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Details for: ACT VENLAFAXINE XR

Company: TEVA CANADA LIMITED

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02304317ACT VENLAFAXINE XRVENLAFAXINE (VENLAFAXINE HYDROCHLORIDE)37.5 MGCAPSULE (EXTENDED RELEASE)ORAL
02304325ACT VENLAFAXINE XRVENLAFAXINE (VENLAFAXINE HYDROCHLORIDE)75 MGCAPSULE (EXTENDED RELEASE)ORAL
02304333ACT VENLAFAXINE XRVENLAFAXINE (VENLAFAXINE HYDROCHLORIDE)150 MGCAPSULE (EXTENDED RELEASE)ORAL
Search Reported Side Effects Report a Side Effect

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

ACT VENLAFAXINE 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

ACT VENLAFAXINE XR belongs to a group of medicines called antidepressants. ACT VENLAFAXINE XR is thought to work by affecting two naturally occurring brain chemicals, serotonin and norepinephrine.

When it should not be used

When it should not be used:

  • Do not use ACT VENLAFAXINE XR if you are allergic to it or to any of the components of its formulation (see lis t 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 unusualside effects.
  • Do not use ACT VENLAFAXINE 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 non-medicinal ingredients are

Colloidal silicon dioxide, copovidone, ethyl cellulose, magnesium stearate, microcrystalline cellulose, povidone and talc. Hard capsules containing gelatin and titanium dioxide .

In addition, the 37.5 mg capsules contain black iron oxide, red iron oxide, yellow iron oxide and red ink. 75 mg capsules contain black iron oxide, red iron oxide and red ink. 150 mg capsules contain FD&C Blue #1, FD&C Red #40, FD&C Yellow #6 and white ink.

What dosage form it comes in

ACT VENLAFAXINE XR comes in extended release capsules containing 37.5 mg, 75 mg or 150 mg 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.

ACT VENLAFAXINE 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 aggression, agitation, hostility, anxiety, impulsivity or thoughts about suicide, self-harm or harm to others. Suicidal thoughts and actions can occurin 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 ACT VENLAFAXINE XR may increase your risk of experiencing sexual problems, which may continue after ACT VENLAFAXINE XR has been discontinued. Tell your doctor if you experience symptoms such as a decrease in sexual desire, performance or satisfaction.

Taking ACT VENLAFAXINE` 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 ACT VENLAFAXINE 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.

Discontinuing ACTVENLAFAXINE 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 ACT VENLAFAXINEXR, 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 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.

Taking ACT VENLAFAXINE XR in mid to late pregnancy may increase the risk for preeclampsia (high blood pressure and protein in the urine) and taking it near delivery may increase the risk of heavy bleeding after giving birth.

If you are pregnant and taking an SSRI, or other newer antidepressant, you should discuss the risks and benefits of the various treatment options with your doctor. It is very important that you do NOT change your dosage of these medications without first consulting your doctor. See SIDE EFFECTS AND WHAT TO DO ABOUT THEM section for more information.

Angle-closure Glaucoma
ACT VENLAFAXINE XR
can cause an acute attack of glaucoma. Having your eyes examined before you take ACT VENLAFAXINE XR 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 ACT VENLAFAXINE XR if you are taking or have recently taken monoamine oxidase inhibitors.

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

Certain laboratory results may be affected by use of ACT VENLAFAXINE 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, amphetamines, 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 pain), 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, s uch 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 ACT VENLAFAXINE XR.  Ketoconazole
Proper use of this medication

Usual Dose:

  • It is very important that you take ACT VENLAFAXINE XR exactly as your doctor has instructed.
  •  Never increase or decrease the amount of ACT VENLAFAXINE 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 ACT VENLAFAXINE 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.  ACT VENLAFAXINE 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 orthe nearest hospital emergency department, even though you may not feel sick.

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

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, ACT VENLAFAXINE 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 ACT VENLAFAXINE 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.

ACT VENLAFAXINE 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.

ACT VENLAFAXINE XR may increase blood pressure in some people. You should have your blood pressure measured prior to starting ACT VENLAFAXINE XR and during treatment. High blood pressure should be controlled before starting ACT VENLAFAXINE 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.

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

Discontinuation Symptoms
Contact your doctor before stopping or reducing your dosage of ACT VENLAFAXINE XR. Your doctor may lower your dosage gradually depending on your dose and how long you have been taking ACT VENLAFAXINE 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 ACT VENLAFAXINE 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 ACT VENLAFAXINE 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 ACT VENLAFAXINE 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 s oon as you can. See WARNINGS AND PRECAUTIONS section for more information.

Serious side effects and what to do about them
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
Common
Increased blood pressure that persists [see also Severe Hypertension below]    
Fast heartbeat    
Uncommon
Allergic 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]    
Low sodium level in blood [symptoms of tiredness, weakness, confusion combined with achy, stiff or uncoordinated muscles]    
Low platelets: Bruising or unusual bleeding from the skin or other areas    
Mania/hypomania [elevated or irritable mood, decreased need for sleep, racing thoughts]    
Mania/hypomania [elevated or irritable mood, decreased need for sleep, racing thoughts]    
Akathisia [feeling restless and unable to sit or stand still]    
Hallucinations [strange visions or sounds]    
Uncontrollable movements of the body or face    
Inability to urinate    
Gastrointestinal bleeding [vomiting blood or passing blood in stools]    
Rare
Seizures [loss of consciousness with uncontrollable shaking “fit”]    
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]    
Liver disorder [symptoms include nausea, vomiting, loss of appetite combined with itching, yellowing of the skin or eyes, dark urine]    
Glaucoma: Swelling or redness in or around the eye, eye pain and changes in vision    
See Warnings and Precautions
New or worsened emotional or behavioural problems    
See Side Effects and What to Do About Them
Severe Hypertension [symptomsinclude 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 ACTVENLAFAXINE XR, contact your doctor or pharmacist.

How to store
  • Store at room temperature (15-30ºC), 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 ACT VENLAFAXINE XR please return any left over medicine to 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

If you want more information about ACT-VENLAFAXINE XR:

This leaflet was prepared by:
Teva Canada Limited
30 Novopharm Court
Toronto, ON, M1B 2K9

www.tevacanada.com

Last revised: July 12, 2021

Date modified: