Apo-Sertraline: Uses, Side Effects and Dosage

Serious Warnings and Precautions

What is APO-SERTRALINE used for?

APO-SERTRALINE is used in adults 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)
• Obsessive-compulsive disorder (recurrent and intrusive thoughts, feelings, ideas, or sensations; recurrent pattern of behaviour, or unwanted thoughts or actions)
• Panic disorder (repeated, unexpected panic attacks)

How does APO-SERTRALINE work?

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

APO-SERTRALINE is thought to work by increasing the levels of a chemical in the brain called serotonin. This helps to relieve your symptoms of depression, obsessive-compulsive disorder and/or panic disorder.

What are the ingredients in APO-SERTRALINE?

Medicinal ingredients: Sertraline Hydrochloride

Non-medicinal ingredients: Colloidal silicon dioxide; corn starch; croscarmellose sodium, stearic acid and talc. 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, and titanium dioxide (all strengths).

APO-SERTRALINE comes in the following dosage forms:

Capsules: 25 mg, 50 mg and 100 mg sertraline (as sertraline hydrochloride).

Do not use APO-SERTRALINE if:

• you are allergic to sertraline hydrochloride or to any of the non-medicinal ingredients in APO-SERTRALINE (see What are the ingredients in APO-SERTRALINE).
• you are currently taking or have recently taken any monoamine oxidase inhibitors (MAOIs), such as phenelzine sulphate, tranylcypromine sulphate, moclobemide If you are unsure, ask your healthcare professional.
• you are currently taking pimozide

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take APO-SERTRALINE. Talk about any health conditions or problems you may have, including if you:

• have any diseases or conditions that affect your metabolism or heart function

• have or have a history of:

  • seizures
  • liver disease
  • high cholesterol
  • heart disease
  • heart rhythm problems
  • slow heart beat
  • taking medications for your heart
  • manic episodes
• have a family history of people younger than 50 years of age having a heart attack
• have 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
• have had a stroke
• are known to have heart problems or have been told you are at risk for heart problems
• have diabetes
• have or have a history of a bleeding disorder or have been told that you have low platelets
• have blood pressure problems;
• are pregnant or thinking about becoming pregnant, or if you are breast feeding
• had a recent bone fracture or were told you have osteoporosis or risk factors for osteoporosis
• drink alcohol and/or use street drugs
• have ever had any allergic reaction to medications, food, etc.

Other warnings you should know about:

Do NOT stop taking APO-SERTRALINE without talking to your healthcare professional first, as it may cause unwanted side effects such as headache, insomnia, numbness, tingling, burning, or prickling, nervousness, anxiety, nausea, sweating, dizziness, jitteriness and weakness.

Pregnancy: Only take APO-SERTRALINE during pregnancy if you and your healthcare professional have discussed the risks and have decided that you should. If you take APO-SERTRALINE near the end of your pregnancy, you may be at a higher risk of heavy vaginal bleeding shortly after birth. If you become pregnant while taking APO-SERTRALINE, tell your healthcare professional right away.

Effects on newborns: In some cases, babies born to a mother taking APO-SERTRALINE, during pregnancy may require hospitalization, breathing support and tube feeding. Be ready to seek medical help for your newborn if they:

• have trouble breathing or feeding,
• have muscle stiffness, or floppy muscles (like a rag doll)
• have seizures (fits)
• are shaking (jitteriness)
• are constantly crying

If you take APO-SERTRALINE:

• During early pregnancy, there is a possible slight increased risk that your newborn may have a heart defect.
• During late pregnancy, your newborn may be at risk of having a serious lung condition called Persistent Pulmonary Hypertension of the Newborn (PPHN), which causes breathing problems.

