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Mylan-Paroxetine
Common Name
paroxetine
How does this medication work? What will it do for me?
Paroxetine belongs to the class of medications called selective serotonin reuptake inhibitors (SSRIs). It is used to treat depression, obsessive-compulsive disorder, panic disorder, social phobia (social anxiety disorder), generalized anxiety disorder, and posttraumatic stress disorder. It works by affecting the balance of chemicals in the brain that are associated with depression and anxiety disorders.
It may take several weeks before the full beneficial effects of this medication are achieved. Continue taking the medication until you have consulted with your doctor, even if you feel your symptoms are not improving.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. As well, some forms of this medication may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
What form(s) does this medication come in?
10 mg
Each yellow, film-coated, normal convex tablet, debossed "P1" on one side and "G" on the other side, contains paroxetine HCl equivalent to paroxetine free base 10 mg. Nonmedicinal ingredients: calcium hydrogen phosphate anhydrous, colloidal anhydrous silica, magnesium stearate and sodium starch glycolate; tablet coating: D&C Yellow No. 10, dimethyl aminoethyl methacrylate copolymer, FD&C Blue No. 2, FD&C Yellow No. 6, purified talc, and titanium dioxide.
20 mg
Each pink, film-coated, normal convex tablet, debossed "P" scoreline "2" on one side and "G" on the other side, contains paroxetine HCl equivalent to paroxetine free base 20 mg. Nonmedicinal ingredients: calcium hydrogen phosphate anhydrous, colloidal anhydrous silica, magnesium stearate and sodium starch glycolate; tablet coating: D&C Red No. 27, dimethyl aminoethyl methacrylate copolymer, FD&C Blue No. 1, FD&C Blue No. 2, FD&C Red No. 40, purified talc, and titanium dioxide.
30 mg
Each blue, film-coated, normal convex tablet, debossed "P3" on one side and "G" on the other side, contains paroxetine HCl equivalent to paroxetine free base 30 mg. Nonmedicinal ingredients: calcium hydrogen phosphate anhydrous, colloidal anhydrous silica, magnesium stearate, sodium starch glycolate; tablet coating: dimethyl aminoethyl methacrylate copolymer, FD&C Blue No. 1, FD&C Blue No. 2, FD&C Red No. 40, purified talc, and titanium dioxide.
How should I use this medication?
The recommended adult dose of paroxetine ranges from 20 mg to 60 mg once daily in the morning, with or without food. The dose depends on the individual and on the condition being treated. Swallow the tablet whole - do not chew it.
Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones given here, do not change the way that you are taking the medication without consulting your doctor.
It is important that this medication be taken exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Store this medication at room temperature and keep it out of the reach of children.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Who should NOT take this medication?
Paroxetine should not be taken by anyone who:
- is allergic to paroxetine or to any of the ingredients of the medication
- is taking a MAO inhibitor (e.g., phenelzine, tranylcypromine, moclobemide) or has taken a MAO inhibitor within the past 2 weeks (do not start treatment with an MAO inhibitor until at least 2 weeks after stopping paroxetine treatment)
- takes pimozide
- takes thioridazine
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
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Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- absence of or decrease in body movements
- agitation
- difficulty speaking
- erection without sexual stimulation accompanied by pain or tenderness
- fast or irregular heartbeat
- feelings of paranoia
- inability to move eyes
- incomplete, sudden, or unusual body or facial movements
- low blood sodium (confusion, seizures, drowsiness, dryness of mouth, increased thirst, lack of energy)
- muscle pain or weakness
- problems with urination
- rapid, involuntary eye movements
- red or purple patches on skin
- skin rash
- talking, feeling, and acting with excitement and activity you cannot control
- vision changes
Stop taking the medication and seek immediate medical attention if any of the following occur:
- chest pain
- seizure or convulsions
- serotonin syndrome (signs include agitation, confusion, diarrhea, fever, overactive reflexes, poor coordination, restlessness, shivering, sweating, talking or acting with excitement you cannot control, trembling or shaking, twitching)
- thoughts of suicide or hurting yourself
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
Abnormal bleeding: Other medications similar to paroxetine may cause abnormal bleeding, including bleeding in the stomach or intestines. People who have or have had a history of bleeding disorders should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Report any unusual bruising or bleeding to your doctor, especially if you are taking medications that affect blood clotting. These medications include acetylsalicylic acid (ASA), clopidogrel, dipyridamole, nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., ibuprofen or naproxen), other anticoagulant medications (e.g., warfarin), and certain antipsychotic medications.
Depression: People taking this medication for depression should be closely monitored by their doctor.
Diabetes: For people with diabetes, paroxetine may alter blood sugar control. As is true for many other types of medication when taken by people with diabetes, dosages of insulin or antidiabetes tablets may need adjustment when starting or stopping paroxetine.
Drowsiness/reduced alertness: Although paroxetine is not known to cause drowsiness, people taking the medication should avoid driving or operating hazardous machinery until they determine that paroxetine does not impair their ability to do these things safely.
Glaucoma: People with narrow-angle glaucoma should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Heart disease: People with heart disease should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Kidney or liver disease: People with kidney or liver disease should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. They may need lower doses of this medication and their doctor may order kidney and liver tests to monitor kidney and liver function.
Mania: Paroxetine may activate mania. People with a history of mania should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Seizures: People with a history of seizures who take this medication should be closely monitored by their doctor. Anyone who develops seizures while taking this medication should discuss the risks and benefits of continuing to take this medication with their doctor as soon as possible.
Stopping the medication: Stopping this medication suddenly may lead to side effects such as dizziness, abnormal dreams, numbness or tingling sensations, agitation, anxiety, nausea, vomiting, sweating, or other symptoms. If you are thinking of stopping the medication, check with your doctor first. Your doctor may want you to decrease the dose of the medication gradually when it is time to stop taking paroxetine.
Suicidal or agitated behaviour: People taking this medication may feel agitated (restless, anxious, aggressive, emotional, and feeling not like themselves), or they may want to hurt themselves or others. These symptoms may occur within several weeks after starting this medication. If you experience these side effects or notice them in a family member who is taking this medication, contact your doctor immediately. You should be closely monitored by your doctor for emotional and behaviour changes while taking this medication.
Pregnancy: It has been reported that babies born to women who took medications of this kind during the last trimester of their pregnancy may experience adverse effects (such as breathing problems, seizures, trouble feeding, vomiting, low blood sugar, shaking, jitteriness, irritability, and constant crying). This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking paroxetine, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children and adolescents: The safety and effectiveness of paroxetine for those under 18 years of age have not been established. The use of this medication by children and adolescents younger than 18 may cause behavioural and emotional changes, such as suicidal thoughts and behaviour.
Seniors: Seniors may need lower doses of this medication, and they should be closely monitored by their doctor when taking paroxetine.
What other drugs could interact with this medication?
There may be an interaction between paroxetine and any of the following:
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If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
All material © 1996-2013 MediResource Inc. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition.
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