Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Menarini International Operations Luxembourg S.A., 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg
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).
Skudexa is intended for short term use only and the treatment must be strictly limited to the symptomatic period and in any case not more than 5 days. Switching to a single agent 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 2 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 recommended for the general population only after good general tolerance has been ascertained.
Limited data are available in patients over 75 years, therefore Skudexa should be used with caution in these patients (see section 4.4).
Patients with mild to moderate hepatic dysfunction should start therapy at reduced number of doses (total daily dose 2 film-coated tablets Skudexa) and be closely monitored.
Skudexa should not be used in patients with severe hepatic dysfunction (see section 4.3).
The initial total daily dosage should be reduced to 2 film-coated tablets Skudexa in patients with mildly impaired renal function (creatinine clearance 60-89 ml/min) (see section 4.4).
Skudexa should not be used in patients with moderate to severe renal dysfunction (creatinine clearance ≤59 ml/min) (see section 4.3).
The safety and efficacy of Skudexa in children and adolescents have not been established. No data are available.
Therefore Skudexa should not be used in children and adolescents.
Oral use.
Skudexa should be swallowed with a sufficient amount of fluid (e.g. one glass of water). Concomitant administration with food delays the absorption rate of the drug (see section 5.2), for a faster effect the tablets may be taken at least 30 minutes before meals.
No cases of overdose have been reported in the clinical studies. Data reported for dexketoprofen and tramadol as single agents should be taken into account.
The symptomatology following overdose due to dexketoprofen is not known.
Medicinal products containing dexketoprofen have produced gastrointestinal (vomiting, anorexia, abdominal pain) and neurological (somnolence, vertigo, disorientation, headache) disorders.
In tramadol overdose, in principle, the same symptoms occur as for all other central acting analgesics (opioids). In particular, these include miosis, vomiting, cardiovascular collapse, consciousness disorders up to coma, convulsions and respiratory depression up to respiratory arrest.
In case of accidental or excessive intake, immediately initiate symptomatic 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. In such case 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 treatment of acute intoxication with tramadol with haemodialysis or haemofiltration alone is not suitable for detoxification.
30 months if the product is packed in PA/Aluminium/PVC //Aluminium and PVC/PVDC//Aluminium blister;
24 months if the product is packed in PVC/PE/PVDC//Aluminium blister.
This medicinal product does not require any special temperature storage conditions.
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
Skudexa: 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.
No special requirements.
Any unused product or waste material should be disposed of in accordance with local requirements.
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