PHL-Sertraline: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

phl-SERTRALINE 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)

• Obsessive-compulsive disorder
• Panic disorder (repeated, unexpected panic attacks)

What it does:

phl-SERTRALINE belongs to a group medicines known as antidepressants, more specifically to the family of medicines called SSRIs (Selective Serontonin Reuptake Inhibitors).

phl-SERTRALINE 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 phl-SERTRALINE 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 phl-SERTRALINE if you are currently taking or

  have recently taken monoamine oxidase inhibitors, antidepressants (e.g. phenelzine sulphate, tranylcypromine sulphate, moclobemide)

• Do not use phl-SERTRALINE at the same time as pimozide

What the medicinal ingredient is:

Sertraline hydrochloride.

What the nonmedicinal ingredients are:

Corn starch, Lactose, Magnesium Stearate and Sodium Lauryl Sulfate. In addition the capsule shells contain the following additional ingredients:

The 25 mg capsules: D&C Yellow #10, FD&C Yellow #6, gelatin, titanium dioxide.

The 50 mg capsules: D&C Yellow #10, FD&C Yellow #6, gelatin, titanium dioxide.

The 100 mg capsules: D&C Yellow #10, FD&C Red #40, gelatin, titanium dioxide.

What dosage forms it comes in:

Capsules: 25 mg, 50 mg, 100 mg

WARNINGS AND PRECAUTIONS

Treatment with these types of medication is most safe and effective when you and your doctor have good communication about how you are feeling.

phl-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. They may experience new or worsened feeling 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.

Taking phl-SERTRALINE 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 you use phl-SERTRALINE talk to your doctor or pharmacist:

• 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 or have recently taken (within last 14 days), especially monoamine oxidase (MAO) inhibitors (e.g. phenelzine sulfate, tranylcypromine sulfate, moclobemide) or any other antidepressants, pimozide (an antipsychotic drug), drugs used to treat diabetes, drugs used to thin the blood (anticoagulant), the antibiotic linezolid, methylthioninium chloride (methylene blue) or drugs that affect serotonin (including but not limited to fentanyl, fenfluramine and tryptophan).
• if you are pregnant or thinking about becoming pregnant, or if you are breast feeding;

• you have a recent bone fracture or were told you have

  osteoporosis or risk factors for osteoporosis·

• if you have glaucoma or increased pressure in your eyes.
• 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.

• if you have ever had any allergic reaction to medications

  food, etc;

Effects on Pregnancy and Newborns

If you are already taking phl-SERTRALINE and have just found out that you are pregnant; you should talk to your doctor immediately. You should also talk to your doctor if you are planning to become pregnant.

Some newborns whose mothers took an SSRI (selective serotonin reuptake inhibitor) or other newer anti-depressants, such as phl-SERTRALINE, 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 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: When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like phl-SERTRALINE may increase the risk of a serious lung condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), that causes breathing difficulties in newborns soon after birth, making the baby breathe faster and appear bluish. These symptoms usually begin during the first 24 hours after the baby is born. If this happens to your baby you should contact your doctor immediately.

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.

INTERACTIONS WITH THIS MEDICATION

Do not use phl-SERTRALINE if you are taking or have recently taken monoamine oxidase inhibitors.

You should avoid taking St. John’s Wort if you are taking phl-SERTRALINE

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, tramadol, tryptophan, triptans used to treat migraines
• certain medicines used to treat pain, such as fentanyl (used in anaesthesia or to treat chronic paint), tramadol, tapentadol, meperidine, methadone, pentazocine
• certain medicines used to treat cough, such as dextromethorphan
• 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, dabigatran), acetylsalicylic acid (e.g. 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 phl-SERTRALINE

PROPER USE OF THIS MEDICATION

Usual dose:

• It is very important that you take phl-SERTRALINE exactly as your doctor has instructed.
• Never increase or decrease the amount of phl-SERTRALINE you, or those in your care if you are a caregiver or guardian, are taking unless your doctor tells you to
• Do not stop taking this medication without consulting your doctor.

• As with all antidepressants improvement with phl-

  SERTRALINE is gradual. You should continue to take phl-SERTRALINE even if you do not feel better, as it may take several weeks for your medication to work. Improvement may be gradual.

• phl-SERTRALINE should be taken with food either in morning or evening. You should swallow the capsule whole, 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:

In case of overdose, contact your doctor, the regional Poison Control Centre, or the nearest hospital emergency department, even though you may not feel sick. Take your medicine with you.

Missed Dose:

If you happen to miss a dose, do not take the missed dose. Just take your next dose at the right time. Do not take a double dose to make up for a forgotten dose.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medications, phl-SERTRALINE 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 phl-SERTRALINE are:

• headache
• nausea
• dry mouth
• diarrhea
• loss of appetite
• sleepiness
• dizziness
• insomnia

• sexual problems including decreased libido, erectile,

  dysfunction and ejaculation failure

• nervousness
• Tremor

phl-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.

Cases of loss of blood sugar level control including both higher and lower-than normal sugar level have been reported in patients receiving SSRIs including phl-SERTRALINE, with and without pre-existing diabetes. Symptoms associated with low blood sugar level in your blood include weakness, hunger, anxiety, sweating, numbness or tingling in your extremities. These are early warning symptoms and should not be ignored. Contact your doctor if you experience these symptoms.

phl-SERTRALINE may raise cholesterol levels in some patients. Blood cholesterol tests may be required by your doctor during treatment with phl-SERTRALINE.

Discontinuation Symptoms

Contact your doctor before stopping or reducing your dosage of phl-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 phl-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 phl-SERTRALINE to alleviate the symptoms.

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

HOW TO STORE IT

• Store between 15^oC and 30^oC.
• Keep container tightly closed.
• Keep all medicines out of reach and sight of children.

• If your doctor tells you to stop taking phl-SERTRALINE

  please return any leftover 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, Ontario

  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 obtained by contacting Pharmel Inc. at 1-888-550-6060.

Pharmel Inc.

Montreal, Canada

H4P 2T4

Last revised: July 11, 2013