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

Manufacture: Pfizer Inc.
Country: Canada
Condition: Anxiety, Autism, Depression, Generalized Anxiety Disorder, Major Depressive Disorder, Panic Disorder, Postpartum Depression, Social Anxiety Disorder, Vulvodynia
Class: Serotonin-norepinephrine reuptake inhibitors
Form: Capsules
Ingredients: venlafaxine hydrochloride, black iron oxide nf, ethylcellulose nf, gelatin nf, hydroxypropyl-methylcellulose usp, microcrystalline cellulose nf, opacode red print s-15094/95, red iron oxide, talc, titanium dioxide, white ink tekprint sb-0007p, yellow iron oxide

(Venlafaxine Hydrochloride)

Extended Release Capsules

About This Medication

What the Medication is Used For

EFFEXOR XR has been prescribed to you by your doctor to relieve your symptoms of the following conditions:

  • Depression (feeling sad, a change in appetite or weight, difficulty concentrating or sleeping, feeling tired, headaches, unexplained aches and pain)
  • Generalized anxiety or nervousness
  • Social phobia (social anxiety disorder) – avoidance and/or fear of social situations
  • Panic disorder (repeated, unexpected panic attacks)

What It Does

EFFEXOR XR belongs to a group of medicines called anti-depressants. EFFEXOR XR is thought to work by affecting two naturally occurring brain chemicals, serotonin and norepinephrine.

When It Should not be Used

  • Do not use EFFEXOR XR if you are allergic to it or to any of the components of its formulation (see list of components at the end of this section). Stop taking the drug and contact your doctor immediately if you experience an allergic reaction or any severe or unusual side effects.
  • Do not use EFFEXOR XR if you are currently taking or have recently taken monoamine oxidase inhibitor antidepressants (e.g. phenelzine sulphate, moclobemide).

What the Medicinal Ingredient Is

Venlafaxine Hydrochloride

What the Nonmedicinal Ingredients Are

Black Iron Oxide NF**, Ethylcellulose NF, Gelatin NF, Hydroxypropyl-methylcellulose USP, Microcrystalline cellulose NF, Opacode Red Print S-15094/95****, Red Iron Oxide*, Talc, Titanium Dioxide*, White Ink TekPrint SB-0007P***, Yellow Iron Oxide*.

* Present (in capsule) in all strengths
** Present (in capsule) in 37.5 mg strength only
*** 150 mg strength
**** 37.5 and 75 mg strengths

 

What Dosage Forms It Comes In

EFFEXOR XR is available in extended release capsules containing 37.5 mg (grey and peach), 75 mg (peach) and 150 mg (dark orange) venlafaxine.

Warnings and Precautions

During treatment with these types of medication it is important that you and your doctor have good ongoing communication about how you are feeling.

EFFEXOR XR is not for use in children under 18 years of age.

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 to 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 or have an anxiety disorder, 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 EFFEXOR XR 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.

Before taking EFFEXOR XR tell your doctor or pharmacist:

  • if you have ever had any allergic reaction to medications, food, etc;
  • all your medical conditions, including a history of seizures, liver disease, kidney disease, heart problems or high cholesterol
  • if you have a bleeding disorder or have been told that you have low platelets.
  • if you have blood pressure problems;
  • any medications (prescription or non-prescription) which you are taking, especially monoamine oxidase (MAO) inhibitors (e.g. phenelzine sulfate, tranylcypromine sulfate, moclobemide or selegeline) or any other antidepressants, weight-loss medication, sleeping pills, antianxiety drugs, or medication to control blood pressure;
  • if you are pregnant or thinking about becoming pregnant, or if you are breast feeding;
  • your habits of alcohol and/or street drug consumption;
  • any natural or herbal products you are taking (e.g., St. John’s Wort).
  • if you had a recent bone fracture or were told you have osteoporosis or risk factors for osteoporosis.
  • if you drive a vehicle or perform hazardous tasks during your work.
  • if you have glaucoma or increased pressure in your eyes.

Discontinuing EFFEXOR XR

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.

Effects on Pregnancy and Newborns

Post-marketing reports indicate that some newborns whose mothers took an SSRI (selective serotonin reuptake inhibitor) or other newer anti -depressants, such as EFFEXOR XR, 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 SSRI or other newer anti-depressant 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.

If you are pregnant and taking an SSRI, or other newer anti - depressant, 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

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

You should avoid taking St. John’s Wort if you are taking EFFEXOR XR.

Certain laboratory results may be affected by use of EFFEXOR XR, 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, non-prescription or natural/herbal), especially:

  • other antidepressants, such as SSRIs and certain tricyclics
  • other drugs that affect serotonin such as, lithium, linezolid, sibutramine, tryptophan, triptans used to treat migraines
  • certain medicines used to treat pain, such as fentanyl (used in anaesthesia or to treat chronic paint), tramadol, tapentadol, meperidine, methadone, pentazocine
  • certain medicines used to treat cough, such as dextromethorphan
  • certain medicines used to treat schizophrenia
  • certain medicines used to treat bipolar depression, such as lithium
  • metoprolol or other medications used to treat high blood pressure and angina
  • certain medicines 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)
  • certain medicines used to treat epilepsy
  • cimetidine
  • In general, drinking alcoholic beverages should be kept to a minimum or avoided completely while taking EFFEXOR XR.
  • Ketoconazole.

Proper Use of This Medication

Usual Dose

  • It is very important that you take EFFEXOR XR exactly as your doctor has instructed.
  • Never increase or decrease the amount of EFFEXOR XR you, or those in your care if you are a caregiver or guardian, are taking unless your doctor tells you to and do not stop taking this medication without consulting your doctor.
  • As with all antidepressants improvement with EFFEXOR XR is gradual. You may not have noticeable effect in the first few days of treatment. Some symptoms may begin to improve within about 2 weeks but significant improvement can take several weeks.
  • EFFEXOR XR should be taken once a day with food, as prescribed; do not divide, crush or chew the capsules.

REMEMBER: This medicine has been prescribed only for you. Do not give it to anybody else. If you have any further questions, please ask your doctor or pharmacist.

Overdose

In case of overdose, contact your doctor or the nearest hospital emergency department, even though you may not feel sick.

Missed Dose

If you happen to miss a dose, do not try to make up for it by doubling up on the dose next time. Just take your next regularly scheduled dose and try not to miss any more.

Side Effects and What to Do About Them

Like all medications, EFFEXOR XR 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 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 contact your doctor immediately.

Some side effects of EFFEXOR XR are:

  • headache
  • nausea
  • dry mouth
  • constipation
  • loss of appetite
  • vomiting
  • sleepiness
  • dizziness
  • insomnia
  • sexual problems
  • weakness
  • sweating
  • nervousness
  • abnormal vision
  • abnormal dreams

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; for example, they may experience unusual feelings of agitation, hostility or anxiety, or have impulsive or disturbing thoughts such as thoughts of self -harm or harm to others. Should this happen to you, or to those in your care if you are a caregiver or guardian, consult your doctor immediately; do not discontinue your medication on your own.

EFFEXOR XR 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.

Although psychiatric disorders may be associated with decreases in sexual desire, performance and satisfaction, treatment with this medication may also affect sexual functioning.

EFFEXOR XR may increase blood pressure in some people. You should have your blood pressure measured prior to starting EFFEXOR XR and during treatment. High blood pressure should be controlled before starting EFFEXOR XR. Blood pressure changes may sometimes be sudden and without warning. Consult your doctor if you have symptoms that may indicate a sudden rise in your blood pressure, such as headache (particularly in the back of head/neck when waking up); stronger, possibly more rapid, or irregular heart beat; chest pain; dizziness; excessive tiredness; or blurred vision.

EFFEXOR may raise cholesterol levels in some patients. Blood cholesterol tests may be required by your doctor during treatment with EFFEXOR XR.

Discontinuation Symptoms

Contact your doctor before stopping or reducing your dosage of EFFEXOR XR. Symptoms such as anorexia (loss of appetite, loss of weight), anxiety, agitation (restlessness), aggression, confusion, convulsions, coordination problems, diarrhea, dizziness, dry mouth, fatigue, headache, hypomania (rapid mood swings), insomnia, nausea, nervousness, nightmares, paresthesia (sensation of tingling, burning or crawling of the skin), electric 

shock sensations, sleep disturbances, somnolence (drowsiness), sweating, tinnitus (ringing in the ears), vertigo (sensation that the world is spinning), vomiting and other symptoms have been reported after stopping treatment, reducing the dosage of EFFEXOR XR, 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 EFFEXOR XR to alleviate the symptoms.

Effects on Newborns

Some newborns whose mothers took an SSRI (Selective Serotonin Reuptake Inhibitor) or other newer anti-depressant, such as EFFEXOR XR, 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 / effectTalk with
your doctor or
pharmacist
right away
Seek
urgent
medical
attention
Only
if
severe
In all
cases
CommonIncreased blood pressure that persists
[see also Severe Hypertension below]
CommonFast heartbeat
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]
UncommonLow sodium level in blood [symptoms of tiredness, weakness, confusion combined with achy, stiff or uncoordinated muscles]
UnknownLow Platelets: Bruising or unusual bleeding from the skin or other areas
UncommonMania/hypomania [elevated or irritable mood, decreased need for sleep, racing thoughts]
UncommonAkathisia [feeling restless and unable to sit or stand still]
UncommonHallucinations [strange visions or sounds]
UncommonUncontrollable movements of the body or face
UncommonInability to urinate
UncommonGastrointestinal bleeding [vomiting blood or passing blood in stools]
RareSeizures [loss of consciousness with uncontrollable shaking "fit"]
RareSerotonin 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]
RareLiver disorder [symptoms include nausea, vomiting, loss of appetite combined with itching, yellowing of the skin or eyes, dark urine]
RareGlaucoma: Increased pressure in the eyes, eye pain and blurred vision
See Warnings and PrecautionsNew or worsened emotional or behavioural problems
See Side Effects and What to Do About ThemSevere Hypertension [symptoms include headache, stronger and possibly faster heartbeat, chest pain, dizziness, excessive tiredness, blurred vision]

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

How to Store It

  • Store EFFEXOR XR at room temperature (15-30EC), in a dry place.
  • Keep container tightly closed.
  • Keep all medicines out of the sight and reach of children.
  • If your doctor tells you to stop taking EFFEXOR XR please return any left over medicine to your pharmacist.

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 by contacting the sponsor,

Pfizer Canada Inc.
17,300 Trans-Canada Highway
Kirkland, Quebec H9J 2M5

Or toll-free, at: 1-800-463-6001
or at www.pfizer.ca