Taro-Tramadol ER: Uses, Side Effects and Dosage

Serious Warnings and Precautions

• Even if you take TARO-TRAMADOL ER as prescribed you are at a risk for opioid addiction, abuse, and misuse. This can lead to overdose and death. To understand your risk of opioid addiction, abuse, and misuse you should speak to your healthcare professional.
• When you take TARO-TRAMADOL ER it must be swallowed whole. Do not break, crush, chew, or dissolve the tablet. This can be dangerous and can lead to death or seriously harm you.
• Life-threatening breathing problems can happen while taking TARO-TRAMADOL ER, especially if not taken as directed. Babies are at risk of life-threatening breathing problems if their mothers take opioids while pregnant or nursing.
• Never give anyone your TARO-TRAMADOL ER. They could die from taking it. If a person has not been prescribed TARO-TRAMADOL ER, taking even one dose can cause a fatal overdose. This is especially true for children.

• If you took TARO-TRAMADOL ER while you were pregnant, whether for short or long periods of time or in small or large doses, your baby can suffer life-threatening withdrawal symptoms after birth. This can occur in the days after birth and for up to 4 weeks after delivery. If your baby has any of the following symptoms:

  • has changes in their breathing (such as weak, difficult or fast breathing),
  • is unusually difficult to comfort,
  • has tremors (shakiness),
  • has increased stools, sneezing, yawning, vomiting, or fever, Seek immediate medical help for your baby.

• Taking TARO-TRAMADOL ER with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.

What is TARO-TRAMADOL ER used for?

TARO-TRAMADOL ER is used in adults to manage moderate to moderately severe pain. It is used when continuous treatment is required for several days or more.

How does TARO-TRAMADOL ER work?

TARO-TRAMADOL ER is a painkiller belonging to the class of medicines known as opioids. It relieves pain by acting on specific nerve cells of the spinal cord and brain.

What are the ingredients in TARO-TRAMADOL ER?

Medicinal ingredient: tramadol hydrochloride

Non-medicinal ingredients: cellulose acetate, hydroxypropyl methylcellulose, magnesium stearate, mannitol, nonvolatile components of Opadry Black (ammonium hydroxide, iron oxide black, and shellac glaze), polyethylene glycol, pregelatinised starch, and purified water.

TARO-TRAMADOL ER comes in the following dosage forms:

Extended-release tablets: 100 mg, 200 mg or 300 mg of tramadol hydrochloride.

Do not use TARO-TRAMADOL ER if:

• your healthcare professional did not prescribe it for you.
• you are allergic to tramadol, other opioids, or any of the other ingredients of TARO-TRAMADOL ER .
• your pain can be controlled by the occasional use of painkillers including those available without a prescription.
• you have severe asthma, trouble breathing, or other breathing problems.
• you have any heart problems.
• you have bowel blockage or narrowing of the stomach or intestines.
• you have severe pain in your abdomen.
• you have increased pressure in your skull or have a head injury.
• you have or have a history with epilepsy.
• you have severe kidney problems.
• you have severe liver problems.
• you suffer from alcoholism or alcohol withdrawal.
• you are taking or have taken within the past 2 weeks a Monoamine Oxidase inhibitor (MAOI ) (such as phenelzine sulphate, tranylcypromine sulphate, moclobemide or selegiline).
• you are less than 18 years old and are having (or have recently had) your tonsils or adenoids removed because of frequent interruption of breathing during sleep.
• you are less than 12 years old.
• you have recently taken alcohol, hypnotics, centrally acting analgesics, opioids, or psychotropic medicines. Ask your healthcare professional if you are unsure.

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

• have a history of illicit or prescription drug or alcohol abuse.
• have low blood pressure.
• have past or current depression.
• suffer from chronic or severe constipation.
• have been told that you metabolize tramadol or other pain medications rapidly.
• have problems with your thyroid, adrenal or prostate gland.
• have diabetes.
• have liver problems.
• have kidney problems.
• have or had in the past hallucinations or other severe mental problems.
• have a central nervous system (CNS) infection.
• are dependent on opioids.

• are planning on drinking alcohol. Drinking alcohol while taking TARO-TRAMADOL ER may cause dangerous

  side effects, including death. Do not drink alcohol while taking TARO-TRAMADOL ER.

• have suicidal thoughts or actions.
• have circulatory problems (e.g. body does not get enough oxygen and nutrients to function properly due to lack of blood flow).
• have been told you are at risk of having heart problems, hyponatremia (low sodium levels in the blood), or seizures.
• are going to have a surgery or operation, or have had a surgery within the last 24 hours.
• are weak or frail.
• have difficulty urinating.

• have a sleep disorder which causes pauses in breathing or shallow breathing while sleeping

  (sleep apnea).

• are 65 years of age and older.
• are pregnant or planning to become pregnant or are in labour or delivery.
• are breastfeeding.

Other warnings you should know about:

Taking TARO-TRAMADOL ER can cause the following serious side effects:

• Allergic reactions: Serious but rarely fatal allergic reactions (e.g. swelling of lips and throat, blistering of skin and/or lips or neck, difficulty swallowing or breathing ) have been reported in patients receiving therapy with tramadol. Seek medical attention immediately.

