Consumer Information for: BIO-FLUOXETINE

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

BIO-Fluoxetine 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 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.

Fluoxetine has an effect on the electrical activity of the heart. In very rare cases, this effect can lead to disturbances in heart rhythm. These heart rhythm disturbances are more likely in patients with risk factors, such as heart disease, or in the presence of certain drugs. In general, females and people more than 65 years in age are at higher risk. It is important to follow the instructions of your doctor with regard to dosing.

If you experience any symptoms of a possible heart rhythm disturbance, such as dizziness, palpitations (sensation of rapid, pounding, or irregular heart beat), fainting, or seizures, you should seek immediate medical attention.

Before starting B I O -Fluoxetine, tell your doctor or pharmacists:

• if you have ever had an allergic reaction to any medication
• if you have QT/QTc prolongation or a family history of QT/QTc prolongation;
• if you have a heart disease;
• if you have a personal history of fainting spells;
• if you have a family history of sudden cardiac death at <50 years;
• if you have electrolyte disturbances (e.g., low blood potassium or magnesium levels) or conditions that could lead to electrolyte disturbances (e.g., vomiting, diarrhea, dehydration);
• if you use diuretics, enemas and/or laxatives
• all your medical conditions, including a history of liver or kidney problems, seizures or blackouts, diabetes, bleeding disorder or have been told that you have low platelets
• if you had a recent bone fracture or were told you have osteoporosis or risk factors for osteoporosis.
• any medications (prescription or nonprescription) you are taking or have recently taken, especially monoamine oxidase (MAO) inhibitors(e.g., phenelzine sulfate, tranylcypromine sulfate, moclobemide or selegeline) or thioridazine, or anticoagulants, acetylsalicylic acid (e.g., Aspirin) and other non-steroidal anti-inflammatory drugs (e.g., ibuprofen).
• if you are taking tamoxifen (used to treat breast cancer)
• any natural or herbal products you are taking (e.g. St. John's Wort)
• if you are pregnant or thinking about becoming pregnant, or if you are breast feeding
• your habits of alcohol and /or street drug consumption
• if you drive a vehicle or perform hazardous tasks during your work

Angle-closureGlaucoma

BIO-Fluoxetine can cause an acute attack of glaucoma. Having your eyes examined before you take BIOFluoxetine could help identify if you are at risk of having angle-closure glaucoma. Seek immediate medical attention if you experience:

• eye pain
• changes in vision
• swelling or redness in or around the eye.

Effects on Pregnancy and Newborns

If you are already taking BIO-Fluoxetine and have just found out that you are pregnant, you should talk to your doctor as soon as possible.

Taking BIO-Fluoxetine in early stages of pregnancy:

Some studies have suggested a small increased risk of birth defects affecting the heart in babies whose mothers took fluoxetine capsules during the first few months of pregnancy. In the general population, about 1 in 100 babies are born with a heart defect. The studies found that this increased to about 2 in 100 babies whose mothers took fluoxetine capsules during early pregnancy.

Taking BIO-Fluoxetine in later stages of pregnancy: Possible complications at birth (from taking any newer antidepressant, including BIO-Fluoxetine):

Post-marketing reports indicate that some newborns whose mothers took an SSRI (selective serotonin reuptake inhibitor) or other newer anti-depressant 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 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.

Persistent Pulmonary Hypertension (PPHN) and newer antidepressants:

The use of SSRIs, including BIO-Fluoxetine, during late pregnancy, may increase the risk of a serious lung condition called persistent pulmonary hypertension of the newborn (PPHN) that causes breathing difficulties in newborns soon after birth. In the general population, PPHN is known to occur in about 1 or 2 per 1000 newborns but this may be increased 2 to 6 times in babies whose mothers used SSRIs during late pregnancy.

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.

Taking BIO-Fluoxetine 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.