"The U.S. Food and Drug Administration today approved Inflectra (infliximab-dyyb) for multiple indications. Inflectra is administered by intravenous infusion. This is the second biosimilar approved by the FDA.
Inflectra is biosimilar to"...
(tramadol hydrochloride) Tablets, USP
This leaflet is Part III of a three-part "Product Monograph" published when ULTRAM® was approved for sale in Canada and is designed specifically for Consumers. This leaflet is a summary and will not tell you everything about ULTRAM®. Contact your doctor or pharmacist if you have any questions about the drug.
ABOUT THIS MEDICATION
What the medication is used for:
ULTRAM® (tramadol hydrochloride) is an analgesic. An analgesic is a medication that is used to relieve pain. ULTRAM® tablets are prescribed by doctors for the management of moderate pain, or moderately severe pain. Your doctor is the person who knows if ULTRAM® tablets are a good choice for you.
What it does:
Tramadol hydrochloride, an opioid analgesic, is a pain reliever that works over several hours to maintain pain relief.
When it should not be used:
You should not use ULTRAM® if you are allergic to tramadol, 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 (e.g., skin rash, hives) or any severe or unusual side effects.
ULTRAM® 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 ULTRAM® tablets.
Use of ULTRAM® tablets in pregnant women is not recommended. It is not clear what effects the medication would have on the fetus.
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), if you are taking monoamine oxidase 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, ULTRAM® tablets may be habit-forming. ULTRAM® 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 ingredient is:
What the nonmedicinal ingredients are:
carnauba wax, corn starch, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate and titanium dioxide
What dosage forms it comes in:
50 mg tablets
WARNINGS AND PRECAUTIONS
BEFORE you use ULTRAM®, be sure to tell your doctor or pharmacist if you:
- suffer from liver or kidney disease,
- have diabetes,
- are over 65 years of age,
- have abdominal problems,
- have had a previous head injury,
- are pregnant or plan to become pregnant,
- are breast-feeding,
- if you are taking any other medications.
This will help your doctor to decide whether you should use ULTRAM® and what extra care should be taken during its use.
ULTRAM® 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.
Serious and rarely fatal allergic reactions (e.g., swelling of lips and throat, blistering of skin and/or lips or neck) have been reported in patients receiving therapy with tramadol. Seek medical attention immediately.
Seizures have been reported at therapeutic doses of tramadol and this risk may be increased at doses exceeding the usual upper daily dose limit.
If you are planning surgery, or about to undergo surgery, tell your doctor that you are taking ULTRAM®.
You should take the following precautions while taking ULTRAM® tablets:
You should not take ULTRAM® 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 ULTRAM® does not make you drowsy.
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 ULTRAM® tablets to be less effective, or may cause you to have some side effects or drug reactions.
Drugs that may interact with ULTRAM® include:
- Alcohol or other sedative drugs may enhance the drowsiness caused by tramadol;
- Carbamazepine may increase the metabolism of tramadol and reduce the analgesic effect;
- Tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs) and antipsychotics used concomitantly can lower the seizure threshold;
- Digoxin, warfarin or warfarin-like drugs — rare reports of toxicity have been reported when co-administered with tramadol.
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 ULTRAM® 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.
When you first begin taking ULTRAM®, 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.
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.
The most important sign of overdose is decreased breathing (abnormally slow or weak breathing), or extreme drowsiness.
Consult your doctor for instructions on how to stop this medicine slowly to avoid uncomfortable symptoms such as anxiety, sweating, insomnia, rigors, pain, nausea, tremors, diarrhea, upper respiratory symptoms, piloerection and rarely, hallucinations.
You should not stop taking ULTRAM® all at once if you have been taking it for more than a few days.
To get the full benefit from your treatment, it is important to take ULTRAM® tablets as prescribed.
It is very important that you do not miss any doses. 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. If you miss several doses in succession, talk to your doctor before restarting your medication.
Do not seek additional prescriptions for this medicine from any other doctor unless responsibility for your pain management has been transferred to another doctor.
Should your pain increase, or any other complaint develop as a result of taking ULTRAM®, contact your doctor immediately.
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 ULTRAM® tablets the most common side effects include nausea, vomiting, constipation, headache, dizziness and sleepiness.
Your doctor may order a laxative and stool softener to help relieve your constipation while you are taking ULTRAM®. Tell your doctor about these problems if they arise.
If you experience serious symptoms related to an allergic reaction (such as a severe rash or hives), rapid heartbeat, chest pain, dizziness, leg swelling, low blood pressure, change in your mental status, difficulty in breathing, chest tightness, wheezing, fainting, or other serious or unusual symptoms, please consult a doctor or pharmacist immediately.
Physical dependence, abuse and withdrawal reactions have been rarely reported. See withdrawal reactions listed within the 'Discontinuation' section of this leaflet.
ULTRAM ® 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||Talk with your doctor or pharmacist||Stop taking drug and seek immediate medical help|
|Only if severe||In all cases|
|Very rare||Decreased Blood Sugar (hypoglycemia): dizziness, lack of energy, drowsiness, headache, trembling, sweating||-|
This is not a complete list of side effects. For any unexpected effects while taking ULTRAM®, contact your doctor or pharmacist.
HOW TO STORE IT
ULTRAM® tablets should be stored at room temperature (15oC to 30oC).
Do not use ULTRAM® 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:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Postal Locator 0701E
Ottawa, ON K1A 0K9
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.
This document plus the full product monograph, prepared for health professionals can be found at: http://www.janssen.ca or by contacting the sponsor, Janssen Inc., at: 1-800-567-3331 or 1-800-387-8781.
Last reviewed on RxList: 3/18/2015
This monograph has been modified to include the generic and brand name in many instances.
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