Kye-Escitalopram: Uses, Side Effects and Dosage

Serious Warnings and Precautions

New or worsened emotional or behaviour problems:

• When you first start taking KYE-ESCITALOPRAM or when your dose is adjusted, you may feel worse instead of better. You may feel new or worsened feelings of agitation, hostility, anxiety, or impulsivity.
• During your treatment with KYE-ESCITALOPRAM, it is important that you and your healthcare professional talk regularly about how you are feeling. They will closely monitor you for signs of new or worsened emotions or behaviours while you are taking KYE-ESCITALOPRAM.

• You may find it helpful to tell a relative or close friend that you are depressed. Ask them to read this leaflet. You might ask them to tell you if they:

  • think your depression is getting worse, or
  • are worried about changes in your behaviour.
• If your depression worsens or you experience changes in your behaviour, tell your healthcare professional right away. Do not stop taking your medicine as it takes time for KYE-ESCITALOPRAM to work.

Self-harm or Suicide

• Antidepressants, such as KYE-ESCITALOPRAM, can increase the risk of suicidal thoughts or actions.
• If you have thoughts of harming or killing yourself at any time, tell your healthcare professional or go to a hospital right away. You will be closely observed by your healthcare professional in this situation.

What is KYE-ESCITALOPRAM used for?

KYE-ESCITALOPRAM is used to relieve the symptoms of depression, anxiety, or obsessive compulsive disorder (OCD) in adults. Your health care professional will keep evaluating if KYE-ESCITALOPRAM is still safe and effective for you if you take it for a long time.

How does KYE-ESCITALOPRAM work?

KYE-ESCITALOPRAM is known as an antidepressant and belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs).

Escitalopram oxalate works by increasing the levels of a chemical in the brain called serotonin. Changes in the amount of serotonin in your brain can contribute to the development of depression and related diseases.

What are the ingredients in KYE-ESCITALOPRAM?

Medicinal ingredients: Escitalopram oxalate

Non-medicinal ingredients: Microcrystalline cellulose, silica colloidal anhydrous, croscarmellose sodium, talc, magnesium stearate, purified water, hypromellose, polysorbate 80, polyethylene glycol, titanium dioxide.

KYE-ESCITALOPRAM comes in the following dosage forms:

As tablets containing 15 mg escitalopram (as escitalopram oxalate)

Do not use KYE-ESCITALOPRAM if:

• you are allergic to escitalopram oxalate
• you are allergic to any of the other ingredients in KYE-ESCITALOPRAM or to a component of the container
• you are also taking the medicine pimozide, used to treat schizophrenia
• you are currently taking or have recently taken within 14 days medicines called monoamine oxidase antidepressants such as phenelzine sulphate, tranilcypromine or moclobemide, or other monoamine oxidase inhibitors such as linezolid, methylene blue, selegiline.
• you have been told that you have QT interval prolongation or have been diagnosed with a congenital long QT syndrome

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

• have heart problems
• have diabetes. KYE-ESCITALOPRAM may make it more difficult to control your blood sugar
• have liver or kidney problems
• have or have had a seizure disorder
• have or have had manic episodes or have been diagnosed with bipolar disorders
• are receiving Electroconvulsive Therapy (ECT)
• have a bleeding disorder or have been told that you have low platelets
• have a family history of QT/QTc prolongation (abnormal electrical activity of the heart).
• have electrolyte disturbances like low blood potassium, magnesium, or calcium levels) or conditions that could lead to this such as vomiting, diarrhea, dehydration
• had a recent bone fracture or were told you have osteoporosis or risk factors for osteoporosis
• are taking any other antidepressants, triptans used to treat migraines, lithium, opioids (including to treat pain, or drug dependence) or drugs containing tryptophan.
• ever had an allergic reaction to any medication or any of the ingredients mentioned in this leaflet.
• have habits of alcohol and/or street drug consumption.
• are taking St. John’s Wort, an herbal product used to treat depression

Other warnings you should know about:

It is important that you and your health care professional talk regularly about how you are feeling while you are taking KYE-ESCITALOPRAM.

KYE-ESCITALOPRAM should not be used in children and adolescents under 18 years of age.

Activation of Mania

Tell your healthcare professional if you have or have had manic episodes in the past or if you have been diagnosed with bipolar disorder. KYE-ESCITALOPRAM should be used with caution if you have a history of mania/hypomania. Some patients with bipolar disorder (also known as manic depression) may enter into a manic phase when they start taking KYE-ESCITALOPRAM. Tell your healthcare professional if you experience symptoms of mania such as excessive physical activity, overactive behaviour or thoughts, increased energy, trouble sleeping, racing thoughts, reckless behaviour, excessive happiness or irritability, talking more or faster than usual.