Falls and fractures: APO-SERTRALINE can cause you to feel sleepy or dizzy and can affect your balance. This increases your risk of falling, which can cause fractures or other fall related-injuries, especially if you:

• take sedatives
• consume alcohol
• are elderly
• have a condition that causes weakness or frailty

Serotonin toxicity (also known as Serotonin Syndrome): APO-SERTRALINE can cause serotonin toxicity, a rare but potentially life-threatening condition. It can cause serious changes in how your brain, muscles and digestive system work. You may develop serotonin toxicity if you take APO-SERTRALINE with certain anti-depressants or migraine medications. Serotonin toxicity symptoms include:

• fever, sweating, shivering, diarrhea, nausea, vomiting;
• muscle shakes, jerks, twitches or stiffness, overactive reflexes, loss of coordination
• fast heartbeat, changes in blood pressure;
• confusion, agitation, restlessness, hallucinations, mood changes, unconsciousness, and coma

Driving and using machines: APO-SERTRALINE may make you feel sleepy. Give yourself time after taking APO-SERTRALINE to see how you feel before driving a vehicle or using machinery.

APO-SERTRALINE can cause serious side effects including:

• Angle-closure glaucoma (sudden eye pain or change in vision)
• Heart rhythm problems
• Sexual dysfunction

See the Serious side effects and what to do about them table below for more information on these and other serious side effects.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may also interact with APO-SERTRALINE:

• other antidepressants, such as SSRIs and certain tricyclics
• other drugs that affect serotonin such as, amphetamines, opioids, tryptophan, fenfluramine
• certain medicines called “triptans” which are used to treat migraines, such as almotriptan, sumatriptan, rizatriptan, naratriptan, zolmitriptan
• certain medicines used to treat pain, such as fentanyl (used in anesthesia or to treat chronic pain), tramadol, tapentadol, meperidine, methadone, pentazocine
• metamizole, used to treat fever or pain
• certain medicines used to treat cough, such as dextromethorphan
• certain medicines used to treat bipolar depression, such as lithium
• drugs that affect your electrolyte levels such as diuretics (“water pills”), laxatives and enemas, amphotericin B, high dose corticosteroids (drugs that reduce inflammation)
• drugs that can affect how your blood clots such as warfarin, dabigatran, acetylsalicylic acid (Aspirin) and other non-steroidal anti-inflammatory drugs (NSAIDs)
• certain medicines used to treat seizures such as phenytoin
• cimetidine, a medicine used to treat heartburn
• insulin or oral medicines used to treat diabetes
• an herbal medicine called St. John’s Wort
• alcohol, it is recommended to avoid drinking alcohol while taking APO-SERTRALINE.

How to take APO-SERTRALINE:

• It is very important that you take APO-SERTRALINE exactly as your healthcare professional has instructed.
• Keep taking APO-SERTRALINE unless your healthcare professional tells you to stop.
• Continue to take APO-SERTRALINE even if you do not feel better, as it may take several weeks for your medicine to start working.

• Take with food either in the morning or the evening.

• Swallow the capsules whole, do not divide, crush or chew them.

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.

Usual dose:

Depression: The usual starting dose is 50 mg once daily. Your healthcare professional may decide to slowly increase your dose. The maximum dose is 200 mg daily.

Obsessive-compulsive disorder: The usual starting dose is 50 mg once daily. Your healthcare professional may decide to slowly increase your dose. The maximum dose is 200 mg daily.

Panic disorder: The usual starting dose is 25 mg once daily. Your healthcare professional may decide to slowly increase your dose. The maximum dose is 200 mg daily.

Overdose:

Missed Dose:

If you 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 missed dose.

What are possible side effects from using APO-SERTRALINE?

These are not all the possible side effects you may have when taking APO-SERTRALINE. If you experience any side effects not listed here, tell your healthcare professional.

• headache
• nausea
• dry mouth
• diarrhea
• loss of appetite
• indigestion
• sleepiness
• dizziness
• insomnia
• nervousness
• agitation
• tremor
• increased sweating

Serious side effects and what to do about them

Serious side effects and what to do about them

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

• Store APO-SERTRALINE at room temperature (15°C to 30°C). Protect unit dose packages from high humidity.
• Keep container tightly closed.
• If your healthcare professional tells you to stop taking APO-SERTRALINE please return any leftover medicine to your pharmacist.

Keep out of reach and sight of children.

If you want more information about APO-SERTRALINE:

• Talk to your healthcare professional

• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website:

  (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (http://www.apotex.ca/products), or by calling 1-800-667-4708.

Last Revised: JUN 23, 2023