Taro-Tramadol/Acet: Uses, Side Effects and Dosage

Serious Warnings and Precautions

What is TARO-TRAMADOL/ACET used for?

TARO-TRAMADOL/ACET (acetaminophen and tramadol hydrochloride tablets) is used to manage your pain.

How does TARO-TRAMADOL/ACET work?

TARO-TRAMADOL/ACET 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.

TARO-TRAMADOL/ACET tablets have a combination of two pain relievers – tramadol (an opioid analgesic) and acetaminophen. You may already be familiar with acetaminophen (one brand sold as TYLENOL^®), which acts quickly to relieve pain. Tramadol is a pain reliever that works over several hours to maintain pain relief. Because these two ingredients work together, TARO-TRAMADOL/ACET tablets relieve your pain quickly and help that pain relief last longer.

What are the ingredients in TARO-TRAMADOL/ACET?

Medicinal ingredients: tramadol and acetaminophen.

Nonmedicinal ingredients: hydroxyl propyl methyl cellulose, iron oxide yellow, magnesium stearate, maize starch, polyethylene glycol, polysorbate 80, powdered cellulose, pregelatinized starch, sodium starch glycolate and titanium dioxide.

TARO-TRAMADOL/ACET comes in the following dosage forms:

Each TARO-TRAMADOL/ACET tablet contains 37.5 mg tramadol hydrochloride, and 325 mg acetaminophen.

Do not use TARO-TRAMADOL/ACET if:

• you are allergic to tramadol, acetaminophen, opioids or to any of the other ingredients in TARO-TRAMADOL/ACET (see What are the ingredients in TARO-TRAMADOL/ACET?)
• 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 or narrowing of the stomach or intestines or have been told that you are at risk for this
• you have severe pain in your abdomen
• you have a head injury
• you suffer from severe reduction in functions controlled by the brain such as breathing, heart rate and consciousness, or if you have increased pressure in your head or spinal cord
• you are at risk for seizures
• you have severe kidney disease
• you have severe liver disease
• you suffer from alcoholism, severe alcohol withdrawal or have a seizure disorder
• you are taking, or have taken within the past 2 weeks, a monoamine oxidase inhibitor (MAOI) (e.g., phenelzine sulfate, tranylcypromine sulfate, moclobemide or selegiline)
• you are pregnant, plan to become pregnant, in labour or nursing
• 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 slow or shallow breathing, elevated carbon dioxide levels in the blood or a condition called “cor pulmonale” in which part of the heart is enlarged or does not work correctly due to high blood pressure in the lungs

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TARO-TRAMADOL/ACET. 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 or had 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, or had in the past hallucinations or other severe mental problems
• have liver or kidney problems
• have diabetes
• are over 65 years of age
• have abdominal problems
• suffer from migraines
• are at risk of low sodium levels in your blood

Other warnings you should know about:

TARO-TRAMADOL/ACET 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 doctor.

Sleep apnea: TARO-TRAMADOL/ACET can cause low levels of oxygen in the blood and a problem called sleep apnea (stopping breathing from time to time whilst sleeping). Tell your doctor if you have a history of sleep apnea or if anyone notices you stop breathing from time to time while sleeping.

If you are planning surgery, or about to undergo surgery, tell your doctor that you are taking TARO-TRAMADOL/ACET.

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.

Pregnancy, nursing, labour and delivery:

Do not use TARO-TRAMADOL/ACET 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/ACET can then cause life-threatening breathing problems in your unborn baby or nursing infant.

Adolescents (12 to 18 years old): You should not use TARO-TRAMADOL/ACET 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/ACET 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/ACET. TARO-TRAMADOL/ACET can cause:

• drowsiness
• dizziness or
• light-headedness

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 TARO-TRAMADOL/ACET.

Serotonin Syndrome (also known as Serotonin Toxicity): TARO-TRAMADOL/ACET 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 TARO-TRAMADOL/ACET with certain anti-depressants or migraine medications.

Serotonin Syndrome 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.

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 doctor if you notice a change like this in your pain while you are taking TARO-TRAMADOL/ACET.

You should take the following precautions while taking TARO-TRAMADOL/ACET tablets:

In some individuals tramadol acts more rapidly than in others. This may cause an overdose even at the recommended dose. Seek immediate medical attention if you experience slow breathing or overdose symptoms such as extreme sleepiness, confusion, or shallow breathing.

Serious skin reactions (Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, Hypersensivity Syndrome) Acetaminophen can cause serious skin reactions that can spread to your mouth, lips, face, hands, trunk, arms and legs. This condition is life-threatening.

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 TARO-TRAMADOL/ACET:

• Alcohol. This includes prescription and non-prescription medications that contain alcohol. Do not drink alcohol while you are taking TARO-TRAMADOL/ACET. It can lead to:

