What Pristiq is used for and how to use it
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Pristiq - Consumer Medicine Information

Manufacture: Pfizer Inc.
Country: Canada
Condition: Depression, Major Depressive Disorder
Class: Serotonin-norepinephrine reuptake inhibitors
Form: Tablets
Ingredients: desvenlafaxine succinate, film coating (which consists of polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxides, and sunset yellow aluminum lake), hypromellose, magnesium stearate, microcrystalline cellulose, talc

PRISTIQ Desvenlafaxine Extended-Release Tablets 50 and 100 mg desvenlafaxine, as desvenlafaxine succinate

About This Medication

What the Medication is Used For

PRISTIQ has been prescribed to you by your doctor to treat your depression. Treatment with these types of medications is most safe and effective when you and your doctor have good communication about how you are feeling.

What it Does

PRISTIQ belongs to a class of medicines called serotonin and norepinephrine reuptake inhibitors (SNRIs). It is thought to work by affecting two naturally occurring brain chemicals, serotonin and norepinephrine.

When it Should not be Used

Do not use PRISTIQ if you are:

  • allergic (hypersensitive) to desvenlafaxine, venlafaxine or any of the other ingredients in PRISTIQ.
  • taking or have taken, within the last 14 days, another medicine known as monoamine oxidase inhibitor (MAOI) including linezolid, an antibiotic, and methylene blue, a dye used in certain surgeries. Taking an MAOI together with many prescription medicines including PRISTIQ can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after you stop taking PRISTIQ before you take any MAOI. (See Other Medicines and Nutritional or Herbal Supplements.)
  • taking other drugs that contain venlafaxine or desvenlafaxine.
  • taking any prescription or non-prescription medicines, including nutritional or herbal supplements without checking with your doctor first (see Serotonin syndrome or NMS-like reactions).

What the Medicinal Ingredient Is

Desvenlafaxine Succinate.

What the Nonmedicinal Ingredients Are

The non-medicinal ingredients are:

film coating (which consists of polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxides, and sunset yellow aluminum lake), hypromellose, magnesium stearate, microcrystalline cellulose, and talc.

What Dosage Forms it Comes In

  • The 50 mg tablet is a light pink, square pyramid tablet debossed with “W” over “50” on the flat side (50 mg of desvenlafaxine as desvenlafaxine succinate).
  • The 100 mg tablet is a reddish-orange, square pyramid tablet debossed with “W” over “100” on the flat side (100 mg of desvenlafaxine as desvenlafaxine succinate).

PRISTIQ 50 mg, and 100 mg are available in:

  • HDPE Bottles of 14, 30 and 90 tablets.
  • Unit Dose Blisters of 7, 14§ and 28§ tablets

§ not commercially available in Canada

Warnings and Precautions

New or Worsened Emotional or Behavioural Problems

Particularly in the first few weeks or when doses are adjusted, a small number of patients taking drugs of this type may feel worse instead of better. They may experience new or worsened feelings of agitation, hostility, anxiety, impulsivity, or thoughts about suicide, self-harm or harm to others. Suicidal thoughts and actions can occur in any age group but may be more likely in patients 18 to 24 years old. Should this happen to you or those in your care, consult your doctor immediately. Close observation by a doctor is necessary in this situation. Do not discontinue your medication on your own.

You may be more likely to think like this if you have previously had thoughts about harming yourself.

You may find it helpful to tell a relative or close friend that you are depressed and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.

Taking PRISTIQ 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.

Other Medicines and Nutritional or Herbal Supplements

  • Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
  • Avoid taking PRISTIQ with other medicines containing venlafaxine or desvenlafaxine.
  • Your health professional will decide if you can take PRISTIQ with other medicines.

