Tramadol hydrochloride, paracetamol.
Each film-coated tablet contains: Tramadol (as Hydrochloride) 37.5 mg, Paracetamol 325 mg.
Pharmacology: Pharmacokinetics: Tramadol is metabolized by N- and O-demethylation and glucuronidation or sulfation in the liver. The metabolite O-desmethyltramadol is pharmacologically active. Tramadol is widely distributed, crosses the placenta and appears in small amounts in breast milk. The elimination half life following oral administration is about 6 hours. Paracetamol is readily absorbed from gastrointestinal tract with peak plasma concentrations occurring about 10 to 60 minutes after oral administration. Paracetamol is distributed into most body tissues. It crosses the placenta and is present in the breast milk. Plasma protein binding is negligible at usual therapeutic concentrations out increases with increasing concentration. The elimination half life of paracetamol varies from about 1 to 3 hours.
It is indicated for the management of moderate to severe pain.
Adults and children over 16 years: the maximum single dose is 1 to 2 tablets every 4 to 6 hours as needed for pain relief up to a maximum of 8 tablets per day. It can be administered without regard to food. Or as prescribed by the physician.
Hypersensitivity to tramadol, paracetamol, any other component of this product. It is also contraindicated in cases of acute intoxification with alcohol, hypnotics, narcotics, centrally acting analgesic, opioids or psychotropic.
The product contains FD & C yellow #5 (Tartrazine) that may cause allergic reactions (including bronchial asthma) in certain susceptible individuals.
The recommended dose of tramadol + paracetamol should not be exceeded. It should not be co-administered with other tramadol or paracetamol containing products.
Store at temperatures not exceeding 30°C.
N02AJ13 - tramadol and paracetamol ; Belongs to the class of opioids in combination with other non-opioid analgesics. Used to relieve pain.