Details for: SERTRALINE
Company: PRO DOC LIMITEE
DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
---|---|---|---|---|---|
02241302 | SERTRALINE-25 | SERTRALINE (SERTRALINE HYDROCHLORIDE) | 25 MG | CAPSULE | ORAL |
02241303 | SERTRALINE-50 | SERTRALINE (SERTRALINE HYDROCHLORIDE) | 50 MG | CAPSULE | ORAL |
02241304 | SERTRALINE-100 | SERTRALINE (SERTRALINE HYDROCHLORIDE) | 100 MG | CAPSULE | ORAL |
Summary Reports
Summary Safety Review - Antidepressants - Assessing the Potential Risk of Serious Eye Disorder (Angle-Closure Glaucoma)
Summary Safety Review - Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin-norepinephrine Reuptake Inhibitors (SNRIs) - Assessing the Potential Risk of Sexual Dysfunction despite Treatment Discontinuation
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
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
SERTRALINE belongs to a group of medicines known
as antidepressants, more specifically to the family of
medicines called SSRIs (Selective Serotonin Reuptake
Inhibitors).
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
When it should not be used:
- Do not use 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 SERTRALINE if you are currently taking or have recently taken monoamine oxidase inhibitors, antidepressants (e.g. phenelzine sulphate, tranylcypromine sulphate, moclobemide)
- Do not use SERTRALINE at the same time as pimozide
What the medicinal ingredient is
Sertraline Hydrochloride
What the non-medicinal ingredients are
colloidal silicon dioxide; corn starch; croscarmellose sodium and stearic acid. Capsule shells, imprinted with edible black ink, contain the non-medicinal ingredients; D&C Yellow #10, FD&C red #40 (100 mg capsule), FD&C yellow #6 (25 mg and 50 mg only), gelatin, silicon dioxide, sodium lauryl sulfate and titanium dioxide.
What dosage form it comes in
SERTRALINE is available as 25 mg (yellow capsule), 50 mg (yellow and white capsule) and 100 mg (orange capsule).
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.
SERTRALINE is not for use in children under 18 years of age.
Changes in Feelings and Behaviour
It is important that you have good communication with
your doctor about how you feel. Discussing your feelings
and treatment with a friend or relative who can tell you if
they think you are getting worse is also useful.
Some patients may feel worse when first starting or
changing the dose of drugs such as SERTRALINE. You
may feel more anxious or may have thoughts of hurting
yourself or others, especially if you have had thoughts of
hurting yourself before. These changes in feelings can
happen in patients treated with drugs like SERTRALINE
for any condition, and at any age, although it may be
more likely if you are aged 18 to 24 years old. If this
happens, see your doctor immediately. Do not stop
taking SERTRALINE on your own.
Taking SERTRALINE may increase your risk of
experiencing sexual problems, which may continue after
SERTRALINE has been discontinued. Tell your doctor if
you experience symptoms such as a decreased libido,
erectile dysfunction or ejaculation failure.
Taking 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 taking SERTRALINE tell your doctor or pharmacist:
- all your medical conditions
- if you have a history of:
- seizures
- liver disease
- kidney disease
- high cholesterol
- heart disease
- heart rhythm problems
- slow heart beat
- are taking medications for your heart
- manic episodes
- if in your family there is a history of:
- people younger than 50 years of age having a heart attack
- if the levels of electrolytes in your body are either too high or too low or you have a condition (such as an eating disorder) that can affect your electrolyte levels
- if you have had a stroke
- if you are known to have heart problems (or predispositions) related to a genetic expression (or modification, variant)
- if you have had a head injury
- if you have diabetes
- 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;
- if you have a recent bone fracture or were told you have osteoporosis or risk factors for osteoporosis
- 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 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 antidepressants, such as 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 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.
Angle-closure Glaucoma
SERTRALINE can cause an acute attack of glaucoma. Having your eyes examined before you take SERTRALINE 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
Interactions with this medication
Do not use SERTRALINE if you are taking or have recently taken monoamine oxidase inhibitors.
You should avoid taking St. John’s Wort if you are taking
SERTRALINE.
You should tell your doctor if you are taking or have
recently taken any medications (prescription, nonprescription or natural/herbal), especially:
- other antidepressants, such as SSRIs and certain tricyclics
- other drugs that affect serotonin such as, amphetamines, 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 anticoagulants (e.g. warfarin, dabigatran), acetylsalicylic acid (e.g. Aspirin) and other nonsteroidal 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 SERTRALINE.
Proper use of this medication
Usual Dose
- It is very important that you take SERTRALINE exactly as your doctor has instructed.
- 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
- Do not stop taking this medication without consulting your doctor.
- As with all antidepressants improvement with SERTRALINE is gradual. You should continue to take SERTRALINE even if you do not feel better, as it may take several weeks for your medication to work. Improvement may be gradual.
- SERTRALINE should be taken with food either in the morning or the 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
If you think you have taken too much SERTRALINE, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
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, 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 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
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
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.
SERTRALINE may raise cholesterol levels in some
patients. Blood cholesterol tests may be required by
your doctor during treatment with SERTRALINE.
Discontinuation Symptoms
Contact your doctor 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.
Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Seek immediate emergency medical attention |
---|---|---|---|
Uncommon | |||
Akathisia: feeling restless and unable to sit or stand still | ✔ | ||
Allergic reactions: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing | ✔ | ||
Bruising or unusual bleeding from the skin or other areas | ✔ | ||
Liver Disorder: yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite | ✔ | ||
Low blood sugar: symptoms of dizziness, lack of energy, drowsiness | ✔ | ||
Low sodium level in blood: symptoms of tiredness, weakness, confusion combined with achy, stiff or uncoordinated muscles | ✔ | ||
Mania/hypoman ia: elevated or irritable mood, decreased need for sleep, racing thoughts | ✔ | ||
Uncontrollable movements of the body or face | ✔ | ||
Heart Rhythm problems: dizziness, increased heart rate, fainting or seizures | ✔ | ||
Rare | |||
Gastrointestinal bleeding: vomiting blood or passing blood in stools | ✔ | ||
Glaucoma: swelling or redness in or around the eye, eye pain and changes in vision | ✔ | ||
Seizures: loss of consciousness with uncontrollable shaking “fit” | ✔ | ||
Unknown | |||
Low Platelets: Bruising or unusual bleeding from the skin or other areas | ✔ | ||
See Warnings and Precaution s | |||
Serotonin syndrome: a combination of most or all of the following; confusion, restlessness, sweating, shaking, shivering, sudden jerking of the muscles, hallucinations, fast heartbeat | ✔ | ||
Changes in feelings or behaviour (anger, anxiety, suicidal or violent thoughts) | ✔ |
This is not a complete list of side effects. For any unexpected effects while taking SERTRALINE, contact your doctor or pharmacist
How to store
- Store SERTRALINE at room temperature (15°C to 30°C). Protect unit dose packages from high humidity.
- Keep container tightly closed.
- Keep all medicines out of the reach and sight of children.
- If your doctor tells you to stop taking SERTRALINE please return any leftover medicine to your pharmacist.
Reporting side effects
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
If you want more information about SERTRALINE:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp)); or by contacting Pro Doc Ltée at 1-800-361-8559, www.prodoc.qc.ca or info@prodoc.qc.ca.
This leaflet was prepared by
Pro Doc Ltée, Laval, Québec, H7L 3W9
Last revised: February 10, 2021