Patient Medication Information: uses, side effects, how to take - Novo-Citalopram
ABOUT THIS MEDICATION
What the medication is used for:
NOVO-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:
NOVO-CITALOPRAM belongs to the family of medicines called Selective Serotonin Reuptake Inhibitors (SSRIs).
When it should not be used:
You should not be taking NOVO-CITALOPRAM if you are pregnant or breast feeding.
Do not use NOVO-CITALOPRAM at the same time as
pimozide.
Do not take NOVO-CITALOPRAM if you are allergic to
it, or to any of the components of its formulation.
Stop taking NOVO-CITALOPRAM and contact your
doctor immediately if you experience an allergic reaction or any severe side effect.
What the medicinal ingredient is:
Citalopram hydrobromide
What the important nonmedicinal ingredients are: copovidone, croscarmellose sodium, glycerine,
hydroxypropylmethylcellulose, lactose monohydrate, magnesium stearate, maize starch, microcrystalline cellulose, polyoxyethylene stearate and titanium dioxide.
What dosage forms it comes in:
Tablet; 10 mg, 20 mg & 40 mg.
WARNINGS AND PRECAUTIONS
BEFORE you use NOVO-CITALOPRAM talk to your doctor or pharmacist about:
$ All your medical conditions, including heart problems, history of seizures, liver or kidney disease, diabetes, bleeding disorders.
$ Any medications (prescription or non-prescription)
which you are taking or have taken within the last 14 days, especially a monoamine oxidase inhibitor, or any other antidepressant, lithium, tryptophan, or cimetidine, as well as any herbal product such as St. John's Wort, which may interact with NOVO-CITALOPRAM. $ If you ever had an allergic reaction to any medication. $ If you are pregnant or thinking of becoming pregnant, or if you are breast feeding.
$ Your habits of alcohol consumption.
- 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 your doctor immediately; do not discontinue your medication on your own.
INTERACTIONS WITH THIS MEDICATION
NOVO-CITALOPRAM may interact with many drugs including: Monoamine Oxidase Inhibitors, (e.g., phenelzine, tranylcypromine, moclobemide or selegiline), Metoprolol, Digoxin, Imipramine, Lithium, Cimetidine, Carbamazepine and Serotonergic drugs, Warfarin, Levomepromazine and Pimozide.
PROPER USE OF THIS MEDICATION
Usual dose:
- It is important that you take NOVO-CITALOPRAM exactly as your doctor has instructed. page 42
- Usually your doctor will prescribe 20 mg per day, which you will take as a single dose either in the morning or in the evening. This dose may be increased. Never change the dose of NOVO-CITALOPRAM unless your doctor tells you to.
- You should continue to take NOVO-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 NOVO-CITALOPRAM for as long as your doctor recommends it. Do not stop taking your tablets 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 NOVO-CITALOPRAM for several months. Continue to follow your doctor's instructions.
Swallow the tablets whole with a drink of water. Do not
chew them. NOVO-CITALOPRAM can be taken with or without food.
Overdose:
If you have accidentally taken too much NOVO-CITALOPRAM, contact your doctor or nearest hospital emergency department immediately, even if you do not feel sick. If you go to the doctor or the hospital, take the NOVO-CITALOPRAM container with you.
Missed Dose:
If you miss a dose, do not worry. Do not take the missed tablet(s) -just take the next dose when it is due.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
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.
NOVO-CITALOPRAM may cause unwanted effects
(side-effects). These may include nausea, dry mouth, drowsiness, increased sweating, tremor, diarrhea and sexual problems. Other effects may include dizziness and sleep disturbance.
Contact your doctor before stopping or reducing your
dosage of NOVO-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 NOVO-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 NOVO-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 NOVO-CITALOPRAM please consult your doctor.
Usually NOVO-CITALOPRAM does not affect patients' ability to carry out normal daily activities. However, you should not drive a car or operate machinery until you are reasonably certain that NOVO-CITALOPRAM does not affect you adversely.
Avoid drinking alcohol while taking NOVO-
CITALOPRAM.
This is not a complete list of side effects. For any unexpected effects while taking NOVO-CITALOPRAM, contact your doctor or pharmacist.
HOW TO STORE IT
- This medicine is prescribed for you and only a doctor can prescribe it. Never offer it to any other person even if their symptoms seem to be the same as yours.
- As with all medicines, keep NOVO-CITALOPRAM out of the reach of children. Store your tablets at room temperature (15o-30oC) in a dry place.
- Keep the container tightly closed.
- 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.
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada through the Canada Vigilance collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Canada Vigilance:
By toll-free telephone: 866-234-2345
By toll-free fax 866-678-6789
By email: CanadaVigilance@hc-sc.gc.ca
By regular mail:
Canada Vigilance National Office
Marketed Health Products Safety and Effectiveness Information Division
Marketed Health Products Directorate
Health products and Food Branch
Health Canada
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Before contacting Canada Vigilance, you should contact your physician or pharmacist.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be obtained by contacting Novopharm Limited, at: 1-800-268-4127 ext. 5005 or
druginfo@novopharm.com
Novopharm Limited
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9
Date of Preparation: June 04, 2008