Consumer Information for: ACT ESCITALOPRAM ODT

ACT ESCITALOPRAM ODT 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, they may experience new or worsened feelings of agitation, hostility, anxiety, or thoughts about suicide, 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, and ask them to read this leaflet. You might ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behaviour.

Effects on Pregnancy and Newborns If you are already taking/using ACT ESCITALOPRAM ODT 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 ACT ESCITALOPRAM ODT): Post-marketing reports indicate that some newborns whose mothers took an SSRI (Selective Serotonin Reuptake Inhibitor) such as escitalopram 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, bluish skin, seizures, body temperature changes, vomiting, low blood sugar, tense or overly relaxed muscles, vivid reflexes, tremor, jitteriness, irritability, lethargy, sleepiness, sleeping difficulties 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 (PPHN) and newer antidepressants: When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like ACT ESCITALOPRAM ODT may increase the risk of a serious lung condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), that causes breathing difficulties in newborns soon after birth, making the baby breathe faster and appear bluish. These symptoms usually begin during the first 24 hours after the baby is born. If this happens to your baby you should contact your doctor immediately.

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 ACT ESCITALOPRAM ODT 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:
ACT ESCITALOPRAM ODT 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 ACT ESCITALOPRAM ODT could help identify if you are at risk of having angle-closure glaucoma. Seek immediate medical attention if you experience:

• eye pain
• change in vision
• swelling or redness in or around the eye.

Before you use ACT ESCITALOPRAM ODT, tell your doctor:

• 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 of becoming pregnant, or if you are breastfeeding
• If you are receiving electroconvulsive treatment
• 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.
• If you ever had an allergic reaction to any medication or any of the ingredients mentioned in this leaflet.
• 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.