Apo-Vortioxetine: Uses, Side Effects and Dosage

What is APO-VORTIOXETINE used for?

APO-VORTIOXETINE is used for treatment of depression in adults (18 years of age or older). APO-VORTIOXETINE is used to relieve the symptoms of depression which may include:

• feeling sad
• restless

Serious Warnings and Precautions

• irritable
• change in weight or appetite
• having a hard time concentrating or sleeping
• feeling tired
• headaches
• unexplained aches and pains.

How does APO-VORTIOXETINE work?

APO-VORTIOXETINE belongs to a group of medicines called antidepressants. It is thought to work by correcting the imbalance of serotonin in your brain. This may help ease emotional and physical symptoms of depression.

What are the ingredients in APO-VORTIOXETINE?

Medicinal ingredients: Vortioxetine hydrobromide

Non-medicinal ingredients: Dibasic calcium phosphate, magnesium stearate, mannitol, propyl gallate, polyvinyl alcohol, polyethylene glycol, red ferric oxide (5 mg, 15 mg and 20 mg), sodium starch glycolate, talc, titanium dioxide, yellow ferric oxide.

APO-VORTIOXETINE comes in the following dosage forms:

Tablets: 5 mg (pink), 10 mg (yellow), 15 mg (orange), or 20 mg (red).

Do not use APO-VORTIOXETINE if:

• you are allergic to vortioxetine or to any other ingredients in APO-VORTIOXETINE.

• you take Monoamine Oxidase Inhibitors (MAOIs).

  • Ask your doctor or pharmacist if you are not sure if you take a MAOI
  • Examples of MAOIs include phenelzine, tranylcypromine, moclobemide, selegiline, rasagiline linezolid which is an antibiotic, methylene blue which is a dye used in certain surgeries
  • If you stopped taking a MAOI within the last 14 days, only start APO-VORTIOXETINE if your doctor tells you to.

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

• have ever had any allergic reaction to medications, food, etc.;
• have any medical conditions, including a history of seizures, liver disease, kidney disease, heart problems;
• are taking or have taken medications (prescription or over-the-counter) and any natural or herbal products within the last 14 days;
• have or previously have had glaucoma or increased pressure in your eyes;
• have a history or family history of mania or bipolar disorder;
• are pregnant or intend to become pregnant;
• are breast-feeding;

• have a tendency to easily develop bruises or have known bleeding tendencies, or have
• have been told you have a low sodium level in the blood;
• take certain medicines which may affect blood clotting and increase bleeding, such as oral anticoagulants (e.g., warfarin), acetylsalicylic acid (ASA) and other nonsteroidal anti- inflammatory drugs (NSAIDs);
• are elderly, had a recent bone fracture, were told you have osteoporosis (weak or brittle bones) or have risk factors for osteoporosis;
• have a history of drug abuse.

APO-VORTIOXETINE is not for use in children and adolescents under 18 years of age.

Other warnings you should know about:

New or Worsened Emotional or Behavioural Problems

Treatment with APO-VORTIOXETINE or any type of antidepressant medication is most safe and effective when you and your doctor have good communication about how you are feeling. You may find it helpful to tell a relative or close friend that you are depressed. You might ask them to tell you if they think you are getting worse or if they are worried about changes in your behavior.

You may feel worse instead of better when you first start taking drugs like APO-VORTIOXETINE or when changing your dose. Your doctor should closely monitor you. You may have:

• new or worsened feelings of restlessness, agitation, anger, aggression, nervousness, short temperament. If this happens, speak to your doctor.
• thoughts about suicide, hurting yourself or other people. Thoughts and actions about suicide can occur especially if you have had thoughts of hurting yourself in the past. Suicidal thoughts and actions can occur in any age group but may be more likely if you are 18 to 24 years old. If this happens, seek immediate medical help. Do NOT stop taking APO-VORTIOXETINE on your own.

Ending treatment:

Abruptly ending your treatment of APO-VORTIOXETINE may cause you to experience discontinuation symptoms. If your doctor recommends that you stop taking APO-VORTIOXETINE, they will gradually lower your dose. This may help manage any symptoms of discontinuation, such as:

• dizziness, headache, runny nose
• sweating or feel like you are getting a flu
• increase in dreams/nightmares, having difficulty sleeping or feeling tired
• feeling angry, irritable, confused, or having mood swings
• muscles ache, feel tight or stiff.

Effects on Pregnancy and Newborns

APO-VORTIOXETINE should not be used during pregnancy unless your doctor decides the benefit outweighs the risk to your unborn baby. If you are already taking APO-VORTIOXETINE and have just found out that you are pregnant, you should talk to your doctor immediately.

If you take APO-VORTIOXETINE near the end of your pregnancy, you are at a higher risk of heavy bleeding shortly after birth.

You should also talk to your doctor if you are planning to become pregnant. It is very important that you do NOT stop taking APO-VORTIOXETINE without first talking to your doctor.

Some newborn babies experienced problems at birth when pregnant women took drugs similar to APO-VORTIOXETINE. This happened especially when the drug was taken in the last three months of pregnancy. Some newborns had:

• required breathing support, tube feeding and a longer stay in the hospital
• difficulty feeding or breathing, fits (seizures), tense or overly relaxed muscles and were jittery and cried constantly.
• vomited, had low blood sugar and body temperature changes
• sleeping difficulties
• a serious condition called Persistent Pulmonary Hypertension in the Newborn (PPHN). This made the babies breathe faster and appear blue.

These symptoms normally resolve over time. However, if your newborn baby has any of these symptoms, please contact your doctor immediately.

Effects on Sexual Function

Taking medicines like APO-VORTIOXETINE may increase your risk of having sexual problems. This may continue after APO-VORTIOXETINE has been discontinued, including for months or years afterwards in some cases. Tell your healthcare professional if you experience symptoms such as a decrease in sexual desire, performance or satisfaction. Medicines like APO-VORTIOXETINE may affect sperm quality. Fertility in some men may be reduced while taking APO-VORTIOXETINE.

Risk of breaking bone

Taking APO-VORTIOXETINE 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.

Serotonin Toxicity or Neuroleptic Malignant Syndrome:

Serotonin toxicity (also known as Serotonin syndrome) or Neuroleptic Malignant Syndrome: APO-VORTIOXETINE may cause Serotonin toxicity or Neuroleptic Malignant Syndrome, rare but potentially life-threatening conditions. They can cause serious changes in how your brain, muscles and digestive system work. You may develop Serotonin toxicity or Neuroleptic Malignant Syndrome if you take APO-VORTIOXETINE with certain medications used to treat depression, migraine or other mental health problems such as schizophrenia.

Speak to your doctor immediately about ending your treatment with APO-VORTIOXETINE if you develop a combination of symptoms, such as:

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

Eye Problems

APO-VORTIOXETINE can cause eye problems such as mydriasis. Mydriasis is a condition where your pupils widen in an unusual way. This can cause a build-up of fluid and pressure in your eyes. Tell your doctor right away if you experience visions changes, eye pain, redness in or around the eye.

Driving and Using Machines:

Wait until you know how you feel after you have taken APO-VORTIOXETINE for the first time or when changing your dose. Do not drive or use heavy machines until you know how APO-VORTIOXETINE affects you.

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

Do not use APO-VORTIOXETINE if you are taking Monoamine oxidase inhibitors (MAOIs) or have stopped taking an MAOI in the last 14 days. You will need to wait at least 21 days after you stop taking APO-VORTIOXETINE before you can start taking an MAOI. Taking MAOIs can increase your chances of having serious side effects. Examples of MAOIs are:

• phenelzine
• tranylcypromine
• moclobemide
• selegiline
• linezolid
• methylene blue

The following may interact with APO-VORTIOXETINE:

• other antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs) or Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs) (e.g. fluoxetine, venlafaxine, paroxetine), certain tricyclics (e.g. amitriptyline, desipramine), drugs used to treat schizophrenia (e.g. olanzapine, risperidone), or bipolar depression (e.g. lithium).
• other drugs that affect serotonin, such as lithium, drugs containing tryptophan, St. John’s Wort, triptans used to treat migraines.
• certain opioid medicines used to treat pain, such as fentanyl (used in anaesthesia or to treat chronic pain), tramadol, tapentadol, meperidine, methadone, pentazocine.

