Apo-Tapentadol: Uses, Side Effects and Dosage

Serious Warnings and Precautions

What is APO-TAPENTADOL used for?

APO-TAPENTADOL is used in adults to manage moderate to severe acute pain.

How does APO-TAPENTADOL work?

APO-TAPENTADOL is a painkiller belonging to the class of drugs known as opioids. It relieves pain by acting on specific nerve cells of the spinal cord and brain.

What are the ingredients in APO-TAPENTADOL?

Medicinal ingredients: tapentadol hydrochloride

Non-medicinal ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Yellow #10 Aluminum Lake (50 mg and 75 mg only), magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, Sunset Yellow Aluminum Lake (all tablet strengths), talc, titanium dioxide.

APO-TAPENTADOL comes in the following dosage forms:

APO-TAPENTADOL tablets are available in 50 mg, 75 mg, and 100 mg tapentadol (as tapentadol hydrochloride) dose strengths.

Do not use APO-TAPENTADOL if:

• your doctor did not prescribe it for you
• you are allergic to tapentadol, to opioids, to any of the other ingredients in APO-TAPENTADOL, or to any component of the container
• you can control your pain by the occasional use of other pain medications. This includes those available without a prescription
• you have severe asthma, trouble breathing, or other breathing problems
• you have bowel blockage, problems that affect bowel movement (e.g., ileus of any type or narrowing of the stomach or intestines
• you have severe pain in your abdomen (e.g., acute appendicitis or pancreatitis)
• you have a head injury or problem (e.g. increased pressure in the brain or disturbed consciousness)
• you are at risk for seizures or have convulsive disorders
• you have severe central nervous system (CNS) depression
• you suffer from alcoholism or have delirium tremens
• you are taking or have taken within the past 14 days a Monoamine Oxidase inhibitor (MAOi; such as phenelzine sulphate, tranylcypromine sulphate, moclobemide or selegiline)
• you have severe kidney disease or liver problems

• you are pregnant or are in labour

• you are breastfeeding

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

• have a history of using illicit or prescription drug or alcohol abuse
• are drinking or planning to drink alcoholic beverages or take medications that contain alcohol
• have low blood volume or low blood pressure
• have heart problems
• have past or current depression
• suffer from chronic or severe constipation
• have or had breathing problems (e.g., slow, fast, or shallow breathing)
• have or had brain problems (e.g., tumour, stroke, transient ischemic attack, brain neoplasm, or severe traumatic brain injury)
• have had an epileptic fit or seizures, or at a higher risk of developing these
• suffer from migraines
• have or had lung problems
• have or had pancreas problems (e.g., pancreatitis)
• have or had liver problems
• have urinary problems or problems with your adrenal or prostate gland
• have had serious allergic reactions to other medications (e.g., anaphylaxis)
• have, or had in the past, hallucinations or other severe mental problems
• have had an operation within the last 24 hours, are planning to undergo an operation within the next 24 hours or are planning to undergo an anesthetic procedure
• have sleep-related breathing disorders (e.g. central sleep apnea)
• have an underactive thyroid (hypothyroidism) or severe hypothyroidism (myxedema)
• are planning to become pregnant or to breastfeed

Other warnings you should know about:

Opioid dependence and addiction: There are important differences between physical dependence and addiction. It is important that you talk to your doctor if you have questions or concerns about abuse, addiction or physical dependence.

Driving and using machines: Before you do tasks which may require special attention, you should wait until you know how you react to APO-TAPENTADOL. APO-TAPENTADOL can cause:

• drowsiness
• dizziness or
• lightheadedness

This can usually occur after you take your first dose and when your dose is increased.

Disorder of the adrenal gland: You may develop a disorder of the adrenal gland called adrenal insufficiency. This means that your adrenal gland is not making enough of certain hormones. You may experience symptoms such as:

• nausea, vomiting
• feeling tired, weak or dizzy
• decreased appetite

You may be more likely to have problems with your adrenal gland if you have been taking opioids for longer than one month. Your doctor may do tests, give you another medication, and slowly take you off APO-TAPENTADOL.

Serotonin toxicity (also known as Serotonin Syndrome): APO-TAPENTADOL can cause serotonin syndrome, a rare but potentially life-threatening condition. It can cause serious changes in how your brain, muscles and digestive system work. You may develop serotonin syndrome if you take APO-TAPENTADOL with certain anti-depressants or migraine medications.

Serotonin toxicity symptoms include:

• fever, sweating, shivering, diarrhea, nausea, vomiting;
• muscle shakes, jerks, twitches or stiffness, overactive reflexes, loss of coordination;
• fast heartbeat, changes in blood pressure;
• confusion, agitation, restlessness, hallucinations, mood changes, unconsciousness, and coma.

Opioid withdrawal symptoms: If you are converting from a previous opioid analgesic to APO-TAPENTADOL, or converting from APO-TAPENTADOL to another opioid, you may experience opioid withdrawal symptoms. The symptoms may include: nausea, vomiting, diarrhea, anxiety and shivering. Contact your healthcare professional if you experience these symptoms when switching to or from APO-TAPENTADOL.

Seizures: APO-TAPENTADOL can cause seizures, especially if you are at a higher risk for seizures or have epilepsy. Tell your healthcare professional if you have a seizure. They will stop your treatment accordingly.

Sexual function and reproduction: Long term use of opioids may lead to a decrease in sex hormone levels. It may also lead to low libido (desire to have sex), erectile dysfunction or being infertile.

Sleep Apnea: Opioids can cause sleep-related breathing disorders such as sleep apnea syndromes (including central sleep apnea [CSA]) and hypoxia (including sleep-related hypoxia).

Worsened Pain: Taking opioids for pain can sometimes have the unintended effect of making your pain feel worse (opioid-induced hyperalgesia) even though your opioid dose has been unchanged or increased. This can also include feeling pain in new places in your body, or feeling pain from something that would not normally hurt, for example, feeling pain from clothing touching your skin. Tell your doctor if you notice a change like this in your pain while you are taking APO-TAPENTADOL.

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 APO-TAPENTADOL:

• alcohol. This includes prescription and non-prescription medications that contain alcohol. Do not drink alcohol while you are taking APO-TAPENTADOL. It can lead to:

  • drowsiness
  • unusually slow or weak breathing
  • serious side effects or
  • a fatal overdose
• other sedative medications which may enhance the drowsiness caused by APO-TAPENTADOL
• other opioid analgesics (used to treat pain)
• cough medicines containing opioids such as codeine
• general anesthetics (used during surgery)
• benzodiazepines (used to help you sleep or that help reduce anxiety)
• antidepressants (used for depression and mood disorders). Do not take APO-TAPENTADOL with MAO inhibitors (MAOi) or if you have taken MAOi’s in the last 14 days (e.g., linezolid and methylene blue)
• medications used to treat serious mental or emotional disorders such as schizophrenia (e.g., tranquillizers, hypnotics, antipsychotics, beta-blockers, neuroleptics, phenothiazines, and serotonergic agents). Talk to your healthcare professional, if you are unsure.
• antihistamines (used to treat allergies)
• anti-emetics (used to prevent vomiting)
• medications used to treat muscle spasms and back pain (e.g., muscle relaxants)
• medications used to treat migraines (e.g., triptans)
• St. John’s Wort
• medications used to treat high blood pressure (e.g., central-acting agents)
• medications known as anticholinergic drugs (e.g., oxybutynin, ipratropium bromide, tiotropium, and carbamazepine)

How to take APO-TAPENTADOL:

APO-TAPENTADOL is usually taken every 4 to 6 hours.

Your doctor may prescribe a different, more appropriate dose or interval of dosing, if this is necessary for you. If you feel that the effect of these tablets is too strong or too weak, talk to your doctor or pharmacist.

APO-TAPENTADOL is for oral use. You may take the tablets with or without food.

Always swallow APO-TAPENTADOL tablets whole with sufficient liquid.

Swallow whole. Do not cut, break, crush, chew or dissolve the tablet. This can be dangerous and can lead to death or seriously harm you.

Usual Dose:

Your dose is tailored/personalized just for you. Be sure to follow your doctor’s dosing instructions exactly. Do not increase, decrease your dose, or stop without consulting your doctor.

