Details for: AURO-ESCITALOPRAM
Company: AURO PHARMA INC
DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
---|---|---|---|---|---|
02397358 | AURO-ESCITALOPRAM | ESCITALOPRAM (ESCITALOPRAM OXALATE) | 10 MG | TABLET | ORAL |
02397374 | AURO-ESCITALOPRAM | ESCITALOPRAM (ESCITALOPRAM OXALATE) | 20 MG | TABLET | ORAL |
Summary Reports
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
AURO-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
AURO-ESCITALOPRAM belongs to a group of
medicines known as antidepressants, more
specifically to the family of medicines called SSRIs
(Selective Serotonin Reuptake Inhibitors).
AURO-ESCITALOPRAM is thought to work by
increasing the levels of a chemical in the brain called
serotonin (5-hydroxytryptamine). Disturbances in the
serotonin-system are considered an important factor
in the development of depression and related
diseases.
When it should not be used
- Do not use AURO-ESCITALOPRAM at the same
time as pimozide.
- Do not use AURO-ESCITALOPRAM if you are
currently or have recently taken monoamine
oxidase antidepressants (e.g. phenelzine sulphate,
moclobemide).
- Do not take AURO-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 AURO-ESCITALOPRAM contains”).
- Stop taking AURO-ESCITALOPRAM and
contact your doctor immediately if you experience
an allergic reaction or any severe side effect.
- Do not use AURO-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
Silicified microcrystalline cellulose, Croscarmellose sodium, Butyl hydroxyl toluene, Butyl hydroxyl anisole, Cellulose microcrystalline, silica, hypermellose, macrogol 400, titanium dioxide Magnesium stearate, Talc.
What dosage form it comes in
White 5 mg, 10 mg, 15 mg or 20 mg tablets 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.
AURO-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 AURO-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 AURO-ESCITALOPRAM):
Post-marketing reports indicate that some newborns
whose mothers took an SSRI (Selective Serotonin
Reuptake Inhibitor) such as AURO-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 AURO-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 AURO-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:
Escitalopram can cause dilation of the pupil which
may trigger an acute glaucoma attack in an individual
with narrow ocular angles. Having your eyes
examined before you take AURO-ESCITALOPRAM
could help identify if you are at risk of having angleclosure
glaucoma. Seek immediate medical attention
if you experience:
- eye pain
- changes in vision
- swelling or redness in or around the eye.
Before you use AURO-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 AURO-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 AURO-ESCITALOPRAM. You should check with your doctor or pharmacist before taking any other medication with AURO-ESCITALOPRAM. Other drugs that may interact with AURO-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.
Drugs from the class that AURO-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 AURO-ESCITALOPRAM exactly as your doctor has instructed.
- You should continue to take AURO-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 AURO-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 AURO-ESCITALOPRAM for several months. Continue to follow your doctor’s instructions.
- Take everyday, as a single daily dose.
- Swallow the tablets whole with a drink of water. Do not chew them. AURO-ESCITALOPRAM tablets can be taken with or without food.
Overdose
If you go to the doctor or the hospital, take theAURO-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
- AURO-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 AURO-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 oxalate. 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 orany other symptoms. Your doctor may adjust the dosage of escitalopram oxalate to reduce the symptoms.
- Side-effects are often mild and may disappear after a fewdays. If they are troublesome or persistent, or if you develop any other unusual side-effects while taking AURO-ESCITALOPRAM, please consult your doctor.
- Usually AURO-ESCITALOPRAM do not affect your ability to carry out normal daily activities. However, you should not drive a caror operate machinery until you are reasonably certain that AURO-ESCITALOPRAM do not affect you adversely.
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 | |||
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: Eye pain, change in vision, swelling or redness in or around the eye | ✔ | ||
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 | ✔ |
This list is not a complete list of side effects. If you have any unexpected effects while taking this drug, contact your doctor or pharmacist.
How to store
- Store at room temperature between 15°C and 30°C.
- 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.
- Keep out of the reach and sight of children
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 help improve the safe use of health
products for Canadians by reporting serious and
unexpected side effects to Health Canada. Your
report may help to identify new side effects and
change the product safety information.
3 ways to report:
- Online at MedEffect (www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html);
- By calling 1-866-234-2345 (toll-free);
- By Completing a Consumer Side Effect
Reporting Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
- Mail to: Canada Vigilance Program
Health Canada, Postal
Locator 1908C
Ottawa, ON K1A 0K9
Postage paid labels, and the consumer side effect Reporting Form are available at MedEffect at (www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html);
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
- 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 (health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website www.auropharma.ca, or by calling 1-855-648- 6681
This leaflet was prepared by
Auro Pharma Inc.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada.
Date of Revision: December 6, 2017.