Patient Medication Information: uses, side effects, how to take - Sig-Citalopram
ABOUT THIS MEDICATION
What the medication is used for:
Sig-CITALOPRAM has been prescribed to you by your doctor to relieve your symptoms of depression.
What it does:
Sig-CITALOPRAM belongs to a group of medicines called antidepressants, more specifically to the family of medicines called SSRIs (Selective Serotonin Reuptake Inhibitors).
Sig-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:
Sig-CITALOPRAM should not be used:
If you are currently or have recently (within 14 days) taken
monoamine oxidase anti-depressants (MAOI), (such as phenelzine sulphate, moclobemide).
- If you are currently taking or have recently taken pimozide.
If you have a known hypersensitivity to citalopram
hydrobromide or the components of the drug product (see list of components at the end of this section).
Stop taking Sig-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: Corn (maize) starch, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose PH101, polyethylene glycol, povidone, purified water, titanium dioxide
What dosage forms it comes in:
20 mg and 40 mg tablets.
WARNINGS AND PRECAUTIONS
During treatment with these types of medications, it is important that you and your doctor have good ongoing communication about how you are feeling.
Sig-CITALOPRAM is not for use in children under 18 years of age.
New or Worsened Emotional or Behavioral 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 your doctor immediately. Close observation by a doctor is necessary in this situation. Do not discontinue your medication on your own.
BEFORE you use Sig-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.
- If you are pregnant or thinking of becoming pregnant, or if you are breastfeeding.
If you are currently taking or have taken any other medicines
(prescription or non-prescription) within the last 14 days, especially a monoamine oxidase inhibitor (such as, phenelzine, tranylcypromine, moclobemide or selegiline), or any other antidepressant, lithium, tryptophan, or cimetidine as well as any herbal product such as St. John’s Wort.
- If you ever had an allergic reaction to any medication or any of the ingredients listed in this leaflet.
- Your habits of alcohol consumption.
If you drive a vehicle or perform hazardous tasks during your work.
Effects on Pregnancy and Newborns
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.
INTERACTIONS WITH THIS MEDICATION
Drugs that may interact with Sig-CITALOPRAM include: monoamine oxidase inhibitor (such as phenelzin tranylcypromine, moclobemide or selegiline), pimozide, metoprolol, warfarin, digoxin, imipramine, lithium, cimetidine, carbamazepine, cytochrome P450 Isozymes (such as, ketoconazole, itraconazole, fluconazole, erythromycin, or omperazole), antihistamines, antipertensives or other cardiovascular drugs, and certain pain medications that may affect blood clotting and increase bleeding (such as, aspirin and other non-steroidal anti-inflammatory drugs like ibuprofen).
Herbal products such as St. John’s Wort may interact with citalopram.
Treatment with an SSRI in patients with diabetes may alter glycemic control (hypoglycemia and hyperglycemia).
Avoid drinking alcohol while taking Sig-CITALOPRAM.
PROPER USE OF THIS MEDICATION
Usual dose:
It is important that you take Sig-CITALOPRAM exactly as
your doctor has instructed.
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. If you are elderly or have liver disease, your doctor may prescribe a lower dose. This dose may be increased. Never change the dose of Sig-CITALOPRAM you are taking, or that someone in your care is taking, unless your doctor tells you to.
Swallow the tablets whole with a drink of water. Do not
chew them. Sig-CITALOPRAM can be taken with or without food.
You should continue to take Sig-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 Sig-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 Sig-CITALOPRAM for several months. Continue to follow your doctor=s instructions
Overdose:
If you have accidentally taken too much Sig-CITALOPRAM contact your doctor or nearest hospital emergency department immediately, even if you do not feel sick. Take the Sig-CITALOPRAM container with you to the doctor or hospital.
Missed Dose:
If you are taking Sig-CITALOPRAM regularly and 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
Like all medications, Sig-CITALOPRAM can cause some side effects. You may not experience any of them. For most patients these side effects are likely to be minor and temporary. However, some may be serious. Some of these side effects may be dose related. Consult your doctor if you experience these or other side effects, as the dose may have to be adjusted.
If you experience an allergic reaction (including skin rash, hives, swelling, trouble breathing) or any severe or unusual side effects, stop taking the drug and contact your doctor immediately.
Some common side effects are: nausea, dry mouth, drowsiness, sleep disturbances, increased sweating, tremor, diarrhea, dizziness, and sexual problems.
New or Worsened Emotional or Behavioral 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 your doctor immediately. Close observation by a doctor is necessary in this situation. Do not discontinue your medication on your own.
Discontinuation Symptoms
Contact your doctor before stopping or reducing your dosage of Sig-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 Sig-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 Sig-CITALOPRAM to reduce the symptoms
Effects on Pregnancy and Newborns
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.
Usually Sig-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 Sig-CITALOPRAM does not affect you adversely. 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 Sig-CITALOPRAM, please consult your doctor.
The following serious side effects have been reported during treatment with SSRIs. Most of these side effects are uncommon, rare or very rare with citalopram treatment.
If you experience an allergic reaction [skin rash, hives, swelling, trouble breathing] or seizures [loss of consciousness with uncontrollable shaking (“fit”)] stop taking the drug and call your doctor or pharmacist.
Talk with your doctor or pharmacist, in all cases, if you experience any of the following serious side effects:
Alteration of blood sugar control in diabetic patients
Low blood sugar [symptoms of dizziness, lack of energy, drowsiness, headache, trembling, sweating] High blood sugar [symptoms of increased thirst, increased urination, weakness, confusion, fruity breath odour)
- Bruising or unusual bleeding from the skin or other areas
- Hallucinations [strange visions or sounds]
- Mania [overactive behavior and thoughts]
- Uncontrollable movements of the body or face
- Inability to urinate
*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]
*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]
*New or worsened emotional or behavioral problems (See
Warnings and Precautions)
Akathisia [feeling restless and unable to sit or stand still]
* If you think you have these side effects, it is important that you seek medical advice from your doctor right away. This is not a complete list of side effects. For any unexpected effects while taking Sig-CITALOPRAM contact your doctor or pharmacist.
HOW TO STORE IT
- KEEP OUT OF REACH OF CHILDREN.
- Store at room temperature (15-30° C) in dry place.
- Keep container tightly closed.
- If your doctor tells you to stop taking medicine you should return any leftover tablets to the pharmacist, unless the doctor tells you to keep them 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
To monitor drug safety, Health Canada 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 Health Canada by:
toll-free telephone: 866-234-2345
toll-free fax: 866-678-6789
By email: cadrmp@hc-sc.gc.ca
By regular mail:
National AR Centre
Marketed Health Products Safety and Effectiveness Information Division
Marketed Health Products Directorate
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Sigmacon Lifesciences Inc., at:
1-800-898-7455
Sigmacon Lifesciences Inc.
436 Limestone Cresent
North York, Ontario
M3J 2S4