Ratio-Citalopram: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

ratio-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:

ratio-CITALOPRAM belongs a group of medicines known as antidepressants, more specifically to the family of medicines called SSRIs (Selective Serotonin Reuptake Inhibitors).

ratio-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 ratio-CITALOPRAM at the same time as

  pimozide.

• Do not use ratio-CITALOPRAM if you are currently or

  have recently taken monoamine oxidase antidepressants (e.g. selegiline, moclobemide).

• Do not take ratio-CITALOPRAM if you are allergic to it,

  or to any of the components of its formulation (for list of Ingredients see below).

• Stop taking ratio-CITALOPRAM and contact your

  doctor immediately if you experience an allergic reaction or any severe side effect.

• Do not use ratio-CITALOPRAM, if you have been

  diagnosed with a congenital long QT syndrome.

What the medicinal ingredient is:

Citalopram hydrobromide

What the nonmedicinal ingredients are:

colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol,

titanium dioxide, and triacetin.

What dosage forms it comes in:

ratio-CITALOPRAM is available as white 20 mg & 40 mg tablets in blisters and 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.

ratio-CITALOPRAM 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; for example, they may experience unusual feelings of agitation, hostility or anxiety, or have impulsive or disturbing thoughts such as thoughts of self-harm or harm to others. Should this happen to you, or to those in your care if you are a caregiver or guardian, consult the doctor immediately. Close observation by a doctor is necessary in this situation. Do not discontinue your medication on your own.

Effects on Pregnancy and Newborns

If you are already taking/using ratio-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 ratio-CITALOPRAM)

Post-marketing reports indicate that some newborns whose mothers took an SSRI (Selective Serotonin Reuptake Inhibitor) such as ratio-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 Factures:

An increased risk of bone factures has been observed in patients, mainly 50 years of age and older, taking this type of medicines.

BEFORE you use ratio-CITALOPRAM tell to your doctor or pharmacist:

• All your medical conditions, including heart problems,

  history of seizures, manic-depressive illness, liver or kidney disease, diabetes, or history of bleeding disorders.

• 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 recent bone fractures or were told you have

  osteoporosis or risk factors for osteoporosis.

• If you are pregnant or thinking of 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 a monoamine oxidase inhibitor, pimozide, any other antidepressant, 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 ratio-CITALOPRAM 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 ratio-CITALOPRAM. You should check with your doctor or pharmacist before taking any other medication with ratio-CITALOPRAM.

  Other drugs that may interact with ratio-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)
  • Tramadol
  • Fluconazole, Ketoconazole, Itraconazole
  • Erythromycin
  • Warfarin
  • Omeprazole
  • Any herbal product such as St. John’s Wort
  • Any medicine that affect the rate of clotting of the blood e.g., warfarin, acetylsalicylic acid (ASA) or non-steroidal antiinflammatory drugs (NSAIDS) such as ibuprofen, naproxen, etc. and phenothiazines such as chlorpromazine.

Avoid drinking alcohol while taking ratio-CITALOPRAM.

Drugs from the class that ratio-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 ratio-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 ratio-CITALOPRAM you 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. ratio-CITALOPRAM can be taken with or without food.

• You should continue to take ratio-CITALOPRAM 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 ratio-CITALOPRAM 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 ratio-CITALOPRAM for several months. Continue to follow your doctor's instructions.

Overdose:

If you have accidentally taken too much ratio-CITALOPRAM, 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 ratio-CITALOPRAM 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

• ratio-CITALOPRAM may 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.

• 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; for example, they may experience unusual feelings of agitation, hostility or anxiety, or have impulsive or disturbing thoughts such as thoughts of self-harm or harm to others. Should this happen to you, or to those in your care if you are a caregiver or guardian, consult the doctor immediately; do not discontinue your medication on your own.

• 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 ratio-CITALOPRAM please consult your doctor.
  • Usually ratio-CITALOPRAM 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 ratio-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 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.

* If you think you have these side effects, it is important that you seek medical advice from your doctor immediately.

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 IT

• As with all medicines, keep ratio-CITALOPRAM out of the reach of children. Store your tablets at room temperature (15^o- 30^oC) 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 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 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 MedEffect™ 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 Teva Canada Limited, at:

1-800-268-4127 ext. 5005 (English)

1-877-777-9117 (French)

or druginfo@tevacanada.com

Teva Canada Limited

30 Novopharm Court

Toronto, Ontario

Canada M1B 2K9

Date of Preparation: June 6, 2012