Riva-Paroxetine: Uses, Side Effects and Dosage

Serious Warnings and Precautions

New and worsened emotional or behaviour problems:

• When you first start taking RIVA-PAROXETINE or when your dose is adjusted, you may feel worse instead of better. You may feel new or worsened feelings of agitation, hostility, anxiety or impulsivity.
• During your treatment with RIVA-PAROXETINE, it is important that you and your healthcare professional talk regularly about how you are feeling. They will closely monitor you for signs of new or worsened emotions or behaviours while you are taking RIVA-PAROXETINE.

• You may find it helpful to tell a relative or close friend that you are depressed. Ask them to read this leaflet. You might ask them to tell you if they:

  • think your depression is getting worse, or
  • are worried about changes in your behaviour.
• If your depression worsens or you experience changes in your behaviour, tell your healthcare professional right away. Do not stop taking your medicine as it takes time for RIVA-PAROXETINE to work.

Self-harm or suicide:

• Antidepressants, such as RIVA-PAROXETINE, may increase the risk of suicidal thoughts and actions.
• If you have thoughts of harming or killing yourself at any time, tell your healthcare professional or go to a hospital right away. Close observation by a healthcare professional is necessary in this situation.

What is RIVA-PAROXETINE used for?

RIVA-PAROXETINE is used in adults (18 years of age and older) to relieve symptoms of:

• Major Depressive Disorder (feeling sad, a change in appetite or weight, difficulty concentrating or sleeping, feeling tired, headaches, unexplained aches and pain).

• Obsessive Compulsive Disorder (recurrent and intrusive thoughts, feelings, ideas or sensations;

  recurrent pattern of behaviour, or unwanted thoughts or actions).

• Panic Disorder (with or without agoraphobia) (panic attacks).
• Social Phobia (social anxiety disorder) (avoidance and/or fear of social situations).
• Generalized Anxiety Disorder (anxiety or nervousness).
• Post-Traumatic Stress Disorder (anxiety following a traumatic event, for example a car crash, physical assault, natural disaster such as an earthquake).

RIVA-PAROXETINE is not for use in children under 18 years of age.

How does RIVA-PAROXETINE work?

RIVA-PAROXETINE belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). RIVA-PAROXETINE is thought to work by increasing the levels of a chemical in the brain called serotonin (5- hydroxytryptamine). This helps to relieve your symptoms of depression, obsessive compulsive disorder, panic disorder, social phobia, generalized anxiety disorder or post-traumatic stress disorder. RIVA-PAROXETINE may take a number of weeks to work.

What are the ingredients in RIVA-PAROXETINE?

Medicinal ingredient: Paroxetine hydrochloride.

Non-medicinal ingredients: Dibasic calcium phosphate dehydrate USP, Hypromellose, Sodium Starch Glycolate, Magnesium Stearate, Titanium Dioxide, Macrogol/PEG 400, Polysorbate 80.

RIVA-PAROXETINE 10 mg tablets also contain D&C Yellow No. 10 aluminum lake and FD&C yellow No. 6/Sunset yellow FCF aluminum lake.

RIVA-PAROXETINE 20 mg tablets also contain D&C Red No. 30 Helindon Pink aluminum lake.

RIVA-PAROXETINE 30 mg tablets also contain FD&C Blue No. 2-Indigo carmine aluminum lake.

RIVA-PAROXETINE comes in the following dosage forms:

Tablets: 10 mg, 20 mg, and 30 mg of paroxetine (as paroxetine hydrochloride).

Do not use RIVA-PAROXETINE if:

• you are allergic to paroxetine hydrochloride or to any of the non-medicinal ingredients in RIVA-

  PAROXETINE (see “What are the ingredients in RIVA-PAROXETINE”).

• you are taking or have recently taken in the last 14 days medicines called monoamine oxidase inhibitors (MAOI) including linezolid (an antibiotic) or methylene blue (a dye injected into a vein during surgery, x-rays or other imaging procedures).
• you are taking or have recently taken thioridazine or pimozide. These medicines are used to treat mental health problems.

Ask your healthcare provider or pharmacist if you are not sure if you take a MAOI or one of these medicines, including the antibiotic linezolid or intravenous methylene blue. Do not start taking a MAOI or thioridazine or pimozide for at least 14 days after you stop treatment with RIVA-PAROXETINE.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take RIVA-PAROXETINE. Talk about any health conditions or problems you may have, including if you:

• have epilepsy or a history of seizures.
• have a history of liver or kidney problems.
• have heart problems.
• have a history or family history of mania/hypomania or bipolar disorder.
• have depression or other mental health disorders.
• have high cholesterol.
• have low levels of sodium in your blood.
• have had a recent bone fracture or were told you have osteoporosis or risk factors for osteoporosis.
• have a bleeding disorder or have been told that you have low platelets.
• are pregnant or thinking about becoming pregnant, or are breast feeding.
• have a history of alcohol or drug abuse.
• have ever had any allergic reaction to medications, food, etc.
• are allergic to azo dye (FD&C Yellow No. 6 aluminium lake). The 10 mg tablet contains an azo dye component.
• have an eye condition known as narrow angles (the iris and cornea of the eye are closer than normal).

Other warnings you should know about:

Pregnancy: Only take RIVA-PAROXETINE during pregnancy if you and your healthcare professional have discussed the risks and have decided that you should. If you take RIVA-PAROXETINE near the end of your pregnancy, you are at a higher risk of heavy vaginal bleeding shortly after birth. If you become pregnant while taking RIVA-PAROXETINE, tell your healthcare professional right away.

Effects on newborns: In some cases, babies born to a mother taking RIVA-PAROXETINE during pregnancy may require hospitalization, breathing support and tube feeding. Be ready to seek medical help for your newborn if they:

• Have trouble breathing or feeding,
• Have muscle stiffness, or floppy muscles (like a rag doll),
• Have seizures (fits),
• Are shaking (jitteriness),
• Are constantly crying.

If you take RIVA-PAROXETINE:

• During early pregnancy, there is a possible slight increased risk that your newborn may have birth defects, particularly a heart defect.

• During late pregnancy, your newborn may be at risk of having a serious lung condition called

  Persistent Pulmonary Hypertension of the Newborn (PPHN), which causes breathing problems.

Fertility and sexual function: Taking medicines like RIVA-PAROXETINE may increase your risk of having sexual problems. This may continue after RIVA-PAROXETINE has been discontinued, including for months or years afterwards in some cases. Tell your healthcare professional if you experience symptoms such as a decrease in sexual desire, performance or satisfaction. Medicines like RIVA-PAROXETINE may affect sperm quality. Fertility in some men may be reduced while taking RIVA-PAROXETINE.

Falls and fractures:

RIVA-PAROXETINE can cause you to feel dizzy or lightheaded and can affect your balance. This increases your risk of falling. In addition RIVA-PAROXETINE may increase your risk of breaking a bone if you are:

• elderly,
• 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.

Driving and using machines:

RIVA-PAROXETINE may make you feel sleepy. Avoid driving a vehicle or using machinery until you know how it affects you.

Angle-closure glaucoma:

RIVA-PAROXETINE can cause an acute attack of glaucoma. Having your eyes examined before you take RIVA-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.

Cholesterol and blood tests: RIVA-PAROXETINE can cause abnormal blood test results, including elevated levels of cholesterol. Your healthcare professional will decide when to perform blood tests and will interpret the results.

Do NOT stop taking RIVA-PAROXETINE without talking to your healthcare professional first. If stopped abruptly, RIVA-PAROXETINE may cause unwanted side effects such as:

• light-headedness,
• nausea and vomiting,
• agitation/restlessness,
• anxiety,
• sweating,
• headache,
• sleep disturbance,
• electric shock sensations,
• tinnitus (buzzing, hissing, whistling, ringing or other persistent noise in the ears).

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Serious Drug Interactions

Do not take RIVA-PAROXETINE if you are taking or have recently taken any of the following drugs as you may have serious side effects:

• monoamine oxidase inhibitors (MAOIs) such as the antibiotic linezolid and the intravenous dye methylene blue.
• thioridazine (typically used to treat schizophrenia and psychosis).
• pimozide (typically used to manage Tourette’s syndrome).

Wait 14 days after you stop taking a MAOI, or thioridazine, or pimozide before starting RIVA-PAROXETINE. If you are unsure, ask your healthcare professional.

The following may also interact with RIVA-PAROXETINE:

• other antidepressants, such as SSRIs, SNRIs, and certain tricyclics.

• other drugs that affect serotonin such as, lithium (used to treat bipolar depression), linezolid

  (antibiotic), tramadol (used to treat pain), tryptophan (used to treat anxiety or used as a sleep aid), and triptans (used to treat migraines).

• drugs used to prevent fits or treat epilepsy (anticonvulsants), such as carbamazepine, phenytoin, sodium valproate.
• drugs used to treat pain, such as fentanyl (used in anaesthesia or to treat chronic pain), tramadol, tapentadol, meperidine, methadone, and pentazocine.
• drugs used to treat breast cancer or fertility problems, such as tamoxifen.
• drugs used to treat patients with irregular heart-beats (arrhythmias).
• drugs used to treat schizophrenia.
• drugs used to treat Human Immunodeficiency Virus (HIV) infection, such as a combination of fosamprenavir and ritonavir.
• drugs used to treat Parkinson’s Disease or other movement disorders, such as procyclidine.
• drugs used to treat high blood pressure and angina, such as metoprolol.

• drugs which may affect blood clotting and increase 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).

• drugs that affect the central nervous system, such as haloperidol, amylbarbitone, and oxazepam.
• drugs used to treat cough, such as dextromethorphan.
• drug to treat heartburn, such as cimetidine.
• drugs to treat respiratory diseases (chronic obstructive pulmonary disease (COPD) and asthma), such as theophylline.
• any natural or herbal products (e.g. St. John’s Wort).
• alcohol.

How to take RIVA-PAROXETINE:

• It is very important that you take RIVA-PAROXETINE exactly as your healthcare professional has instructed.

• Take your tablets in the morning, with or without food.

• Swallow the tablet(s) whole with water. Do not chew tablet(s).
• 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 healthcare professional tells you to stop.
• Talk to your healthcare professional 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.

Usual dose:

The starting dose of RIVA-PAROXETINE depends on your illness and current health. It is usually 10 mg or 20 mg once a day in the morning. Your healthcare professional may gradually increase your dose to help control your symptoms, up to a maximum of 50 mg to 60 mg once a day.

Overdose:

If you think you, or a person you are caring for, have taken too much RIVA-PAROXETINE, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

Missed Dose:

If you forget to take your tablet in the morning, take it as soon as possible, unless it is too close to the time of the next dose. 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.

What are possible side effects from using RIVA-PAROXETINE?

These are not all the possible side effects you may have when taking RIVA-PAROXETINE. If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

• blurred vision
• constipation
• diarrhea
• dizziness
• drowsiness
• dry mouth
• feeling agitated
• headache
• loss of appetite
• nausea/vomiting
• nervousness
• sexual problems (decreases in sexual desire, performance and satisfaction, and may also lead to further decreases, which may continue after the drug is stopped)
• skin rash or hives alone
• sleep disturbances (abnormal dreams including nightmares)
• sweating
• tremor (shaking)
• weakness
• weight gain.

Serious side effects and what to do about them

Serious side effects and what to do about them

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

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 healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

• Store at room temperature (15°Cto 30°C).
• Keep container tightly closed.
• If your healthcare professional tells you to stop taking RIVA-PAROXETINE, please return any leftover medicine to your pharmacist.
• You may need to read this package insert again. Please do not throw it away until you have finished your medicine.

• Keep out of reach and sight of children.

  Page 56 of 56 RIVA-PAROXETINE – Product Monograph

If you want more information about RIVA-PAROXETINE:

• Talk to your healthcare professional
• Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug- products/drug-product-database.html); the manufacturer’s website www.labriva.com, or by calling 1-800-363-7988.

Laboratoire Riva Inc.

660 Boul. Industriel

Blainville, Quebec

J7C 3V4

www.labriva.com

Last Revised: JUL 10, 2022