Other Medical Problems

Before you use PRISTIQ, tell your doctor or pharmacist if you:

  • are taking other medicines, herbal or nutritional supplements (see Other Medicines and Nutritional or Herbal Supplements and Serotonin syndrome).
  • have glaucoma or increased pressure in your eyes. have a history of high blood pressure.
  • have a history of heart problems.
  • have a narrowing or blockage of your gastrointestinal tract (your oesophagus, stomach, or small or large intestine).
  • have a history of fits (seizures).
  • have a history of low sodium levels in your blood.
  • have a bleeding disorder or have been told that you have low platelets.
  • had a recent bone fracture or were told you have osteoporosis or risk factors for osteoporosis.
  • have a history of high cholesterol.
  • have a history or family history of mania or bipolar disorder.
  • have kidney problems.
  • are pregnant or thinking about becoming pregnant, or if you are breast feeding.

If any of these conditions apply to you, please talk with your doctor before taking PRISTIQ.

PRISTIQ should not be used for children and adolescents under 18 years of age.

Interactions With This Medication

Do not use PRISTIQ if you are taking or have recently taken monoamine oxidase inhibitors.

Certain laboratory results may be affected by use of PRISTIQ, discuss with your doctor if you receive any unusual lab reports.

You should tell your doctor if you are taking or have recently taken any medications (prescription, nonprescription, or natural/herbal), especially:

  • Monoamine oxidase inhibitors (MAOI) including linezolid, an antibiotic, and methylene blue, a dye used in certain surgeries. Do not take PRISTIQ with an MAOI or within 14 days of stopping an MAOI. Taking an MAOI together with many prescription medicines, including PRISTIQ, can cause serious or even life-threatening side effects. Also, you need to wait at least 7 days after you stop taking PRISTIQ before you take an MAOI.
  • Certain medicines which may affect blood clotting and increase bleeding, such as oral anticoagulants (e.g. warfarin, dabigatran), acetylsalicyclic acid (e.g. Aspirin) and other non-steroidal anti-inflammatory drugs (e.g. ibuprofen).
  • Medicines containing venlafaxine or other medicines containing desvenlafaxine.
  • Serotonin syndrome or a neuroleptic malignant syndrome (NMS)-like reactions: Rare, but potentially life-threatening conditions called serotonin syndrome or NMS-like reactions can cause serious changes in how your brain, muscles and digestive system work and can happen when medicines like PRISTIQ are taken, particularly when taken with certain other medications such as:
    • medicines to treat migraine headaches known as triptans
    • medicines used to treat mood or thought disorders, including tricyclics, lithium, selective serotonin reuptake inhibitors (SSRIs); or serotonin norepinephrine reuptake inhibitors (SNRIs), or dopamine antagonists, including antipsychotics
    • sibutramine
    • certain medicines used to treat pain, such as fentanyl (used in anaesthesia or to treat chronic pain), tramadol, tapentadol, meperidine, methadone, pentazocine
    • certain medicines used to treat cough, such as dextromethorphan
    • St. John’s Wort
    • MAOIs (including linezolid, an antibiotic and methylene blue, a dye sometimes injected before surgery to guide the surgeon)
    • tryptophan supplements
  • medicines to treat migraine headaches known as triptans
  • medicines used to treat mood or thought disorders, including tricyclics, lithium, selective serotonin reuptake inhibitors (SSRIs); or serotonin norepinephrine reuptake inhibitors (SNRIs), or dopamine antagonists, including antipsychotics
  • sibutramine
  • certain medicines used to treat pain, such as fentanyl (used in anaesthesia or to treat chronic pain), tramadol, tapentadol, meperidine, methadone, pentazocine

Before you take PRISTIQ and any of these medicines together, talk to your healthcare professional about the possibility of serotonin syndrome NMS-like reactions.

Signs and symptoms of serotonin syndrome or NMS may include a combination of the following:

  • Agitation (excitability, restlessness), hallucinations, confusion, loss of coordination, muscle twitching or stiffness, fast heart beat, increased body temperature, fast changes in blood pressure, overactive reflexes, diarrhea, coma, nausea, vomiting.

Get medical care right away if you think serotonin syndrome is happening to you.

Central Nervous System drugs: caution is advised when PRISTIQ is taken in combination with other centrally acting drugs or substances, including alcohol and sedative drugs (benzodiazepines, opiates, antipsychotics, phenobarbital, sedative antihistamines). Inform your doctor if you are taking any of these drugs.

