Venlafaxine XR (Cobalt Pharmaceuticals): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

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:

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

When it should not be used:

• Do not use VENLAFAXINE 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 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, talc, titanium dioxide, and hard capsules containing gelatin.

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 forms it comes in:

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.

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

New or Worsened Emotional or Behavioral 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; 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. Close observation by a doctor is necessary in this situation. Do not discontinue your medication on your own.

Before taking 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, or history of any abnormal bleeding;
• 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 drive a vehicle or perform hazardous tasks during your work.

Discontinuing VENLAFAXINE 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 antidepressants, such as VENLAFAXINE 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 antidepressant 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.

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 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 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 VENLAFAXINE XR.

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, tramadol, tryptophan, triptans used to treat migraines

• 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), 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 VENLAFAXINE XR.

• Ketonazole

PROPER USE OF THIS MEDICATION

Usual dose:

• It is very important that you take VENLAFAXINE XR

  exactly as your doctor has instructed.

• Never increase or decrease the amount of 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

    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.

  • 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 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, 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 VENLAFAXINE XR are:

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

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.

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.

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

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

New or Worsened Emotional or Behavioral Problems

A small number of patients taking drugs of this type may feel worse instead of better; for example, they may experience new or worsened feelings of agitation, hostility or anxiety, or thoughts about suicide. Your doctor should be informed of such changes immediately. Close observation by a doctor is necessary in this situation. Do not discontinue your medication on your own. See also the WARNINGS AND PRECAUTIONS section.

Discontinuation Symptoms

Contact your doctor before stopping or reducing your dosage of 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 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 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 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 soon as you can. See WARNINGS AND PRECAUTIONS section for more information.

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

HOW TO STORE IT

• Store at room temperature (15-30ºC), in a dry place.
• Keep container tightly closed.
• Keep all medicines out of the reach of children.

• If your doctor tells you to stop taking VENLAFAXINE

  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, ON 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.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Cobalt Pharmaceuticals Company at: 1-866-254-6111.

Cobalt Pharmaceuticals Company

6500 Kitimat Road

Mississauga ON

L5N 2B8

Last revised: March 29, 2012