Sertraline (Cobalt Pharmaceuticals): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

This medication is used for the treatment of

• Depression (feeling sad, a change in appetite or weight gain,

  difficulty concentrating or sleeping, feeling tired, headches, unexplained aches and pain)

• Obsessive Compulsive Disorder (an anxiety disorder

  characterized by recurrent, unwanted thoughts (obsessions) and/or repetitive behaviors (compulsions))

• Panic Disorder (an anxiety disorder characterized by

  unexpected and repeated periods of intense fear) Treatment with these types of medications is most safe and effective when you and your doctor have good communication about how you are feeling.

What it does:

SERTRALINE belongs to the family of medicines called selective serotonin reuptake inhibitors. Sertraline is thought to work by increasing the levels of a natural substance in the brain called serotonin (5-hydroxytryptamine) that is believed to influence mood.

When it should not be used:

• Do not use SERTRALINE:

  • if you are allergic to it or any of the components of its formulation (see what the important non medicinal ingredients are).
  • if you are currently taking or have recently taken monoamine oxidase inhibitor antidepressants (MAOI) (mood elevators) (e.g., phenelzine sulfate, tranylcypromine sulfate or moclobemide).
  • if you are taking pimozide (a drug used for mental disorders (antipsychotic)).

What the medicinal ingredient is:

Sertraline Hydrochloride

What the important nonmedicinal ingredients are: SERTRALINE contains the following non-medicinal ingredients: • Dibasic calcium phosphate anhydrous

• Magnesium stearate
• Microcrystalline cellulose and

• Sodium starch glycolate.

  • Capsule shells contain dye D & C Yellow #10, gelatin and titanium dioxide. Capsules 25 and 50 mg also contain dye FD & C Yellow #6, and capsules 100 mg also contain FD & C Red #40. They are Tartrazine free.

What dosage forms it comes in:

Capsule 25, 50 & 100 mg.

WARNINGS AND PRECAUTIONS

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

SERTRALINE 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, 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.

SERTRALINE 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.

Avoid alcoholic drinks while taking SERTRALINE.

Contact your physician before stopping or reducing your dosage of SERTRALINE . Symptoms such as dizziness, abnormal dreams, electric shock sensations, agitation, anxiety, difficulty concentrating, headache, tremor, nausea, vomiting, sweating or other symptoms may occur after stopping or reducing the dosage of SERTRALINE . Such symptoms may also occur if 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 SERTRALINE to alleviate the symptoms.

Post-marketing reports indicate that some newborns whose mother took an SSRI (Selective Serotonin Reuptake Inhibitors), or other newer antidepressants, such as SERTRALINE, during pregnancy have developed complications at birth requiring prolonged hospitalization, breathing support, and tube feeding. Reported symptoms include: feeding and/or breathing difficulties, seizures, tense or overly relaxed muscles, jitteriness and constant crying. In most cases, the newer antidepressant 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 you do NOT stop taking these medications without first consulting your doctor.

BEFORE you use SERTRALINE talk to your doctor or pharmacist if:

• You are driving or operate heavy machinery. • You have any medical conditions, including liver or

  kidney disease

• You had any medical conditions in the past, such as a

  history of seizures

• You are pregnant or thinking about becoming pregnant,

  or if you are breast-feeding

• You are taking any medications (prescription or

  nonprescription), especially monoamine oxidase inhibitor antidepressants (e.g. phenelzine sulfate, tranylcypromine sulfate or moclobemide) or any other antidepressants, pimozide (an antipsychotic drug), drugs used to treat diabetes, drugs used to thin the blood (anticoagulants) or drugs containing tryptophan. • You are taking any natural or herbal products (eg., St.

  John’s Wort)

• You are habituated of consuming alcohol. • You are allergic to this drug or its ingredients or

  components of the container

• Your habits of alcohol and/or street drug consumption.

INTERACTIONS WITH THIS MEDICATION

Do not use SERTRALINE if you are taking or have recently taken monoamine oxidase inhibitors or pimozide (Orap®).

You should tell your doctor if you are taking or have recently taken any medications (prescription, non-prescription or natural/herbal), especially:

• anticoagulants (blood thinners) such as warfarin

  (Coumadin)

• other antidepressants such as amitriptyline

  clomipramine, desipramine, doxepin, imipramine, nortriptyline, and trimipramine

• triptans used to treat migraines such as sumatriptan, - cimetidine

• medications for irregular heartbeat such as flecainide and

  propafenone

• oral medications for diabetes such as tolbutamide - CNS active drugs such as carbamazepine, haloperidol or

  phenytoin

• Serotonergic drugs such as tryptophan
• Herbal drugs such as St. John’s Wort

• Lithium

  • Monoamine Oxidase Inhibitors (MAOIs) such as selegiline and moclobemide.

PROPER USE OF THIS MEDICATION

It is very important for you to take SERTRALINE exactly as your doctor has instructed.The usual starting dose is 50 mg of SERTRALINE /day for depression and obsessive-compulsive disorder. If you are taking SERTRALINE for panic disorder, your doctor may start you at 25 mg/day.

Your doctor may decide to increase the dose up to 200 mg/day.

Never increase or decrease the amount of SERTRALINE 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 (See Warnings and Precautions) .

You should continue to take your medicine even if you do not feel better, as it may take approximately four weeks for your medicine to work.

SERTRALINE should be taken with food; either in the morning or evening. You should swallow the capsule whole; do not chew it.

Keep taking SERTRALINE until your doctor tells you to stop. Your doctor may tell you to continue to take your medicine for several months. Continue to follow your doctor’s instructions.

Reminder: This medicine has been prescribed only for you. Do not give it to anybody else. If you have any further question, please ask your doctor or pharmacist.

Overdose:

If you have taken a large number of capsules all at once, contact either your doctor, hospital emergency department or nearest poison control center immediately, even though you may not feel sick.

Missed Dose:

If you miss taking a dose of SERTRALINE, do not worry, just take the next dose when you normally do. Do not take 2 doses at once. It is important to discuss with your doctor what you should do if you miss several doses of this medication.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

New or Worsened Emotional or Behavioral Problems

A small number of patients taking a drug 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 SERTRALINE. Symptoms such as dizziness, lightheadedness, nausea, vomiting, agitiation, nausea, vomitting,

agitation/restlessness, anxiety, sweating, headache, sleep disturbance, electric shock sensations and other symptoms have been reported after stopping treatment, reducing the dosage of SERTRALINE, or when a dose is missed. These symptoms usually disappear without needing treatment. Tell your doctor if you have these or any other symptoms. Your doctor may adjust the dosage of SERTRALINE to alleviate the symptoms. See WARNINGS AND PRECAUTIONS section.

Effects on Newborns

Some newborns whose mothers took an SSRI (Selective Serotonin Reuptake Inhibitor) or other newer antidepressant, such as SERTRALINE, 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.

* If you think you have these side effects, it is important that you seek medical advice from your doctor straight away.

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

HOW TO STORE IT

Store at room temperature (15°C to 30°C) in a dry place. Keep the container tightly closed.

Protect blisters from moisture.

Keep out of reach of children.

If your doctor decides to stop SERTRALINE treatment, return any leftover medicine to your pharmacist to safely dispose of it. Keep it only if your doctor tells you to do so.

Reporting 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 0701C

    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

Cobalt Pharmaceuticals Inc.

6500 Kitimat Road

Mississauga, Ontario L5N 2B8

Canada

This document plus the full product monograph, prepared for health professionals can be found by contacting Cobalt Pharmaceuticals, at: 1-866-254-6111.

Last revised: January 25, 2010