Your doctor will prescribe the lowest dose that works to control your pain. It is recommended that you only take APO-TAPENTADOL for up to 7 days. If you need to take APO-TAPENTADOL for longer, your doctor will determine the best dose for you to lower the risk of side effects and overdose. Higher doses can lead to more side effects and a greater chance of overdose or death.

Review your pain regularly with your doctor to determine if you still need APO-TAPENTADOL. Be sure to use APO-TAPENTADOL only for the condition for which it was prescribed.

If your pain increases or you develop any side effect as a result of taking APO-TAPENTADOL, tell your doctor immediately.

Stopping your Medication:

If you have been taking APO-TAPENTADOL for more than a few days you should not stop taking it all of a sudden. Your doctor will monitor and guide you on how to slowly stop taking APO-TAPENTADOL.

You should do it slowly to avoid uncomfortable symptoms such as having:

• body aches
• diarrhea
• goosebump
• a loss of appetite
• nausea
• a feeling nervousness or restlessness
• a runny nose or sneezing
• tremors or shivering
• stomach cramps
• rapid heart rate (tachycardia)
• trouble sleeping
• an unusual increase in sweating
• heart palpitations
• an unexplained fever
• weakness
• yawning

By reducing or stopping your opioid treatment, your body will become more sensitive to opioids. If you start treatment again, you will need to start at the lowest dose. You may overdose if you restart at the last dose you took before you slowly stopped taking APO-TAPENTADOL.

Refilling your Prescription for APO-TAPENTADOL:

A new written prescription is required from your doctor each time you need more APO-TAPENTADOL. Therefore, it is important that you contact your doctor before your current supply runs out.

Only obtain prescriptions for this medicine from the doctor in charge of your treatment. Do not seek prescriptions from other doctors unless you switch to another doctor for your pain management.

Overdose:

Signs of overdose may include:

• unusually slow or weak breathing
• dizziness
• confusion
• extreme drowsiness

After taking very high doses, the following may be experienced:

• pin-point pupils
• vomiting
• drop in blood pressure
• fast heart beat
• collapse
• disturbed consciousness or coma (deep unconsciousness)
• epileptic fits
• slow, shallow, or stopped breathing

Missed Dose:

If you miss one dose, take it as soon as possible. However, if it is almost time for your next dose, then skip the missed dose. Do not take two doses at once. If you miss several doses in a row, talk to your doctor before restarting your medication.

What are possible side effects from using APO-TAPENTADOL?

These are not all the possible side effects you may have when taking APO-TAPENTADOL. If you experience any side effects not listed here, tell your healthcare professional.

Like all medicines, APO-TAPENTADOL may cause unwanted effects, although not everybody gets them. Some of these effects are on the nervous system and some are outside of the nervous system. APO-TAPENTADOL can cause serious side effects including life-threatening breathing problems

Side effects may include:

• drowsiness
• insomnia (difficult to fall asleep and/or stay asleep)
• dizziness
• nausea, vomiting, or a poor appetite
• dry mouth
• headache
• problems with vision
• weakness
• fatigue
• uncoordinated muscle movement
• itching
• constipation
• low sex drive (libido)
• impotence (erectile dysfunction)
• infertility

Talk with your doctor or pharmacist about ways to prevent constipation when you start using APO-TAPENTADOL.

Serious side effects and what to do about them

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

Storage:

• Store APO-TAPENTADOL at room temperature 15°C to 30°C. Protect from moisture.
• Keep unused or expired APO-TAPENTADOL in a secure place to prevent theft, misuse or accidental exposure.
• Keep APO-TAPENTADOL under lock, out of sight and reach of children and pets
• Never take medicine in front of small children as they will want to copy you. Accidental ingestion by a child is dangerous and may result in death. If a child accidentally takes APO-TAPENTADOL, get emergency help right away.

Do not use APO-TAPENTADOL after the expiry date.

Disposal:

APO-TAPENTADOL should never be thrown into household trash, where children and pets may find it. It should be returned to a pharmacy for proper disposal.

If you want more information about APO-TAPENTADOL:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); Find the Patient Medication Information on the manufacturer’s website http://www.apotex.ca/products, or by calling 1-800-667-4708.

Last Revised: February 16, 2022