Consumer Information for: APO-TRAZODONE TABLETS 100MG

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take APO-TRAZODONE. Talk about any health conditions or problems you may have, including if you:

• are taking or have recently taken a monoamine oxidase inhibitor (MAOI).
• have a history or a family history of heart problems, including: heart disease, heart attack, QT prolongation, and irregular heartbeats.
• have high blood pressure that is not controlled by your medication or any heart problems.
• have a history of drug abuse.
• have a bleeding disorder.
• take certain medicines which may affect blood clotting and increase bleeding, such as oral anticoagulants (e.g., warfarin, dabigatran), acetylsalicylic acid and other non-steroidal anti- inflammatory drugs (e.g., ibuprofen).
• have or had seizures or convulsions.
• take other medications that may increase your chance of a seizure, including drugs for depression and some antibiotics.
• have glaucoma or increased pressure in your eyes.
• have suicidal thoughts.
• have a family history of mania or bipolar disorder.
• have or have had an eating disorder, for example binge eating (bulimia) or anorexia nervosa.
• have liver problems.
• have kidney problems.
• have previous detected breast cancer.
• are pregnant or plan to become pregnant. It is not known if APO-TRAZODONE will harm your unborn baby. Talk to your healthcare professional about the benefits and risks of treating depression during pregnancy.
• are breastfeeding or plan to breastfeed. It is not known if APO-TRAZODONE passes into breast milk. You and your healthcare professional should decide if you should take APO- TRAZODONE while breastfeeding.
• have any other medical conditions.

APO-TRAZODONE is not for use in children under 18 years of age.

Other warnings you should know about:
It is important to talk to your healthcare professional about the risks of treating depression and also the risk of not treating it. You should discuss all treatment options with your healthcare professional.

New or worsened emotional or behaviour problems:
Treatment with these types of medications is most safe and effective when you and your healthcare professional have good communication about how you are feeling. You may find it helpful to tell a relative or close friend that you are depressed. You might ask them to tell you if they think you are getting worse or if they are worried about changes in your behavior.

Some patients may feel worse instead of better when they first start taking drugs like APO- TRAZODONE or when changing the dose. You may have:

• new or worsened feelings of nervousness, tension, anger, agitation, or aggression.
• thoughts about suicide, hurting yourself or other people. Thoughts and actions about suicide can occur especially if you have had thoughts of hurting yourself in the past. Suicidal thoughts and actions can occur in any age group but may be more likely in patients 18 to 24 years old. If this happens, seek immediate medical help. Do NOT stop taking APO-TRAZODONE on your own.

Effects on pregnancy and newborns:
If you are pregnant or are planning to become pregnant while taking APO-TRAZODONE, talk to your healthcare professional about the risks and benefits of various treatment options. It is very important that you keep taking APO-TRAZODONE until your healthcare professional tells you to stop.

When pregnant women took drugs in the same group of medications as APO-TRAZODONE, some newborn babies had complications at birth. This happened especially when the medication was taken in the last three months of pregnancy. Some newborns:

• Required breathing support, tube feeding and a longer stay in the hospital.
• Had difficulty feeding or breathing, seizures, tense or overly relaxed muscles and were jittery and cried constantly.
• Had a serious condition called persistent pulmonary hypertension. This made the babies breathe faster and appear blue in color.

These symptoms normally go away over time. However, if your baby experiences any of these symptoms, consult your healthcare professional as soon as possible.

Angle-closure Glaucoma
APO-TRAZODONE can cause an acute attack of glaucoma. Get immediate medical help if you experience eye pain, changes in vision or swelling or redness in or around the eye.

Risk of breaking a bone
You should tell your healthcare professional if you:

• are elderly and had a recent bone fracture, or
• were told you have osteoporosis or risk factors for osteoporosis.

Taking APO-TRAZODONE 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. This is especially true when you first start taking APO-TRAZODONE and soon after you stop taking it. Take extra care to avoid falling, especially if you get dizzy or have low blood pressure.

Effect on the hormones
In women, medicines of this type may cause changes in the regularity of their monthly period or leakage of milk from the breast even if they are not pregnant. In some men, after prolonged treatment, there may be some diminished sexual function and breast enlargement may be experienced. Tell your healthcare professional if you experience any of these symptoms.

Discontinuation symptoms:
If your healthcare professional recommends that you stop taking APO-TRAZODONE, they will gradually lower the dose of APO-TRAZODONE you are taking. This may help manage any symptoms of discontinuation, such as:

• dizziness, headache, ringing in the ears, seizures;
• nausea, diarrhea, vomiting;
• tingling, burning, or prickling sensation of your skin, excessive sweating;
• feeling nervous, confused, irritated, restless, or having an unstable mood;
• fatigue, insomnia (inability to sleep), nightmares.

These symptoms will usually disappear without needing treatment. Tell your healthcare professional immediately if you have these or any other symptoms. Your healthcare professional may adjust the dosage of APO-TRAZODONE to alleviate the symptoms.

Driving and Using Machines:
APO-TRAZODONE can make you feel sleepy or may affect your ability to think clearly, make decisions or react quickly. Wait until you know how you feel after you have taken APO-TRAZODONE before you drive or use heavy machines.