Bio-Duloxetine: Uses, Side Effects and Dosage

What is Bio-Duloxetine used for?

• Chronic (ongoing) low-back pain
• Chronic (ongoing) osteoarthritis knee pain

• Diabetic nerve pain:

  • pain that may be burning, stabbing, stinging, shooting, aching or like an electric shock
  • pain may be caused by touch, heat, cold, or pressure
  • there may be loss of feeling in the affected area

• Depression:

  • feeling sad, restless, irritable, tired
  • experiencing a change in appetite or weight, difficulty concentrating or sleeping, headaches, unexplained aches and pains
• Generalized anxiety: feeling very anxious and worried

How does Bio-Duloxetine work?

Bio-Duloxetine belongs to a group of medicines called “serotonin and norepinephrine reuptake inhibitors” (SNRIs). Bio-Duloxetine increases the levels of two chemical messengers (serotonin and norepinephrine) found naturally in your brain and other parts of your body.

Depression and Anxiety

Depression and anxiety are mental illnesses. They may happen when chemicals in the brain, such as serotonin and norepinephrine, are not in balance. Bio-Duloxetine works to help balance these chemicals. This helps to relieve the emotional and physical symptoms of depression and anxiety.

You may notice that your depression or anxiety symptoms feel better within 1 to 4 weeks after starting Bio-Duloxetine.

Diabetic Nerve Pain, Chronic Low Back Pain, and Chronic Osteoarthritis Knee Pain

Bio-Duloxetine works by increasing the levels of serotonin and norepinephrine. This helps to reduce the pain in these conditions.

You may notice that your pain symptoms feel better within 1 week after starting Bio-Duloxetine.

What are the ingredients in Bio-Duloxetine?

Medicinal ingredient: Duloxetine hydrochloride

Non-medicinal ingredients: gelatin, hypromellose, sugar spheres, mannitol, talc, polyethylene glycol, methacrylic acid-ethyl acrylate copolymer dispersion, titanium dioxide, triethyl citrate, sodium hydroxide, sodium lauryl sulphate.

In addition to the above nonmedicinal ingredients 30 mg capsules contain FD&C Blue No. 1, FD & C Red 40 and 60 mg capsules contain FD &C Blue No. 2, yellow iron oxide.

Bio-Duloxetine comes in the following dosage forms: 30mg and 60 mg delayed release capsules.

Do not use Bio-Duloxetine if:

• You are younger than 18 years of age
• You are allergic to any of the ingredients in Bio-Duloxetine (please read “What are the ingredients in Bio-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 Bio-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. Bio-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 Bio-

  Duloxetine 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. Bio-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

BIO-DULOXETINE can cause an acute attack of glaucoma. Having your eyes examined before you take BIO-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:

Bio-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 Bio-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 Bio-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 Bio-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 Bio-Duloxetine on your own.

Effects on pregnancy and newborns:

If you are or become pregnant while taking Bio-Duloxetine, talk to your healthcare professional about the risks and benefits of various treatment options. It is very important that you keep taking Bio-Duloxetine until your healthcare professional tells you to stop.

Some women experienced rapid loss of blood at birth. This happened especially when the medication was taken in the last 30 days of pregnancy.

Some women have given birth earlier than expected. This happened mostly between 35 and 36 weeks of pregnancy.

When pregnant women took drugs in the same group of medications as Bio-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 Bio-Duloxetine may increase your risk of breaking a bone. This is especially true when you first start taking Bio-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 Bio-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 Bio-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.

The following may interact with Bio-Duloxetine:

• Medications for depression called monoamine oxidase inhibitors (MAOIs), like phenelzine and moclobemide
• An antibiotic called linezolid
• A dye called methylene blue used during surgery
• A medication to manage psychosis (serious mental illness) called thioridazine.
• Some antibiotics, like ciprofloxacin or enoxacin

• Other medications to treat depression such as:

  • selective serotonin reuptake inhibitors (SSRIs) or SNRIs like fluoxetine, venlafaxine and paroxetine
  • tricyclics like amitriptyline and desipramine
  • potent CYP1A2 inhibitors like fluvoxamine
• Medications used to treat schizophrenia like olanzapine and risperidone
• Medications used to treat bipolar disorder like lithium

• Medications that can affect blood clotting and increase bleeding such as:

  • oral anticoagulants like warfarin and dabigatran
  • acetylsalicylic acid or ASA
  • non-steroidal anti-inflammatory drugs (NSAIDs) used to treat pain and fever like ibuprofen and naproxen
• Some medications used to treat patients with irregular heartbeats like flecainide and encainide

• Some medications that affect the chemical messenger serotonin, like

  • lithium
  • medications containing tryptophan, used to treat bipolar disorder
  • St. John’s Wort (also called Hypericum perforatum), an herbal product often used to treat depression
  • a group of medications called triptans used to treat migraines, like sumatriptan and rizatriptan
• Some pain medications in a group of drugs called opioids, like fentanyl, tramadol, tapentadol, meperidine, methadone and pentazocine
• Some medications used to treat cough, like dextromethorphan (a cough syrup)

In general, drink only small amounts of alcohol while you are taking Bio-Duloxetine.