• certain medicines which may affect blood clotting and increase bleeding, such as oral anticoagulants (e.g. warfarin, dabigatran), acetylsalicylic acid (ASA) and other non-

  • -inflammatory drugs (e.g. ibuprofen).
• certain medicines that can increase the risk of seizures by lowering the seizure threshold (e.g. medicines to treat depression (tricyclics, SSRIs, SNRIs); medicines to treat mental disorders (belonging to the groups called phenothiazines, thioxanthenes, butyrophenones); mefloquin (a medicine to prevent and treat malaria); bupropion (a medicine to treat depression also used to wean from smoking); tramadol (a strong painkiller).
• certain medicines used to treat cough, such as dextromethorphan.
• certain medicines that are strong inhibitors of CYP3A4. Such as itraconazole (antifungal medicine), clarithromycin (antibacterial medicine) and HIV protease inhibitors.
• bupropion (an antidepressant and smoking cessation aid), as this may increase your blood levels of APO-VORTIOXETINE.
• rifampicin (an antibiotic) as this may lower your blood levels of APO-VORTIOXETINE.

APO-VORTIOXETINE and urine drug tests: Taking APO-VORTIOXETINE may cause false results. APO-VORTIOXETINE may cause a urine drug test to show positive results for methadone. If this happens, a more specific test can be performed.

APO-VORTIOXETINE and alcohol: Combining APO-VORTIOXETINE with alcohol is not advisable.

How to take APO-VORTIOXETINE:

• Take one tablet with a glass of water, with or without food.
• Take exactly as the doctor tells you to take it.

Usual dose:

18 to 64 years of age: The usual dose is 10 mg once a day. Depending on how you respond, your doctor may:

• Increase your maximum dose to 20 mg once a day
• Decrease your minimum dose to 5 mg once a day

65 years of age and over: The usual starting dose is 5 mg once a day.

Stopping treatment

Continue to take APO-VORTIOXETINE for as long as your doctor recommends. Do not suddenly stop taking or change the dose without talking to your doctor first. Suddenly stopping treatment or changing the dose may cause unpleasant side effects.

Overdose:

Some of the signs of an overdose could be:

• Dizziness and nausea
• Diarrhea and stomach discomfort
• Itching of whole body
• Sleepiness
• Reddening of skin
• Fits (seizures)
• A rare condition called serotonin toxicity

Missed Dose:

If you missed a dose of this medication, you do not need to make up the missed dose. Skip the missed dose and continue with your next scheduled dose. Do not take two doses at the same time.

What are possible side effects from using APO-VORTIOXETINE?

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

The most common side effects of APO-VORTIOXETINE are:

• Abdominal pain, bloating
• Common cold, Influenza (flu) symptoms
• Nausea, vomiting
• Decreased appetite
• Abnormal dreams and difficulty sleeping
• Dizziness
• Dry Mouth
• Diarrhea, Constipation
• Fatigue, sleepiness
• Sedated (feeling calm)
• Body feels itchy
• Joint and muscle pain
• Increase in sweating
• Cough

Other possible side effects of APO-VORTIOXETINE may include:

• Abnormal excessive sweating
• Dry eye
• Grinding teeth
• Headache
• Reddening of skin
• Night sweats
• Weight gain
• Muscle twitching
• Yawning
• Dehydration
• Late menstrual cycle (period) and sensitive breasts
• Sexual problems (decreases in sexual desire, performance and satisfaction, may also lead to further decreases, which may continue after the drug is stopped)

APO-VORTIOXETINE may also cause serious side effects including those mentioned above in “Other warnings you should know about” and the table below.

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

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, talk to your healthcare professional.

Reporting Side Effects

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

Storage:

Keep out of sight and reach of children.

Store at room temperature 15^oC to 30^oC. Protect from moisture.

Do not use APO-VORTIOXETINE after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

If you want more information about APO-VORTIOXETINE:

• 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: MAR 7, 2025