the package insert of the medicine Ultracet. Therapeutic class of Analgesic. Active principles Hydrochloride tramadol and paracetamol .
Pain of moderate-to-severe character acute, sub-acute and chronic.
When should I not use?
Hypersensitivity to tramadol, paracetamol or to any component of the formula
or opioids; acute poisonings by alcohol, hypnotics, analgesics action
central, opioids or psychotropic drugs; patients on treatment with inhibitors of
oxidase (MAO) or treated with these agents in the last 14 days.
How to use?
The maximum daily dose of Ultracet is 1 to 2 tablets every 4 to 6 hours as needed for pain relief, up to a maximum of 8 tablets a day. The administration of the tablets can be made regardless of the meals.
In the painful conditions chronic, the treatment should be started with 1 pill a day and increased by 1 tablet every 3 days, according to the tolerance of the patient, until it reaches the dose of 4 tablets a day. After that, Ultracet may be administered at a dose of 1-2 tablets every 4-6 hours, up to a maximum of 8 tablets a day.
In the painful conditions acute, the treatment can be started with the dose
therapy complete (1-2 tablets every 4-6 hours), up to a maximum of 8
pills a day.
What are the evils that can cause me?
The adverse events reported with the greatest frequency occurred in the Central Nervous System and Gastrointestinal, and reports the most common were dizziness, nausea and drowsiness.
Adverse events the following have been frequently observed, although with
frequency is usually lower.
the Organism as a whole: asthenia, fatigue, hot flashes.
Central and Peripheral Nervous system: headache, tremor.
Gastrointestinal system: abdominal pain, constipation, diarrhea, dyspepsia, gas,
dry mouth, vomiting.
Psychiatric disorders: anorexia, anxiety, confusion, euphoria, insomnia, nervousness.
Skin and appendages: pruritus, “rash”, increased sweating.
The reports of unusual adverse experiences clinically significant with at
unless a causal link can with Ultracet* include:
Body as a whole: chest pain, stiffness, syncope, withdrawal syndrome.
Cardiovascular disorders: hypertension, aggravated hypertension, hypotension.
Central and Peripheral Nervous system: ataxia, convulsions, hypertonia, migraine,
worsening of migraine, muscle contractions involuntary, paraesthesia,
Gastrointestinal system: dysphagia, melena, edema of the tongue.
Disorders Hearing and Vestibular: tinnitus.
Disorders Heart rate and Rhythm: arrhythmia, palpitation, tachycardia.
System Liver and Biliary: abnormal liver function.
Disorders Nutritional and Metabolic: loss of weight.
Psychiatric disorders: amnesia, depersonalization, depression, drug abuse, emotional lability, hallucination, impotence, nightmares, thoughts abnormal.
Disorders related to the Haematologic System: anemia, granulocytopenia.
Respiratory system: dyspnea.
The Urinary system: albuminúria, disturbance of urination, oliguria, urinary retention.
Disturbances of Vision: abnormal vision.
Warnings and Precautions
what should I know before using?
Tell your doctor about any medicine you are using, before the commencement, or during the treatment. Tell your doctor if you have epilepsy, liver or kidney problems, taking medications for depression, or consume regularly drinks alcoholic beverages.
Attention: This medicinal product contains Sugar (starch), therefore, should be used
with caution in patients with Diabetes. Do not use any other product that contains paracetamol.
Effects on ability to drive and operate machinery even when taken according to the instructions, the drug may modify the reactions that need a lot of attention, such as driving a motor vehicle or operate dangerous machinery. This applies particularly in the case of use of alcoholic beverages in conjunction with the medicine. During the treatment, the patient should not drive vehicles or operate machinery, as your skill and attention may be harmed.
Use in pregnancy and lactation: Ultracet should only be used during the
pregnancy if the potential benefit justify the potential risk to the fetus. Ultracet should not be used in pregnant women prior to or during delivery except if the benefits override the risks. The chronic use during pregnancy can lead to
physical dependence and withdrawal symptoms in the newborn. Tramadol crosses the placenta.
Ultracet is not recommended as a preoperative medication obstetric, or in the
analgesia post-partum in lactating women, since safety in infants and newborns has not been studied.
what to do if someone use a larger amount than is recommended?
once that Ultracet is a combination of two drugs, the clinical picture of an excessive dose can include signs and symptoms of toxicity of tramadol,
paracetamol or of both. The initial symptoms of tramadol include depression
respiratory and/or seizures, and acetaminophen, observed within the first 24
hours, include: anorexia, nausea, vomiting, malaise, pallor and diaforese.
Tramadol: When dealing with an excessive dose of Ultracet the main attention should be
for the maintenance of adequate ventilation and supportive treatment. At the same
time that naloxone reverses some, but not all of the symptoms of a superdose of Ultracet, the risk of seizures is also increased by the administration of
naloxone. Based on experience with tramadol, hemodialysis is not useful because it removes less than 7% of the administered dose in a 4-hour period of dialysis.
Paracetamol: In the superdose of paracetamol, the adverse event more serious is the
necrosis of the liver, a potentially fatal and dose-dependent, and may also occur, necrosis, renal tubular, hypoglycaemic coma, and thrombocytopenia. The initial symptoms of a superdose potentially hepatotóxica may include
nausea, vomiting, diaforese and general unwellness. Clinical evidence and laboratory
liver toxicity may not be apparent before 48 to 72 hours after ingestion. In adults, it was rarely reported liver toxicity with acute dose of less than 7.5 to 10 grams, or fatalities with less than 15 g. clinical experience suggests that children are less susceptible to liver injury than adults; however, the minimum dose of the toxic should be considered as 150 mg/kg.