NTP-Venlafaxine XR: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

NTP-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:

NTP-VENLAFAXINE XR belongs to the family of medicines called antidepressants. NTP-VENLAFAXINE XR is thought to work by affecting two naturally occurring brain chemicals, serotonin and norepinephrine. Treatment with these types of medications is most effective when you and your doctor have good communication about how you are feeling.

When it should not be used:

• Do not use NTP-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 NTP-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:

37.5 mg

Ammonium hydroxide, black iron oxide, n-butyl alcohol, D&C yellow 10, dehydrated ethanol, dibutyl sebacate, ethylcellulose, FD&C yellow 6, gelatin, isopropyl alcohol, polyethylene glycol, povidone, propylene glycol, purified water, shellac, starch, sucrose, talc, and titanium dioxide.

75 mg

Ammonium hydroxide, black iron oxide, n-butyl alcohol, dehydrated ethanol, dibutyl sebacate, D&C yellow 10, ethylcellulose, FD&C yellow 6, gelatin, isopropyl alcohol, polyethylene glycol, povidone, propylene glycol, purified water, shellac, starch, sucrose, talc, and titanium dioxide.

150 mg

Ammonium hydroxide, black iron oxide, n-butyl alcohol, dehydrated ethanol, dibutyl sebacate, ethylcellulose, FD&C yellow 6, gelatin, isopropyl alcohol, polyethylene glycol, povidone, propylene glycol, purified water, shellac, starch, sucrose, talc, and titanium dioxide.

What dosage forms it comes in:

NTP-VENLAFAXINE XR 37.5 mg is supplied as a hard gelatin capsule, with a grey cap and peach body, filled with white to off-white pellets. Imprinting on Body: 37.5 Cap: N.

NTP-VENLAFAXINE XR 75 mg is supplied as a hard gelatin capsule, with a peach cap and peach body, filled with white to off-white pellets. Imprinting on Body: 75 Cap: N

NTP-VENLAFAXINE XR 150 mg is supplied as a hard gelatin capsule, with a dark orange cap and dark orange body, filled with white to off-white pellets. Imprinting on Body: 150 Cap: N

WARNINGS AND PRECAUTIONS

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

NTP-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 NTP-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 or blood pressure problems or high cholesterol, or history of any abnormal bleeding;

• Any medications (prescription or non-prescription)

  which you are taking, especially monoamine oxidase (MAO) inhibitors (e.g. phenelzine sulphate, tranylcypromine sulphate, moclobemide or selegeline) or any other antidepressant, 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 drugs

  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 NTP-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 NTP-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 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 NTP-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 NTP-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, tramodol, tryptophan, St. John’s Wort, 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 NTP-VENLAFAXINE XR.
  • Ketoconazole

PROPER USE OF THIS MEDICATION

Usual dose:

• It is very important that you take NTP-VENLAFAXINE XR exactly as your doctor has instructed.

• Never increase or decrease the amount of NTP-

  VENLAFAXINE XR you 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 NTP-

  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.

• NTP-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:

What to do in case of overdose

Contact your doctor or the nearest hospital emergency department, even though you may not feel sick. In the event of overdosage, contact your doctor, hospital emergency department or regional Poison Control Centre.

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, NTP-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 skin rash, hives, swelling, trouble breathing) or any severe or unusual side effects, stop taking the drug and contact your doctor immediately.

Some side effects of NTP-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.

NTP-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.

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

NTP-VENLAFAXINE XR Capsules may raise cholesterol levels in some patients. Blood cholesterol tests may be required by your doctor during treatment with NTP-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 NTP-VENLAFAXINE XR Capsules. Symptoms such as anorexia (loss of appetite, loss of weight), anxiety, agitation (restlessness), aggression, confusion, convulsions, coordination problems, diarrheoa, 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 NTP-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 NTP-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 NTP-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 NTP-VENLAFAXINE XR, contact your doctor or pharmacist.

HOW TO STORE IT

• Store NTP-VENLAFAXINE XR at room temperature (15-

  30˚C), in a dry place.

• Keep container tightly closed.
• Keep all medicines out of reach of children.

• If your doctor tells you to stop taking NTP-VENLAFAXINE

  XR please return any left over medicine to your pharmacist.

REPORTING SUSPECTED SIDE EFFECTS

To monitor drug safety, Health Canada through the Canada Vigilance Program collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Canada Vigilance:

By toll-free telephone: 866-234-2345

By toll-free fax 866-678-6789

Online: www.healthcanada.gc.ca/medeffect

By email: CanadaVigilance@hc-sc.gc.ca

By regular mail:

Canada Vigilance National Office

Marketed Health Products Safety and Effectiveness Information Bureau

Marketed Health Products Directorate

Health Products and Food Branch

Health Canada

Tunney’s Pasture, AL 0701C

Ottawa ON K1A 0K9

NOTE: Should you require information related to the management of the side effect, please contact your health care provider before notifying Canada Vigilance. 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, Teva Canada Limited.

at: 1-800-268-4127 ext. 5005

or druginfo@novopharm.com

Teva Canada Limited

30 Novopharm Court

Toronto, Ontario

M1B 2K9

Canada

Date of Revison: September 23, 2013