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Tramacet

Generic Name: tramadol and acetaminophen (Oral route)

TRAM-a-dol hye-droe-KLOR-ide, a-seet-a-MIN-oh-fen

Commonly used brand name(s):

In the U.S.

Ultracet

In Canada

Tramacet

Available Dosage Forms:

Tablet

Therapeutic Class: Analgesic Combination

Chemical Class: Tramadol

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Uses For Tramacet

Combination medicines containing narcotic analgesics such as tramadol and acetaminophen are used to relieve pain. An opioid analgesic and acetaminophen used together may provide better pain relief than either medicine used alone. In some cases, you may get relief with lower doses of each medicine.

Opioid analgesics act in the central nervous system (CNS) to relieve pain. Many of their side effects are also caused by actions in the CNS. When opioids are used for a long time, your body may get used to them so that larger amounts are needed to relieve pain. This is called tolerance to the medicine. Also, when opioids are used for a long time or in large doses, they may become habit-forming (causing mental or physical dependence). Physical dependence may lead to withdrawal symptoms when you stop taking the medicine.

Acetaminophen does not become habit-forming when taken for a long time but it may cause other unwanted effects, when taken in large doses including liver damage, if too much is taken.

This medicine is available only with your doctor's prescription.

Before Using Tramacet

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of tramadol and acetaminophen in children up to 16 years of age with use in other age groups.

Geriatric

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Rasagiline
Selegiline

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acetophenazine
Amitriptyline
Amoxapine
Bromperidol
Carbamazepine
Chlorpromazine
Chlorprothixene
Citalopram
Clomipramine
Clorgyline
Clovoxamine
Clozapine
Cyclobenzaprine
Desipramine
Desvenlafaxine
Dothiepin
Doxepin
Duloxetine
Escitalopram
Ethopropazine
Femoxetine
Fluoxetine
Flupenthixol
Fluphenazine
Fluvoxamine
Haloperidol
Imipramine
Isocarboxazid
Ketamine
Linezolid
Lofepramine
Loxapine
Melperone
Mesoridazine
Methotrimeprazine
Milnacipran
Mirtazapine
Moclobemide
Molindone
Nortriptyline
Olanzapine
Paroxetine
Penfluridol
Perphenazine
Phenelzine
Pimozide
Pipotiazine
Prochlorperazine
Promazine
Promethazine
Propiomazine
Protriptyline
Remoxipride
Risperidone
Sertraline
Sulpiride
Tapentadol
Thiethylperazine
Thioridazine
Thiothixene
Tranylcypromine
Trifluoperazine
Triflupromazine
Trimeprazine
Trimipramine
Venlafaxine
Zuclopenthixol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acenocoumarol
Carbamazepine
Digoxin
Isoniazid
Phenytoin
Quinidine
Warfarin
Zidovudine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Cabbage

Proper Use of tramadol and acetaminophen

This section provides information on the proper use of a number of products that contain tramadol and acetaminophen. It may not be specific to Tramacet. Please read with care.

Take this medicine only as directed by your medical doctor or dentist. Do not take more of it, do not take it more often, and do not take it for a longer time than your medical doctor or dentist ordered. This is especially important for young children and elderly patients, who may be more sensitive than other people to the effects of analgesics. If too much of a analgesic is taken, it may become habit-forming (causing mental or physical dependence) or lead to medical problems because of an overdose. Taking too much acetaminophen may cause liver damage.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets):
- For pain:
  - Adults and adolescents 16 years and older—Take 2 tablets every 4–6 hours as needed for up to 5 days.
  - Children under 16 years of age–use and dose must be determined by your doctor.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Tramacet

The analgesic in this medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine or narcotics; opioids; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Also, there may be a greater risk of liver damage if you drink three or more alcoholic beverages while you are taking acetaminophen. Do not drink alcoholic beverages, and check with your medical doctor or dentist before taking any of the medicines listed above, while you are using this medicine.

This medicine may cause some people to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem.

Nausea or vomiting may occur, especially after the first couple of doses. This effect may go away if you lie down for a while. However, if nausea or vomiting continues, check with your medical doctor or dentist. Lying down for a while may also help relieve some other side effects, such as dizziness or lightheadedness, that may occur.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine.

Analgesics may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if dry mouth continues for more than 2 weeks, check with your dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

If you have been taking this medicine regularly , do not suddenly stop taking it without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely, to lessen the chance of withdrawal side effects. This will depend on which of these medicines you have been taking, and the amount you have been taking every day.

Tramacet Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

Burning, itching, and redness of skin; vomiting
chest pain
cough; difficulty swallowing; dizziness; fast heartbeat; hives; itching; puffiness or swelling of the eyelids or around the eyes, face, lips or tongue; shortness of breath; skin rash; tightness in chest; unusual tiredness or weakness; wheezing
seizures

Symptoms of Overdose

Get emergency help immediately if any of the following symptoms of overdose occur:

Chest pain or discomfort
convulsions
difficulty breathing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Abdominal pain
aches, pains or weakness of muscles; numbness or tingling of hands, legs, and feet
acid or sour stomach; belching; heartburn; indigestion; stomach discomfort
anxiety
bloated full feeling; excess air or gas in stomach or intestines
confusion
constipation
dizziness
dry mouth
false or unusual sense of well-being
feeling of warmth; redness of the face, neck, arms, and occasionally the upper chest
headache
increased sweating
increase in bowel movements; loose stools; soft stools
itching skin
loss of appetite; weight loss
loss of strength or energy; muscle pain or weakness
mood or mental changes
nausea
nervousness
painful or difficult urination
rash
sleepiness or unusual drowsiness
sleeplessness; trouble sleeping; unable to sleep
unusual tiredness or weakness
vomiting

Rare

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

Abnormal thinking
bloody or black, tarry stools; vomiting of blood or material that looks like coffee grounds; sever stomach pain; constipation
blurred vision; dizziness; severe or continuing, dull headache; pounding in the ears; slow or fast heartbeat
change in vision
chills; cold sweats; confusion; dizziness; faintness, or light-headedness when getting up from lying or sitting position
continuing ringing or buzzing or other unexplained noise in ears
crying; depersonalization; dysphoria; euphoria; mental depression; paranoia; quick to react or overreact emotionally; rapidly changing moods
decreased awareness or responsiveness
decrease in amount of urine
decrease in urine volume; decrease in frequency of urination; difficulty in passing urine [dribbling]; painful urination
depression
difficulty swallowing
dizziness or lightheadedness; feeling of constant movement of self or surroundings; sensation of spinning
drug abuse and dependence
fainting; fast, pounding, or irregular heartbeat or pulse; palpitations
feeling unusually cold; shivering
high or low blood pressure; dizziness; lightheadedness
increased muscle tone
involuntary muscle contractions
loss in sexual ability, desire, drive, or performance; decreased interest in sexual intercourse; inability to have or keep an erection
loss of memory; problems with memory
loss of sense of reality
morbid dreaming
migraine headache
seeing, hearing, or feeling things that are not there
shakiness and unsteady walk; clumsiness, unsteadiness, trembling, or other problems with muscle control or coordination
shortness of breath; difficult or labored breathing; tightness in chest; wheezing
swelling of tongue
trouble in holding or releasing urine; painful urination
unusual tiredness or weakness
weight loss
yellow eyes or skin

Anxiety
diarrhea
fever, runny nose, or sneezing
gooseflesh
increased sweating
nausea or vomiting
nervousness, restlessness, or irritability
pain
seeing, hearing, or feeling things that are not there
shivering or trembling
trouble in sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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