Details for: RIVA-CITALOPRAM
Company: LABORATOIRE RIVA INC.
DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
---|---|---|---|---|---|
02303256 | RIVA-CITALOPRAM | CITALOPRAM (CITALOPRAM HYDROBROMIDE) | 10 MG | TABLET | ORAL |
02303264 | RIVA-CITALOPRAM | CITALOPRAM (CITALOPRAM HYDROBROMIDE) | 20 MG | TABLET | ORAL |
02303272 | RIVA-CITALOPRAM | CITALOPRAM (CITALOPRAM HYDROBROMIDE) | 40 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
RIVA-CITALOPRAM has been prescribed to you by your doctor to relieve your symptoms of depression. 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
RIVA-CITALOPRAM belongs to a group of medicines known as antidepressants, more specifically to the family of medicines called SSRIs (Selective Serotonin Reuptake Inhibitors).
RIVA-CITALOPRAM is thought to work by increasing the levels of a chemical in the brain called serotonin (5-hydroxytryptamine).
When it should not be used
- Do not use RIVA-CITALOPRAMat the same time as
pimozide.
- Do not use RIVA-CITALOPRAMif you are currently or
have recently taken monoamine oxidase antidepressants
(e.g. selegiline, moclobemide).
- Do not take RIVA-CITALOPRAMif you are allergic to it, or
to any of the components of its formulation (for list of
ingredients see below).
- Stop taking RIVA-CITALOPRAMand contact your doctor
immediately if you experience an allergic reaction or any
severe side effect.
- Do not use RIVA-CITALOPRAMif you have been diagnosed with a congenital long QT syndrome.
What the medicinal ingredient is
citalopram hydrobromide
What the non-medicinal ingredients are
Colloidal silicon dioxide, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate and titanium dioxide.
What dosage form it comes in
Tablets: 10 mg, 20 mg and 40 mg
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.
RIVA-CITALOPRAMis 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, impulsivity or thoughts about
suicide, self-harm 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 or have an anxiety disorder, and ask them to read
this leaflet. You might ask them to tell you if they think your
depression or anxiety is getting worse, or if they are worried
about changes in your behaviour.
Effects on Pregnancy and Newborns
If you are already taking/using RIVA-CITALOPRAM 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 RIVA-CITALOPRAM):
Post-marketing reports indicate that some newborns whose
mothers took an SSRI (Selective Serotonin Reuptake Inhibitor)
such as citalopram 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,
seizures, tense or overly relaxed muscles, jitteriness 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 of the Newborn (PPHN)
and newer antidepressants:
Preliminary information suggests that use of SSRIs during the
second half of pregnancy may be associated with an increased
rate of a serious lung condition called persistent pulmonary
hypertension of the newborn (PPHN) that causes breathing
difficulties in newborns soon after birth. According to the study,
babies born with this condition were 6 times more likely than
healthy babies to have been exposed to SSRIs. In the general
population, PPHN is known to occur at a rate of about 1-2 per
1000 newborns.
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 RIVA-CITALOPRAM 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:
RIVA-CITALOPRAM 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 RIVACITALOPRAM
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 RIVA-CITALOPRAM tell your doctor or pharmacist:
- 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.
- 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.
- 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 RIVA-CITALOPRAM if you are taking or have recently taken:
- Monoamine oxidaxe 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 RIVACITALOPRAM.
You should check with your doctor or
pharmacist before taking any other medication (prescription, nonprescription
or natural/herbal) with RIVA-CITALOPRAM.
Other drugs that may interact with RIVA-CITALOPRAM
include:
- drugs to treat heart rhythm disturbances (antiarrhythmics)
- antipsychotics
- opioid painkillers
- drugs to treat infections
- drugs to treat nausea and vomiting
- cancer drugs
- asthma drugs
- diuretics (water pills)
- Carbamezepine
- Other SSRIs e.g., escitalopram or any other antidepressant (e.g., imipramine, desipramine)
- Lithium
- Tryptophan
- Cimetidine
- Triptans (e.g., sumatriptan, zolmitriptan, naratriptan)
- Fluconazole, Ketoconazole, Itraconazole
- Erythromycin
- 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 (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 RIVA-CITALOPRAM.
