Cipralex (Escitalopram Oxalate)

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

Cipralex 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 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 CIPRALEX 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 CIPRALEX):

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

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

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

Before you use CIPRALEX, 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 about becoming pregnant, or if you are breast feeding
• 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

Cipralex may cause unwanted effects (side effects). These may include nausea, increased sweating, diarrhoea, fatigue, fever, constipation, clogged or runny nose, sleep disturbance, loss of appetite, increased appetite, increased weight, decreased interest in sex, decreased ability to reach orgasm, erectile dysfunction, anxiety, restlessness, abnormal dreams, difficulties falling asleep, drowsiness, yawning, tremor (shakiness), prickling of the skin, dizziness, dry mouth, heartburn, pain in muscles and joints, stomach pain and changes in heart rate.

Contact your doctor before stopping or reducing your dosage of CIPRALEX. 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 Cipralex. 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 escitalopram 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 CIPRALEX, please consult your doctor.

Usually CIPRALEX do 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 CIPRALEX do not affect you adversely.

Serious Drug Interactions

Do not use CIPRALEX 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 CIPRALEX. You should check with your doctor or pharmacist before taking any other medication (prescription, non-prescription or natural/herbal) with CIPRALEX.

Other drugs that may interact with Cipralex include:

• Drugs to treat heart rhythm disturbances (antiarrhythmics)
• Antipsychotics
• Opioid painkillers
• Drugs to treat infections
• Diuretics (water pills)
• Laxatives (including enemas)
• Other SSRIs (citalopram) or any other antidepressant (e.g., imipramine, desipramine)
• Lithium
• Tryptophan
• Cimetidine
• Triptans (e.g., sumatriptan, zolmitriptan, naratriptan)
• Fluconazole
• Ketoconazole
• Itraconazole
• Racemic Citalopram (Celexa)
• Warfarin
• Omeprazole
• Any herbal product such as St. John's wort
• Certain medicines which may affect blood clotting and increase bleeding, such as oral anticoagulants (e.g., warfarin, dabigatran), acetylsalicylic acid (e.g., Aspirin) and other non-steroidal anti-inflammatory drugs (e.g., ibuprofen)
• Certain medicines used to treat pain, such as fentanyl (used in anaesthesia or to treat chronic pain), tramadol, tapentadol, meperidine, methadone, pentazocine
• Certain medicines used to treat cough, such as dextromethorphan.

Avoid drinking alcohol while taking CIPRALEX.

Drugs from the class that Cipralex belong 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.

Usual dose:

• It is important that you take CIPRALEX exactly as your doctor has instructed.
• Usually your doctor will prescribe 10 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 CIPRALEX you are taking, or that someone in your care is taking unless your doctor tells you to.
• You should continue to take CIPRALEX 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 CIPRALEX 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 CIPRALEX for several months. Continue to follow your doctor's instructions.

Proper Handling Instructions:

Cipralex Tablets:

• Take everyday, as a single daily dose.
• Swallow the tablets whole with a drink of water. Do not chew them. Cipralex tablets can be taken with or without food.

Overdose:

• If you have accidentally taken too much CIPRALEX contact your doctor, the Regional Poison Control Centre or nearest hospital emergency department immediately, even if you do not feel sick. If you go to the doctor or the hospital, take the CIPRALEX container with you. Some of the signs of an overdose could be dizziness, tremor, agitation, convulsion, coma, nausea, vomiting, change in heart rhythm, decreased blood pressure and seizure.

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.