also sometimes used to treat chronic headaches, tingling 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 Paroxetine for your condition.
Paroxetine may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before taking paroxetine,
- tell your doctor and pharmacist if you are allergic to paroxetine or any other medications.
do not take paroxetine if you are taking monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl), and tranylcypromine (Parnate), or have stopped taking them within the past two weeks. If you stop taking paroxetine, you should wait at least 2 weeks before you start to take an MAO inhibitor. Do not take paroxetine if you are taking thioridazine (Mellaril).
- tell your doctor and pharmacist what other prescription and nonprescription medications, and vitamins you are taking. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin); antidepressants (mood elevators) such as amitriptyline (Elavil), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Adapin, Sinequan), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil); antihistamines; aspirin and other nonsteroidal anti-inflammatory medications (NSAIDs) such as ibuprofen (Advil, Motrin), and naproxen (Aleve, Naprosyn); atazanavir (Reyataz); bromocriptine (Parlodel); bupropion (Wellbutrin); buspirone (Buspar); celecoxib (Celebrex); chlorpromazine (Thorazine); cimetidine (Tagamet); clopidogrel (Plavix); codeine (found in many cough and pain medications); dexamethasone (Decadron); dextromethorphan (found in many cough medications); diazepam (Valium); dicloxacillin (Dynapen); digoxin (Lanoxin); dipyridamole (Persantine); diuretics ('water pills'); haloperidol (Haldol); isoniazid (INH, Nydrazid); lithium (Eskalith, Lithobid); medications for irregular heartbeat such as amiodarone (Cordarone, Pacerone), encainide (Enkaid), flecainide (Tambocor), mexiletine (Mexitil), moricizine (Ethmozine): propafenone (Rythmol), and quinidine (Quinidex); medications for mental illness and nausea; medications for seizures such as phenobarbital (Luminal, Solfoton) and phenytoin (Dilantin); meperidine (Demerol); methadone (Dolophine); metoclopromide (Reglan); metoprolol (Lopressor, Toprol XL); odansetron (Zofran); other selective serotonin reuptake inhibitors such as citalopram (Celexa), fluoxetine (Prozac, Sarafem); fluvoxamine (Luvox); and sertraline (Zoloft); pimozide (Orap); procyclidine (Kemadrin); propoxyphene (Darvon); propranolol (Inderal); ranitidine (Zantac); rifampin (Rifadin, Rimactane); risperidone (Risperdal); ritonavir (Norvir); sumatriptan (Imitrex); tamoxifen (Nolvadex); terbinafine (Lamisil); theopylline (Theobid, Theo-Dur); ticlopidine (Ticlid); timolol (Blocadren); tramadol (Ultram); trazodone (Desyrel); and venlafaxine (Effexor). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor what herbal products and nutritional supplements you are taking, especially St. John's wort and tryptophan.
- tell your doctor if you or anyone in your family has or has ever had depression, bipolar disorder (mood that changes from depressed to abnormally excited), or mania (frenzied, abnormally excited mood), or if you or anyone in your family has thought about or attempted suicide. Also 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 or have ever had glaucoma (an eye disease); seizures; bleeding from your stomach or esphagus (tube that connects the mouth and stomach) or liver, kidney, or heart disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking paroxetine, call your doctor.
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 Paroxetine affects you.
- ask your doctor about the safe use of alcoholic beverages while you are taking paroxetine.
you should know that your mental health may change in unexpected ways, especially at the beginning of your treatment and any time that your dose is increased or decreased. These changes may occur at any time if you have depression or another mental illness, whether or not you are taking paroxetine or any other medication. You, your family, or 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 when you are unable to seek treatment on your own.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do if I forget 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 Paroxetine 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 or feeling "drugged"
- difficulty falling asleep or staying asleep
- upset stomach
- vomiting
- diarrhea
- constipation
- gas
- stomach pain
- heartburn
- changes in ability to taste food
- decreased appetite
- weight loss or gain
- changes in sex drive or ability
- dry mouth
- sweating
- yawning
- sensitivity to light
- runny nose
- cough
- lump or tightness in throat
- pain in the back, muscles, joints, or anywhere in the body
- muscle weakness or tightness
- flushing
- problems with teeth
- unusual dreams
- painful or irregular menstruation
Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them or those listed in the IMPORTANT WARNING section, call your doctor immediately:
- blurred vision
- rapid, pounding, or irregular heartbeat
- chest pain
- seizure
- abnormal bleeding or bruising
- sore throat, fever, chills, and other signs of infection
- shaking hands that you cannot control
- sudden muscle twitching or jerking that you cannot control
- numbness or tingling in your hands, feet, arms, or legs
- difficult, frequent, or painful urination
- swelling, itching, burning, or infection in the vagina
- painful erection that lasts for hours
sudden upset stomach, vomiting, weakness, cramping, bloating, swelling, tightness in hands and feet, dizziness, headache and/or confusion
- hives
- skin rash
- itching
- swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
- hoarseness
- difficulty breathing or swallowing
- black and tarry stools
- red blood in stools
- bloody vomit
- vomiting material that looks like coffee grounds
Paroxetine may cause other side effects. Call your doctor if you have any unusual problems while taking Paroxetine.
What storage conditions are needed for Paroxetine?
Keep Paroxetine 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). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
- drowsiness
- coma
- upset stomach
- shaking hands that you cannot control
- fast, pounding, irregular, or slow heartbeat
- confusion
- vomiting
- dizziness
- seizures
- fainting
- blurred vision
- extreme tiredness
- unusual bruising or bleeding
- lack of energy
- loss of appetite
- pain in the upper right part of the stomach
- flu like symptoms
- yellowing of the skin and eyes
- aggressive behavior
- muscle pain, stiffness or weakness
- sudden muscle twitching or jerking that you cannot control
- dark red or brown urine
- difficulty urinating
- diarrhea
- frenzied, abnormally excited mood
- sweating
- fever
- difficulty walking
What other information should I know?
Keep all appointments with your doctor.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
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