Bleeding Problems

Before taking KYE-ESCITALOPRAM tell your healthcare professional if you have a bleeding disorder including low blood platelets. Drugs from the class that KYE-ESCITALOPRAM belongs to may increase the chance of a bleeding event such as nose bleeds, bruising and even life-threatening bleeding. This is more likely if you have a history of a bleeding disorder or are taking other drugs that are known to affect blood clotting. Talk to your healthcare professional about drugs that might increase bleeding.

Pregnancy

Before taking KYE-ESCITALOPRAM, tell your healthcare professional if you are pregnant, think you might be pregnant or are planning to become pregnant. You should not take KYE-ESCITALOPRAM if you are pregnant unless you and your healthcare professional have discussed the risks and decided that you should take it. Tell your healthcare professional right away if you become pregnant while taking KYE-ESCITALOPRAM. If you take KYE-ESCITALOPRAM near the end of your pregnancy, you could have heavy vaginal bleeding shortly after giving birth.

Effects on Newborns

Some newborn babies whose mothers took medications such as escitalopram oxalate during pregnancy have developed problems at birth. These problems include prolonged hospitalisation, breathing support and tube feeding. Symptoms can include:

• feeding and/or breathing difficulties
• bluish skin
• seizures
• body temperature changes
• vomiting
• low blood sugar
• tense or overly relaxed muscles
• vivid reflexes
• tremor
• jitteriness
• irritability
• weakness
• sleepiness, sleeping difficulties and constant crying.

In most cases, these medications were taken during the third trimester of pregnancy. These symptoms are caused by the medication itself or from the effects of suddenly stopping the medication. These symptoms normally go away over time. However, if your baby experiences any of these symptoms, contact your healthcare professional as soon as you can.

Persistent Pulmonary Hypertension of the Newborn (PPHN):

If you take KYE-ESCITALOPRAM towards the end of your pregnancy, your newborn may be at risk of having a serious lung condition called Persistent Pulmonary Hypertension of the Newborn (PPHN). This causes breathing problems in newborns soon after birth. Newborn babies may breathe faster and appear bluish. These symptoms usually begin during the first 24 hours after the baby is born. If this happens to your newborn baby, get immediate medical help for them.

Breastfeeding

Tell your healthcare professional if you are breastfeeding or planning to breastfeed. KYE-ESCITALOPRAM is released into breast milk. It is not known if this is safe for your baby. You should not breastfeed a baby if you are taking KYE-ESCITALOPRAM unless you and your healthcare professional have discussed the risks and decided that you should.

Effects on the electrical activity of the heart

KYE-ESCITALOPRAM has an effect on the electrical activity of the heart known as QT/QTc prolongation (abnormal electrical activity of the heart). This can lead to disturbances in heart rhythm (arrhythmias/dysrhythmias) that could result in dizziness, palpitations (sensation of rapid, pounding, or irregular heart beat), fainting or cardiac arrest. This is more likely in patients with risk factors, such as heart disease, heart attack, or in the presence of certain drugs that could interact with the activity of the heart. If you experience any symptoms of a possible heart rhythm disturbance (abnormal heart rate or rhythm), such as dizziness, palpitations (sensation of rapid, pounding, or irregular heart beat), fainting, you should seek immediate medical attention.

Serotonin Toxicity (also known as Serotonin syndrome) or Neuroleptic malignant syndrome:

Serotonin toxicity (also known as Serotonin syndrome): KYE-ESCITALOPRAM can 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 KYE-ESCITALOPRAM with certain medications used to treat depression, migraine or other mental health problems such as schizophrenia.

Serotonin toxicity or Neuroleptic malignant syndrome symptoms include:

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

Effects on Sexual Function:

Taking medicines like KYE-ESCITALOPRAM may cause symptoms of sexual dysfunction. In some cases these symptoms have continued after stopping KYE-ESCITALOPRAM treatment. Talk to your healthcare professional if you experience symptoms such as a decrease in sexual desire, performance or satisfaction.

Risk of Bone Fractures

Taking KYE-ESCITALOPRAM may increase your risk of breaking a bone if you are elderly, have osteoporosis or 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.

Angle-closure Glaucoma

KYE-ESCITALOPRAM can cause dilation of the pupil. This may cause an acute glaucoma attack in an individual with narrow ocular angles. Having your eyes examined before you take KYE- ESCITALOPRAM could help identify if you are at risk of having angle-closure glaucoma. Get immediate medical attention if you experience:

• eye pain
• changes in vision
• swelling or redness in or around the eye.

Driving and using machines

KYE-ESCITALOPRAM may impair your ability to drive or to use machines. Wait until you know how KYE-ESCITALOPRAM affects you before driving or using machines. Do not drive or use machines if KYE-ESCITALOPRAM impairs your ability to do so safely.

Discontinuation Symptoms

Contact your healthcare professional before stopping or reducing your dosage of escitalopram. If you stop or reduce the dosage of KYE-ESCITALOPRAM abruptly, or if you miss a dose, you may experience symptoms such as dizziness, abnormal dreams, sensory disturbances like electric shock sensations, agitation, anxiety, emotional indifference, difficulty concentrating, headache, migraine, tremor (shakiness), nausea, vomiting, sweating or other symptoms. Tell your healthcare professional immediately if you have these or any other symptoms. Your healthcare professional or may adjust the dosage of escitalopram to reduce the symptoms.

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

The following may interact with KYE-ESCITALOPRAM:

• drugs to treat heart rhythm disturbances (antiarrhythmics)
• antipsychotics, used to treat schizophrenia
• opioids (including for pain, drug dependence or anesthesia) such as methadone, buprenorphine, tramadol, fentanyl, tapentadol, meperidine or pentazocine.
• drugs to treat infections
• diuretics (water pills)

• laxatives (including enemas)

  Serious Drug Interactions

Do not use KYE-ESCITALOPRAM if you:

• are taking or have taken within 14 days monoamine oxidase inhibitor such as phenelzine, tranylcypromine, moclobemide or selegiline linezolid (as antibiotic) or Methylene blue (intravenous)

• are taking pimozide

  • other SSRIs (e.g.,citalopram) or any other antidepressant (e.g., imipramine, desipramine) used to treat depressions
  • lithium, used to treat mood disorder
  • tryptophan, for sleep aid or treating anxiety
  • cimetidine, for acidity problems
  • triptans (e.g., sumatriptan, zolmitriptan, naratriptan), for Migraine
  • fluconazole, for treating fungal infection
  • ketoconazole, for treating fungal infection
  • itraconazole, for treating fungal infection
  • warfarin, used to prevent clot of blood
  • omeprazole, used to treat stomach problems
  • any herbal product such as St. John’s Wort
  • 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 non-steroidal anti-inflammatory drugs (e.g., ibuprofen)
  • certain medicines used to treat cough, such as dextromethorphan. Avoid drinking alcohol while taking KYE-ESCITALOPRAM.

How to take KYE-ESCITALOPRAM:

• Take KYE-ESCITALOPRAM exactly as your healthcare professional has told you

• You may divide the 15 mg tablet into equal parts as recommended by your healthcare professional. To divide the tablet:

  • Place the tablet on a flat surface with the score facing upwards
  • Using both forefingers, press down on each end of the tablet
  • Swallow the whole or half tablets with water. Do not chew the tablets as they have a bitter taste

• You can take KYE-ESCITALOPRAM with or without food

• Take KYE-ESCITALOPRAM once a day at the same time every day
• Continue taking KYE-ESCITALOPRAM even if you do not feel better. It may take several weeks for it to work and improvement may be gradual
• Keep taking KYE-ESCITALOPRAM for as long as your healthcare professional recommends. Do not stop taking KYE-ESCITALOPRAM abruptly even if you feel better unless your healthcare professional has told you to.
• Never take more KYE-ESCITALOPRAM than your healthcare professional has prescribed for you.
• Follow all instructions given to you by your healthcare professional

Usual dose:

The usual dose is one 10 mg tablet once a day. Your healthcare professional might prescribe a lower dose to you if you are elderly, have liver problems or in other situations.

Overdose:

Some of the signs of an overdose could be dizziness, tremor, agitation, sweating, drowsiness, coma, nausea, vomiting, change in heart rhythm, decreased blood pressure and seizure.

Missed Dose:

If you forget a dose, take the next dose as planned. Do not take a double dose to make up for a forgotten dose.

What are possible side effects from using KYE-ESCITALOPRAM?

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

Side effects may include:

• nausea,
• increased sweating,
• diarrhea,
• fatigue,
• fever,
• constipation,
• clogged or runny nose,
• sleep disturbance,
• loss of appetite,
• increased appetite,
• increased weight,
• decreased interest in sex,
• decreased ability to reach orgasm,
• erectile dysfunction,
• anxiety,
• restlessness,
• abnormal dreams,
• difficulties falling asleep,
• drowsiness,
• yawning,
• tremor (shakiness),
• prickling of the skin,
• dizziness,
• dry mouth,
• heartburn,
• pain in muscles and joints,
• stomach pain and changes in heart rate,
• bone fracture,
• increased levels of the hormone prolactin, that may lead to breast discomfort, leakage of milk from the breasts, menstrual irregularity.

If you think you, or a person you are caring for, have taken too much, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

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.

Storage:

• Keep KYE-ESCITALOPRAM out of the reach and sight of children.
• Store KYE-ESCITALOPRAM at room temperature (15-30°C) in a dry place and keep the container tightly closed.

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.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.

If you want more information about KYE-ESCITALOPRAM:

• 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 www.kyepharma.com, or by calling 1-888-822-7126.