Venlafaxine Hydrochloride Extended-Release Capsules: Uses, Side Effects and Dosage

What the medication is used for:

Venlafaxine hydrochloride extended-release capsule 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)

• Social phobia (social anxiety disorder)

  • avoidance and/or fear of social situations

What it does:

Venlafaxine hydrochloride extended- release capsule belongs to a group of

medicines called antidepressants. Venlafaxine hydrochloride extended-release capsule is thought to work by affecting two naturally occurring brain chemicals, serotonin and norepinephrine.

When it should not be used:

• Do not use venlafaxine hydrochloride extended-release capsules 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 hydrochloride extended-release capsules 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:

Basic Butylated Methacrylate copolymer Ph.Eur. (Eudragit EPO), Ethyl Cellulose NF (7 cps), Hard Gelatin Capsule Shell, Medium Chain Triglycerides NF, Microcrystalline Cellulose, NF (Avicel PH 112), Povidone USP (PVP K 90), Sodium Stearyl Fumarate NF, Talc, USP.

What dosage forms it comes in:

venlafaxine hydrochloride extended-release capsule is available in extended release capsules containing 37.5 mg (gray and pink), 75 mg (pink) and 150 mg (Swedish orange) venlafaxine.

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 hydrochloride extended-release capsule 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; 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 hydrochloride extended-release capsules 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 Hydrochloride Extended-Release Capsules

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 hydrochloride extended-release capsules, 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 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.

Do not use venlafaxine hydrochloride extended-release capsules if you are taking or have recently taken monoamine oxidase inhibitors.

You should avoid taking St. John’s Wort if you are taking venlafaxine hydrochloride extended-release capsules.

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 hydrochloride extended-release capsules.
  • Ketoconazole.

Capsules should be swallowed whole. DO NOT open, divide, crush or chew the capsules.

Usual Adult Dose:

• It is very important that you take venlafaxine hydrochloride extended-release capsules exactly as your doctor has instructed.
• Never increase or decrease the amount of venlafaxine hydrochloride extended-release capsules 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 hydrochloride extended-release capsules 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 hydrochloride extended-release capsules 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:

“Contact your doctor, nearest hospital emergency department, or the regional 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.

Like all medications, venlafaxine hydrochloride extended-release capsules 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 hydrochloride extended-release capsules 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 hydrochloride extended-release capsules 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 hydrochloride extended-release capsules may increase blood pressure in some people. You should have your blood pressure measured prior to starting venlafaxine hydrochloride

extended-release capsules and during treatment.CTS AND WHAT TO DO

High blood pressure should be controlled before starting venlafaxine hydrochloride extended-release capsules. 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 hydrochloride extended-release capsules may raise cholesterol levels in some patients. Blood cholesterol tests may be required by your doctor during treatment with venlafaxine hydrochloride extended-release capsules.

New or Worsened Emotional or Behavioural 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 hydrochloride extended-release capsules. 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 hydrochloride extended-release capsules, 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 hydrochloride extended-release capsules 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 hydrochloride extended-release capsules, 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 hydrochloride extended-release capsules, contact your doctor or pharmacist.

• Store venlafaxine hydrochloride extended-

  release capsules at 20°-25°C (68°-77°F), 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 hydrochloride extended-release capsules 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 KIA 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect ^TM Canada Web site 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.

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor,

Dr.Reddy’s Laboratories Inc., 200 Somerset Corporate BLVD Floor 7, Bridgewater,

New Jersey 08807

Or toll-free, at: 1-866-733-3952

Last Revised: September 20, 2011