• 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 healthcare professional may do tests, give you another medication, and slowly take you off TARO-TRAMADOL ER.

• Hypoglycemia (low blood sugar levels): TARO-TRAMADOL ER can decrease your blood sugar levels. Diabetic patients may need to monitor their blood sugar more often. If you notice changes, discuss this with your healthcare professional.
• Seizures (fits): Seizures have been experienced by patients taking TARO-TRAMADOL ER at the doses prescribed. This risk may increase with higher doses.

• Serotonin toxicity (also known as serotonin syndrome): TARO-TRAMADOL ER can cause serotonin toxicity, 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 toxicity if you take TARO-TRAMADOL ER 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.
• Sleep apnea: Opioids can cause a problem called sleep apnea (stopping breathing from time to time while sleeping). Tell your healthcare professional if you have a history of sleep apnea or if anyone notices that you stop breathing from time to time while sleeping.

See the Serious side effects and what to do about them table for more information on these and other serious side effects.

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

Pregnancy, nursing, labour and delivery: TARO-TRAMADOL ER is not recommended while pregnant, nursing, during labour or delivery. Opioids can be transferred to your baby through breast milk, or while still in the womb. TARO-TRAMADOL ER can then cause life-threatening breathing problems in your unborn baby or nursing infant. Your healthcare professional will determine if the benefits of using TARO-TRAMADOL ER outweigh the risks to your unborn baby or nursing infant.

If you become pregnant and are taking TARO-TRAMADOL ER, it is important that you don’t stop taking your medication all of a sudden. If you do, it can cause a miscarriage or a still-birth. Your healthcare professional will monitor and guide you on how to slowly stop taking TARO-TRAMADOL ER. This may help avoid serious harm to your unborn baby.

Adolescents (12 to 18 years old): You should not use TARO-TRAMADOL ER if your child:

• is overweight (obese)
• has obstructive sleep apnea (a condition where your breathing starts and stops while you sleep)
• has severe lung disease

There is a higher risk of serious breathing problems if your child takes TARO-TRAMADOL ER and has any of the above conditions.

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

• drowsiness,
• dizziness, or
• lightheadedness.

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

Sexual Function/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.

Worsening 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 healthcare professional if you notice a change like this in your pain while you are taking TARO-TRAMADOL ER.

Testing and check-ups:

• TARO-TRAMADOL ER can decrease your blood sugar levels. Your healthcare professional will decide when

  to perform blood tests and will interpret the results.

• Your healthcare professional will also regularly monitor you for signs of misuse and abuse.

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

Serious Drug Interactions

Serious drug interactions with TARO-TRAMADOL ER include:

• benzodiazepines used to help you sleep or that help reduce anxiety.

• central nervous system (CNS) depressants used to slow down the nervous system. These can include:

  • other opioids used to relieve pain (e.g., methadone);
  • hypnotics used to help with sleeping;
  • antidepressants used for depression and mood disorders (e.g., fluoxetine, citalopram, venlafaxine; tricyclic antidepressants such as amitriptyline, imipramine, maprotiline, paroxetine; serotonin norepinephrine re-uptake inhibitors [SNRIs]; and selective serotonin re-uptake inhibitors [SSRIs] such as St. John’s Wort);
  • anxiolytics, tranquilizers, and phenothiazines used to treat mental or emotional disorders;
  • muscle relaxants used to treat muscle spasms and back pain;
  • general anaesthetics used during surgery;
  • antipsychotics and neuroleptics used to treat mental health disorders (e.g., chlorpromazine, pimozide, haloperidol, droperidol, ziprasidone, and risperidone);
  • antihistamines used to treat allergies;
  • antiemetics used to prevent nausea or vomiting (e. g., domperidone, granisetron, dolasetron, and ondansetron);
  • sedatives which may enhance the drowsiness;
  • beta blockers used to lower blood pressure;
  • alcohol. This includes prescription and non-prescription medications that contain alcohol. Do not drink alcohol while you are taking TARO-TRAMADOL ER. It can lead to drowsiness, usually slow or weak breathing, serious side effects, or a fatal overdose.
• monoamine oxidase inhibitors (MAOIs) used to treat depression. Do not take TARO-TRAMADOL ER with MAOIs or if you have taken MAOIs in the last 14 days.

The following may interact with TARO-TRAMADOL ER:

• anticoagulants used to thin the blood and prevent blood clots (e.g. warfarin, and coumadin).
• antiretrovirals used to treat viral infections (e.g. ritonavir).
• antifungals used to treat fungal infections (e.g., ketoconazole, fluconazole, and voriconazole).
• antibiotics used to treat bacterial infections (e.g., rifampin, erythromycin, clarithromycin, azithromycin, tacrolimus, moxifloxacin, levofloxacin, ciprofloxacin, and pentamidine).
• heart medications (e.g., digoxin, quinidine, procainamide, disopyramide, amiodarone, sotalol, ibutilide, dronedarone, flecainide, propafenone, sunitinib, nilotinib, ceritinib, vandetanib, salmeterol and formoterol).
• antimalarials used to treat malaria (e.g., quinine and chloroquine).
• medicines used to treat cancer (e.g., vorinostat and arsenic trioxide).
• grapefruit juice.
• medicines used to decrease electrolyte levels in the body (e.g., diuretics, laxatives, enemas, amphotericin B, high doses of corticosteroids, and proton pump inhibitors).

