Details for: NRA-DULOXETINE

Serious Warnings and Precautions

Do not use NRA-Duloxetine if:

• You are younger than 18 years of age
• You are allergic to any of the ingredients in NRA-Duloxetine (please read “What are the ingredients in NRA-Duloxetine?”, above)
• You have a liver impairment or disorder. A liver disorder is when your liver can no longer carry out its normal function
• You have severe kidney disease
• You are taking or have just stopped taking any of these drugs in the last 14 days:
• monoamine oxidase inhibitors (MAOI), such as phenelzine or moclobemide, to treat depression
• linezolid to treat infection(s)
• You have been given a dye called methylene blue during surgery in the last 14 days
• You are on a drug or have been on a drug to manage psychosis (serious mental illness) called thioridazine
• You are taking a medication to treat depression, like fluvoxamine, a potent CYP1A2 inhibitor
• You are taking certain antibiotics, like ciprofloxacin or enoxacin

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

• Have or have a history of liver, kidney, or heart problems, diabetes, or seizures
• Have high blood pressure. NRA-Duloxetine may raise your blood pressure.
• Have low sodium levels in your blood
• Are pregnant, are thinking about getting pregnant, or are breast-feeding
• Drink alcohol or use street drugs. Drinking a large amount of alcohol while taking NRADuloxetine may lead to serious liver problems and death.
• Have an allergy to any medication
• Have a bleeding disorder that makes you more likely to bleed, or if you have low platelet levels (a type of blood cell)
• Have problems urinating
• Have a rare hereditary disease that means you should not eat sugar. NRA-Duloxetine contains a type of sugar called sucrose. These diseases include:
• Fructose intolerance
• Glucose-galactose malabsorption
• Sucrose-isomaltase insufficiency.

Other warnings you should know about:

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

Driving and using machines:
NRA-Duloxetine may make you feel dizzy or tired, especially just after you start taking it or after the dose is increased. Wait to see how you feel while taking NRA-Duloxetine before driving or using machines.

Changes in your behaviour and feelings, thoughts and actions about suicide:
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 or have an anxiety disorder. You might ask them to tell you if they think you are getting worse or if they are worried about changes in your behaviour.
Some patients may feel worse instead of better when first starting drugs like NRA-Duloxetine or when changing the dose. You may feel more anxious, agitated, hostile, aggressive, impulsive, and feel like you are not yourself or become less inhibited. You may have thoughts of 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. These changes in behaviour and feelings can happen in patients of any age treated with NRA-Duloxetine. Changes in suicidal thoughts and actions may be more likely if you are 18 to 24 years old. If this happens, seek immediate medical help. Do NOT stop taking NRA-Duloxetine on your own.

Effects on pregnancy and newborns:
If you are or become pregnant while taking NRA-Duloxetine, talk to your healthcare professional about the risks and benefits of various treatment options. It is very important that you keep taking NRA-Duloxetine until your healthcare professional tells you to stop. When pregnant women took drugs in the same group of medications as NRA-Duloxetine, 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.

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

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

• are elderly and had a recent bone fracture or
• were told you have osteoporosis or risk factors for osteoporosis.
• Taking NRA-Duloxetine may increase your risk of breaking a bone. This is especially true when you first start taking NRA-Duloxetine and soon after you stop taking it. Take extra care to avoid falling, especially if you get dizzy or have low blood pressure.

Serotonin syndrome/neuroleptic malignant syndrome (NMS):
This is a rare side effect of the group of medications like NRA-Duloxetine. It is life-threatening and can lead to death. It can cause serious changes in how your brain, muscles, digestive system and nervous system work. The reaction is more likely if you take NRA-Duloxetine with certain other medications. Please read the box called “Serious side effects and what to do about them”, below.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.