Drugs from the class that RIVA-CITALOPRAM 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 RIVA-CITALOPRAM
exactly as your doctor has instructed.
- Usually your doctor will prescribe 20 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 RIVA-CITALOPRAMyou are
taking, or that someone in your care is taking unless
your doctor tells you to. Dosage directions should be
followed carefully. Never exceed the prescribed dose.
- Swallow the tablets whole with a drink of water. Do
not chew them. RIVA-CITALOPRAMcan be taken with
or without food.
- You should continue to take RIVA-CITALOPRAMeven
if you do not feel better, as it may take several weeks for
your medication to work. Improvement may be gradual.
- Continue to take RIVA-CITALOPRAMfor 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 RIVA-CITALOPRAMfor several months. Continue to follow your doctor’s instructions.
Overdose
- If you have accidentally taken too much RIVACITALOPRAM contact your doctor or the Regional Poison Control Centre immediately, even if you do not feel sick. If you go to the doctor or the hospital, take the RIVACITALOPRAM container with you.
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
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
- RIVA-CITALOPRAMmay cause unwanted effects
(side-effects). These may include fatigue, dry mouth,
increased sweating, tremor (shakiness), nausea, diarrhea,
somnolence (sleepiness), ejaculation disorder and upper
respiratory tract infection.
- Contact your doctor before stopping or reducing your
dosage of citalopram. 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 citalopram. 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
citalopram 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
RIVA-CITALOPRAM, please consult your doctor.
- Usually RIVA-CITALOPRAMdoes 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 RIVA-CITALOPRAM
does not affect you adversely.
- Post-marketing reports indicate that some newborns
whose mothers took an SSRI (Selective Serotonin
Reuptake Inhibitor) such as citalopram hydrobromide 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, seizures, tense or overly relaxed muscles,
jitteriness 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.
- 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.
- If you experience any symptoms of a possible heart rhythm disturbance, such as dizziness, palpitations, fainting or seizures, you should seek immediate medical attention.
Symptom / effect | Talk with your doctor or pharmacist right away only if severe | Talk with your doctor or pharmacist right away in all cases | Stop taking drug and seek immediate emergency medical assistance |
---|---|---|---|
Uncommon | |||
Low Platelets:Bruising or unusual bleeding from the skin or other areas | ✔ | ||
Mania: Overactive behaviour and thoughts | ✔ | ||
Rare | |||
Gastrointestinal bleeding: Vomiting blood or passing blood in stools | ✔ | ||
Glaucoma: Eye pain, change in vision, swelling or redness in or around the eye | ✔ | ||
Low sodium level in blood: Symptoms of tiredness, weakness, confusion combined with achy, stiff or uncoordinated muscles | ✔ | ||
Serotonin syndrome: A combination of symptoms, possibly including: agitation, confusion, tremor, sudden jerking of muscles, high fever | ✔ | ||
Very Rare | |||
Liver disorder: Symptoms include nausea, vomiting, loss of appetite combined with itching, yellowing of the skin or eyes, dark urine | ✔ | ||
Seizures: Loss of consciousness with uncontrollable shaking (”fit”) | ✔ | ||
See Warnings & Precautions | |||
Akathisia: Feeling restless and unable to sit or stand still | ✔ | ||
New or Worsened Emotional or Behavioural Problems | ✔ | ||
Unknown | |||
Abnormal heart rate or rhythm, palpitations, fainting | ✔ | ||
Signs of serious skin reactions: e.g.: Stevens- Johnson Syndrome: SJS (skin rash, redness of the skin, blistering of the lips, eyes or mouth, skin peeling, accompanied by fever, chills, headache,cough, body aches) | ✔ |
This is not a complete list of side effects. For any unexpected effects while taking RIVA-CITALOPRAM contact your doctor or pharmacist.
How to store
As with all medicines, keep RIVA-CITALOPRAM out of the reach and sight of children. Store your tablets at room temperature (15 - 30°C), in a dry place.
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 left over tablets to the pharmacist, unless your 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
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full product monograph, prepared for health professionals, can be obtained by contacting Laboratoire Riva Inc. at 1-800-363-7988.
This leaflet was prepared by
Laboratoire Riva Inc.
660 Boul. Industriel
Blainville, Québec
J7C 3V4
www.labriva.com
Last revised: December 22, 2016