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What you should know before using

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.

Pediatrics

There is no specific information on the relationship of age to the effects of tramadol tablets in patients less than 16 years of age, and tramadol extended-release tablets in patients less than 18 years of age.

Geriatric

Studies in older adults show that tramadol stays in the body a little longer than it does in younger adults. Your doctor will consider this when deciding on your doses.

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.

Drug Interactions

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

Other Interactions

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Abdominal or stomach conditions (severe)—Tramadol may hide signs of other medical conditions.
  • Addiction problems or
  • Suicidal—Tramadol should not be used.
  • Alcohol or drug abuse, or history of—May increase the serious side effects of tramadol.
  • Epilepsy or
  • History of seizures
  • Increased risk for seizures caused by alcohol and drug withdrawal, brain or spinal cord infections, or head trauma—Risk of seizures may be increased.
  • Head injury—Tramadol can hide signs of other medical conditions.
  • Kidney disease or
  • Liver disease—The chance of side effects may be increased. Your doctor will consider this when deciding on your doses.

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