  • drowsiness
  • unusually slow or weak breathing
  • serious side effects or
  • a fatal overdose
• other opioid analgesics used to treat pain
• general anesthetics used during surgery
• benzodiazepines used to help you sleep or reduce anxiety
• antidepressants (for depression and mood disorders) such as selective serotonin reuptake inhibitors (SSRIs) (e.g. paroxetine), serotonin norepinephrine reuptake inhibitors (SNRIs) (e.g., venlafaxine and duloxetine), certain tricyclic antidepressants (e.g., imipramine and amitriptyline) or other tricyclic compounds (e.g., cyclobenzaprine, promethazine) or bupropion, fluoxetine, lithium, mirtazapine, St. John’s Wort and trazodone.
• Do not take TARO-TRAMADOL/ACET with MAO inhibitors (MAOI) or if you have taken MAOIs in the last 14 days (e.g., phenelzine sulfate, tranylcypromine sulfate, moclobemide or selegiline)
• drugs used to treat serious mental or emotional disorders (such as schizophrenia)
• antihistamines used to treat allergies
• anti-emetics used for the prevention of vomiting
• drugs used to treat muscle spasms and back pain
• warfarin (such as COUMADIN) and other anticoagulants (used for prevention or treatment of blood clots)
• anti-retrovirals (used to treat viral infections e.g. ritonavir)
• anti-fungals used to treat fungal infections e.g. ketoconazole
• antibiotics used to treat bacterial infections e.g. erythromycin, rifampin, linezolid, floxacillin
• some heart medication (such as beta-blockers)
• triptans used to treat migraines
• drugs containing tryptophan
• carbamazepine used to treat epilepsy and some types of pain
• phenytoin used to treat seizures
• quinidine used to treat heart conditions (antiarrhythmics)
• digoxin used to treat heart failure
• grapefruit juice

Medicines that may increase the risk of hyponatremia (low sodium in the blood) such as antidepressants, benzodiazepines, diuretics.

How to take TARO-TRAMADOL/ACET:

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.

Do not take other medications that contain acetaminophen (including over-the-counter preparations containing acetaminophen) or tramadol while you are taking TARO-TRAMADOL/ACET tablets.

You may take your TARO-TRAMADOL/ACET tablets with or without food.

Do not take more than the recommended dose of TARO-TRAMADOL/ACET. The lowest effective dose should be used for the shortest period of time.

Usual Adult Starting Dose:

Take the tablets only as directed by your doctor. It is very important that you do not take more tablets than your doctor advised. Usually, 1 or 2 tablets are

taken every 4 to 6 hours when needed for relief of pain.

When you first begin taking your tablets, your doctor may ask you to start slowly and gradually increase the number of tablets you take.

However, you should not take more than 8 tablets per day. Exceeding these recommendations can result in respiratory depression (shallow, slow breathing), seizures, liver damage, coma, heart stoppage and death. Taking a significant overdose can result in hepatic toxicity.

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

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

If your pain increases or you develop any side effect as a result of taking TARO-TRAMADOL/ACET, tell your doctor immediately.

Stopping your Medication

If you have been taking TARO-TRAMADOL/ACET for more than a few days you should not stop taking it all of a sudden. You should check with your doctor 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
• runny nose
• sneezing
• tremors or shivering
• stomach cramps
• rapid heart rate (tachycardia)
• having trouble sleeping
• an unusual increase in sweating
• an unexplained fever
• weakness
• yawning

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/ACET:

Refilling your Prescription for TARO-TRAMADOL/ACET:

A new written prescription is required from your doctor each time you need more TARO-TRAMADOL/ACET. 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:

Accidental swallowing of TARO-TRAMADOL/ACET tablets, especially by children, can result in breathing difficulties, with slow or shallow breathing, and/or fits (seizures). Deaths have been reported.

Signs of overdose may include:

• unusually slow or weak breathing
• dizziness
• confusion
• extreme drowsiness
• fits (seizures)
• irritation and discomfort in the stomach and gut
• loss of appetite
• nausea
• vomiting
• feeling unwell
• unusually pale colour and sweating
• toxic leukoencephalopathy (a brain disorder affecting the brain’s white matter)

Signs and symptoms of liver damage may develop 1 to 2 days after taking an overdose of acetaminophen, such as increased sweating, nausea, vomiting, stomach pain or loss of appetite, yellowing of the skin/eyes, dark urine.

Cases of abnormal electrical conduction of the heart (QT prolongation) have been reported.

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 succession, talk to your doctor before restarting your medication.

What are possible side effects from using TARO-TRAMADOL/ACET?

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

Side effects may include:

• Drowsiness
• Insomnia
• Dizziness
• Fainting
• Nausea, vomiting, or a poor appetite
• Dry mouth
• Headache
• Problems with vision
• Weakness, uncoordinated muscle movement
• Itching
• Sweating
• Constipation
• Low sex drive, impotence (erectile dysfunction), infertility

Talk with your doctor or pharmacist about ways to prevent constipation when you start using TARO-TRAMADOL/ACET.

TARO-TRAMADOL/ACET can cause abnormal blood test results including decreased blood sugar. Your doctor will decide when to perform blood tests and will interpret the results.

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:

TARO-TRAMADOL/ACET tablets should be stored at room temperature (15^oC to 30^oC).

Do not use TARO-TRAMADOL/ACET tablets after the expiry date. All expired medications should be returned to your pharmacist.

Keep unused or expired TARO-TRAMADOL/ACET in a secure place to prevent theft, misuse or accidental exposure. It may harm people who may take this medicine by accident, or intentionally when it has not been prescribed for them.

Keep TARO-TRAMADOL/ACET out of sight and reach of children and pets.

Disposal:

TARO-TRAMADOL/ACET 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/ACET:

• Talk to your healthcare professional

Serious side effects and what to do about them

• 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);or by calling 1-866-840-1340.

Sun Pharma Canada Inc.

Brampton, ON L6T 1C1

Last revised: October 25, 2023