Consumer Information for: DOM-SERTRALINE

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

Dom-SERTRALINE is not for use in children under 18 years of age.

Changes in Feelings and Behaviour:
It is important that you have good communication with your doctor about how you feel. Discussing your feelings and treatment with a friend or relative who can tell you if they think you are getting worse is also useful.

Some patients may feel worse when first starting or changing the dose of drugs such as Dom-SERTRALINE. You may feel more anxious or may have thoughts of hurting yourself or others, especially if you have had thoughts of hurting yourself before. These changes in feelings can happen in patients treated with drugs like Dom-SERTRALINE for any condition, and at any age, although it may be more likely if you are aged 18 to 24 years old. If this happens, see your doctor immediately. Do not stop taking Dom-SERTRALINE on your own.

Taking Dom-SERTRALINE 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 Dom-SERTRALINE talk to your doctor or pharmacist:

• all your medical conditions
• if you have a history of:
  • seizures
  • liver disease
  • kidney disease
  • high cholesterol
  • heart disease
  • heart rhythm problems
  • slow heart beat
  • are taking medications for your heart
  • manic episodes
• if in your family there is a history of:
  • people younger than 50 years of age having a heart attack
• if the levels of electrolytes in your body are either too high or too low or you have a condition (such as an eating disorder) that can affect your electrolyte levels;
• if you have had a stroke;
• if you are known to have heart problems (or predispositions) related to a genetic expression (or modification, variant);
• if you have had a head injury;
• if you have diabetes;
• if you have a bleeding disorder or have been told that you have low platelets;
• if you have blood pressure problems;
• any medications (prescription or non-prescription) which you are taking or have recently taken (within last 14 days), especially monoamine oxidase (MAO) inhibitors (e.g., phenelzine sulfate, tranylcypromine sulfate, moclobemide) or any other antidepressants, pimozide (an antipsychotic drug), drugs used to treat diabetes, drugs used to thin the blood (anticoagulant), the antibiotic linezolid, methylthioninium chloride (methylene blue) or drugs that affect serotonin (including but not limited to fentanyl, fenfluramine and tryptophan);
• if you are pregnant or thinking about becoming pregnant, or if you are breastfeeding;
• if you have a recent bone fracture or were told you have osteoporosis or risk factors for osteoporosis;
• 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;
• if you have ever had any allergic reaction to medications, food, etc.

Effects on Pregnancy and Newborns
If you are already taking Dom-SERTRALINE 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.

Some newborns whose mothers took an SSRI (selective serotonin reuptake inhibitor) or other newer anti-depressants, such as Dom-SERTRALINE, during pregnancy have developed complications at birth requiring prolonged hospitalization, breathing support and tube feeding. Reported symptoms included feeding and/or breathing difficulties, seizures, tense or overly relaxed muscles, jitteriness and constant crying.

In most cases, the SSRI or other newer anti-depressant was taken during the third trimester of pregnancy. These symptoms are consistent with either a direct adverse effect of the anti-depressant 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 Dom- SERTRALINE 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.

Angle-closure Glaucoma
Dom-SERTRALINE can cause an acute attack of glaucoma. Having your eyes examined before you take Dom-SERTRALINE 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