Patient Medication Information: uses, side effects, how to take - Venlafaxine XR (NT Pharma Canada)
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)
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 nonmedicinal ingredients are:
Dibutyl Sebecate, Ethyl Cellulose, Povidone and Sugar Spheres. **Red Iron Oxide, **Yellow Iron Oxide, *Titanium dioxide, *Gelatin, **Black Iron Oxide, ****Glob. Yellow Iron Oxide, ****Global Red Iron Oxide.
* Present (in capsule) in all strengths ** Present (in capsule) in 37.5 mg strength only *** Present (in capsule) in 75 mg strength only **** Present (in capsule) in both 75 mg and 150 mg strengths
What dosage forms it comes in:
Extended Release Capsules: 37.5 mg (grey and peach), 75 mg (peach) and 150 mg (dark orange).
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: | ||
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| food, etc; | ||
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| seizures, liver disease, kidney disease, heart problems or | ||
| high cholesterol, or history of any abnormal bleeding; | ||
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| 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; | ||
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| or if you are breast feeding; | ||
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| ||
| John’s Wort). | ||
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| 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 anti-depressants, 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 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.
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 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), acetylsalicylic acid 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.
- Ketoconazole
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, the nearest hospital emergency department or your local poison control centre, 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: | |
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| 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. | |||||||||
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN | |||||||||
| AND WHAT TO DO ABOUT THEM | |||||||||
| Symptom/effect | Talk with your doctor or pharmacist right away | Seek urgent medical attention | |||||||
| Only if severe | In all cases | ||||||||
| Common | Increased blood pressure that persists [see also Severe Hypertension below] | ||||||||
| Common | 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] | ||||||||
| Uncommon | Low sodium level in blood [symptoms of tiredness, weakness, confusion combined with achy, stiff or uncoordinated muscles] | ||||||||
| Uncommon | Bruising or unusual bleeding from the skin or other areas | ||||||||
| Uncommon | Mania/hypomania [elevated or irritable mood, decreased need for sleep, racing thoughts] | ||||||||
| Uncommon | Akathisia [feeling restless and unable to sit or stand still] | ||||||||
| Uncommon | Hallucinations [strange visions or sounds] | ||||||||
| Uncommon | Uncontrollable movements of the body or face | ||||||||
| Uncommon | Inability to urinate | ||||||||
| Uncommon | Gastrointestinal bleeding [vomiting blood or passing blood in stools] | ||||||||
| Rare | Seizures [loss of consciousness with uncontrollable shaking “fit”] | ||||||||
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN | |||||||||
| AND WHAT TO DO ABOUT THEM | |||||||||
| Symptom/effect | Talk with your doctor or pharmacist right away | Seek urgent medical attention | |||||||
| Only if severe | In all cases | ||||
| Rare | Serotonin syndrome [a combination of most or all of the following; confusion, restlessness, sweating, shaking, shivering, sudden jerking of the muscles, hallucinations, fast heartbeat] | ||||
| Rare | Liver disorder [symptoms include nausea, vomiting, loss of appetite combined with itching, yellowing of the skin or eyes, dark urine] | ||||
| Very rare | Increased pressure in the eyes [symptoms of eye pain, decreased or blurred vision, red eye, swelling of the eye] | ||||
See Warnings and Precautions | New or worsened emotional or behavioral problems | ||||
See Side Effects and What to Do About Them | Severe 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 Venlafaxine XR, contact your doctor or | |||||
| pharmacist. | |||||
HOW TO STORE IT
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| a dry place. | |
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| 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 0701D Ottawa, ON K1A 0K9 Postage paid labels, Canada Vigilance Reporting Form and the adverse reactions reporting guidelines are available on the MedEffectTM Canada Website 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 obtained by contacting the sponsor, NT Pharma Canada Limited., at:
1-800-268-4127 ext. 5005 (English); 1-877-777-9117 (French) or druginfo@tevacanada.com
NT Pharma Canada Ltd.
5691 Main Street
Stouffville, Ontario
L4A 1H5, Canada