Description
Tramadol Generic. Each tablet contains: 37.5 mg tramadol hydrochloride Paracetamol 325 mg Excipient c.b.p. 1 tablet. Each tablet contains: 18.75 mg tramadol hydrochloride Paracetamol 162.5 mg Excipient c.b.p. 1 tablet. Route of administration: Oral. Tramacet ® should be administered as follows: Adults (over 16 years): The recommended dose is Tramacet ® 1-2 tablets every 4-6 hours, according to the response to pain relief, up 8 tablets per day.
Some patients may benefit from a starting dose titration Tramacet ® 18.75 mg / 162.5 mg every 4-6 hours to improve tolerability. Tramacet ® can be administered with food. The pain long term Tramacet ® should be initiated with 1 tablet / day and titrated every three days in increments of 1 tablet, if well tolerated, up to 4 tablets (150 mg / 1,300 mg of paracetamol) by day.
Subsequently Tramacet ® can be administered every 6 to 8 hours to a maximum of 8 tablets per day, as needed. Based on experience with HCL, one component of Tramacet ®, adjusting the dose that results in lower rates of discontinuation is recommended. Pediatric patients (under 16 years): The safety and efficacy of Tramacet ® has not been established in pediatric patients. Elderly: No overall differences were found regarding the safety and pharmacokinetics in adults ³ 65 years and young adults.
Tablets must be swallowed whole, with a sufficient quantity of liquid. They must not be broken or chewed.
– Hypersensitivity to the active substance or to any of the excipients listed in section 6.1,
– acute intoxication with alcohol, hypnotic drugs, centrally-acting analgesics, opioids or psychotropic drugs,
– Tramadol hydrochloride/Paracetamol should not be administered to patients who are receiving monoamine oxidase inhibitors or within two weeks of their withdrawal (see 4.5. Interactions with other medicinal products and other forms of interaction),
– severe hepatic impairment,
– In adults and adolescents 12 years and older. The maximum dose of 8 tablets of Tramadol hydrochloride/Paracetamol should not be exceeded. In order to avoid inadvertent overdose, patients should be advised not to exceed the recommended dose and not to use any other paracetamol (including over the counter) or tramadol hydrochloride containing products concurrently without the advice of a physician.
– In patients with severe hepatic impairment Tramadol hydrochloride/Paracetamol should not be used ( See Section 4.3). The hazards of paracetamol overdose are greater in patients with non-cirrhotic alcoholic liver disease. In moderate cases prolongation of dosage interval should be carefully considered.
– In severe respiratory insufficiency, Tramadol hydrochloride/Paracetamol is not recommended.
– Tramadol is not suitable as a substitute in opioid-dependent patients. Although it is an opioid agonist, tramadol cannot suppress morphine withdrawal symptoms.
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