How to take Bio-Duloxetine:

• Once each day, at about the same time every day

• Swallow capsules whole with a drink of water.

• Take with or without food. Taking it with food can reduce nausea at the start of treatment
• Take exactly as prescribed. Do NOT give it to anybody else. They may have unwanted side effects that may be serious.
• Do NOT chew, crush or open the capsule. Do NOT mix with liquids or sprinkle on food or drink.
• If you accidentally break or open the capsules, do NOT touch the powder. Wash away any loose powder right away with water. If you get powder in your eyes, rinse them with water right away and contact your healthcare professional.

Usual dose:

The usual adult dose is 60 mg once daily.

Elderly patients with generalized anxiety:

The starting dose is 30 mg once daily. After 2 weeks, your healthcare professional may increase the dose to 60 mg once daily.

Your healthcare professional may adjust the dose during the course of your treatment. Only increase the amount of Bio-Duloxetine you are taking if your healthcare professional tells you to.

You should continue to take Bio-Duloxetine for several months or longer, as directed by your healthcare professional.

Stopping Bio-Duloxetine:

Do NOT stop taking Bio-Duloxetine without discussing it with your healthcare professional. This may help you avoid discontinuation symptoms. Follow your healthcare professional’s instructions. They may gradually reduce the dose you are taking.

Patients being treated for nerve pain caused by diabetes:

Continue to see your healthcare professional regularly for the proper management of your diabetes. This will help to control your blood sugar levels and prevent further nerve damage. It is important that you continue to do daily foot examinations.

Overdose:

If you think you have taken too much Bio-Duloxetine, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose:

If you miss a dose of Bio-Duloxetine by a few hours, take the dose when you remember. If most of the day has passed, wait until your next scheduled dose. Try not to miss any more. Do NOT take a double dose to make up for a missed dose.

What are possible side effects from using Bio-Duloxetine?

These are not all the possible side effects you may feel when taking Bio-Duloxetine. If you experience any side effects not listed here, contact your healthcare professional.

Most side effects are minor and temporary. However, some may be serious. The most common side effects with Bio-Duloxetine are:

• Constipation
• Diarrhea
• Dizziness
• Dry Mouth
• Erectile dysfunction (trouble getting or keeping an erection)
• Feeling tired
• Headache
• Insomnia (trouble falling asleep and/or staying asleep)
• Less appetite
• More sweating
• Nausea
• Pain in the belly
• Sleepiness
• Vomiting (throwing up)

These side effects have been shown to decrease with continued treatment. Tell your healthcare professional if:

• any of the side effects discussed above affect you severely
• you experience other side effects not listed here.

Some of these side effects may be related to the dose you are taking. Your healthcare professional will decide if your dose needs to be changed.

Depression and anxiety may decrease your sexual desire, performance and satisfaction. This medication may further decrease sexual enjoyment.

You may also have symptoms after you stop taking Bio-Duloxetine:

• Anxiety
• Diarrhea
• Dizziness
• Feeling tired
• Headache
• Insomnia
• Irritability
• Muscle pain
• Nausea
• Nerve sensations (numbing, tingling, burning or prickling)
• Nightmares
• Sleepiness
• Severe sweating
• Vertigo (feeling of spinning when not moving)
• Vomiting

These symptoms usually go away without treatment. Tell your healthcare professional right away if you have these or other symptoms.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

Visiting the Web page on Adverse Reaction Reporting

(https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or

• Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. I

Storage:

• Keep out of reach and sight of children.
• Keep capsules in their original package.
• Store between 15° and 30°C.
• Keep the package in a dry place.
• Keep the package out of direct sunlight.
• Use capsules before the expiry date on the box. Do NOT use tablets after the expiry date.
• Return any expired or leftover medication to your pharmacist.

If you want more information about Bio-Duloxetine:

For more information, please contact your healthcare professionals or pharmacist first, or Biomed Pharma at: 1-888-731-6703 or info@biomed-pharma.ca.

The information in this document is current as of the last revision date shown below. For the most current information please visit our website or contact us directly.

Biomed Pharma

1B-9450 Boulevard Langelier

Montreal, Quebec H1P 3H8

Canada

Last Revised: October 18, 2021