Sandoz Tramadol: Uses, Side Effects and Dosage

Serious Warnings and Precautions

• Even if you take Sandoz Tramadol as prescribed you are at a risk for opioid addiction, abuse and misuse. This can lead to overdose and death.
• Do not crush, chew or dissolve the tablet. This can be dangerous and can lead to death or seriously harm you.
• You may get life-threatening breathing problems while taking Sandoz Tramadol. This is less likely to happen if you take it as prescribed by your doctor. Babies are at risk of life-threatening breathing problems if their mothers take opioids while pregnant or nursing.
• You should never give anyone your Sandoz Tramadol. They could die from taking it. If a person has not been prescribed Sandoz Tramadol, taking even one dose can cause a fatal overdose. This is especially true for children.

• If you took Sandoz Tramadol 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 Sandoz Tramadol 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 Sandoz Tramadol used for?

Sandoz Tramadol is used to manage your pain.

How does Sandoz Tramadol work?

Sandoz 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 Sandoz Tramadol?

Medicinal ingredient: tramadol

Non-medicinal ingredients: colloidal silicon dioxide, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch, glycolate and titanium dioxide

Sandoz Tramadol comes in the following dosage forms:

50 mg tablets

Do not use Sandoz Tramadol if:

• you are allergic to tramadol or any of the other ingredients in Sandoz Tramadol (see What are the ingredients in Sandoz 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 Sandoz 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:

Sandoz 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 Sandoz Tramadol.

Drug Addiction, Dependence and Tolerance

Like any opioid, if you use Sandoz Tramadol for a long time, it may cause mental and physical dependence. Sandoz 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 Sandoz 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 Sandoz 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. Sandoz Tramadol can then cause life-threatening breathing problems in your unborn baby or nursing infant. Your doctor will determine if the benefits of using Sandoz Tramadol outweigh the risks to your unborn baby or nursing infant.

If you are pregnant and are taking Sandoz 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 Sandoz Tramadol. This may help avoid serious harm to your unborn baby.

Adolescents (12 to 18 years old): You should not use Sandoz 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 Sandoz 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 Sandoz Tramadol. Sandoz 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 Sandoz Tramadol.

Serotonin Syndrome: Sandoz 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 Sandoz 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 Sandoz 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 Sandoz Tramadol:

• Alcohol. This includes prescription and non-prescription medications that contain alcohol. Do not drink alcohol while you are taking Sandoz Tramadol. 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 Sandoz 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 Sandoz Tramadol:

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

Do not take Sandoz Tramadol tablets with other tramadol-containing products.

You may take Sandoz Tramadol tablets with or without food.

Do not take more than the recommended dose of Sandoz 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 Sandoz Tramadol. Be sure to use Sandoz 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 Sandoz Tramadol, tell your doctor immediately.

When you first begin taking Sandoz 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 Sandoz 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 Sandoz Tramadol.

Refilling your Prescription for Sandoz Tramadol:

A new written prescription is required from your doctor each time you need more Sandoz 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:

Accidental swallowing of Sandoz 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

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,

If you think you, or a person you are caring for, have taken too much Sandoz Tramadol, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

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 Sandoz Tramadol?

These are not all the possible side effects you may feel when taking Sandoz 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
• Seeing or hearing things that are not there (hallucinations)

Talk with your doctor or pharmacist about ways to prevent constipation when you start using Sandoz Tramadol.

Sandoz 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

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:

Sandoz Tramadol tablets should be stored at room temperature (15oC to 30oC). Keep unused or expired Sandoz 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 Sandoz Tramadol out of sight and reach of children and pets.

Disposal:

Sandoz 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 Sandoz Tramadol tablets after the expiry date. All expired medications should be returned to your pharmacist.

If you want more information about Sandoz 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 (www.sandoz.ca), or by calling 1-800-361-3062.

  or by written request at:

  110, rue de Lauzon

  Boucherville, (QC), Canada

  J4B 1E6

  or by e-mail at:

  medinfo@sandoz.com

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.

Last Revised: March 4, 2022