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Treatment of acute and chronic, moderately severe to severe pain. Above all it is used in surgery, orthopedics, midwifery, oncology, rheumatology, neurology, after dental interventions and in other fields.
Hypersensitivity to any component of the preparation, acute intoxication with alcohol, hypnotics, centrally active analgesics, opioids, psychotropic drugs or with other drugs producing CNS depression. It should not be administered to patients who are receiving monoamine oxidase inhibitors or within two weeks of their withdrawal. Relative contraindications are pregnancy and lactation.
Dosage and administration
The dosage is individual; it should be adjusted according to the severity of the pain and the clinical response of the individual patient. Adults and adolescents above 14 years (with body weight over 50 kg): Initial dose is 100 mg given every 12 hours, preferably in the morning and in the evening. If needed, dosage should be increased to 150-200 mg twice daily. The total daily dose 400 mg is usually sufficient. Higher dosage is used only in special clinical circumstances and for a short time as possible; with this dosage it is necessary to recon with higher appearance of undesirable effects. Due to need of the individual patient the dosage interval may be shortened, but it should not be less than 6 hours. In hepatic and renal impairment the dosage interval should be increased or other form of tramadol should be used.
Instruction for use
The tablets should be swallowed whole with a glass of water; regardless of food. They may be halved in the score-line (150 and 200 mg), should not be solved, chewed or crushed.
Store between 15-25 degree C, in original immediate packaging and in the carton.
What is tramadol?
Tramadol is a narcotic-like pain reliever.
Tramadol is used to treat moderate to severe pain.
The extended-release form of tramadol is for around-the-clock treatment of pain. This form of tramadol is not for use on an as-needed basis for pain.
Tramadol may also be used for purposes not listed in this medication guide.
You should not take tramadol if you have used alcohol, sedatives, tranquilizers, or narcotic medications within the past few hours.
Tramadol can slow or stop your breathing, especially when you start using this medicine or whenever your dose is changed. Never take tramadol in larger amounts, or for longer than prescribed. Do not crush, break, or open an extended-release pill. Swallow it whole to avoid exposure to a potentially fatal dose.
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Seizures (convulsions) have occurred in some people taking this medicine. Tramadol may be more likely to cause a seizure if you have a history of seizures or head injury, a metabolic disorder, or if you are taking certain medicines such as antidepressants, muscle relaxers, narcotic, or medicine for nausea and vomiting
Tramadol may be habit-forming, even at regular doses. Take this medicine exactly as prescribed by your doctor. Never share the medicine with another person. MISUSE OF NARCOTIC PAIN MEDICATION CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.
Tell your doctor if you are pregnant. Tramadol may cause life-threatening addiction and withdrawal symptoms in a newborn.
Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with tramadol.
Do not crush the tramadol tablet. This medicine is for oral (by mouth) use only. Powder from a crushed tablet should not be inhaled or diluted with liquid and injected into the body. Using this medicine by inhalation or injection can cause life-threatening side effects, overdose, or death.
Before taking this medicine
You should not take tramadol if you are allergic to it, or if you have:
severe asthma or breathing problems;
a blockage in your stomach or intestines;
if you have recently used alcohol, sedatives, tranquilizers, or narcotic medications.
Seizures have occurred in some people taking tramadol. Talk with your doctor about your seizure risk, which may be higher if you have:
a history of head injury, epilepsy or other seizure disorder;
a history of drug or alcohol addiction;
a metabolic disorder; or
if you are also using certain medicines to treat migraine headaches, muscle spasms, depression, mental illness, or nausea and vomiting.
To make sure tramadol is safe for you, tell your doctor if you have:
liver or kidney disease;
a stomach disorder; or
a history of drug abuse, alcohol addiction, mental illness, or suicide attempt.
Tramadol is more likely to cause breathing problems in older adults and people who are severely ill, malnourished, or otherwise debilitated.
Tramadol may be habit forming and should be used only by the person it was prescribed for. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Selling or giving away tramadol to any other person is against the law.
FDA pregnancy category C. It is not known whether this medicine will harm an unborn baby. Tramadol may cause breathing problems, behavior changes, or life-threatening addiction and withdrawal symptoms in your newborn if you use the medication during pregnancy. Tell your doctor if you are pregnant.
Tramadol can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are taking this medicine.
Do not give this medication to anyone younger than 16 years old without the advice of a doctor. Ultram ER should not be given to anyone younger than 18 years old.
Rybix ODT may contain phenylalanine. Talk to your doctor before using this form of tramadol if you have phenylketonuria (PKU).
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