Patient Medication Information: uses, side effects, how to take - Auro-Tramadol
Serious Warnings and Precautions
Seek immediate medical help for your baby.
|
What is Auro-Tramadol used for?
Auro-Tramadol is used to manage your pain.
How does Auro-Tramadol work?
Auro-Tramadol 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 Auro-Tramadol?
Medicinal ingredient: Tramadol Hydrochloride
Non-medicinal ingredients: Lactose Monohydrate, Microcrystalline Cellulose, Com Starch, Povidone USP, Sodium Starch Glycolate, Magnesium Stearate and Instacoat Universal White ICG-U-I0352.
Instacoat Universal White ICG-U-I0352 contains: Hypromellose, Titanium dioxide, Polyethylene glycol, Polysorbate 80, Carnauba wax.
Auro-Tramadol comes in the following dosage forms:
50 mg tablets
Do not use Auro-Tramadol if:
- you are allergic to tramadol or any of the other ingredients in Auro-Tramadol (see What are the ingredients in Auro-Tramadol?)
- 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
- 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
- you are taking or have taken within the past 2 weeks a monoamine oxidase inhibitor (MAOI) (such as phenelzine sulfate, tranylcypromine sulfate, 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 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 Auro-Tramadol. 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
- are at risk of low sodium levels in your blood
- have liver or kidney problems
- have diabetes
- are over 65 years of age
- have abdominal problems
- suffer from migraines
- are pregnant or plan to become pregnant
- are nursing
Other warnings you should know about:
Auro-Tramadol 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.
If you are planning surgery, or about to undergo surgery, tell your doctor that you are taking Auro-Tramadol.
Drug Addiction, Dependence and Tolerance
Like any opioid, if you use Auro-Tramadol for a long time, it may cause mental and physical dependence. Tramadol also has the potential to cause addiction. There are important differences between physical dependence and addiction. If you use opioids for a long time, you may develop tolerance. This means that you may need higher doses of Auro-Tramadol to feel the same level of pain relief. It is important that you talk to your doctor if you have questions or concerns about addiction, physical dependence, or tolerance. Your healthcare professional should prescribe and administer Auro-Tramadol with the same degree of caution appropriate to the use of other oral opioid medications. It is not recommended to use these products for a long period of time.
Pregnancy, nursing, labour and delivery: Opioids can be transferred to your baby through breast milk, or while still in the womb. Auro-Tramadol can then cause life-threatening breathing problems in your unborn baby or nursing infant. Your doctor will determine if the benefits of using Auro-Tramadol outweigh the risks to your unborn baby or nursing infant.
If you are pregnant and are taking Auro-Tramadol, it is important that you don’t stop taking your medication all of a sudden. Your doctor will monitor and guide you on how to slowly stop taking Auro-Tramadol. This may help avoid serious harm to your unborn baby.
Adolescents (12 to 18 years old): You should not use Auro-Tramadol 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 Auro-Tramadol 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 Auro-Tramadol.
Auro-Tramadol 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 Auro-Tramadol.
Serotonin Syndrome (also known as Serotonin Toxicity): Auro-Tramadol 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 Auro-Tramadol 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.
Sleep apnea: Opioids can cause a problem called sleep apnea (stopping breathing from time to time while 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.
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 Auro-Tramadol.
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.
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 Auro-Tramadol:
Alcohol. This includes prescription and non-prescription medications that contain alcohol. Do not drink alcohol while you are taking Auro-Tramadol. It can lead to:
o drowsiness
o unusually slow or weak breathing
o serious side effects or
o 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 Auro-Tramadol with MAO inhibitors (MAOIs) 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
- 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 Auro-Tramadol:
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 Auro-Tramadol tablets with other tramadol-containing products.
You may take Auro-Tramadol tablets with or without food.
Do not take more than the recommended dose of Auro-Tramadol. The lowest effective dose should be used for the shortest period of time.
Usual Adult Starting Dose:
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 Auro-Tramadol. Be sure to use Auro-Tramadol only for the condition for which it was prescribed.
If your pain increases or you develop any side effect as a result of taking Auro-Tramadol, tell your doctor immediately.
When you first begin taking Auro-Tramadol, 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.
Stopping your Medication:
If you have been taking Auro-Tramadol 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 Auro-Tramadol.
Refilling your Prescription for Auro-Tramadol:
A new written prescription is required from your doctor each time you need more Auro-Tramadol. 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:
| If you think you, or a person you are caring for, have taken too much Auro-Tramadol, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
Accidental swallowing of Auro-Tramadol 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)
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 Auro-Tramadol?
These are not all the possible side effects you may feel when taking Auro-Tramadol. 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 Auro-Tramadol.
Auro-Tramadol 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
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
| Only if severe | In all cases | |
| RARE | ||
| Overdose: hallucinations, confusion, inability to walk normally, slow or weak breathing, extreme sleepiness, sedation, or dizziness, floppy muscles/low muscle tone, cold and clammy skin | ||
| √ | ||
| Respiratory Depression: slow, shallow or weak | ||
| √ | ||
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.
Storage:
Store at room temperature (15ºC to 30ºC). Keep unused or expired Auro-Tramadol 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 Auro-Tramadol out of sight and reach of children and pets.
Disposal:
Auro-Tramadol should never be thrown into household trash, where children and pets may find it. It should be returned to a pharmacy for proper disposal.
Do not use Auro-Tramadol tablets after the expiry date. All expired medications should be returned to your pharmacist.
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
| breathing | |||
| Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing | √ | ||
Bowel Blockage (impaction): abdominal pain, severe constipation, nausea | √ | ||
| Withdrawal: nausea, vomiting, diarrhea, anxiety, shivering, cold and clammy skin, body aches, loss of appetite, sweating | √ | ||
| Fast, Slow or Irregular Heartbeat: heart palpitations. | √ | ||
| Low Blood Pressure: dizziness, fainting, light-headedness | √ | ||
Serotonin toxicity: a reaction which may cause feelings of agitation or restlessness, flushing, muscle twitching, involuntary eye movements, heavy sweating, high body temperature (>38°C ), or rigid muscles | √ | ||
| Hallucinations: seeing or hearing things that are not there | √ | ||
| VERY RARE | |||
| Hyponatremia (low sodium in the blood): lethargy, confusion, muscular twitching, seizure and coma | √ | ||
| Decreased Blood Sugar (hypoglycemia): dizziness, lack of energy, drowsiness, headache, trembling, sweating | √ | ||
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. |
If you want more information about Auro-Tramadol:
- 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); the manufacturer’s website http:// www.auropharma.ca, or by calling 1-855-648-6681.
Auro Pharma Inc.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada.