Details for: PRIVA-PAROXETINE
Company: PHARMAPAR INC
DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
---|---|---|---|---|---|
02444313 | PRIVA-PAROXETINE | PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) | 10 MG | TABLET | ORAL |
02444321 | PRIVA-PAROXETINE | PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) | 20 MG | TABLET | ORAL |
02444348 | PRIVA-PAROXETINE | PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) | 30 MG | TABLET | ORAL |
Summary Reports
Summary Safety Review - Antidepressants - Assessing the Potential Risk of Serious Eye Disorder (Angle-Closure Glaucoma)
Summary Safety Review - Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin-norepinephrine Reuptake Inhibitors (SNRIs) - Assessing the Potential Risk of Sexual Dysfunction despite Treatment Discontinuation
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
Priva-PAROXETINE has been prescribed to you by your doctor to relieve your symptoms of:
- depression (feeling sad, a change in appetite or weight,difficulty concentrating or sleeping, feeling tired,headaches, unexplained aches and pain)
- panic attacks
- social phobia (social anxiety disorder) - avoidanceand/or fear of social situations
- generalized anxiety or nervousness
- obsessive compulsive disorder (recurrent and intrusivethought, feeling, idea or sensation; recurrent pattern ofbehaviour, or unwanted thoughts or actions), or
- posttraumatic stress disorder (anxiety following atraumatic event, for example a car crash, physicalassault, natural disaster such as an earthquake)
What it does
Priva-PAROXETINE belongs to the family of medicines called selective serotonin reuptake inhibitors. Priva-PAROXETINE is thought to work by increasing the levels of a chemical in the brain called serotonin (5-hydroxytryptamine).
When it should not be used
Do not use Priva-PAROXETINE if you are:
- allergic to it or any of the components of itsformulation (see list of components at the end of thissection)
- currently taking or have recently taken monoamineoxidase (MAO) inhibitor antidepressants (e.g.phenelzine sulphate, moclobemide) or linezolid, aMAO inhibitor antibiotic
- currently taking or have recently taken thioridazine orpimozide
What the medicinal ingredient is
Paroxetine hydrochloride
What the non-medicinal ingredients are
Dibasic calcium phosphate dehydrate, hypromellose, sodium starch glycolate, magnesium stearate, opadry yellow, opadry pink and opadry blue. Hypromellose, titanium dioxide, macrogol/PEG 400, polysorbate 80, D&C yellow No. 10 aluminum lake (10 mg tablets only), FD&C yellow No. 6 sunset yellow FCF aluminum lake (10 mg tablets only), D&C red no. 30 helindon pink aluminum lake(20 mg tablets only), FD&C blue no. 2-indigo carmine aluminum lake (30 mg tablets only).
What dosage form it comes in
Priva-PAROXETINE is available as tablets containing 10 mg (yellow), 20 mg (pink), or 30 mg (blue) paroxetine (as paroxetine hydrochloride).
Warnings and precautions
During treatment with these types of medications it is important that you and your doctor have good ongoing communication about how you are feeling.
Priva-PAROXETINE is not for use in children under 18 years of age.
Changes in Feelings and Behaviour:
It is important that you have good communication with your doctor about how you feel. Discussing your feelings and treatment with a friend or relative who can tell you if they think you are getting worse is also useful.
Some patients may feel worse when first starting or changing the dose of drugs such as Priva-PAROXETINE. You may feel more anxious or may have thoughts of hurting yourself or others, especially if you have had thoughts of hurting yourself before. These changes in feelings can happen in patients treated with drugs like paroxetine for any condition, and at any age, although it may be more likely if you are aged 18 to 24 years old. If this happens, see your doctor immediately. Do not stop taking Priva-PAROXETINE on your own.
Taking Priva-PAROXETINE may increase your risk of breaking a bone if you are elderly or have osteoporosis or
have other major risk factors for breaking a bone. You should take extra care to avoid falls especially if you get dizzy or have low blood pressure.
Medicines like Priva-PAROXETINE may affect your sperm. Fertility in some men may be reduced while taking Priva-PAROXETINE.
BEFORE you use Priva-PAROXETINE tell your doctor or pharmacist:
- all your medical conditions, including a history ofseizures, liver or kidney disease, heart problems
- any medications (prescription or non prescription)which you are taking or have recently taken, especiallymonoamine oxidase inhibitor antidepressants (e.g.phenelzine sulphate, moclobemide) or any otherantidepressants, thioridazine, pimozide, drugs used toprevent fits (anticonvulsants), drugs for Parkinson’sdisease, or drugs containing tryptophan
- if you are taking tamoxifen (used to treat breast cancer)
- if you have ever had any allergic reaction tomedications, food, etc.
- any natural or herbal products you are taking (e.g. St.John’s Wort)
- if you are pregnant or thinking about becomingpregnant, or if you are breast feeding
- your habits of alcohol and /or street drug consumption
- if you drive a vehicle or perform hazardous tasks duringyour work
- if you had a recent bone fracture or were told you haveosteoporosis or risk factors for osteoporosis
- if you have a bleeding disorder or have been told thatyou have low platelets
- if you have glaucoma or increased pressure in your eyes
Effects on Pregnancy and Newborns:
As stated above, ask your doctor or pharmacist for advice before taking any medicine including Priva-PAROXETINE. If you are already taking/using Priva-PAROXETINE and have just found out that you are pregnant, you should talk to your doctor immediately. You should also talk to your doctor if you are planning to become pregnant.
Taking Priva-PAROXETINE in early stages of pregnancy:
Some studies have suggested an increased risk of birth defects particularly heart defects, in babies whose mothers received paroxetine hydrochloride in the first few months of pregnancy. These studies found that about 2 in 100 babies (2%) whose mothers received paroxetine in early pregnancy had a heart defect, compared with the normal rate of 1 in 100 babies (1%) seen in the general population. Also, in cases where paroxetine hydrochloride has been used, there have been reports of premature births although it is not known if these premature births are due to the use of paroxetine hydrochloride.
Taking Priva-PAROXETINE in later stages of pregnancy:
Possible complications at birth (from taking any newer antidepressant, including Priva-PAROXETINE):
Post-marketing reports indicate that some newborns whose mothers took an SSRI (selective serotonin reuptake inhibitor) or other newer antidepressant, during pregnancy have developed complications at birth requiring prolonged hospitalization, breathing support and tube feeding. Reported symptoms included feeding and/or breathing difficulties, seizures, tense or overly relaxed muscles, jitteriness and constant crying.
In most cases, the newer antidepressant was taken during the third trimester of pregnancy. These symptoms are consistent with either a direct adverse effect of the antidepressant on the baby, or possibly a discontinuation syndrome caused by sudden withdrawal from the drug. These symptoms normally resolve over time. However, if your baby experiences any of these symptoms, contact your doctor as soon as you can.
Persistent Pulmonary Hypertension (PPHN) and newer antidepressants, including Priva-PAROXETINE:
The use of Priva-PAROXETINE during pregnancy, particularly during late pregnancy, may increase the risk of a serious lung condition called persistent pulmonary hypertension of the newborn (PPHN) that causes breathing difficulties in newborns soon after birth. In the general population, PPHN is known to occur in about 1 or 2 per 1000 newborns but this may be increased 4 to 6 times in babies whose mothers used paroxetine hydrochloride during late pregnancy.
If you are pregnant and taking an SSRI, or other newer antidepressants, you should discuss the risks and benefits of the various treatment options with your doctor. It is very important that you do NOT stop taking these medications without first consulting your doctor. See SIDE EFFECTS AND WHAT TO DO ABOUT THEM section for more information.
Interactions with this medication
You should tell your doctor if you are taking or have recently taken any medications (prescription, non-prescription or natural/herbal), especially:
- other antidepressants, such as SSRIs and certaintricyclics
- other drugs that affect serotonin such as, lithium,linezolid, tramadol, tryptophan, St. John’s Wort,triptans used to treat migraines
- certain medicines used to treat pain, such as fentanyl(used in anaesthesia or to treat chronic pain),tramadol, tapentadol, meperidine, methadone,pentazocine
- tamoxifen, which is used to treat breast cancer orfertility problems
- certain medicines used to treat patients with irregularheart beats (arrhythmias)
- certain medicines used to treat schizophrenia
- certain medicines used to treat bipolar depression,such as lithium
- a combination of fosamprenavir and ritonavir, usedto treat Human Immunodeficiency Virus (HIV)infection
- procyclidine, which is used to treat Parkinson’sDisease or other movement disorders
- metoprolol, which is used to treat high bloodpressure and angina
- certain medicines which may affect blood clottingand increase bleeding, such as oral anti-coagulants(e.g. warfarin, dabigatran), acetylsalicylic acid (e.g.aspirin) and other non-steroidal anti-inflammatorydrugs (e.g. ibuprofen)
- certain medicines used to treat epilepsy
- in general, drinking alcoholic beverages should bekept to a minimum or avoided completely whiletaking Priva-PAROXETINE
- certain medicines used to treat cough, such asdextromethorphan
Proper use of this medication
Usual Dose
- It is very important that you take Priva-PAROXETINE exactly as your doctor hasinstructed. Generally most people take between 20mg to 40 mg of Priva-PAROXETINE per day fordepression, obsessive-compulsive disorder, panicdisorder, social phobia (social anxiety disorder),generalized anxiety disorder and posttraumaticstress disorder; although your doctor may start youat 10 mg per day for panic disorder
- Take your tablets in the morning, preferably withfood. You should swallow the tablets whole withwater. Do not chew them
- You should continue to take your medicine even ifyou do not feel better, as it may take a number ofweeks for your medicine to work
- Keep taking your tablets, as instructed, until thedoctor tells you to stop
- Talk to your doctor before you stop taking yourmedication on your own
Remember: This medicine has been prescribed only for you. Do not give it to anybody else, as they may experience undesirable effects, which may be serious.
Missed Dose
If you forget to take your tablet in the morning, take it as soon as you remember. Take your next dose at the normal time the next morning, then carry on as before. Do not try to make up for a missed dose by taking a double dose the next time.
Overdose
If you have taken a large number of tablets all at once, contact your doctor or the nearest hospital emergency department immediately, even though you may not feel sick. Show the doctor your pack of tablets.
Side effects and what to do about them
Like all medications, Priva-PAROXETINE can cause some side effects. You may not experience any of them. For most patients these side effects are likely to be minor and temporary. However, some may be serious. Some of these side effects may be dose related. Consult your doctor if you experience these or other side effects, as the dose may have to be adjusted.
If you experience an allergic reaction (including skin rash, hives, swelling, trouble breathing) or any severe or unusual side effects, stop taking the drug and contact your doctor immediately.
The most common side effects of Priva-PAROXETINE are:
- nausea/vomiting
- dry mouth
- drowsiness
- weakness
- dizziness
- sweating
- tremor
- nervousness
- sleep disturbances
- weight gain
- sexual problems
- Although psychiatric disorders are oftenassociated with decreases in sexual desire,performance and satisfaction, treatment with thismedication may lead to further decreases.
Other effects may include loss of appetite, constipation, diarrhea, abnormal dreams (including nightmares), headache and menstrual period disorders (including heavy periods, bleeding between periods and absence of periods).
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Paroxetine hydrochloride does not usually affect people’s normal activities. However, some people feel sleepy while taking it, in which case they should not drive or operate machinery.
Priva-PAROXETINE may raise cholesterol levels in some patients.
Discontinuation Symptoms
Contact your doctor before stopping or reducing your dosage of Priva-PAROXETINE. Symptoms such as dizziness, lightheadness, nausea, vomiting, agitation/restlessness, anxiety, sweating, headache, sleep disturbance, electric shock sensations, tinnitus (buzzing, hissing, whistling, ringing or other persistent noise in the ears) and other symptoms have been reported after stopping treatment, reducing the dosage of paroxetine hydrochloride, or when a dose is missed. These symptoms usually disappear without needing treatment. Tell your doctor immediately if you have these or any other symptoms. Your doctor may adjust the dosage of Priva-PAROXETINE to alleviate the symptoms. See WARNINGS AND PRECAUTIONS section for more information.
