Patient Medication Information: uses, side effects, how to take - Act Tramadol/Acet
ABOUT THIS MEDICATION
What the medication is used for:
ACT TRAMADOL/ACET (tramadol hydrochloride/ acetaminophen) is an analgesic. An analgesic is a medication that is used to relieve pain. ACT 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 ACT TRAMADOL/ACET tablets are a good choice for you.
What it does:
ACT 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®), 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, ACT TRAMADOL/ACET tablets relieve your pain quickly and help that pain relief last longer.
When it should not be used:
You should not use ACT TRAMADOL/ACET if you are allergic to tramadol, acetaminophen, opioids or to any of the nonmedicinal ingredients in the product (see What the nonmedicinal ingredients are). Contact your doctor immediately if you experience an allergic reaction such as wheezing, skin rash, itching or hives or any severe or unusual side effects.
You should never take TYLENOL® or any other products containing acetaminophen with ACT TRAMADOL/ACET.
ACT TRAMADOL/ACET should not be used for minor pain that can be relieved by readily available (over-the-counter) painkillers.
Children under 18 years of age should not take ACT TRAMADOL/ACET tablets.
Use of ACT TRAMADOL/ACET tablets in pregnant women is not recommended. It is not clear what effects the medication would have on the fetus.
ACT TRAMADOL/ACET tablets are not recommended for obstetrical preoperative medication or for post- delivery analgesia in nursing mothers because its safety in infants and newborns has not been studied.
If you 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), are taking monoamine oxidase (MAO) inhibitors, have an infection of the central nervous system, or are taking antidepressant medication, do not take this medication before discussing your history with your doctor.
Like some pain relievers, ACT TRAMADOL/ACET tablets may be habit-forming. ACT TRAMADOL/ACET tablets may not be the best medicine for you if you have had problems with addiction, drug dependence, or drug abuse in the past. Tell your doctor and pharmacist if you have had these conditions before.
What the medicinal ingredients are:
ACT TRAMADOL/ACET tablets combine two centrally acting analgesics, tramadol and acetaminophen.
What the nonmedicinal ingredients are:
Nonmedicinal ingredients for ACT TRAMADOL/ACET are: hypromellose, magnesium stearate, maize starch, polyethylene glycol, polysorbate 80, powdered cellulose, pregelatinized starch, sodium starch glycolate, titanium dioxide, and yellow iron oxide.
What dosage forms it comes in:
Each ACT TRAMADOL/ACET tablet contains 37.5 mg tramadol hydrochloride, and 325 mg acetaminophen.
WARNINGS AND PRECAUTIONS
BEFORE you use ACT TRAMADOL/ACET, be sure to tell your doctor or pharmacist if you:
- suffer from serious liver or kidney disease,
- have diabetes,
- are over 65 years of age,
- have abdominal problems,
- have had a previous head injury,
- have chronic alcoholism,
- are pregnant or plan to become pregnant,
- are breast-feeding,
- 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).
This will help your doctor to decide whether you should use ACT TRAMADOL/ACET and what extra care should be taken during its use.
ACT 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 ACT TRAMADOL/ACET.
You should take the following precautions while taking ACT TRAMADOL/ACET tablets:
Serious skin reactions (Stevens - Johnson Syndrome, Toxic Epidermal Necrolysis, Hypersensitivity 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.
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).
Alcohol
You should not take ACT TRAMADOL/ACET tablets with any alcohol-containing beverages. Also, you should tell your doctor if you drink alcohol regularly, or have a history of alcoholism.
Driving or operating machinery
Do not drive a car or operate other potentially hazardous machinery until you are sure that taking ACT TRAMADOL/ACET does not make you drowsy.
Other medications
You should not take other medications that contain acetaminophen (including over-the-counter preparations containing acetaminophen) or tramadol while you are taking ACT TRAMADOL/ACET tablets.
There are also other drugs, such as tranquillizers, antidepressants, hypnotics, sleeping pills, certain Parkinson’s disease medications, or other analgesics, that can cause some serious reactions when taken by someone who is also taking ACT TRAMADOL/ACET tablets. You must tell your doctor and pharmacist if you are taking any other medications—they will tell you what you should do.
INTERACTIONS WITH THIS MEDICATION
There are other medications that may cause ACT TRAMADOL/ACET tablets to be less effective, or may cause you to have some side effects or drug reactions.
Drugs that may interact with ACT TRAMADOL/ACET include: fluoxetine, paroxetine, quinidine, amitriptyline, carbamazepine, MAO inhibitors and serotonin reuptake inhibitors, digoxin, warfarin-like compounds.
You must tell your doctor and pharmacist if you are taking any other medications.
PROPER USE OF THIS MEDICATION
Usual adult dose:
You may take your ACT TRAMADOL/ACET tablets with or without food. 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.
In patients with kidney problems, the time between doses may be longer. Please speak with your doctor.
Discontinuation:
Stopping the ACT 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 ACT TRAMADOL/ACET tablets as prescribed.
Overdose:
In Case of Accidental Overdose: Call a Poison Control Centre or doctor immediately, even if you do not notice any signs or symptoms such as increased sweating, nausea, vomiting, stomach pain or loss of appetite.
Signs and symptoms of liver damage may develop 1 to 2 days after taking an overdose.
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 ACT 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.
ACT 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 OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | |||||
|---|---|---|---|---|---|
Symptom/effect The following side effects are all very rare: | Talk with your doctor, nurse or pharmacist | Stop taking drug and seek immediate medical help | |||
| Only if severe | In all cases | ||||
| Decreased Blood Sugar (hypoglycemia): dizziness, lack of energy, drowsiness, headache, trembling, sweating | √ | ||||
| Serious Skin Reactions (Stevens – Johnson Syndrome, Toxic Epidermal Necrolysis, Hypersensitivity 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 pain, yellowing of the skin or eyes, dark urine. | √ | ||||
| Liver Injury: yellowing of the skin or eyes, dark urine. Abdominal pain, nausea, vomiting, loss of appetite. | √ | ||||
This is not a complete list of side effects. For any unexpected effects while taking ACT TRAMADOL/ACET, contact your doctor or pharmacist.
HOW TO STORE IT
ACT TRAMADOL/ACET tablets should be stored at room temperature (15°C to 30°C).
Do not use ACT 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 away from children.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways: -------------------------------------------------------------------------
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect. ------------------------------------------------------------------------- NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice. |
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Actavis Pharma Company, at: 1-866-234-6111.
The “Part III: Consumer Information” document is also available at: http://www.actavis.ca.
Actavis Pharma Company
6733 Mississauga Road, Suite 400
Mississauga, ON
Canada, L5N 6J5