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Details for: BIO-SERTRALINE

Company: BIOMED PHARMA

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02445042BIO-SERTRALINESERTRALINE (SERTRALINE HYDROCHLORIDE)25 MGCAPSULEORAL
02445050BIO-SERTRALINESERTRALINE (SERTRALINE HYDROCHLORIDE)50 MGCAPSULEORAL
02445069BIO-SERTRALINESERTRALINE (SERTRALINE HYDROCHLORIDE)100 MGCAPSULEORAL
Search Reported Side Effects Report a Side Effect

Summary Reports

Summary Safety Review - Selective Serotonin Reuptake Inhibitors (SSRIs) - Assessing the Potential Risk of Autism
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

BIO-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

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

BIO-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 BIO-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 BIO-SERTRALINE if you are currently taking or have recently taken monoamine oxidase inhibitors, antidepressants (e.g. phenelzine sulphate, tranylcypromine sulphate, moclobemide)
  • Do not use BIO-SERTRALINE at the same time as pimozide
What the medicinal ingredient is

Sertraline hydrochloride

What the non-medicinal ingredients are

Corn starch, lactose monohydrate and magnesium Stearate. Capsule shells contain gelatin, titanium dioxide and dye D&C Yellow #10. In addition, capsules 25 and 50 mg also contain dye FD&C Yellow #6 and capsules 100 mg also contain dye FD&C Red #40.

BIO-SERTRALINE is available as 25 mg (yellow capsule), 50 mg (white and yellow capsule) and 100 mg (orange capsule).

What dosage form it comes in

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.

BIO-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 BIOSERTRALINE. 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 BIO-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 BIO-SERTRALINE on your own.

Taking BIO-SERTRALINE may increase your risk of experiencing sexual problems, which may continue after BIO-SERTRALINE has been discontinued. Tell your doctor if you experience symptoms such as a decreased libido, erectile dysfunction or ejaculation failure.

Taking BIO-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 BIO-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 BIO-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 BIO-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 BIO-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 BIO-SERTRALINE can cause an acute attack of glaucoma. Having your eyes examined before you take BIO-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 BIO-SERTRALINE if you are taking or have recently taken monoamine oxidase inhibitors.

You should avoid taking St. John’s Wort if you are taking BIO-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, 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 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 BIOSERTRALINE.
Proper use of this medication

Usual Dose

  • It is very important that you take BIOSERTRALINE exactly as your doctor has instructed.
  • Never increase or decrease the amount of BIO-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 BIOSERTRALINE is gradual. You should continue to take BIO-SERTRALINE even if you do not feel better, as it may take several weeks for your medication to work. Improvement may be gradual.
  • BIO-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

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, BIO-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 BIO-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

BIO-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 BIO-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.

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

Discontinuation Symptoms

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

Serious side effects and what to do about them
Symptom / effect Talk to your healthcare professional Only if severe Talk to your healthcare professional In all cases Stop taking drug and get immediate medical help
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/hypomania: 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 reduce in or around eye, eye pain and change 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 Precautions
Serotonin syndrome: a combination of most or all of the following; confusion, restlessness, sweating, shaking, shivering, sudden jerking of the muscles, hallucinatio ns, fast heartbeat    
Changes in feelings or behavior (anger, anxiety, suicidal or violent thoughts)    

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

How to store
  • Store BIO-SERTRALINE at room temperature (15°C-30°C), in a dry place.
  • Keep container tightly closed.
  • Keep all medicines out of the reach and sight of children.
  • If your doctor tells you to stop taking BIOSERTRALINE please return any leftover medicine to your pharmacist.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

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 BIO-SERTRALINE:

This leaflet was prepared by
Biomed Pharma
1B-9450 Boulevard Langelier
Montreal, Quebec
H1P 3H8

Date of Revision: August 12, 2020

Date modified: