Consumer Information for: BIO-CITALOPRAM

Treatment with these types of medications is most safe and effective when you and your doctor have good communication about how you are feeling.

Bio-CITALOPRAM tablets are 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 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 citalopram tablets):
Post-marketing reports indicate that some newborns whose mothers took an SSRI (Selective Serotonin Reuptake Inhibitor) such as citalopram tablets 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 Bio-CITALOPRAM tablets 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.

Before you use Bio-CITALOPRAM tablets 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 glaucoma or increased pressure in your eyes
• 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.