Patient Medication Information: uses, side effects, how to take - Mylan-Tramadol/Acet
ABOUT THIS MEDICATION
What the medication is used for:
MYLAN-TRAMADOL/ACET is an analgesic. An analgesic is a medication that is used to relieve pain. MYLAN-TRAMADOL/ACET tablets are prescribed by doctors for the management of moderate pain, or moderately severe pain. Your doctor is the person who knows if MYLAN-TRAMADOL/ACET tablets are a good choice for you.
MYLAN-TRAMADOL/ACET is not to be used for minor pain that can be relieved by readily available (over-the-counter) painkillers.
What it does:
MYLAN-TRAMADOL/ACET tablets have a combination of two pain relievers - tramadol hydrochloride (an opioid analgesic) and acetaminophen. You may already be familiar with acetaminophen (one brand sold as Tylenol® (acetaminophen)), which acts quickly to relieve pain. Tramadol hydrochloride is a pain reliever that works over several hours to maintain pain relief. Because these two ingredients work together, MYLAN-TRAMADOL/ACET tablets relieve your pain quickly and help that pain relief last longer.
When it should not be used:
Do not use MYLAN-TRAMADOL/ACET if:
- you are allergic to tramadol, acetaminophen, opioids or to any of the non-medicinal ingredients in the product (see What the nonmedicinal ingredients are).
- you have bowel blockage or narrowing of the stomach or intestines or have been told that you are at risk for this.
- you have serious liver or kidney disease.
- you are taking, or have taken within the past 2 weeks, a monoamine oxidase (MAO) inhibitor medication (e.g., phenelzine sulphate, tranylcypromine sulfphate, moclobemide or selegiline).
- you have severe asthma or severe breathing problems.
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.
- you suffer from alcoholism, severe alcohol withdrawal or have a seizure disorder.
- you suffer from severe reduction in functions controlled by the brain such as breathing, heart rate and consciousness, or if you have a head injury or increased pressure in your head or spinal cord.
you are pregnant, plan to become pregnant, are in labour or are breastfeeding.
- you are under 18 years of age.
What the medicinal ingredients are:
MYLAN-TRAMADOL/ACET tablets combine two centrally acting analgesics, tramadol and acetaminophen.
What the nonmedicinal ingredients are:
Nonmedicinal ingredients for MYLAN-TRAMADOL/ACET tablets are: Colloidal anhydrous silica, crospovidone, glycerol triacetate, hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate polyethylene glycol, povidone, pregelatinized starch, stearic acid and titanium dioxide.
What dosage forms it comes in:
Each MYLAN-TRAMADOL/ACET tablet contains 37.5 mg tramadol hydrochloride, and 325 mg acetaminophen.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
Liver injury
Liver injury can occur when more than the maximum daily dose of acetaminophen is taken. Follow your doctor’s instructions to know how much acetaminophen you can take in a day. Acetaminophen can be in oral solutions/drops, syrup, pills, capsules, suppositories, intravenous solutions etc. To calculate how much acetaminophen you have had in a day, read the labels on all products to see if they contain acetaminophen. Keep track of how much acetaminophen is in each dose and how much you have taken in a 24 hour period. Seek medical attention as soon as an acetaminophen overdose is suspected. Do not wait for symptoms to appear (see Overdose).
BEFORE you use MYLAN-TRAMADOL/ACET, be sure to tell your doctor or pharmacist if you:
- have liver or kidney problem.
- have difficulties in breathing, for example asthma.
- have diabetes.
- are over 65 years of age.
- have abdominal problems.
- drink alcohol regularly, or have a history of alcoholism.
- are pregnant or plan to become pregnant,
- are breast-feeding
- are at risk of low sodium levels in your blood.
- if you are taking any other medications including natural health products, prescription drugs, salicylates, other pain and fever relief medications or nonsteroidal anti-inflammatory drugs (NSAIDS).
- have had seizures (convulsions) or have a condition that may put you at increased risk of seizures (epilepsy, head injury, metabolic disorders, alcohol or drug withdrawal).
- have had problems with addiction, drug dependence, or drug abuse.
- have been told that you metabolize tramadol or other pain medications rapidly.
MYLAN-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.
If you are planning surgery, or about to undergo surgery, tell your doctor that you are taking MYLAN-TRAMADOL/ACET.
You should take the following precautions while taking
MYLAN-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.
Driving or operating machinery
Do not drive a car or operate other potentially hazardous machinery until you are sure that taking MYLAN-TRAMADOL/ACET does not make you drowsy.
INTERACTIONS WITH THIS MEDICATION
Tell your doctor and pharmacist about all the medicines you take, including any drugs,vitamins, minerals, natural supplements or alternative medicines.
Do not take MYLAN-TRAMADOL/ACET if you are currently taking (or recently stopped taking) a monoamine oxidase inhibitor medication (e.g., phenelzine sulphate, tranylcypromine sulfate, moclobemide or selegiline).
Do not take any other medications that contain acetaminophen (including over-the-counter preparations containing acetaminophen), while you are taking MYLAN-TRAMADOL/ACET
Do not consume alcohol while taking MYLAN-TRAMADOL/ACET. Severe or possibly fatal liver damage may occur.
Drugs that may interact with MYLAN-TRAMADOL/ACET include:
Medicines that may increase the risk of seisures such as selective serotonin reuptake inhibitors (SSRIs), serotonin- norepinephrine reuptake inhibitors (SNRIs) (e.g., venlafaxine and duloxetine), tricyclic antidepressants (TCAs) (e.g., imipramine and amitriptyline), other tricyclic compounds (e.g., cyclobenzaprine, promethazine), anti-psychotics and other seizure threshold lowering drugs.
Medicines that affect serotonin (a chemical in your body), including certain antidepressants such as selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) (e.g., venlafaxine and duloxetine), certain tricyclic antidepressants (e.g., imipramine and amitriptyline), triptans (for migraine headaches), or other medicines such as lithium, St. John’s Wort and drugs containing tryptophan. When taken with MYLAN-TRAMADOL/ACET these medicines may lead to high levels of serotonin in your blood and increase the risk of Serotonin Syndrome.
Medicines that may increase the risk of hyponatremia (low sodium in the blood) such as antidepressants, benzodiazepines, diuretics.
Medicines that may reduce the effect of tramadol such as fluoxetine, paroxetine, quinidine, amitriptyline, carbamazepine.
Other opioids, anesthetics, sedatives, hypnotics, antihistamines, sleeping aids, phenothiazines, neuroleptics, some heart medications (e.g., digoxin, warfarin), that may enhance the side effects caused by tramadol.
You must tell your doctor and pharmacist if you are taking any other medications.
PROPER USE OF THIS MEDICATION
Do not take other medications that contain acetaminophen (including over-the-counter preparations containing acetaminophen) or tramadol while you are taking MYLAN-TRAMADOL/ACET tablets.
You may take your MYLAN-TRAMADOL/ACET tablets with or without food.
Usual adult 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.
Discontinuation:
Stopping MYLAN-TRAMADOL/ACET tablets too quickly may cause some side effects, so your doctor may ask you to gradually stop taking your medication over several days. To get the full benefit from your treatment, it is important to take MYLAN-TRAMADOL/ACET tablets as prescribed.
Overdose:
| If you think you have taken too much MYLAN-TRAMADOL/ACET, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. |
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.
Other important signs of an overdose of tramadol include decreased breathing (abnormally slow or weak breathing), dizziness, confusion, or extreme drowsiness.
Missed Dose:
If you miss a dose, take it as soon as you remember. But, if it is almost time for the next dose, do not take the missed dose. Instead, take the next scheduled dose. Do not try to make up for the missed dose by taking a double dose next time.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Most medications have some side effects; however, not all people have the same side effects, and some people experience few, if any, side effects. When taking MYLAN-TRAMADOL/ACET tablets the most common side effects include nausea, vomiting, constipation, headache, dizziness and sleepiness. If you experience serious symptoms or any other unusual symptoms, tell your doctor immediately.
If you experience serious symptoms from an allergic reaction such as wheezing, skin rash, itching or hives), difficulty in breathing, lethargy, pallor (paleness), tell your doctor immediately.
Physical dependence, abuse and withdrawal reactions have been rarely reported. See withdrawal reactions listed within the ‘Discontinuation’ section of this leaflet.
MYLAN-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, HOW OFTEM THEY HAPPEN AND WHATTO DO ABOUT THEM | ||||
| Symptoms / effect | Talk with your doctor or pharmacist | Stop taking drug and seek immediate help | ||
| Only if severe | In all cases | |||
| Very rare | Respiratory Depression: abnormally slow or weak breathing | Τ | ||
| Serotonin Syndrome: a combination of most or all of the following symptoms: agitation, confusion, delirium, rapid heart rate and high blood pressure, stiffness, lack of coordination, nausea, vomiting, diarrhea, sweating, fever, shivering, seizure and coma | Τ | |||
| Hyponatremia (low sodium in the blood): lethargy, confusion, muscular twitching, seizure and coma | Τ | |||
| Decreased Blood Sugar (hypoglycemia): dizziness, lack of energy, drowsiness, headache, trembling, sweating | Τ | |||
Serious Skin Reactions (Stevens - Johnson Syndrome, Toxic Epidermal Necrolysis, Hypersensivity Syndrome): any combination of itchy skin rash, redness, blistering and peeling of the skin and/or of the lips, eyes, mouth, nasal passages or genitals, accompanied by fever, chills, headache, cough, body aches or joint | Τ | |||
pain, yellowing of the skin or eyes, dark urine. | |||
| Severe Allergic Reactions: swelling of face, eyes, lips, or tongue, trouble swallowing or breathing, skin rash | Τ | ||
Liver Injury: yellowing of the skin or eyes, dark urine. Abdominal pain, nausea, vomiting, loss of appetite. | Τ | ||
This is not a complete list of side effects. For any unexpected effects while taking MYLAN-TRAMADOL/ACET, contact your doctor or pharmacist.
HOW TO STORE IT
MYLAN-TRAMADOL/ACET tablets should be stored at controlled room temperature (15oC to 30oC).
Do not use MYLAN-TRAMADOL/ACET tablets after the expiry date. All expired medications should be returned to your pharmacist.
Keep this and all medicines in a safe place out of the sight and reach of children.
REPORTING SUSPECTED SIDE EFFECTS
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information. 3 ways to report:
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| 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. |
NOTE: Should you require information related to the management of the side effect, please contact your health care provider before notifying Canada Vigilance. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
This document can be found at: www.mylan.ca.
The full Product Monograph prepared for health professionals can be obtained by contacting the sponsor, Mylan Pharmaceuticals ULC at: 1-800-575-1379
Etobicoke, Ontario M8Z 2S6
Revised on: July 18, 2016
Mylan Pharmaceuticals ULC Etobicoke, ON M8Z 2S6 1-800-575-1379 www.mylan.ca