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Details for: NRA-PAROXETINE

Company: NORA PHARMA INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02479753NRA-PAROXETINEPAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE)10 MGTABLETORAL
02479761NRA-PAROXETINEPAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE)20 MGTABLETORAL
02479788NRA-PAROXETINEPAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE)30 MGTABLETORAL
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Summary Reports

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

NRA-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/orfear 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, physical assault,natural disaster such as an earthquake)
What it does

NRA-PAROXETINE belongs to the family of medicines called selective serotonin reuptake inhibitors. NRA-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 NRA-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 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 (10mg tablets only), FD&C Yellow No. 6 Sunset Yellow FCF Aluminum Lake (10mg tablets only), D&C Red No. 30 Helindon Pink Aluminum Lake(20mg tablets only), FD&C Blue No. 2-Indigo Carmine Aluminum Lake (30mg tablets only)

What dosage form it comes in

NRA-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.

NRA-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 NRA-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 NRA-Paroxetine on your own.

Taking NRA-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 NRA-PAROXETINE may affect your sperm. Fertility in some men may be reduced while taking NRA-PAROXETINE.

BEFORE you use NRA-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 tasksduring your 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

Effects on Pregnancy and Newborns:
As stated above, ask your doctor or pharmacist for advice before taking any medicine including NRA-PAROXETINE. If you are already taking/using NRA-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 NRA-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 NRA-PAROXETINE in later stages of pregnancy:
Possible complications at birth (from taking any newer antidepressant, including NRA-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 NRA-PAROXETINE:

The use of NRA-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.

Angle-closure Glaucoma:
NRA-PAROXETINE can cause an acute attack of glaucoma. Having your eyes examined before you take NRA-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 NRA-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, triptansused 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, suchas lithium
  • a combination of fosamprenavir and ritonavir, used totreat Human Immunodeficiency Virus (HIV) infection
  • procyclidine, which is used to treat Parkinson’s Diseaseor other movement disorders
  • metoprolol, which is used to treat high blood pressureand angina
  • certain medicines which may affect blood clotting andincrease bleeding, such as oral anti-coagulants (e.g.warfarin, dabigatran), acetylsalicylic acid (e.g. aspirin)and other non-steroidal anti-inflammatory drugs (e.g.ibuprofen)
  • certain medicines used to treat epilepsy
  • in general, drinking alcoholic beverages should be keptto a minimum or avoided completely while takingNRA-PAROXETINE
  • certain medicines used to treat cough, such asdextromethorphan
Proper use of this medication

Usual dose:

  • It is very important that you take NRA-PAROXETINEexactly as your doctor has instructed. Generally mostpeople take between 20 mg to 40 mg of NRA-PAROXETINE per day for depression, obsessive-compulsive disorder, panic disorder, social phobia(social anxiety disorder), generalized anxiety disorderand posttraumatic stress disorder; although your doctormay 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. Donot chew them
  • You should continue to take your medicine even if youdo not feel better, as it may take a number of weeks foryour medicine to work
  • Keep taking your tablets, as instructed, until the doctortells 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.

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Side effects and what to do about them

SIDE EFFECTS AND WHAT TO DO ABOUT THEM Like all medications, NRA-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 NRA-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 associatedwith decreases in sexual desire, performance andsatisfaction, treatment with this medication maylead 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).

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.

NRA-PAROXETINE may raise cholesterol levels in some patients.

Discontinuation Symptoms
Contact your doctor before stopping or reducing your dosage of NRA-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 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 NRA-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 NRA-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.

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
Symptom / effect Talk with your doctor or pharmacist right away Only if severe Talk with your doctor or pharmacist right away 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 [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 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 feelings or behaviour (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 NRA-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 dry place
  • Keep container tightly closed
  • If your doctor tells you to stop taking NRA-PAROXETINE please return any leftover medicineto your pharmacist.
Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

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

You may need to read this package insert again. Please do not throw it away until you have finished your medicine. This document plus the full product monograph, prepared for health professionals by:

Nora Pharma Inc.
205-2900 Boul Cote-Vertu
Saint-Laurent, Quebec, H4R 3E8
1-877-352-7314

Date of revision: 01 August, 2018

Date modified: