Details for: NRA-ESCITALOPRAM
Company: NORA PHARMA INC
DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
---|---|---|---|---|---|
02476851 | NRA-ESCITALOPRAM | ESCITALOPRAM (ESCITALOPRAM OXALATE) | 10 MG | TABLET | ORAL |
02476878 | NRA-ESCITALOPRAM | ESCITALOPRAM (ESCITALOPRAM OXALATE) | 20 MG | TABLET | ORAL |
Summary Reports
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
NRA-Escitalopram has been prescribed to you by your doctor to relieve your symptoms of depression or obsessive compulsive disorder. Treatment with these types of medications is most safe and effective when you and your doctor have good communication about how you are feeling.
What it does
NRA-Escitalopram belongs to a group of medicines known as antidepressants, more specifically to the family of medicines called SSRIs (Selective Serotonin Reuptake Inhibitors).
NRA-Escitalopram is thought to work by increasing the levels of a chemical in the brain called serotonin (5- hydroxytryptamine). Disturbances in the serotoninsystem are considered an important factor in the development of depression and related diseases.
When it should not be used
- Do not use NRA-Escitalopram at the same time as pimozide.
- Do not use NRA-Escitalopram if you are currently or have recently taken monoamine oxidase antidepressants (e.g. phenelzine sulphate, moclobemide).
- Do not take NRA-Escitalopram if you are allergic to it, or to any of the components of its formulation (for list of components see the section on “What NRA-Escitalopram contains”).
- Stop taking NRA-Escitalopram and contact your doctor immediately if you experience an allergic reaction or any severe side effect.
- Do not use NRA-Escitalopram if you have been diagnosed with a congenital long QT syndrome
What the medicinal ingredient is
Escitalopram oxalate
What the non-medicinal ingredients are
NRA-Escitalopram (Escitalopram Tablets USP): Colloidal Anhydrous Silica, Croscarmellose Sodium, Hypromellose E5, Hypromellose E15, Magnesium Stearate, Microcrystalline cellulose (Avicel PH 101), Polyethylene Glycol 400, Purified Talc & Titanium dioxide (E171)
What dosage form it comes in
NRA-Escitalopram 10 mg: Each film-coated, White to off-white, oval, biconvex, film coated tablets debossed with ‘1’ and ‘0’ on either side of break line and plain on other side contains: escitalopram 10 mg (as escitalopram oxalate) in blister packs or bottles.
NRA-Escitalopram 20 mg: Eachfilm-coated, White to off-white, oval, biconvex, film coated tablets debossed with ‘2’ and ‘0’ on either side of break line and plain on other side contains: escitalopram 20 mg (as escitalopram oxalate) in blister packs or bottles.
Warnings and precautions
Treatment with these types of medications is most safe and effective when you and your doctor have good communication about how you are feeling.
NRA-Escitalopram is not for use in children under 18 years of age.
New or Worsened Emotional or Behavioural Problems
Particularly in the first few weeks or when doses are
adjusted, a small number of patients taking drugs of this
type may feel worse instead of better, they may
experience new or worsened feelings of agitation,
hostility, anxiety, or thoughts about suicide, or harm to
others. Suicidal thoughts and actions can occur in any
age group but may be more likely in patients 18 to 24
years old. Should this happen to you, or to those in
your care, consult your doctor immediately. Close
observation by a doctor is necessary in this situation. Do
not discontinue your medication on your own.
You may be more likely to think like this if you have previously had thoughts about harming yourself.
You may find it helpful to tell a relative or close friend that you are depressed, and ask them to read this leaflet. You might ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behaviour.
Effects on Pregnancy and Newborns
If you are already taking / using NRA-Escitalopram
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.
Possible complications at birth (from taking any newer
antidepressant, including NRA-Escitalopram):
Post-marketing reports indicate that some newborns
whose mothers took an SSRI (Selective Serotonin
Reuptake Inhibitor) such as NRA-Escitalopram or other
newer antidepressant during pregnancy have developed
complications at birth requiring prolonged hospitalisation,
breathing support and tube feeding. Reported symptoms
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, lethargy, sleepiness,
sleeping difficulties and constant crying. In most cases,
the newer antidepressant was taken during the third
trimester of pregnancy. These symptoms are consistent
with either a direct adverse effect of the antidepressant
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 NRA-Escitalopram
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.
Risk of Bone Fractures:
Taking NRA-Escitalopram 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.
Angle-closure Glaucoma:
NRA-Escitalopram can cause dilation of the pupil which
may trigger an acute glaucoma attack in an individual with
narrow ocular angles. Having your eyes examines before
you take NRA-Escitalopram 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.
Before you use NRA-Escitalopram, tell your doctor:
- All your medical conditions, including heart problems, history of seizures, manic-depressive illness, liver or kidney disease, or diabetes
- You have a bleeding disorder or have been told that you have low platelets
- If you have QT / QTc prolongation or a family history of QT / QTc prolongation
- If you have a personal history of fainting spells
- If you have a family history of sudden cardiac death at <50 years
- If you have electrolyte disturbances (e.g., low blood potassium, magnesium, or calcium levels) or conditions that could lead to electrolyte disturbances (e.g., vomiting, diarrhea, dehydration)
- If you have an eating disorder or are following a strict diet
- If you had a recent bone fracture or were told you have osteoporosis or risk factors for osteoporosis
- If you are pregnant or thinking about becoming pregnant, or if you are breast feeding
- If you are receiving electroconvulsive treatment
- Any medications (prescription or non-prescription) which you are taking or have taken within the last 14 days, especially monoamine oxidase inhibitors, pimozide, any other antidepressants, triptans used to treat migraines, lithium, tramadol or drugs containing tryptophan.
- If you ever had an allergic reaction to any medication or any of the ingredients mentioned in this leaflet.
- 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.
Interactions with this medication
Serious Drug Interactions
Do not use NRA-Escitalopram if you are taking or have recently taken:
- Monoamine oxidase inhibitor (e.g.,phenelzine, tranylcypromine, moclobemide or selegiline)
- Pimozide
- Linezolid (an antibiotic)
- Methylene blue (intravenous)
The following list includes some, but not all, of the drugs that may increase the risk of side-effects while receiving NRA-Escitalopram. You should check with your doctor or pharmacist before taking any other medication (prescription, non- prescription or natural/herbal) with NRA-Escitalopram. Other drugs that may interact with NRA-Escitalopram include:
- drugs to treat heart rhythm disturbances (antiarrhythmics)
- antipsychotics
- opioid painkillers
- drugs to treat infections
- Diuretics (water pills)
- Laxatives (including enemas)
- Other SSRIs (citalopram) or any other antidepressant (e.g., imipramine, desipramine)
- Lithium
- Tryptophan
- Cimetidine
- Triptans (e.g., sumatriptan, zolmitriptan, naratriptan)
- Fluconazole
- Ketoconazole
- Itraconazole
- Racemic Citalopram (Celexa)
- Warfarin
- Omeprazole
- 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 nonsteroidal anti-inflammatory drugs (e.g.., ibuprofen)
- Certain medicines used to treat pain, such as fentanyl (used in anaesthesia or to treat chronic pain), tramadol, tapentadol, meperidine, methadone, pentazocine.
- Certain medicines used to treat cough, such as dextromethorphan.
Avoid drinking alcohol while taking NRA-Escitalopram
Drugs from the class that NRA-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 your platelets.
Treatment with an SSRI in patients with diabetes may alter glycaemic control (hypoglycaemia and hyperglycaemia).
Tell your doctor all the medicines (prescription or over the counter) and natural health products that you are using or thinking of taking.
Proper use of this medication
Usual dose
- It is important that you take NRA-Escitalopram exactly as your doctor has instructed.
- Usually your doctor will prescribe 10 mg per day, which you will take once daily preferably at the same time each day. If you are elderly, your doctor may prescribe a lower dose. This dose may be increased. Never change the dose of NRA-Escitalopram you are taking, or that someone in your care is taking unless your doctor tells you to.
- You should continue to take NRA-Escitalopram even if you do not feel better, as it may take several weeks for your medication to work. Improvement may be gradual.
- Continue to take NRA-Escitalopram for as long as your doctor recommends it. Do not stop taking your tablets abruptly even if you begin to feel better, unless you are told to do so by your doctor. Your doctor may tell you to continue to take NRA-Escitalopram for several months. Continue to follow your doctor’s instructions.
Proper Handling Instructions
- Take everyday, as a single daily dose.