You should avoid alcohol while taking PRISTIQ.

Switching from other antidepressants

Side effects from discontinuing antidepressant medication have occurred when patients switched from other antidepressants, including venlafaxine, to PRISTIQ. Your doctor may gradually reduce the dose of your initial antidepressant medication to help to reduce these side effects.

Proper Use of This Medication

Always take PRISTIQ exactly as your health professional has told you. You should check with your health professional if you have any questions.

PRISTIQ is for oral use.

  • PRISTIQ should be taken at approximately the same time each day with or without food. Tablets must be swallowed whole with fluid and not divided, crushed, chewed, or dissolved as it is time released.
  • PRISTIQ is prepared as a matrix tablet that slowly releases the medicine inside your body. You may notice something in your stool that looks like a tablet, but it is an empty matrix. Seeing the empty matrix is not a cause for concern. There is no need to take an extra tablet. The active medication has already been absorbed by the time you see the matrix.

Do not stop taking PRISTIQ without talking to your doctor.

Usual Dose

The usual dose is 50 mg taken once daily. Your doctor may increase your dose if you need it.

Overdose

In case of an overdose, call your health professional and/or poison control centre or go to emergency at a hospital right away. Take your medicines with you to show the doctor.

Missed Dose

If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only a single dose as usual. Do not take a double dose to make up for a forgotten tablet.

What Should you Do Before Stopping PRISTIQ

Do not stop taking or change the dose of PRISTIQ without first discussing this with your health professional. Your health professional may want to slowly decrease your dose of PRISTIQ to help avoid side effects. Some patients, who suddenly stop taking PRISTIQ after more than 1 week of therapy, have felt dizzy, sick (nausea), had a headache or experienced irritability, insomnia, diarrhea, anxiety, abnormal dreams, fatigue, sweating. These symptoms are usually not serious and disappear within a few days, but if you have symptoms that are troublesome you should ask your doctor for advice.

Pregnancy and Breast-feeding

The safety of PRISTIQ during human pregnancy has not been established. Desvenlafaxine is excreted in human milk. Tell your doctor immediately if you become pregnant, or if you are trying to become pregnant or are breastfeeding. If you do become pregnant while taking this drug, do not stop taking it without consulting your doctor.

Postmarketing reports indicate that some newborns whose mothers took an SNRI (Serotonin Norepinephrine Reuptake Inhibitor), SSRI (Selective Serotonin Reuptake Inhibitor) or other newer antidepressants, during pregnancy have developed complications at birth requiring prolonged hospitalization, breathing support and tube feeding. Reported symptoms include: feeding and/or breathing difficulties, seizures, tense or overly relaxed muscles, jitteriness and constant crying. These symptoms are consistent with either a direct adverse effect of the medication 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.

Driving and Using Machines

Do not drive or operate any tools or machines until you know how PRISTIQ affects you. Do not drive or operate any tools or machines if PRISTIQ affects you in a way that prevents you from safely performing these operations.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Side Effects and What to Do About Them

Like all medications, PRISTIQ 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 can 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 need to be adjusted.

If you experience an allergic reaction (including red skin, hives, itching, swelling of the lips, face, tongue, throat, trouble breathing, wheezing, shortness of breath, skin rashes, blisters of the skin, sores or pain in the mouth or eyes) or any severe or unusual side effects, stop taking the drug and seek emergency medical attention immediately.

Frequency of Side Effects

Very Common (in More Than 1 in 10 Patients)

Nausea, Constipation, Dry mouth, Tiredness, Decreased appetite, Dizziness, Trouble sleeping, Sweating

Common (in More Than 1 in 100 Patients, but in Less Than 1 in 10 Patients)

Heart pounding, Heart racing, Ringing in the ears, Vertigo, Dilated pupils, Vision blurred, Vomiting, Diarrhoea, Weakness, Chills, Feeling Jittery, Irritability, Weight Decreased, Weight Increased, Blood Pressure Increased, Musculoskeletal Stiffness, Drowsiness, Shaking, Disturbance in Attention, Tingling sensations, Taste changes, Orgasm abnormal, No orgasms, Anxiety, Nervousness, Interest in sex decreased, Abnormal dreams, Urinary hesitation, Ejaculation delayed (in men), Erectile dysfunction (in men), Yawning, Rash, Hot flush.

Uncommon (in More Than 1 in 1000 Patients, but in Less Than 1 in 100 Patients)

Drug withdrawal syndrome, Hypersensitivity, Blood cholesterol increased, Blood prolactin increased, Blood triglyceride increased, Liver function tests abnormal, Fainting, Depersonalization, Nose bleeds, Drop in blood pressure when standing, Coldness in hands and feet, Loss of hair.

Rare (in More Than 1 in 10,000 Patients, but in Less Than 1 in 1000 Patients)

Seizures, Protein in the urine, Movement Disorders, Sodium levels decreased, Swelling beneath the skin (e.g. throat, face, hands).

Other Side effect Information

These are not all the possible side effects of PRISTIQ. Call your health professional right away if the side effects become serious, if you notice any side effects not listed in this leaflet, or if there is any other side effect that concerns you.

Discontinuation Symptoms

Contact your doctor before stopping or reducing your dosage of PRISTIQ. Symptoms such as dizziness, nausea, headache, irritability, trouble sleeping, diarrhoea, anxiety, abnormal dreams, tiredness, and sweating have been reported after stopping treatment with PRISTIQ. These symptoms usually disappear without needing treatment. Tell your doctor immediately if you have any of these or other symptoms. Your doctor may adjust the dosage of PRISTIQ to alleviate the symptoms.

Serious Side Effects, how Often They Happen and What to Do About Them

Symptom / effectTalk with your
doctor or
pharmacist
right away
Stop taking
drug and
seek
immediate
medical
help
Only
if
severe
In all
cases
CommonHigh Blood
Pressure on 3
occasions
CommonIncreased Blood
Pressure
CommonIncreased
Cholesterol
UncommonAllergic reactions:
red skin, hives,
itching, swelling of
the lips, face,
tongue, throat,
trouble breathing,
wheezing, shortness
of breath, skin
rashes, blisters of
the skin, sores or
pain in the mouth or
eyes
UnknownLow Platelets:
Bruising or unusual
bleeding from the
skin or other areas
RareMania /
Hypomania:
elevated or irritable
mood, decreased
need for sleep,
racing thoughts
RareSeizures: loss of
consciousness with
uncontrollable
shaking; “fit”
RareSevere Increased
Blood Pressure:
headache, stronger
and possibly faster
heart beat, chest
pain, dizziness,
excessive tiredness,
and blurred vision
RareUncontrollable
movements of the
body or face
RareGlaucoma:
increased pressure
in the eyes, eye
pain, and blurred
vision
See
Warnings
and
Precautions
Low sodium level
in blood: tiredness,
weakness, confusion
combined with
achy, stiff or
uncoordinated
muscles
See
Warnings
and
Precautions
New or worsened
emotional or
behavioural
problems
See
Warnings
and
Precautions
Serotonin
Syndrome: a
combination of most
or all of the
following:
confusion,
restlessness,
sweating, shaking,
shivering, high
fever, sudden
jerking of the
muscles,
hallucinations, fast
heartbeat

This is not a complete list of side effects. For any unexpected effects while taking PRISTIQ, contact your doctor or pharmacist.

How to Store It

Keep out of the reach and sight of children.

Store at 15 ° to 30 °.

Do not use PRISTIQ after the expiration date (EXP), which is stated on the package. The expiration date refers to the last day of that month.

Medicines should not be disposed of in wastewater or in household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Reporting Suspected 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 3 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, Ontario
      K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect 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 at: www.pfizer.ca or can be obtained by contacting the sponsor, Pfizer Canada Inc., at: 1-800-463-6001 (Medical Information)