Details for: ACT VENLAFAXINE XR
Company: TEVA CANADA LIMITED
DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
---|---|---|---|---|---|
02304317 | ACT VENLAFAXINE XR | VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) | 37.5 MG | CAPSULE (EXTENDED RELEASE) | ORAL |
02304325 | ACT VENLAFAXINE XR | VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) | 75 MG | CAPSULE (EXTENDED RELEASE) | ORAL |
02304333 | ACT VENLAFAXINE XR | VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) | 150 MG | CAPSULE (EXTENDED RELEASE) | ORAL |
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
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.
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.
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:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.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 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:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Consumer 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.tevacanada.com, or by calling 1-800-268-4127 ext 3.
This leaflet was prepared by:
Teva Canada Limited
30 Novopharm Court
Toronto, ON, M1B 2K9
www.tevacanada.com
Last revised: July 12, 2021