- Swallow the tablets whole with a drink of water. Do not chew them. NRA-Escitalopram can be taken with or without food.
Overdose
If you have accidentally taken too much NRA-Escitalopram contact your doctor, the Regional Poison Control Centre or nearest hospital emergency department immediately, even if you do not feel sick. If you go to the doctor or the hospital, take the NRA-Escitalopram container with you. Some of the signs of an overdose could be dizziness, tremor, agitation, convulsion, 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.
Side effects and what to do about them
- NRA-Escitalopram may cause unwanted effects (side-effects). These may include nausea, increased sweating, diarrhoea, 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.
- Contact your doctor before stopping or reducing your dosage of NRA-Escitalopram. Symptoms such as dizziness, abnormal dreams, electric shock sensations, agitation, anxiety, emotional indifference, difficulty concentrating, headache, migraine, tremor (shakiness), nausea, vomiting, sweating or other symptoms may occur after stopping or reducing the dosage of escitalopram. 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 escitalopram to reduce the symptoms.
- Side-effects are often mild and may disappear after a few days. If they are troublesome or persistent, or if you develop any other unusual side-effects while taking NRA-Escitalopram, please consult your doctor.
- Usually NRA-Escitalopram does not affect your ability to carry out normal daily activities. However, you should not drive a car or operate machinery until you are reasonably certain that NRA-Escitalopram does not affect you adversely.
Symptom / effect | Talk with your doctor or pharmacist right away Only if severe | Talk with your doctor or pharmacist right away In all cases | Seek immediate emergency medical assistance |
---|---|---|---|
Uncommon | |||
Allergic reactions: 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 | ✔ | ||
Allergic reactions: skin rash alone, hives alone | ✔ | ||
Alteration of blood sugar control in patients with diabetes: Low blood sugar (symptoms of dizziness, lack of energy, drowsiness, headache, trembling, sweating) or High blood sugar (symptoms of increased thirst, increased urination, weakness, confusion, fruity breath odour) | ✔ | ||
Low Platelets: Bruising or unusual bleeding from the skin or other areas | ✔ | ||
Hallucinations: Strange visions or sounds | ✔ | ||
Mania: Overactive behaviour and thoughts | ✔ | ||
Uncontrollable movements of the body or face | ✔ | ||
Inability to urinate | ✔ | ||
Rare | |||
Serotonin syndrome: a combination of symptoms, possibly including: agitation, confusion, tremor, sudden jerking of muscles, high fever | ✔ | ||
Low sodium level in blood: Symptoms of tiredness, weakness, confusion combined with achy, stiff or uncoordinated muscles | ✔ | ||
Glaucoma: Increased pressure in the eye, eye pain, and blurred vision | ✔ | ||
Very Rare | |||
Seizures: Loss of consciousness with uncontrollable shaking (“fit”) | ✔ | ||
Liver disorder: symptoms include nausea, vomiting, loss of appetite combined with itching, yellowing of the skin or eyes, dark urine | ✔ | ||
Gastrointestinal bleeding: Vomiting blood or passing blood in stools | ✔ | ||
See Warnings & Precautions | |||
New or Worsened Emotional or Behavioural Problems | ✔ | ||
Akathisia: Feeling restless and unable to sit or stand still | ✔ | ||
Unknown | |||
Abnormal heart rate or rhythm, palpitations, fainting | ✔ |
How to store
- As with all medicines, keep NRA-Escitalopram out of the reach and sight of children.
- Store your NRA-Escitalopram (Escitalopram tablets USP) at room temperature (15-30°C) in a dry place and keep the container tightly closed.
- There is an expiry date on the label. Do not use the medicine after this date.
- If your doctor tells you to stop taking your medicine you should return any leftover tablets to the pharmacist, unless the doctor tells you to keep them at home.
REMEMBER: This medicine is for YOU. Only a doctor can prescribe it, so never offer it to any other person, even if their symptoms seem to be the same as yours.
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 (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.
More information
If you want more information about NRA-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 (www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); or by calling the sponsor Nora Pharma Inc. at 1-877- 352-7314
This leaflet was prepared by:
Nora Pharma Inc.
205-2900 Boul Cote-Vertu
Saint-Laurent, Quebec, H4R 3E8
Last Revised: June 4, 2018