Effects on Newborns
Some newborns whose mothers took an SSRI (Selective Serotonin Reuptake Inhibitor) or other newer antidepressant, such as Priva-PAROXETINE, during pregnancy have shown such symptoms as breathing and feeding difficulties, jitteriness and constant crying. If your baby experiences any of these symptoms, contact your doctor as soon as you can. See WARNINGS AND PRECAUTIONS section for more information.
Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Seek immediate emergency medical assistance |
---|---|---|---|
Uncommon | |||
Hallucinations [strange visions or sounds] | ✔ | ||
Uncontrollable movements of the body or face | ✔ | ||
Inability to urinate or loss of control of the bladder (urinary incontinence) | ✔ | ||
Dilated pupils | ✔ | ||
Low blood pressure (may cause dizziness, lightheadedness or fainting when standing up from a sitting down or lying position) | ✔ | ||
Low Platelets [bruising or unusual bleeding from the skin or other areas] | ✔ | ||
Rare | |||
Severe allergic reactions [red and lumpy skin rash, hives, itching, swelling of the lips, face, tongue, throat, trouble breathing, wheezing, shortness of breath, skin rashes, collapse or loss of consciousness] | ✔ | ||
Allergic reactions (skin rash alone) | ✔ | ||
Low sodium level in blood [symptoms of tiredness, weakness, confusion combined with achy, stiff or uncoordinated muscles] | ✔ | ||
Akathisia [feelingnrestless and unable to sit or stand still] | ✔ | ||
Mania [overactive behaviour and thoughts] | ✔ | ||
Seizures [loss of consciousness with uncontrollable shaking (“fit”)] | ✔ | ||
Restless Legs Syndrome (irresistible urge to move the legs) | ✔ | ||
Glaucoma [increased pressure in the eyes, eye pain and blurred vision] | ✔ | ||
Abnormal secretion of breast milk in men and women | ✔ | ||
Increased sensitivity of the skin to sunlight | ✔ | ||
Swelling of hands, ankles or feet | ✔ | ||
Menstrual period disorders (including heavy periods, bleeding between periods and absence of periods). | ✔ | ||
Rare | |||
Serotonin syndrome and Neuroleptic Malignant Syndrome [a combination of most or all of the following: confusion, restlessness, sweating, shaking, shivering, high fever, hallucinations, sudden jerking of the muscles, muscle stiffness, feeling very agitated or irritable, fast heartbeat]. The severity can increase, leading to loss of consciousness. | ✔ | ||
Increased pressure in the eyes [symptoms of eye pain and blurred vision] | ✔ | ||
Gastrointestinal bleeding [vomiting blood or passing blood in stools] | ✔ | ||
Liver disorder [symptoms include nausea, vomiting, loss of appetite combined with itching, yellowing of the skin or eyes, dark urine. | ✔ | ||
A severe wide spread rash with blisters and peeling skin, often with sores or pain in the mouth or eyes. | ✔ | ||
Skin rash, which may blister, and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) called erythema multiforme | ✔ | ||
See warnings & precautions | |||
Changes in the feelings or behavior (anger, anxiety, suicidal or violent thoughts) | ✔ | ||
Thoughts of death or suicide | ✔ |
This is not a complete list of side effects. For any unexpected effects while taking Priva-PAROXETINE, contact your doctor or pharmacist.
How to store
- Keep all medicines out of sight and reach ofchildren
- Store at room temperature (15-30°C) in a dryplace
- Keep container tightly closed
- If your doctor tells you to stop taking Priva-PAROXETINE please return any leftovermedicine to your pharmacist.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full product monograph, prepared for health professionals can be found by contacting Pharmapar Inc.
This leaflet was prepared by:
Pharmapar Inc.
100-5950, Ch. de la Côte de Liesse
Mont-Royal, QC H4T 1E2
Phone# (514) 731-2003; Fax: (514) 731-2004
Date of preparation: August 18, 2015