Source: Health Products Regulatory Authority (ZA) Revision Year: 2023 Publisher: LeBasi Pharmaceuticals (Pty) Ltd, San Domenico Building, Unit 6, Ground Floor, 10 Church Street, Durbanville 7551
Symptomatic short-term treatment of moderate to severe acute pain in adult patients whose pain is considered to require a combination of tramadol and dexketoprofen.
The recommended dosage is one film-coated tablet (corresponding to 75 mg of tramadol hydrochloride and 25 mg of dexketoprofen). Additional doses can be taken as needed, with a minimum dosing interval of 8 hours. The total daily dose should not exceed three film-coated tablets per day (corresponding to 225 mg of tramadol hydrochloride and 75 mg of dexketoprofen). LENIZAK is intended for short-term use only and the treatment must be strictly limited to the symptomatic period, with a maximum duration of 5 days. Switching to a single component medicine for analgesia should be considered according to pain intensity and response of the patient.
Undesirable effects may be minimised by using the lowest number of doses for the shortest duration necessary to control symptoms (see section 4.4).
In elderly patients the starting recommended dosage is one film-coated tablet; additional doses can be taken as needed with the minimum dose interval of 8 hours and not exceeding the total daily dose of two film-coated tablets (corresponding to 150 mg of tramadol hydrochloride and 50 mg of dexketoprofen). The dosage may be increased to a maximum of 3 daily film-coated tablets as for adults <65 years of age only after good general tolerance has been ascertained. Limited data are available in patients over 75 years, therefore LENIZAK should be used with caution in these patients (see section 4.4).
Patients with mild to moderate hepatic dysfunction should not exceed a total daily dose of two filmcoated tablets LENIZAK and be closely monitored. LENIZAK should not be used in patients with severe hepatic impairment (see section 4.3).
The total daily dosage should be reduced to two film-coated tablets LENIZAK in patients with mildly impaired renal function (creatinine clearance 60–89 mL/min) (see section 4.4).
LENIZAK should not be used in patients with moderate to severe renal impairment (creatinine clearance ≤59 mL/min) (see section 4.3).
The safety and efficacy of LENIZAK in children and adolescents < 18 years of age have not been established. No data are available.
Therefore LENIZAK should not be used in children and adolescents < 18 years of age.
Oral use.
LENIZAK should be swallowed with a sufficient amount of fluid (e.g. one glass of water) at least 30 minutes before a meal as concomitant administration with food delays the absorption rate of LENIZAK (see section 5.2).
Data reported for dexketoprofen and tramadol as single medicines should be taken into account.
In dexketoprofen overdose symptoms included gastrointestinal (vomiting, anorexia, abdominal pain) and neurological (somnolence, vertigo, disorientation, headache) adverse events. Prolonged use at higher than recommended doses may result in severe hypokalaemia and renal tubular acidosis. Symptoms may include reduced level of consciousness and generalised weakness (see sections 4.4 and section 4.8).
In tramadol overdose, symptoms included miosis, vomiting, cardiovascular collapse, consciousness disorders, coma, convulsions, respiratory depression and respiratory arrest.
In case of accidental or excessive intake, immediately initiate symptomatic and supportive therapy according to the patient’s clinical condition.
If more than 5 mg/kg has been ingested by an adult or a child, activated charcoal should be administered within the first hour after ingestion. Dexketoprofen may be removed by dialysis.
Keep the respiratory tract open (and avoid aspiration), maintain respiration and circulation depending on the symptoms. The antidote for respiratory depression is naloxone. In animal experiments naloxone had no effect on convulsions. When convulsions occur, a benzodiazepine such as diazepam should be given intravenously.
In case of orally intoxication, gastrointestinal decontamination with activated charcoal is recommended within two hours after tramadol intake.
Tramadol may be removed by dialysis, but it is minimally eliminated from the serum by haemodialysis or haemofiltration. Therefore, haemodialysis or haemofiltration alone is not suitable for detoxification.
60 months.
Store at or below 30°C.
Store in the original package in order to protect from light.
Film-coated tablets are provided in blister packs, in three alternative materials:
PA/Aluminium/PVC//Aluminium blister
PVC/PE/PVDC//Aluminium blister
PVC/PVDC//Aluminium blister
Pack sizes: 2, 4, 10, 15, 20, 30, 50, 100 film-coated tablets/pack or multipacks containing 500 (5 packs of 100) film-coated tablets/pack.
Not all pack sizes may be marketed.
Any unused medicine or waste material should be disposed of in accordance with local requirements.
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