Patient Medication Information: uses, side effects, how to take - Tramaphen-Odan
ABOUT THIS MEDICATION
What the medication is used for:
TRAMAPHEN-ODAN (acetaminophen and tramadol hydrochloride) is an analgesic. An analgesic is a medication that is used to relieve pain. TRAMAPHEN-ODAN tablets are prescribed by doctors for the management of moderate pain, or moderately severe pain. Your doctor is the person who knows if TRAMAPHEN-ODAN tablets are a good choice for you.
What it does:
TRAMAPHEN-ODAN 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, TRAMAPHEN-ODAN tablets relieve your pain quickly and help that pain relief last longer.
When it should not be used:
You should not use TRAMAPHEN-ODAN 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). 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 TRAMAPHEN-ODAN.
TRAMAPHEN-ODAN 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 TRAMAPHEN-ODAN tablets.
Use of TRAMAPHEN-ODAN tablets in pregnant women is not recommended. It is not clear what effects the medication would have on the fetus.
TRAMAPHEN-ODAN 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, TRAMAPHEN-ODAN tablets may be habit-forming. TRAMAPHEN-ODAN 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:
TRAMAPHEN-ODAN tablets combine two centrally acting analgesics, tramadol hydrochloride and acetaminophen.
What the nonmedicinal ingredients are:
Nonmedicinal ingredients for TRAMAPHEN-ODAN are: Hydroxyl propyl methyl cellulose, titanium dioxide, polyethylene glycol, iron oxide yellow, polysorbate 80, Pregelatinized starch, Powdered cellulose, Sodium starch glycolate, Maize starch and Magnesium stearate.
What dosage forms it comes in:
Each TRAMAPHEN-ODAN tablet contains 37.5 mg tramadol hydrochloride, and 325 mg acetaminophen.
WARNINGS AND PRECAUTIONS
BEFORE you use TRAMAPHEN-ODAN, be sure to tell your doctor or pharmacist if you have:
- suffer from serious liver or kidney disease,
- have abdominal problems,
- have had a previous head injury,
- have chronic alcoholism,
- are pregnant or plan to become pregnant,
- are breast-feeding, and
- 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 TRAMAPHEN-ODAN and what extra care should be taken during its use.
If you are planning surgery, or about to undergo surgery, tell your doctor that you are taking TRAMAPHEN-ODAN.
You should take the following precautions while taking TRAMAPHEN-ODAN tablets:
Alcohol
You should not take TRAMAPHEN-ODAN 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 TRAMAPHEN-ODAN 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 TRAMAPHEN-ODAN 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 TRAMAPHEN-ODAN 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 TRAMAPHEN-ODAN tablets to be less effective, or may cause you to have some side effects or drug reactions.
Drugs that may interact with TRAMAPHEN-ODAN 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 TRAMAPHEN-ODAN 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 TRAMAPHEN-ODAN 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 TRAMAPHEN-ODAN tablets as prescribed. Overdose:
In case of drug overdose, contact a health care practitioner, 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.
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 TRAMAPHEN-ODAN 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.
This is not a complete list of side effects. For any unexpected effects while taking TRAMAPHEN-ODAN, contact your doctor or pharmacist.
HOW TO STORE IT
TRAMAPHEN-ODAN tablets should be stored at room temperature (15oC to 30oC).
Do not use TRAMAPHEN-ODAN 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 in the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect | ||
| NOTE: Should you require information related to the management of the side effect, 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 obtained by contacting Odan Laboratories Ltd. Pointe-Claire, QC, Canada H9R 2Y6. Phone# 1-800-387-9342
Date of Preparation: July 3, 2012