Consumer Information for: DOM-VENLAFAXINE XR

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

Dom-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 agitation, hostility, anxiety, impulsivity or thoughts about suicide, self-harm or harm to others. Suicidal thoughts and actions can occur in 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 Dom-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 Dom-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.
• if you have glaucoma or increased pressure in your eyes.

Discontinuing Dom-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 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.