Ratio-Fluoxetine: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

ratio-FLUOXETINE (fluoxetine hydrochloride) has been prescribed by your doctor to relieve your symptoms of: $ depression (feeling sad, a change in appetite or

weight, difficulty concentrating or sleeping, feeling tired, headaches, unexplained aches and pain) $ bulimia (eating disorder, characterized by self-

induced vomiting after eating)

$ or obsessive-compulsive disorder (recurrent and

intrusive, thought, feeling, idea, or sensation; recurrent pattern of behavior, or unwanted thoughts or actions)

What it does:

ratio-FLUOXETINE (fluoxetine hydrochloride) belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). ratio-FLUOXETINE is thought to work by increasing the levels of a chemical in the brain called serotonin (5-hydroxytryptamine).

When it should not be used:

Do not use ratio-FLUOXETINE if you are:

• allergic to it or any of the components of its

  formulation (see What the nonmedicinal ingredients are: )

• currently or have recently taken the drug

  thioridazine.

• currently or have recently taken monoamine oxidase

  anti-depressants (e.g. phenelzine sulphate, moclobemide).

What the medicinal ingredient is:

ratio-FLUOXETINE capsules contain the active ingredient: fluoxetine hydrochloride

What the nonmedicinal ingredients are:

ratio-FLUOXETINE 10 mg and 20 mg capsules contain: Black iron oxide (for 10 mg), D&C yellow #10, FD&C blue # 1, FD&C yellow # 6, gelatin, pregelatinized corn starch, silicone dioxide and titanium dioxide.

There is no gluten, lactose, sulfite or tartrazine in ratio-FLUOXETINE.

What dosage forms it comes in:

ratio-FLUOXETINE is available as a 10 mg grey and light green capsule and a 20 mg ivory and light green capsule.

WARNINGS AND PRECAUTIONS

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

ratio-FLUOXETINE is not for use in children under 18 year of age.

New or Worsened Emotional or Behavior 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 those in your care if you are a caregiver or guardian, consult your doctor immediately, do not discontinue your medication on your own.

Before starting ratio-FLUOXETINE tell your doctor or pharmacists:

$ if you have ever had an allergic reaction to any medication

$ all your medical conditions, including a history of liver or kidney problems, seizures or blackouts, diabetes, and heart problems or abnormal bleeding $ 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 $ 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

Effects on Pregnancy and Newborns

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

Taking ratio-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 ratio-FLUOXETINE 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 ratio-FLUOXETINE during early pregnancy.

Taking ratio-FLUOXETINE in later stages of pregnancy:

Possible complications at birth (from taking any newer antidepressant, including ratio-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 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.

Persistent Pulmonary Hypertension (PPHN) and newer antidepressants:

The use of SSRIs, including ratio-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 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 ratio-FLUOXETINE if you are taking or have recently taken monoamine oxidase (MAO) inhibitors or thioridazine.

You should tell your doctor if you are taking or have recently taken any medications (prescription, nonprescription or natural/herbal), especially: $ other anti-depressants, such as SSRIs, certain tricyclics, drugs used to treat schizophrenia, or bipolar depression (e.g. lithium)

$ drugs which may affect blood clotting and increase bleeding, such as drugs used to thin the blood (anticoagulants, e.g. warfarin), as well as acetylsalicylic acid (e.g. Aspirin) and other non-steroidal anti-inflammatory drugs (e.g. ibuprofen) $ certain medicines used to treat patients with irregular heart beats

$ certain drugs used to treat diabetes

$ other drugs that affect serotonin, such as lithium, linezolid, tramadol, drugs containing tryptophan, St. Johns Wort, triptans used to treat migraines $ sedatives such as benzodiazapines

As with many drugs that work directly on the brain, use of alcohol while taking ratio-FLUOXETINE should be limited/moderate.

PROPER USE OF THIS MEDICATION

Usual dose:

$ It is very important that you take ratio-FLUOXETINE exactly as your doctor has instructed. Generally people take between 20 mg to 80 mg per day for depression and obsessive-compulsive disorder and between 20 and 60 mg per day for bulimia.

$ ratio-FLUOXETINE is usually taken once a day. It may be taken with or without food. If you are taking capsules you should swallow the capsules whole; do not chew them.

$ You should continue to take your medicine even if you do not feel better, as it may take a number of weeks for your medicine to work.

$ Keep taking your ratio-FLUOXETINE until the doctor tells you to stop.

$ Talk to your doctor before you stop taking your medication on your own.

Remember:

This medicine has been prescribed only for you. Do not give it to anybody else, as they may experience undesirable effects, which may be serious.

Missed Dose:

If you forget to take a dose of ratio-FLUOXETINE, take it as soon as you remember. Take your next dose at the next scheduled time; do not try to make up for a missed dose by taking a double dose the next time.

Overdose:

If you have taken a large number of tablets all at once, contact your doctor or the regional Poison Control Centre, the nearest hospital emergency department immediately, even though you may not feel sick. Show the doctor your prescription bottle.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like other medications, ratio-FLUOXETINE can cause some side effects. You may not experience any of them. For most patients, 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.

The most common side effects of ratio-FLUOXETINE are: $ nausea

$ dizziness

$ headache

$ anxiety

$ nervousness

$ drowsiness

$ insomnia (difficulty falling or staying asleep) $ fatigue

$ weakness

$ diarrhea

$ upset stomach

$ dry mouth

$ loss of appetite

$ excessive sweating

ratio-FLUOXETINE 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.

New or Worsened Emotional or Behavior Problems A small number of patients taking a drug of this type may feel worse instead of better such as experiencing new or worsened feelings of agitation, hostility, 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 WARNINGS AND PRECAUTIONS section.

Discontinuation Symptoms

Contact your doctor before stopping or reducing your dosage of ratio-FLUOXETINE. Symptoms such as headache, insomnia, paresthesias (numbness, tingling, burning, or prickling sensation), nervousness, anxiety, nausea, sweating, dizziness, jitteriness and weakness and other symptoms have been reported after stopping fluoxetine. 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 ratio-FLUOXETINE to alleviate the symptoms. See WARNINGS AND PRECAUTIONS section for more information.

Effects on Newborns

Some newborns whose mothers took an SSRI (Selective Serotonin Uptake Inhibitor) or other newer antidepressants 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.

The following table is based on data from placebo-controlled clinical trials involving 10,782 patients.

* If you think you have these side effects, stop taking the drug.

This is not a complete list of side effects. For any unexpected effects while taking ratio-FLUOXETINE, contact your doctor or pharmacist.

HOW TO STORE IT

Keep all medicines out of reach of children. ratio-FLUOXETINE should be stored in its original package at room temperature , in a dry place and out of direct sunlight. The expiry date of this medicine is printed on the package label. Do not use the medicine after the expiry date. If your doctor tells you to stop taking ratio-FLUOXETINE or you find that they have passed their expiry date, please return any left over medicine to your pharmacist.

REPORTING SUSPECTED SIDE EFFECT 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 K1A 0K9

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

MORE INFORMATION

This document plus the full Product Monograph, prepared for health professionals can be found by contacting the sponsor.

ratiopharm inc.

17 800 Lapointe, Mirabel, Quebec

Canada, J7J 1P3

1-800-337-2584

You may need to read this package insert again. Please do not throw it away until you have finished your medicine.

Last revised: October 7, 2011