Details for: PAROXETINE
Company: PRO DOC LIMITEE
DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
---|---|---|---|---|---|
02248913 | PAROXETINE-10 | PAROXETINE (PAROXETINE HYDROCHLORIDE) | 10 MG | TABLET | ORAL |
02248914 | PAROXETINE-20 | PAROXETINE (PAROXETINE HYDROCHLORIDE) | 20 MG | TABLET | ORAL |
02248915 | PAROXETINE-30 | PAROXETINE (PAROXETINE HYDROCHLORIDE) | 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
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) - avoidance and/or fear of social situations
- generalized anxiety or nervousness
- obsessive compulsive disorder (recurrent and intrusive thought, feeling, idea or sensation; recurrent pattern of behaviour, or unwanted thoughts or actions), or
- posttraumatic stress disorder (anxiety following a traumatic event, for example a car crash, physical assault, natural disaster such as an earthquake)
What it does
PAROXETINE belongs to the family of medicines called selective serotonin reuptake inhibitors. 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 PAROXETINE if you are:
- allergic to it or any of the components of its formulation (see list of components at the end of this section).
- currently taking or have recently taken monoamine oxidase (MAO) inhibitor antidepressants (e.g. phenelzine sulphate, moclobemide) or linezolid, a MAO inhibitor antibiotic.
- currently taking or have recently taken thioridazine or pimozide.
What the medicinal ingredient is
What the non-medicinal ingredients are
Non-medicinal ingredients include anydrous lactose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol, sodium starch glycolate, titanium dioxide, and the following colouring agents all extended on an aluminum substrate: D&C yellow #10 and FD&C yellow #6 (10 mg tablets only), D&C red #30 (20 mg tablets only), and FD&C blue #2 (30 mg tablets only).
What dosage form it comes in
PAROXETINE is available as tablets containing 10 mg (yellow), 20 mg (pink) and a 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.
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 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 PAROXETINE on
your own.
Taking medicines like PAROXETINE may increase
your risk of experiencing sexual problems, which may continue after PAROXETINE has been
discontinued, including for months or years
afterwards in some cases. Tell your doctor if you
experience symptoms such as a decrease in sexual
desire, performance or satisfaction.
Taking 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 PAROXETINE may affect your sperm.
Fertility in some men may be reduced while taking
PAROXETINE.
BEFORE you use PAROXETINE tell your doctor or pharmacist:
- all your medical conditions, including a history of seizures, liver or kidney disease, heart problems
- any medications (prescription or non prescription) which you are taking or have recently taken, especially monoamine oxidase inhibitor antidepressants (e.g. phenelzine sulphate, moclobemide) or any other antidepressants, thioridazine, pimozide, drugs used to prevent fits (anticonvulsants), drugs for Parkinson’s disease, or drugs containing tryptophan
- if you are taking tamoxifen (used to treat breast cancer)
- if you have ever had any allergic reaction to medications, food, etc.
- any natural or herbal products you are taking (e.g. St. John’s Wort)
- if you are pregnant or thinking about becoming pregnant, or if you are breast feeding
- your habits of alcohol and /or street drug consumption
- if you drive a vehicle or perform hazardous tasks during your work
- if you had a recent bone fracture or were told you have osteoporosis or risk factors for osteoporosis
- If you have a bleeding disorder or have been told that you have low platelets
- If you are allergic to a particular yellow dye known as FD&C Yellow No. 6 alumnium lake
Effects on Pregnancy and Newborns
As stated above, ask your doctor or pharmacist for advice before taking any medicine including PAROXETINE. If you are already taking/using 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 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 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 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.
Taking PAROXETINE in later stages of pregnancy
Possible complications at birth (from taking any
newer antidepressant, including PAROXETINE):
Post-marketing reports indicate that some newborns
whose mothers took an SSRI (selective serotonin
reuptake inhibitor) or other newer anti-depressant,
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 anti-depressant 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 PAROXETINE:
The use of 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 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.
Angle-closure Glaucoma:
PAROXETINE can cause an acute attack of
glaucoma. Having your eyes examined before you
take PAROXETINE could help identify if you are at
risk of having angle-closure glaucoma. Seek
immediate medical attention if you experience:
- eye pain
- changes in vision
- swelling or redness in or around the eye
Interactions with this medication
Do not use PAROXETINE if you are taking or
have recently taken (within the last 2 weeks)
monoamine oxidase inhibitors, methylthioninium
chloride (methylene blue), thioridazine, or
pimozide.
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 certain tricyclics
- 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 or fertility problems
- certain medicines used to treat patients with irregular heart beats (arrhythmias)
- certain medicines used to treat schizophrenia
- certain medicines used to treat bipolar depression, such as lithium
- a combination of fosamprenavir and ritonavir, used to treat Human Immunodeficiency Virus (HIV) infection
- procyclidine, which is used to treat Parkinson’s Disease or other movement disorders
- metoprolol, which is used to treat high blood pressure and angina
- certain medicines which may affect blood clotting and increase bleeding, such as oral anticoagulants (e.g. warfarin, dabigatran), acetylsalicylic acid (e.g. aspirin) and other nonsteroidal anti-inflammatory drugs (e.g. ibuprofen)
- certain medicines used to treat epilepsy
- in general, drinking alcoholic beverages should be kept to a minimum or avoided completely while taking PAROXETINE.
- certain medicines used to treat cough, such as dextromethorphan
Proper use of this medication
Usual Dose
- It is very important that you take PAROXETINE exactly as your doctor has instructed. Generally most people take between 20 mg to 40 mg of PAROXETINE per day for depression, obsessive-compulsive disorder, panic disorder, social phobia (social anxiety disorder), generalized anxiety disorder and posttraumatic stress disorder; although your doctor may start you at 10 mg per day for panic disorder.
- Take your tablets in the morning, preferably with food. You should swallow the tablets whole with water. Do not chew them.
- You should continue to take your medicine even if you do not feel better, as it may take a number of weeks for your medicine to work.
- Keep taking your tablets, as instructed, until the doctor tells you to stop.
- Talk to your doctor before you stop taking your medication 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.
If you think you have taken too much PAROXETINE, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Side effects and what to do about them
Like all medications, 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 PAROXETINE are:
- nausea/vomiting
- dry mouth
- drowsiness
- weakness
- dizziness
- sweating
- tremor
- nervousness
- feeling agitated
- blurred vision
- sleep disturbances
- weight gain
- sexual problems. Although psychiatric disorders are often associated with decreases in sexual desire, performance and satisfaction, treatment with this class of medication may lead to further decreases, which may continue after the drug is stopped.
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).
PAROXETINE 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.
PAROXETINE may raise cholesterol levels in some
patients.
Discontinuation Symptoms
Contact your doctor before stopping or reducing your dosage of PAROXETINE. Symptoms such as dizziness, lightheadedness, 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, 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 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 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 to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
---|---|---|---|
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 [feeling restless 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) | ✔ | ||
Angle-closure Glaucoma [eye pain changes in vision and swelling or redness in or around the eye] | ✔ | ||
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). | ✔ | ||
Very 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. | ✔ | ||
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 widespread 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 | |||
|
✔ | ||
|
✔ |
This is not a complete list of side effects. For any unexpected effects while taking PAROXETINE, contact your doctor or pharmacist.
How to store
- Keep all medicines out of sight and reach of children
- Store at room temperature 15°-30ºC (59°-86ºF). Protect from moisture
- Keep container tightly closed.
- If your doctor tells you to stop taking PAROXETINE please return any leftover medicine to your pharmacist.
Reporting side effects
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
If you want more information about PAROXETINE:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Consumer information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp).
This leaflet plus the full product monograph, prepared for health professionals, can be obtained by contacting Pro Doc Ltée at 1-800-361-8559, www.prodoc.qc.ca or info@prodoc.qc.ca.
This leaflet was prepared by
Pro Doc Ltée Laval, Québec H7L 3W9
Date of revision: February 10, 2021