• medicines that can lower seizure threshold (e.g., bupropion, mirtazapine, and

  tetrahydrocannabinol (THC)).

• carbamazepine, used to treat certain types of seizures.

If you are unsure about the medications you are taking, ask your healthcare professional.

How to take TARO-TRAMADOL ER:

• TARO-TRAMADOL ER must be taken orally, by mouth.
• Take TARO-TRAMADOL ER every 24 hours as prescribed, with a glass of water.
• Take TARO-TRAMADOL ER once daily at breakfast, at approximately the same time every day.
• Swallow whole. Do n ot break, crush, chew or dissolve the tablet. This can be dangerous and can lead to death or seriously harm you.

• Review your pain regularly with your healthcare professional to determine if you still need

  TARO-TRAMADOL ER. Be sure to use TARO-TRAMADOL ER only for the condition for which it was prescribed.

• If your dosage is changed by your healthcare professional, be sure to write it down at the time your healthcare professional calls or sees you, and follow the new directions exactly.

Usual dose:

Your dose is tailored/personalized just for you. Take it exactly as your healthcare professional has told you to. Your dose of TARO-TRAMADOL ER will be clearly labelled on the medication bottle. Do not increase or decrease your dose without consulting your healthcare professional. Taking higher doses can lead to more side effects and a greater chance of overdose.

The usual starting dose of TARO-TRAMADOL ER is 100 mg per day.

You should not take more than the maximum recommended dose of 300 mg of TARO-TRAMADOL ER per day. Exceeding this recommendation can result in respiratory depression (shallow, slow breathing), seizures, coma, heart stoppage and death.

Stopping your Medication:

If you have been taking TARO-TRAMADOL ER for more than a few days you should not stop taking it all of a sudden. You should check with your healthcare professional for directions on how to slowly stop taking it. You should do it slowly to avoid uncomfortable symptoms such as having:

• body aches
• diarrhea
• gooseflesh
• loss of appetite
• nausea
• feeling nervous or restless
• pain
• runny nose
• sneezing
• tremors or shivering
• stomach cramps
• rapid heart rate (tachycardia)
• rigors
• having trouble sleeping
• an unusual increase in sweating
• an unexplained fever
• upper respiratory symptoms
• weakness
• yawning
• and rarely, hallucinations

By reducing or stopping your opioid treatment, your body will become less used 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 TARO-TRAMADOL ER.

Refilling your Prescription for TARO-TRAMADOL ER:

A new written prescription is required from your healthcare professional each time you need more TARO-TRAMADOL ER. Therefore, it is important that you contact your healthcare professional before your current supply runs out.

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

Overdose:

Signs of an overdose with TARO-TRAMADOL ER may include:

• toxic leukoencephalopathy (a brain disorder affecting the brain’s white matter)
• unusually slow or weak breathing
• dizziness
• confusion
• extreme drowsiness
• fits (seizures)
• irritation and discomfort in the stomach and gut
• nausea
• vomiting
• feeling unwell
• pale color and sweating
• lack of muscle shape and tone
• cold and clammy skin
• shrinking of pupils
• slow heart rate
• low blood pressure

If you think you, or a person you are caring for, have taken too much Taro-Tramadol ER, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada's toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Missed Dose:

It is very important that you do not miss any doses. If you miss:

• One dose: Skip the missed dose and take your next dose as scheduled. Do not take two doses at once to make-up for a missed dose.
• Several doses in a row: Talk to your healthcare professional before restarting your medication.

What are possible side effects from using TARO-TRAMADOL ER?

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

Side effects may include:

• drowsiness
• insomnia
• dizziness
• fainting
• nausea, vomiting, poor appetite
• dry mouth
• headache
• problems with vision
• weakness, uncoordinated muscle movement
• itching
• sweating
• constipation. Talk with your healthcare professional about ways to prevent constipation when you start using TARO-TRAMADOL ER.
• low sex drive, impotence (erectile dysfunction), infertility

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, tell 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 (canada.ca/drug-device-reporting) 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.

Storage:

• Store TARO-TRAMADOL ER at room temperature (15°C to 30°C).
• Keep unused or expired TARO-TRAMADOL ER in a secure place to prevent theft, misuse or accidental exposure.
• Do not use TARO-TRAMADOL ER tablets after the expiry date. All expired medications should be returned to your pharmacist.
• Keep TARO-TRAMADOL ER out of sight and reach of children and pets.
• TARO-TRAMADOL ER 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 TARO-TRAMADOL ER:

• 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 Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.taro.ca, or by calling 1-800-268-1975.
• You may need to read this package insert again. Please do not throw it away until you have finished your medicine.

Last Revised: NOV 14, 2025